Stockwinners Market Radar for April 03, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

21:17 EDT Teck Resources seeking shareholder approval to separate into two companies - Teck Resources "announced it has filed the management proxy circular and related materials for its annual and special meeting of shareholders to be held on April 26, 2023. At the Meeting, Teck is seeking shareholder approval for, among other things, the previously announced reorganization of Teck's business to separate Teck into two independent, publicly-listed companies: Teck Metals Corp. and Elk Valley Resources Ltd., and the previously announced proposal to introduce a six-year sunset for the multiple voting rights attached to the Class A common shares of Teck, all of which are described in the Circular. Teck also announced today that the Supreme Court of British Columbia has granted interim orders in connection with the Separation and the Dual Class Amendment. The Interim Orders authorize the calling and holding of the Meeting to approve the Separation and the Dual Class Amendment. Copies of the Interim Orders are attached to the Circular. The Board of Directors of Teck is recommending that shareholders vote for each of the Separation and the Dual Class Amendment."

20:10 EDT Nano Dimension revises proposal to buy Stratasys for $20.05 per share - Nano Dimension (NNDM) "announced that it has further increased its offer to acquire Stratasys (SSYS) for $20.05 per share in cash. Under the terms of the increased proposal, Nano Dimension would acquire the remaining shares of Stratasys it does not currently own for an aggregate of approximately $1.22 billion on a fully diluted basis. This offer represents a premium of 41% to the closing trading price as of March 3rd, 2023, a 44% premium to the Company's 30-day VWAP, a 54% premium to the 60-day VWAP and a 51% premium to the 90-day VWAP as of March 3rd, 2023. Nano Dimension's revised offer represents another increase in value of $2.05 per share, or approx. 11.4%, as compared to its March 6th, 2023, proposal and $0.50, or approx. 3%, as compared to its March 29th, 2023 proposal. The proposal, as with the prior offers, presents a significant opportunity for Stratasys shareholders to realize compelling and certain value."

20:02 EDT Cathie Wood's ARK Investment bought 115.6K shares of Joby Aviation today

19:13 EDT FTC Solar director buys $202K in common stock - In a regulatory filing, FTC Solar disclosed that its director Thurman Rodgers bought 89.6K shares of common stock on April 3rd in a total transaction size of $202.4K.

18:30 EDT Vista Outdoor announces $50M cost reduction program - In a regulatory filing, the company states: "On April 3, 2023, the Company announced an over $50 million cost reduction and earnings improvement program, which includes office closures, spending cuts, EBIT improvements and headcount reductions across our brands and corporate teams. The changes are being implemented in response to elevated retail inventory levels, rising interest rates and inflation, which have pressured our top and bottom lines and impacted our outlook for Fiscal Year 2024. The changes will help the Company compete in the current challenging economic environment and prepare for the separation of its Outdoor Products and Sporting Products segments into two independent, publicly traded companies, which is expected to occur in calendar year 2023. Within the Company's Outdoor Products segment, the Company is accelerating the merger of its Bell, Blackburn, Copilot, Fox, Giro, Krash and Raskullz businesses through leadership and facility consolidations. As part of these measures, the current Bell/Giro headquarters in Scotts Valley, California, will be closed effective September 1, 2023, with affected employees relocating to a revamped Innovation Center in the current Fox Headquarters in Irvine, California. Within the Company's Sporting Products segment, the Company is promoting Jason Vanderbrink to Chief Executive Officer of Sporting Products, effective immediately. Mr. Vanderbrink will continue to serve as President of Sporting Products for the Company. Following the Separation, Mr. Vanderbrink will continue to serve as President and Chief Executive Officer of the new Sporting Products Company. At the Corporate level, the Company has taken steps to streamline its corporate costs and operating model by reducing headcount, cutting outside spend and redeploying resources to maximize brand autonomy and corporate scale. These changes will drive efficiencies in the deployment of corporate services and enable more results from our Supply Chain, E-commerce, Licensing and M&A Centers of Excellence. The cost reductions bring Vista Outdoor's Fiscal Year 2024 strategic priorities into focus and help prepare the Company for the Separation this year."

18:06 EDT L'Oreal, Natura &Co in pact to acquire Aesop at enterprise value of $2.525B - L'Oreal (LRLCY) announced that it has signed an agreement with Natura &Co (NTCO) to acquire Aesop, the Australian luxury beauty brand. The proposed transaction values Aesop at an enterprise value of $2.525B. Nicolas Hieronimus, Chief Executive Officer, L'Oreal Groupe, said, "I am very excited to welcome Aesop and its teams to the L'Oreal Groupe family. Aesop is the epitome of avant-garde beauty, whose products are not only made with great care and exceptional attention to detail; they are a superb combination of urbanity, hedonism and undeniable luxury. Aesop taps into all of today's ascending currents and L'Oreal will contribute to unleash its massive growth potential, notably in China and Travel retail." The closing is subject to certain regulatory approvals and other customary conditions.

17:56 EDT Five Below director Kathleen Barclay sells $506K in company shares - Director of Five Below Kathleen Barclay disclosed in a regulatory filing that she had sold 2,500 shares of company stock at $202.38 per share on March 30, for a total transaction amount of $505,950.

17:28 EDT NuVasive, Globus Medical continue to expect transaction to close mid-2023 - In a regulatory 8-K filing, NuVasive states: As previously disclosed, on February 8, 2023, NuVasive (NUVA) entered into an Agreement and Plan of Merger with Globus Medical (GMED) and Zebra Merger Sub, Inc., a wholly owned subsidiary of Globus Medical. The Merger Agreement provides, among other things, that subject to the satisfaction or waiver of the conditions set forth therein, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the "HSR Act", Merger Sub will merge with and into NuVasive, with NuVasive surviving the Merger as a wholly owned s ubsidiary of Globus Medical. As part of the parties' continuing cooperation with the regulatory review, on March 31, 2023, Globus Medical, in consultation with NuVasive, voluntarily withdrew its Premerger Notification and Report Form under the HSR Act, in connection with the proposed acquisition of NuVasive by Globus Medical. Globus Medical re-filed the HSR Filing on April 3, 2023 in order to restart the initial waiting period under the HSR Act and to provide the U.S. Federal Trade Commission additional time to review the proposed transaction. A new 30-day waiting period under the HSR Act commenced on the date of such refiling. The waiting period under the HSR Act for the Merger will expire at 11:59 pm ET on May 3, 2023, unless such period is terminated earlier or extended. NuVasive and Globus Medical continue to expect that the proposed transaction will close in the middle of 2023, subject to the satisfaction or waiver of the closing conditions. In addition to the expiration or termination of the applicable waiting period under the HSR Act, completion of the transaction remains subject to the satisfaction or waiver of other customary closing conditions, including but not limited to NuVasive and Globus Medical stockholder approvals. As previously announced, NuVasive and Globus Medical have scheduled their respective special meetings of stockholders for April 27, 2023 to vote on the proposed transaction."

17:17 EDT L3Harris Technologies awarded $584M Air Force contract - L-3 Harris Technologies has been awarded a $584M ceiling, indefinite-delivery/indefinite-quantity contract for production, engineering services, and repair support for the ALQ-211 4, 8, 9 Advanced Integrated Defensive Electronic Warfare Suite, or AIDEWS. This contract provides for AIDEWS block cycle software development, engineering support, technical orders, system integrity and travel. Work is expected to be completed April 2, 2028. This contract involves Foreign Military Sales to Pakistan, India, Poland, Chile, Oman, Turkey, Iraq, and Morocco. This contract was a sole-source acquisition. The first order will obligate a total of $2.07M and will utilize Special Defense Acquisition Funds. Air Force Life Cycle Management Center is the contracting activity.

17:10 EDT Charah Solutions discloses NYSE listing notice - Charah Solutions "announced that the Company was notified by the NYSE of its determination to commence proceedings to delist and suspend trading of the Company's common stock and 8.5% Senior Notes due 2026 due to failure to meet the NYSE's $15 million, 30-trading day average market capitalization standard. The Company anticipates that, effective April 4, 2023, its common stock will commence trading on the OTC Pink marketplace under the trading symbol "CHRA" and the Notes will commence trading on the OTC Pink under the trading symbol "CHRB". The Company's transition to the OTC Pink is not expected to affect the Company's business operations."

17:03 EDT Seagen, Astellas announce FDA grants Padcev with Keytruda accelerated approval - Seagen (SGEN) and Astellas Pharma (ALPMY) announced the FDA has granted Padcev with Keytruda accelerated approval in the U.S. as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in the EV-302 confirmatory trial.

17:01 EDT FDA approves Merck's Keytruda in combination with Padcev in la/mUC - Merck "announced the FDA has approved KEYTRUDA, Merck's anti-PD-1 therapy, in combination with Padcev, enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma, or la/mUC, who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This marks the first time an anti-PD-1 therapy has been approved in combination with an antibody-drug conjugate in the U.S. in these patients. The approval is based on data from the KEYNOTE-869 trial (also known as EV-103) dose escalation cohort, Cohort A and Cohort K, which was conducted in collaboration with Seagen and Astellas. The median follow-up time for the dose escalation cohort + Cohort A was 44.7 months (range, 0.7 to 52.4 months) and for Cohort K was 14.8 months. In the combined efficacy analysis of the dose escalation cohort, Cohort A and Cohort K (n=121), KEYTRUDA in combination with enfortumab vedotin demonstrated an objective response rate of 68% (95% CI: 58.7, 76.0), with complete and partial response rates of 12% and 55%, respectively. The median duration of response (DOR) for the dose escalation cohort + Cohort A was 22.1 months and for Cohort K was not reached (range, 1.2 to 24.1+ months)".

16:58 EDT Palo Alto Networks CEO sell $3.24M in common stock - In a regulatory filing, Palo Alto Networks disclosed that its CEO Nikesh Arora sold 16.2K shares of common stock on March 31st in a total transaction size of $3.24M.

16:39 EDT SPX Corporation acquires TAMCO for $125M - SPX Technologies announced that it has acquired privately held TAMCO for approximately C$170M, or $125M, in cash. Headquartered in Smiths Falls, Ontario, Canada, TAMCO specializes in motorized and non-motorized dampers that control airflow in large-scale specialty applications in commercial, industrial, and institutional markets. TAMCO, which has operations in Canada and the US, is well-known for its eco-friendly solutions, which provide very low levels of air leakage in critical thermal applications, such as data centers and healthcare facilities. TAMCO is now a part of SPX Technologies' HVAC segment and expands the company's position in Engineered Air Movement solutions. TAMCO has annual revenue of more than $50M, and its margins and anticipated revenue growth rate are higher than the HVAC segment average.

16:35 EDT Centene says Fred Eppinger to assume role of Chairman of the Board - Centene announced that Fred Eppinger will assume the role of Chairman of the Centene Board of Directors, and Wayne DeVeydt will assume the role of Chairman of the Audit and Compliance Committee. Both changes are effective as of March 31.

16:34 EDT Endo: Par Pharmaceutical begins shipping generic version of Merck's Noxafil - Endo International(ENDP) announced that one of its operating companies, Par Pharmaceutical, has begun shipping the authorized generic version of Merck's Noxafil 200 mg/5 mL oral suspension in the U.S.

16:32 EDT Precigen amends exclusive license agreement with Alaunos Therapeutics - Precigen (PGEN) announced the amendment of its exclusive license agreement with Alaunos Therapeutics (TCRT). With this amendment, Precigen has the unique ability to utilize the clinically validated UltraCAR-T platform for unencumbered development and commercialization of two proven CAR-T targets, CD19 and B-cell maturation antigen. These targets enhance Precigen's UltraCAR-T library approach, which is designed to transform the personalized cell therapy landscape for cancer patients through the development and validation of a library of non-viral plasmids to target various hematological and solid tumor-associated antigens. Enabled by the design and manufacturing advantages of UltraCAR-T, coupled with the capabilities of the UltraPorator system, Precigen is working to empower cancer centers to deliver personalized, autologous CAR-T treatment with overnight manufacturing for cancer patients. The addition of CD19 and BCMA targets positions Precigen as a front runner in the CAR-T space. Precigen also regained exclusive rights to its interleukin-12 gene therapy, including application through the off-the-shelf AdenoVerse immunotherapy platform, paving the way for potential future treatments in oncology given the important role of IL-12 cytokines in targeting many types of tumors such as HPV-associated cancers. Precigen maintains the right to pursue non-neoantigen T-cell receptors. As part of the amendment, all milestone payments and royalties between the parties have been eliminated.

16:30 EDT Oncternal Therapeutics trading resumes

16:24 EDT USD Partners closes $33M Casper Terminal sale - A wholly-owned subsidiary of USD Partners LP announced that on March 31, 2023, it closed the previously announced sale of the Casper rail terminal to South 49 Holdings Ltd., a member of the Midstream Energy Partners group of companies, for a cash purchase price of approximately $33.0 million, subject to customary adjustments.

16:20 EDT Chembio Diagnostics CEO issues letter to shareholders - Chembio Diagnostics released the following letter to stockholders concerning the pending tender offer by Biosynex. "As previously communicated, Chembio Diagnostics entered into an Agreement and Plan of Merger dated as of January 31 with Biosynex , and Project Merci Merger Sub Pursuant to the Merger Agreement, the Purchaser commenced a tender offer to purchase all of the issued and outstanding shares of the Company's common stock, par value $0.01 per share for a purchase price of 45c per share, net to the seller in cash, without interest and subject to any required tax withholding. Biosynex previously announced, on March 15 an extension of the Offer until 6:00 p.m, New York City time, on March 28. On March 29 , Biosynex announced a second extension of the Offer until 6:00 p.m., New York City time, on April 12. There are substantial risks if the Offer and merger between Biosynex and Chembio are not completed. As discussed in further detail in the Schedule 14D-9, as amended. There are substantial risks if the Offer and merger between Biosynex and Chembio are not completed. As discussed in further detail in the Schedule 14D-9, as amended, the Company's letter to stockholders dated March 15, 2023 and the Company's Annual Report on Form 10-K that was filed with the U.S. Securities and Exchange Commission ("SEC") on March 29, 2023, these risks include: breaching a financial covenant in its Credit Agreement related to debt maturing in September 2023 that could force the Company to pursue a transaction or financing arrangement that is highly dilutive to existing stockholders or a bankruptcy or restructuring proceeding; being delisted by Nasdaq as soon as the current month; and the Company's ability to continue as a going concern due to its net losses from operations and ongoing liquidity concerns. If less than a majority of the outstanding shares of Chembio common stock are tendered, the Offer will not be completed and Chembio will not merge with Biosynex. For the Offer to be completed, more than 50% of the outstanding Shares must be validly tendered.

16:17 EDT Rithm Capital announces expansion into Europe - Rithm Capital "announced that it will be expanding its business into Europe and opening a new office in London, England. Rithm Europe will be led by recently hired Marty Migliara, the former long-standing head of EMEA origination and lending in Bank of America's global mortgages and securitized products team. Rithm Europe will seek equity and debt investments across the real estate and consumer finance sectors in the region, sourcing opportunities for both private funds and Rithm Capital's ~$32 billion balance sheet. The opening of the new office in London highlights Rithm Capital's conviction in opportunities across Europe and its plan to build on its success in the United States to expand in the European market."

16:16 EDT Greif increases ownership in Centurion Container from 9% to 80% - Greif announced it has completed an acquisition increasing its ownership in Centurion Container from 9% to 80% in an all-cash transaction for $145M, subject to customary closing adjustments, funded through Greif's existing credit facility. Since joint venture inception in 2020, Centurion's experienced management team has successfully scaled a broad reconditioning network which, now under Greif majority ownership, will greatly expand Greif's presence in North America and Centurion's offering of reusable and sustainable packaging solutions. Centurion's financial results will be reported within the Greif Global Industrial Packaging segment.

16:15 EDT Myers Industries names Grant Fitz CFO - Myers Industries announced the appointment of Grant E. Fitz to the position of Executive Vice President and Chief Financial Officer, effective May 8, 2023. As CFO, Mr. Fitz will lead Myers' entire finance organization and financial activities including accounting and controllership, financial planning and analysis, tax, investor relations, and treasury. "Grant's proven track record as a leader who can drive profitable growth and execute transformational strategies made him a natural choice to serve as Myers' Chief Financial Officer," said Mike McGaugh, Myers Industries' President and CEO. "Grant will be a strong partner as we continue to execute our 3-Horizon strategy and I am delighted to welcome him to Myers Industries."

16:12 EDT Oncternal Therapeutics to resume trading at 4:30pm ET - Trading in Oncternal Therapeutics shares will resume at 4:30pm ET, with quotation to restart 4:25pm ET, according to Nasdaq. Shares had been halted ahead of the announcement that the company is halting development of zilovertamab, ibrutinib combination.

16:11 EDT Histogen announces exclusive IP license pact with Johns Hopkins University - Histogen announced that the company has signed an exclusive license agreement with Johns Hopkins University. The intellectual property associated with this license covers the use of emricasan for the treatment of disease in humans resulting from viral or bacterial infections . The license agreement with Johns Hopkins is an instrumental addition to Histogen's intellectual property portfolio. Rights to these patent applications, together with recently issued internal patents, are expected to provide freedom to operate and exclusivity worldwide to the Histogen's entire caspase inhibitor portfolio."We believe that emricasan has the potential to treat infections in a different way; by protecting the competence of the human body's immune system thereby restoring the body's natural process to combat invading organisms," stated Steven J. Mento, President and CEO of Histogen. "The World Health Organization names antibiotic resistance as one of the biggest threats facing humanity. By focusing on optimizing the immune response, we believe that we have an opportunity to provide emricasan as a viable treatment option for physicians without the risk of generating antibiotic resistance. We look forward to the anticipated initiation of clinical development activities using emricasan for the treatment of acute bacterial skin and skin structure infections in the second half of 2023," concluded Dr. Mento.As announced previously, emricasan improved symptoms in patients infected with COVD-19 potentially employing a similar mechanism of protecting the competence of the immune system. Patients in the placebo arm who completed the study showed either delay or no symptom resolution for the duration of the study.

16:11 EDT Becton Dickinson names Michelle Quinn as general counsel - Becton Dickinson announced that Michelle Quinn has been named executive vice president and general counsel for the company, effective April 1. Quinn has responsibility for leading the Law Group at BD. She will continue to report to Tom Polen, chairman, CEO and president of BD. Quinn joined BD in 2019 and prior to her current role served as acting general counsel as well as senior vice president, deputy general counsel, and chief ethics and compliance officer. Before joining BD, she was vice president and general counsel of North America for Sandoz, a division of Novartis, and prior to that served as vice president and associate general counsel at Catalent Pharma Solutions.

16:08 EDT Cardiovascular Systems completes enrollment of ECLIPSE clinical trial - Cardiovascular Systems announced the company completed the enrollment of its 2,000 patient ECLIPSE coronary trial. ECLIPSE is a prospective, multi-center, randomized clinical trial of approximately 2,000 subjects with severely calcified coronary lesions in the United States. Half of the participants received orbital atherectomy prior to drug-eluting stent implantation, while the other half received conventional angioplasty, including specialty balloons, followed by DES implantation. The trial is powered to demonstrate differences in the primary endpoints of post-procedural in-stent minimal cross-sectional area (assessed by Optical Coherence Tomography (OCT) imaging in a subset of approximately 400 patients), as well as in the clinical outcome of target vessel failure at one year. ECLIPSE will also evaluate key health economic outcomes. Results from ECLIPSE are expected to be shared in the fall of 2024. Jeffrey W. Chambers, M.D., CSI's Chief Medical Officer, said, "ECLIPSE is important because it tests two treatment strategies for managing one of the most difficult challenges for interventional cardiologists. We believe the data from this study will be beneficial in defining an optimal treatment plan for patients with severely calcified coronary arteries."

16:07 EDT Gulfport Energy names Michael Hodges CFO - Gulfport Energy Corporation named Michael Hodges Executive Vice President and Chief Financial Officer and announced that William "Bill" Buese will be transitioning from the Chief Financial Officer role effective April 3, 2023. In addition, on March 1, 2023, Matthew Rucker joined the Gulfport leadership team as Senior Vice President, Operations. John Reinhart, Gulfport's Chief Executive Officer commented, "We are very pleased to welcome Michael to Gulfport. He brings over 20 years of experience as a seasoned financial leader with deep expertise in the oil and gas industry and we look forward to his future contributions to our organization."

16:06 EDT Vista Outdoor announces $20M cost reduction program - In a regulatory filing, the company states: "On April 3, 2023, the Company announced an over $50 million cost reduction and earnings improvement program, which includes office closures, spending cuts, EBIT improvements and headcount reductions across our brands and corporate teams. The changes are being implemented in response to elevated retail inventory levels, rising interest rates and inflation, which have pressured our top and bottom lines and impacted our outlook for Fiscal Year 2024. The changes will help the Company compete in the current challenging economic environment and prepare for the separation of its Outdoor Products and Sporting Products segments into two independent, publicly traded companies, which is expected to occur in calendar year 2023. Within the Company's Outdoor Products segment, the Company is accelerating the merger of its Bell, Blackburn, Copilot, Fox, Giro, Krash and Raskullz businesses through leadership and facility consolidations. As part of these measures, the current Bell/Giro headquarters in Scotts Valley, California, will be closed effective September 1, 2023, with affected employees relocating to a revamped Innovation Center in the current Fox Headquarters in Irvine, California. Within the Company's Sporting Products segment, the Company is promoting Jason Vanderbrink to Chief Executive Officer of Sporting Products, effective immediately. Mr. Vanderbrink will continue to serve as President of Sporting Products for the Company. Following the Separation, Mr. Vanderbrink will continue to serve as President and Chief Executive Officer of the new Sporting Products Company. At the Corporate level, the Company has taken steps to streamline its corporate costs and operating model by reducing headcount, cutting outside spend and redeploying resources to maximize brand autonomy and corporate scale. These changes will drive efficiencies in the deployment of corporate services and enable more results from our Supply Chain, E-commerce, Licensing and M&A Centers of Excellence. The cost reductions bring Vista Outdoor's Fiscal Year 2024 strategic priorities into focus and help prepare the Company for the Separation this year."

16:06 EDT Butterfly Network announces FDA-cleared AI-enabled lung tool - Butterfly Network announced that it has received 510(k) clearance for a groundbreaking AI-enabled Auto B-line Counter that may simplify how healthcare professionals evaluate adults with suspected diminished lung function and can potentially accelerate their ability to make informed treatment decisions at the point of care. Butterfly's Auto B-line Counter leverages deep learning technology to produce a B-line count from just a six second ultrasound clip - a drastic change from traditionally manual, subjective counting processes to more consistent interpretation of B-lines. B-lines on an ultrasound scan appear as bright, vertical lines that indicate wetness in the lungs and are associated with pulmonary air-space disease, such as congestive heart failure, chronic obstructive pulmonary disease, pneumonia and COVID-19. "Our goal at Butterfly is to give healthcare practitioners, and eventually consumers, a real time full color, annotated, window into the human body. Applying AI to make ultrasound easier to use is core to Butterfly, and will enable powerful ultrasound to be in the palm of more clinician's hands, across specialities, to monitor, assess, and prescribe treatments in a more informed way," said Dr. Jonathan Rothberg, Butterfly Network's Founder and Interim Chief Executive Officer. "Our AI-enabled Auto B-line Counter empowers providers to assess lung conditions faster and with more confidence - and in turn, will aid in earlier detection, diagnosis, and treatment of cardiovascular diseases, a leading cause of death globally, taking nearly 18 million lives each year."

16:04 EDT Gossamer Bio reports FDA placed partial clinical hold on all trials of GB5121 - In a regulatory filing, Gossamer Bio disclosed that on April 3, the company announced that the U.S. Food and Drug Administration has placed a partial clinical hold on all trials of GB5121, in response to serious adverse events that have been observed in the Phase 1b/2 STAR-CNS study, including atrial fibrillation, a sudden death event and a fatal intracranial hemorrhage. The company previously announced on March 17 that it had paused enrollment of the Phase 1b/2 STAR-CNS Study based on the benefit / risk profile observed to date and a prioritization of resources to support the company's seralutinib program. "Based on the foregoing factors, the company has decided to terminate all ongoing studies and discontinue development of GB5121," the filing stated.

16:01 EDT Legend Biotech establishes strategic advisory board - Legend Biotech "announced the formation of a strategic advisory board and the appointments of Michel Vounatsos, former CEO of Biogen Inc., and John Maraganore, PhD, former CEO of Alnylam Pharmaceuticals, as advisors. Mr. Vounatsos and Dr. Maraganore will work closely with Legend Biotech's leadership team and Board of Directors to advise on strategic initiatives to advance the Company's cell therapy platforms."

15:52 EDT DOJ files proposed consent decree to address Activision esports concerns - The U.S. Justice Department filed a civil antitrust lawsuit against Activision Blizzard for imposing rules that limited competition for players in Activision's Overwatch and Call of Duty professional esports leagues and suppressed the wages of esports players in these leagues in violation of the Sherman Act. The complaint, filed today in the U.S. District Court for the District of Columbia, alleges that in two esports leagues owned by Activision, Activision and the independently-owned teams in each league implemented a so-called Competitive Balance Tax. As alleged in the complaint, the Tax was structured to penalize teams in the Overwatch and Call of Duty Leagues, respectively, if a team's player compensation exceeded a threshold set by Activision. At the same time, the Antitrust Division filed a proposed consent decree to address its competition concerns. If approved by the Court, the proposed consent decree would prohibit Activision from imposing any rule that would, directly or indirectly, limit player compensation in any of Activision's professional esports leagues, or that would tax, fine, or otherwise penalize any team for exceeding a certain amount of compensation for its players. The proposed consent decree with Activision would also require Activision to certify that it has ended all Competitive Balance Taxes in its professional esports leagues, to implement revised antitrust compliance and whistleblower protection policies, and to provide notice and an explanation of the final judgment to teams and players in its professional esports leagues.

15:05 EDT Southern First Bancshares names Andy Borrmann as CFO - Southern First Bancshares, Inc. (NASDAQ: SFST), holding company for Southern First Bank, is pleased to announce the appointment of Andy Borrmann as CFO and Executive Vice President. Borrmann joins Southern First with nearly 30 years of experience in the financial industry. For the past eleven years, Borrmann has served as CFO of SouthCrest Bank and SouthCrest Financial Group and was named CFO and Chief Strategy Officer following their merger with Colony Bank.

15:01 EDT CSX reports tentative paid sick leave pact with SMART-TD B&O union - CSX announced that it has reached a tentative agreement with the Sheet Metal, Air, Rail and Transportation Workers-Transportation Division B&O, or SMART-TD B&O, union to provide CSX trainmen and conductors with paid sick leave benefits. Pending ratification by SMART-TD B&O members, the agreement will increase the number of CSX operating employees with paid sick leave benefits to more than 10,000, or 60% of the company's union-represented workforce, the company stated.

14:24 EDT Volkswagen of America reports Q1 sales up 4.4% to 67,853 units - Volkswagen of America reports Q1 sales were up 4.4% from the prior year to 67,853 units. Reference Link

13:42 EDT FCA reports U.S. sales down 9% to 368,237 vehicles in Q1 - FCA US reports sales of 368,237 vehicles in the first quarter for 2023. Overall, total U.S. sales for the first quarter declined 9% versus the same period last year. "As we continue to navigate the market conditions transpiring across the automotive industry, together with our dealer network, we are making the necessary adjustments to meet our customer's expectations. We also continue to see strong demand for our plug-in hybrid vehicles, with the Jeep Wrangler 4xe and Grand Cherokee 4xe placing No. 1 and No. 2, respectively, as America's best-selling PHEV vehicles. And with the Alfa Romeo Tonale production start announced last week, in addition to the impending arrival of the Dodge Hornet R/T in dealerships this spring, we are excited to bring customers another addition to our electric offerings," said U.S. Head of Sales Jeff Kommor. Reference Link

13:25 EDT Disney announces live action 'Moana' in development - Walt Disney Studios tweeted: "JUST ANNOUNCED: From Dwayne Johnson and Auli'i Cravalho, a live-action reimagining of Disney's Moana is in the works!" along with an announcement video from Johnson. Reference Link

13:02 EDT Coastal Financial COO Dickson retires - Coastal Financial Corporation announced that John Dickson has retired from his role as Chief Operating Officer of the Bank. Dickson will continue part-time with the Bank in an advisory role for a period of time to ensure a smooth transition. "John has been key in building out our Banking as a Service team, CCBX," said CEO Eric Sprink. "From the inception of CCBX, John has ensured that we have a wide depth of expertise and knowledge within the Bank, which positions us for this transition. While we will miss John and the skills and insights he brought to the Bank, he leaves us prepared to move forward."

12:58 EDT Avila Energy to list on Nasdaq through combination with Insight Acquisition

12:47 EDT Cryptyde to change name to Eightco Holdings, effect reverse stock split - Cryptyde announced that it intends to change its name to "Eightco Holdings Inc." and to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 50 pre-split shares. The name change and the reverse stock split will become effective at 4:05 p.m. on Monday, April 3, 2023. The Company's common stock will continue to be traded on the Nasdaq Capital Market under the new symbol "OCTO" and will begin trading on a split-adjusted basis when the market opens on Tuesday, April 4, 2023. At a special meeting of stockholders held on March 15, 2023, Cryptyde's stockholders granted the company's Board of Directors the discretion to effect a reverse stock split of the Company's common stock through an amendment to its Certificate of Incorporation at a ratio of not less than 1-for-2 and not more than 1-for-50, such ratio to be determined by the company's Board of Directors.

12:37 EDT Ocean Biomedical Inc trading halted, volatility trading pause

12:12 EDT Interactive Brokers reports March DARTs down 16% y/y - Interactive Brokers Group reported its Electronic Brokerage monthly performance metrics for March. Brokerage highlights for the month included: 2.055 million Daily Average Revenue Trades, 16% lower than prior year and 3% lower than prior month. Ending client equity of $343.1B, 4% lower than prior year and 3% higher than prior month. Ending client margin loan balances of $39.4B, 18% lower than prior year and 1% higher than prior month. Ending client credit balances of $96.6B, including $2.4 billion in insured bank deposit sweeps, 4% higher than prior year and 1% lower than prior month. 2.20 million client accounts, 21% higher than prior year and 2% higher than prior month. 213 annualized average cleared DARTs per client account. Average commission per cleared Commissionable Order of $3.21 including exchange, clearing and regulatory fees.

12:00 EDT Cosmos Holdings completes acquisition of ZipDoctor - Cosmos Health (COSM) completed the acquisition of ZipDoctor from American International Holdings Corp (AMIH). The financial terms of the acquisition were not disclosed. ZipDoctor is a direct-to-consumer subscription-based telemedicine platform, that expects to provide its customers affordable, unlimited, 24/7 access to board certified physicians and licensed mental and behavioural health counsellors and therapists. ZipDoctor's online telemedicine platform will be available to customers across the United States and shall offer English and Spanish coverage with virtual visits taking place either via the phone or through a secured video chat platform.

12:00 EDT Metropolitan Bank falls -11.2% - Metropolitan Bank is down -11.2%, or -$3.80 to $30.09.

12:00 EDT Annovis Bio falls -23.0% - Annovis Bio is down -23.0%, or -$3.55 to $11.86.

12:00 EDT Teck Resources rises 15.2% - Teck Resources is up 15.2%, or $5.54 to $42.04.

11:55 EDT Multi Ways Holdings opens at $3.05, IPO priced at $2.50 per share - Multi Ways Holdings, a supplier of a range of heavy construction equipment for sales and rental in Singapore and the surrounding region, priced its initial public offering of 7.24M ordinary shares at a public offering price of $2.50 per share. Multi Ways is offering 6.04M ordinary shares, and a certain selling shareholder is offering 1.2M ordinary shares. The shares are trading on the NYSE American under the ticker symbol "MWG." Spartan Capital is acting as the sole book-running manager for the offering.

11:31 EDT Nissan reports Q1 U.S. sales up 17.3% to 235,818 vehicles - Nissan reports Q1 U.S. sales of 235,818 vehicles versus 201,081 in 2022, or up 17.3%.

11:11 EDT Illumina to move expeditiously to divest GRAIL if it does not prevail in appeal

11:09 EDT Illumina to appeal FTC decision in federal court - Illumina announced that it will appeal the Federal Trade Commission's decision ordering the unwinding of Illumina's acquisition of GRAIL. Illumina intends to file a petition for review promptly with a US Court of Appeals and will seek expedited treatment of the appeal. The FTC's order to unwind the acquisition will be automatically stayed pending appeal. "Following the FTC Chief Administrative Law Judge's decision in favor of Illumina in September 2022, Illumina believes that it has a strong case on appeal. Illumina will move as quickly as possible and seeks to arrive at a resolution in the US Court of Appeals by late 2023 or early 2024, at approximately the same time as the decision in the European Court of Justice jurisdictional appeal. Winning both appeals would maximize value for shareholders. It enables Illumina to expand the availability, affordability and profitability of the groundbreaking Galleri test in the $44-plus billion multi-cancer screening market. It also protects Illumina's ability to optimize a future divesture should that be in the best interest of shareholders. If Illumina does not prevail in this appeal or the ECJ jurisdictional appeal, the company expects to move expeditiously to divest GRAIL in a manner that serves the best interests of Illumina's shareholders."

11:04 EDT Toyota reports March U.S. sales down 9.1% to 176,456 vehicles - Toyota Motor North America reported March U.S. sales of 176,456 vehicles, down 9.1% on a volume and daily selling rate, or DSR, basis versus March 2022. "Sales of electrified vehicles for the month represented 27.5% of total sales volume," Toyota stated. For the first quarter, TMNA reported sales of 469,558 vehicles, down 8.8% on a volume and DSR basis versus March 2022. "Sales of electrified vehicles for the first quarter totaled 118,836, representing 25.3% of total sales volume," the company added. Reference Link

10:59 EDT Quebecor closes acquisition of Freedom Mobile - Quebecor (QBCRF) and Shaw Communications (SJR) announced that the acquisition of Freedom Mobile by Videotron, a wholly-owned subsidiary of Quebecor, has been completed, creating "the fourth strong, competitive wireless service provider that Canadian consumers and governmental and regulatory authorities have been waiting for." Pierre Karl Peladeau, President and CEO of Quebecor, said: "We are very pleased to be closing the acquisition of Freedom Mobile today, bringing its Canadian footprint as well as the expertise and experience of its employees into our fold. The alliance of Freedom and Videotron will permanently transform Canada's wireless market for the benefit of consumers and create a new competitive environment that delivers innovative products and services at better prices." The acquisition was completed on the basis of an enterprise value of C$2.85B. Videotron paid C$2.17B in cash and assumed certain debts, primarily lease obligations. The consideration paid is subject to certain post-closing adjustments. Videotron and Rogers (RCI) have also settled a commercial dispute related to a shared 4G/LTE network in Quebec and the Ottawa area. "The companies remain committed to continuing this agreement and investing in the joint network for the benefit of their respective customers," the companies stated.

10:48 EDT Honda reports March U.S. sales up 8% to 116,746 vehicles - Honda sales reached 103,000 for the first time in March since July 2021 and the best first quarter in two years, the company said in a statement. Total March sales were up 8% to 116,716, while Q1 sales were up 6.8% to 284,507 vehicles. "The strength of our all-new products is becoming clear as our inventory grows. Record sales of our electrified Honda CR-V and Accord and the best sales month yet for the all-new Acura Integra delivered our best first quarter in two years," said Mamadou Diallo, senior vice president of Auto Sales at American Honda Motor.

10:41 EDT Rogers Communications completes merger with Shaw Communications - Rogers Communications (RCI) announced it has completed its merger with Shaw Communications (SJR). "This is a momentous day for our customers, who will benefit from the latest services and network technology, and for our teams, who have worked so hard to get us here. We're proud to bring together these two iconic companies to deliver more value, more connectivity, and more innovation for Canadians... "We plan to bring together our products and services for Canadians in a way we never have before. This is a business of scale, and we can now deliver even more value for consumers and businesses on Canada's largest and best national network," said Tony Staffieri, President and CEO, Rogers. As a result of the merger, the Shaw family has become one of the largest shareholders of Rogers. Brad Shaw and Trevor English, Shaw's former Executive Vice President and Chief Financial and Corporate Development Officer, have been designated for nomination to the Rogers Board of Directors. They are expected to be appointed to the Rogers Board on April 4, the companies stated.

10:11 EDT Illumina ordered to divest cancer detection test maker GRAIL by FTC - The Federal Trade Commission issued an Opinion and Order requiring DNA sequencing provider, Illumina, Inc., to divest GRAIL, Inc., which makes a multi-cancer early detection test, finding that the deal would stifle competition and innovation in the U.S. market for life-saving cancer tests. The Opinion reverses an Administrative Law Judge's Initial Decision that dismissed the antitrust charges in a complaint brought by FTC staff. The Commission found that the acquisition would diminish innovation in the U.S. market for MCED tests while increasing prices and decreasing choice and quality of tests. This Opinion and Order will now become final unless Respondents file a petition for review in a federal Court of Appeals within 60 days from the date of the service of this Order. The Commission vote to issue the Opinion and Order was 4-0. Reference Link

10:04 EDT Caravelle signs three-year procurement contract with Bestwood Joiner - Caravelle announced that the Company, through its Singapore Garden Technology subsidiary, has signed a 3-year procurement contract with Bestwood Joinery worth $60M. According to the terms of the procurement contract, Caravelle will source 120,000 cubic meters of various species of lumber from Indonesia, transport the lumber to Bestwood Joinery in Cape Town, South Africa, and dry the wood in transit using Caravelle's revolutionary CO-Tech technology using only recycled heat from the ship's engine.

10:01 EDT BAE Systems receives $491M in contracts from Lockheed Martin - BAE Systems (BAESY) has received $491M in contracts from Lockheed Martin (LMT) to produce state-of-the-art Block 4 electronic warfare systems for future Lot 17 F-35 Lightning II fighter jets, adding to the 1,200 F-35 EW systems it has delivered to date. The powerful Block 4 systems will accelerate the delivery of advanced EW capabilities to warfighters by combining adaptable hardware and incremental software updates.

10:00 EDT StarTek falls -13.8% - StarTek is down -13.8%, or -57c to $3.56.

10:00 EDT NGL Energy Partners rises 13.1% - NGL Energy Partners is up 13.1%, or 38c to $3.28.

10:00 EDT Nine Energy Service rises 15.8% - Nine Energy Service is up 15.8%, or 88c to $6.44.

09:47 EDT A10 Networks falls -10.3% - A10 Networks is down -10.3%, or -$1.60 to $13.89.

09:47 EDT NGL Energy Partners rises 11.7% - NGL Energy Partners is up 11.7%, or 34c to $3.24.

09:47 EDT Nine Energy Service rises 13.8% - Nine Energy Service is up 13.8%, or 77c to $6.33.

09:43 EDT Knightscope receives purchase order for Mt. San Antonio College - Knightscope announced that Mt. San Antonio College issued a purchase order for 11 K1 Blue Light Towers, 7 K1 Emergency Phones and a 1-year full service maintenance plan. Mt. San Antonio College is an existing customer broadening its emergency communications capabilities and, therefore, access to critical help in times of need.

09:39 EDT Guardforce AI Co Ltd trading halted, volatility trading pause

09:27 EDT Ceco Environmental acquires Transcend Solutions, terms not stated - CECO Environmental "announced it has completed the acquisition of Transcend Solutions, LLC, a Houston-based process filtration solution design and manufacturing company with applications in hydrocarbon and chemical processing. The addition of Transcend to CECO's Separation and Filtration business platform advances CECO's capability to offer customers around the world a turnkey performance-enhancing engineered solution for process fluid separation and filtration in a wide range of high-performance applications. Transcend is the second acquisition for CECO in 2023, following the previously announced deal for U.K.-based Wakefield Acoustics Ltd. in January 2023 and four transactions in 2022, continuing CECO's steady execution of its programmatic M&A strategy launched in early 2022."

09:26 EDT Mogo announces Coinsquare to combine with WonderFi , CoinSmart - Mogo announced that Coinsquare, in which Mogo has a 34% ownership stake, WonderFi Technologies and CoinSmart Financial have entered into a business combination agreement to combine their respective businesses. Mogo is Coinsquare's largest shareholder and is expected to be the largest shareholder of the publicly traded combined company following closing of the transaction with approximately 14% ownership. The combined company will have transacted over $17B since 2017 and have over $600M in assets under custody, with a registered user base in excess of 1.65M Canadians. The companies generated a total of approximately $37M in revenue for FY22 and are expected to have cash and investments of approximately $50M at close. It is anticipated that the shareholders meetings of each party to the business combination agreement will occur in the second quarter of 2023. Closing is expected to occur thereafter, subject to satisfaction of the closing conditions under the Business Combination Agreement. Following completion of the transaction, the shares of the combined company are expected to trade on the TSX, subject to approval or acceptance of each stock exchange in respect of the transaction. In connection with the entering of the business combination agreement by the parties thereto, Mogo has agreed to enter into an investor rights agreement with WonderFi, a voting and support agreement with Coinsquare, WonderFi and CoinSmart and a voting agreement with certain officers, directors and principals of Coinsquare, WonderFi and CoinSmart. Concurrently, certain directors, officers and significant shareholders of WonderFi, Coinsquare and CoinSmart have also entered into similar agreements to establish the size and composition of the board of directors of the combined company, expected to be comprised of nine members, as well as certain voting and governance matters related to the combined company. Pursuant to the IRA, which becomes effective on closing of the transaction, subject to certain conditions and until the later of 24 months following the effective date and the second annual general meeting of the combined company, the parties thereto have agreed that the new board shall consist of nine directors and that so long as Mogo owns, controls or directs, directly or indirectly, 5% or more of the then-outstanding shares of the combined company on a non-diluted basis, Mogo will be entitled to nominate one nominee to the new board. Pursuant to the VSA, subject to certain conditions, Mogo has agreed to vote its Coinsquare shares in favor of the transaction at any meeting of Coinsquare shareholders held to consider the transaction or any of the other transactions contemplated by the business combination agreement. Subject to certain conditions, the shares that are to be issued to Mogo on closing of the transaction, will be subject to escrow and will become freely tradeable over an 18-month period in three equal installments of 1/3rd The aforementioned escrow period may be shortened to a date that is not less than 12 months following the effective date, if on such date Mogo owns, controls or directs, directly or indirectly, less than 5% of the then-outstanding shares and Mogo does not have a representative on the new board.

09:21 EDT Vicinity Motor issues Deferred Share Units - Vicinity Motor announces the granting of Deferred Share Units. Certain Eligible Directors have requested that their respective director's remuneration for the calendar year 2023 be paid in DSUs and accordingly, the Company has granted 180,378 DSUs in connection with Directors Remuneration for the first quarter.

09:20 EDT Recruiter.com launches Recruiter Marketplace platform - Recruiter.com is pleased to announce the launch of the Recruiter Marketplace, a platform to transform the talent acquisition landscape. The company said, "The platform connects employers with vetted freelance talent acquisition professionals by leveraging automation, offering unmatched flexibility, cost savings, and access to a global talent network."

09:19 EDT Focus Universal says USPTO issues notifications for two patents - Focus Universal provided an update on its patent portfolio. The United States Patent and Trademark Office issued an Issue Notification for U.S. Patent No. 11580558 entitled "Dynamic Anti-Counterfeit System and Method." The USPTO also issued an Issue Notification for U.S. Patent Application No. 11546017 entitled "System and Method of Power Line Communication." Both patents cover patent applications regarding the Company's PLC business.

09:18 EDT Willdan awarded electric vehicle readiness plan development for Merced County - Willdan Group announced that it has been awarded a contract to develop the 'Electric Vehicle Readiness Plan' for Merced County Association of Governments MCAG . This plan will serve as a roadmap for the implementation of electric vehicle charging infrastructure for MCAG and their member agencies including Atwater, Livingston, Gustine, and Los Banos. The scope of this contract includes planning for vehicle and charger selection, space availability, permitting, funding, utility program participation, electrical infrastructure, contracting, procurement, and construction. "Merced County Association of Governments is excited to prepare for growing electric vehicle adoption and future infrastructure investment in the Merced region," said Blake Dunford, MCAG's Associate Planner. "This plan will provide key insights for transforming our region to encourage electric vehicle usage." "This contract expands Willdan's successful electric vehicle planning work for public agencies across the country," said Tom Brisbin, Willdan's CEO and Chairman. "We are proud to advise Merced County and other California clients on electrification at a time when the state is experiencing rapid change in the transportation sector."

09:18 EDT Beamr Imaging teams up with Wochit as a design partner - Beamr Imaging announced that it has teamed up with Wochit as a design partner for its upcoming SaaS offering. This partnership comes after a successful test of Beamr's video optimization technology on Wochit's recently launched AI-based video creation tool. With this partnership, Wochit will benefit from the storage and delivery savings provided by Beamr's video optimization platform, enabling more efficient and cost-effective video creation for its clients. The integration of Beamr's technology into Wochit's platform will also provide users with faster end to end video delivery, enabling them to create high-quality videos more quickly and easily. "We are thrilled to have Wochit as a design partner for our upcoming SaaS offering," said Sharon Carmel, CEO of Beamr. "Their experience and expertise in video creation will be invaluable as we work to bring our technology to even more customers."

09:17 EDT Anika Therapeutics continues to expand addressable market for Tactoset - Anika Therapeutics announced that it has received an additional 510(k) clearance from FDA for Tactoset Injectable Bone Substitute. This new indication expands the use of Tactoset to be combined with autologous bone marrow aspirate, BMA. "Tactoset, a regenerative solutions product, continues to be a key growth driver within our joint preservation and restoration portfolio, as it is uniquely positioned to address unmet needs in patients with insufficiency fractures and poor-quality bone including cysts where augmenting hardware, such as suture anchors, gives surgeons additional confidence in their repair constructs," said Cheryl R. Blanchard, PhD, President and CEO, Anika Therapeutics. "This new FDA clearance for mixing Tactoset with BMA provides a product with improved regenerative capacity and showcases Anika's commitment to developing unique solutions that are meaningful to our customers and their patients. It also further reinforces our confidence that we can increase Tactoset's addressable market to well beyond $100 million by creating a new market for hardware augmentation. The BMA clearance, together with the release of enhanced cannulas and our distribution of the Marrow Cellution Bone Marrow Aspiration Needle announced today, highlight our continued investment in differentiated products that expand and reinforce our regenerative solutions portfolio and enhance growth and profitability for our shareholders."

09:16 EDT INmune Bio submits IND application for INKmune to FDA - INmune Bio announced that the Company has submitted an Investigational New Drug application to the U.S. Food and Drug Administration for the use of INKmune to treat metastatic castration-resistant prostate cancer. The trial is expected to take place in four or more medical centers in the U.S and will enroll approximately 30 patients in a flexible Bayesian design. Matt Rettig MD, Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer, will be Principal Investigator of the INKmune mCRPC trial. The goal of the trial is to define the safety of INKmune and demonstrate the ability of INKmune-primed NK cells to attack prostate cancer. The results should allow us to choose the best dose of INKmune to move into a blinded randomized trial. Given the novel nature of the treatment, the Company expects a period of consultation with the FDA prior to initiating the planned trial. The 6-month trial will test three doses of INKmune. The therapeutic potential of INKmune in mCRPC will be tested in two ways. First, the immunologic effects of INKmune therapy will be measured by the ability of INKmune to convert the patient's resting NK cells into cancer killing memory-like NK cells, the ability of those cells to kill a tumor target in vitro and the persistence of that response after treatment. Second, the tumor response to INKmune therapy will be measured using traditional biomarkers of prostate cancer response - progression free survival, changes in blood PSA level and imaging studies. Novel biomarkers of tumor response, change in PMSA PET scan and circulating tumor DNA, will also be studied.

09:13 EDT StealthGas announces management estimate of NAV per share of $14.50 - STEALTHGAS announced today that the Company's management estimate of the Net Asset Value per share is region $14.50 based on the number of common shares currently outstanding. The closing price of the Company's stock on March 31, 2023 was $2.61.

09:10 EDT 180 Degree reports +5.7% gross total return in public, related portfolio in Q1 - 180 Degree Capital reported preliminary results of its public and related portfolio as of March 31, 2023. "We are pleased to report a +5.7% gross total return in our public and related portfolio for the first quarter of 2023," said Kevin M. Rendino, Chief Executive Officer of 180. "This performance compares favorably to the -2.9% total return of the Russell Microcap Index. Following 2022, a year of significant damage to perceived risk assets and where business fundamentals took a back seat to overwhelming fears of recession, we began to see a turn of sentiment during the first quarter of 2023. Our permanent capital allowed us to add to positions in Q4 2022 that we believed were undervalued, and these additions, in part, contributed to our outperformance versus the benchmark during the quarter. While it remains early in 2023, and risks abound, we are encouraged with our performance during Q1 2023. With the restructuring of our business largely behind us, changes in 180's NAV will be substantially driven by, and reflective of, our public market stock picking, rather than our historically opaque legacy private holdings."

09:08 EDT Celularity receives FDA preliminary assessment for its FUSE Bone Void Filler - Celularity announced that it received notice from the U.S. Food and Drug Administration, FDA, that the FDA's Office of Combination Products, OCP, completed its preliminary product classification and jurisdictional assessment of Celularity's investigational FUSE Bone Void Filler, FUSE. FUSE is being developed for use as a passive osteoconductive bone filler in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects that are not dependent on chemical action to mediate an effect. "We are delighted to receive the FDA's feedback about the preliminary FUSE product classification and CDRH jurisdiction, on the basis of which we anticipate a 510(k) pre-market notification submission for FUSE in early 2024," said Robert Hariri, M.D., Ph.D., Celularity's CEO, Chairman and Founder. "Celularity's unique technology platform is grounded in our use of the post-partum placenta as the source of cells and biomaterials for the development of therapeutics. This creates two independent but complimentary product opportunities in cellular and regenerative medicine. FUSE is an example of how Celularity develops innovative products from the placenta, leveraging our more than 15 biomaterial-related patent families and multiple issued patents. For Celularity, our suite of biomaterial products is a revenue engine that supports continuous new product research and development and enhances the value proposition for our investors."

09:08 EDT Ageagle Aerial Systems unveils Field Check for Measure Ground Control - AgEagle Aerial Systems released Field Check for the Measure Ground Control mobile app and announced new pricing tiers for the software. Measure Ground Control is a complete Software-as-a-Service solution for drone program management that is available as a web app and mobile app for both iOS and Android devices. The software's capabilities include mission and equipment management, flight control, data processing and analysis, secure data storage and sharing, online collaboration and reporting. Field Check's unique feature set enables users to review and validate the quality of their drone-captured imagery on-site. Capturing target imagery right the first time in one trip to a project site allows users to eliminate time loss and costs associated with project reworks by ensuring data capture is complete and ready for processing into high-resolution outputs before leaving a site. AgEagle also introduced new subscription pricing tiers for Measure Ground Control software, tailored to users ranging from individuals and small drone businesses to enterprises. A new Basic subscription plan has been added, the Pro and Teams pricing has been updated, and annual plans at reduced rates have been introduced.

09:06 EDT PetMed Express completes acquisition of PetCareRx - PetMed Express completed its previously announced acquisition of PetCareRx, a leading supplier of pet medications, food, and supplies, for total consideration of approximately $36M in an all-cash transaction. The acquisition will expand PetMeds' overall addressable market from pet medication to a broader healthcare category leader. PetCareRx adds approximately 10,000 incremental food, diet and wellness products to the PetMeds current product offering. PetMeds believes it can expand its growth through a broader product catalog and differentiated services. "We are extremely excited to welcome the PetCareRx team into the PetMeds Pack," said Matt Hulett, CEO and President of PetMeds. "PetCareRx is a proven brand with a large loyal audience. Their broader pet product catalog greatly expands the ability for PetMeds to sell more products to our existing base of over two million active customers. Incorporating the PetCareRx catalog will greatly enhance PetMeds' ability to provide products and services from nose to tail, at a good value, to a growing number of pet parents."

09:05 EDT ZimVie ennounces expanded reimbursement for Mobi-C in France - ZimVie announced that the French Republic has published its approval for the reimbursement of the Mobi-C Cervical Disc in both the public and private sectors in France. In addition, the clinical data for Mobi-C was awarded the highest quality rating of 10A by the Orthopaedic Data Evaluation Panel in the United Kingdom. Physicians have used Mobi-C, ZimVie's market-leading device for cervical disc replacement at one level or two contiguous levels, to treat patients in France and the U.K. since 2004. On March 19, 2023, the French Republic's Ministry of Health and Prevention issued in JORF N degrees 0067, a new version of the List of Products and Services reimbursable by health insurance and covered by the Health Insurance Fund. The LPP now includes the newly introduced medical device code 3174999 for "Cervical Disc Prostheses - Mobi-C Plug & Fit." Implants included on the LPP must be CE-marked devices that have a therapeutic, diagnostic, or assistive added value, supported by clinical studies demonstrating the benefits of the solution. Another validation of the Mobi-C Cervical Disc came through the recent 10A rating from the Orthopaedic Data Evaluation Panel in the United Kingdom. ODEP provides the objective, systematic review and rating of the strength of evidence supporting the performance of medical devices. Its rating is comprised of several components: The numerical portion of the rating indicates the number of years of clinical evidence, with ten years representing full compliance with the benchmark from the National Institute for Health and Care Excellence, which provides national guidance and advice to improve health and social care in the United Kingdom. The "A" designates "Strong Evidence" based on a generally higher number of patients, with all patients being subject to follow-up. Finally, the addition of the star denotes a benchmark replacement rate of less than 1 in 20 at 10 years. There is no higher quality rating than A.

09:04 EDT Dominari Holdings names George Way as CFO - Dominari Holdings announced that George Way has been named CFO, effective April 3. Way brings more than 30 years of experience in finance, accounting, acquisitions and investments, and has a proven track record of solving complex business challenges. Most recently, Way served as Director of Finance and Accounting of Steward Partners, a wealth advisory and asset management firm.

09:01 EDT Heron Therapeutics: Craig Collard to succeed Barry Quart as CEO - Heron Therapeutics announced the appointment of Craig Collard as CEO, effective April 3. Collard succeeds Barry Quart, Pharm.D., who has stepped down as CEO and Chairman of the Board. In addition, as part of the leadership change, the Board elected Adam Morgan as Chairman. Collard brings more than three decades of experience leading innovative pharmaceutical companies through periods of strategic change to deliver growth and enhanced value for stockholders. Most recently, as CEO of Veloxis Pharmaceutics A/S before its acquisition by Asahi Kasei Corp.

08:56 EDT Sinclair announces holding company reorganization to rename company as Sinclair - Sinclair Broadcast Group announced that it intends to implement a reorganization in which a new holding company, Sinclai , would become the publicly-traded parent of Sinclair Broadcast and its subsidiarie .These are simplified illustrations of our business structure before and after the Reorganization. Beyond its familiar broadcast business, Sinclair Broadcast and its affiliates own, manage and/or operate technical and software services companies, intellectual property for the advancement of broadcast technology, and other media and non-media related businesses and assets including real estate, venture capital, private equity, and direct investments. These other businesses and assets include, among other things, Compulse, a marketing technology and managed services company, and Tennis Channel. As part of the Reorganization, these other businesses and assets will be held by New Sinclair through a new subsidiary to be known as Sinclair Ventures, rather than by Sinclair Broadcast or its direct subsidiary, Sinclair Television Group, Inc. "We believe the new structure will provide greater flexibility for creating value within the company. The new structure simplifies the corporate structure and improves the transparency of financial disclosures on the value drivers of the company," commented Christopher S. Ripley, President and CEO of the company. "We believe these other assets, some of which are currently buried in the broadcast division, can receive greater visibility outside the 'broadcast' umbrella, while Sinclair Broadcast will become a broadcast-focused subsidiary for which stockholders can better value its true performance. In short, we believe a holding company structure can unlock unrecognized value and provide structural flexibility for the growth and monetization of our current and potential future media and non-media businesses."

08:54 EDT Alzamend Neuro inititates Phase I/IIA Trial for LZN002 to treat dementia - Alzamend Neuro announced the initiation of a phase I/IIA clinical trial for its immunotherapy vaccine, ALZN002, to treat mild to moderate dementia of the Alzheimer's type. The purpose of this trial is to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of placebo in 20-30 subjects with mild to moderate morbidity. The primary goal of this clinical trial is to determine an appropriate dose of ALZN002 for treatment of patients with Alzheimer's in a larger Phase IIB efficacy and safety clinical trial, which Alzamend expects to initiate within three months of receiving data from the initial trial. "Alzamend's motto is 'Making Alzheimer's just a memory.' There remains a need to develop new therapies that alter the progression of Alzheimer's and prevent, reverse or slow neurodegeneration and cognitive decline. Today, we are on the threshold of importantly advancing the art and science of anti-beta amyloid therapy by treating each Alzheimer's patient's individual immune system," said Stephan Jackman, Chief Executive Officer of Alzamend. "Intermittent use of our immunotherapeutic vaccine, ALZN002, may be expected to limit the number of infusions needed, may reduce the potential for adverse reactions, and provide more substantive cognitive and functional outcomes to the millions of Americans afflicted with this devastating disease."

08:51 EDT Heico's Dukane Seacom enters exclusive license agreement with Honeywell - HEICO Corporation (HEI) announced that its Dukane Seacom subsidiary entered into an exclusive license and acquired key assets for the Aircraft Emergency Locator Transmitter product line from Honeywell International (HON). The transaction was structured as an exclusive perpetual license and asset purchase. Dukane Seacom is part of HEICO's Electronic Technologies Group. Transaction terms and financial details were not disclosed. HEICO stated that it expects the license and asset acquisition to be accretive to its earnings in the year following closing. The transaction provides Dukane Seacom with all rights to produce, sell and repair both fixed and portable Honeywell ELTs, as well as various support equipment. Prior to the transaction, Dukane Seacom and Honeywell had been longstanding technology and manufacturing partners for ELT products. Dukane Seacom is now solely responsible for the activities formerly performed by Honeywell and will conduct its engineering, production and customer support functions from Dukane Seacom's Sarasota, FL facility.

08:48 EDT Comera Life Sciences announces expansion of patent portfolio - Comera Life Sciences announced the expansion of its patent portfolio with one new patent granted in South Korea and two Notices of Allowance in the U.S. and Japan covering expansion of claims and exclusive rights pertaining to certain excipients in its proprietary SQore platform. The recent developments consist of the following: Notice of Allowance from the United States Patent and Trademark Office for expansion of core viscosity reduction patent claims toward antibody formulations and processing improvements with new excipient 1,3-dimethyluracil. Issuance of South Korean Patent No. 2493469, which provides Comera exclusive rights pertaining to excipients hordenine, tryptamine, and trigonelline, with or without caffeine, in its SQore(TM) platform as viscosity-lowering agents. Notice of Allowance from Japan's Patent Office for Japanese Patent Application No. 2020-546123, titled "Excipient compounds for protein formulations," for hordenine as viscosity-reducing excipient. "This patent and two Notices of Allowance strengthen Comera's robust, global patent portfolio with both expansion of claims to our core SQore platform and also geographic expansion outside of the U.S.," said Jeffrey Hackman, Chairman and Chief Executive Officer of Comera. "In conjunction with our existing patents, we believe this expanded intellectual property portfolio will provide value for our existing and future partners by increasing the potential commercial market and lifecycle extension opportunities with our SQore platform."

08:46 EDT Corvus Pharmaceuticals announces interim data on CPI-818 - Corvus Pharmaceuticals announced interim data demonstrating the potential of CPI-818, the Company's ITK inhibitor, for the treatment of T cell lymphoma, TCL, at the 10th Whistler Global Summit on Hematologic Malignancies, which took place March 29 to April 2, 2023 in Whistler British Columbia, Canada. The CPI-818 data was presented by John Reneau, MD, PhD, from The Ohio State University Comprehensive Cancer Center. CPI-818 is currently being studied in a Phase 1/1b clinical trial as a single agent therapy in patients with relapsed TCL. As of February 23, 2023, 20 patients were enrolled in the 200 mg cohort, including 13 evaluable for tumor response. There have been 1 complete response of 24 months duration, 1 equivocal CR awaiting confirmatory PET scan of 13+ months duration, 1 nodal CR of 21 months duration and 1 PR of 7 months duration. Ten patients continue on therapy, including seven who have not yet been evaluated for tumor response. Corvus has identified minimum absolute lymphocyte count above 900 per cubic milliliter of blood as a biomarker associated with response to CPI-818. Interim data from the 200 mg cohort in the Phase 1/1b clinical trial indicate that this minimum ALC level is required for tumor response and disease control. New interim data, as of February 23, 2023, presented by Dr. Reneau evaluated the effect of ALC on PFS of patients based on their last prior chemotherapy treatment before receiving CPI-818. There was no significant difference in the PFS achieved in patients with ALC less than 900 per cubic milliliter compared to patients with ALC greater than or equal to 900 per cubic milliliter, which suggests the ALC biomarker is not predictive for standard therapies. This result is consistent with CPI-818's proposed mechanism of action, which involves the enhancement of normal lymphocyte function, and indicates that the improved results seen with CPI-818 in patients with ALC above 900 is not due to more favorable patient characteristics.

08:44 EDT Bridgeline Digital signs over $1.4M in new sales, $4M in license renewals in Q2 - Bridgeline Digital provided the following update for the end of its second quarter of fiscal 2023. In its second quarter, Bridgeline signed $1.4M in new sales, including $600 thousand in licenses representing more than $300 thousand in annual recurring revenue, plus $800 thousand in services. Most new sales contracts were for a three-year term, and HawkSearch represented the bulk of the new bookings. Over 200 of Bridgeline's existing customers, representing over 90% of customers and recurring revenue that was contracted for renewal during the quarter, renewed $4 million in license subscriptions with several customers increasing the size of their license. Renewals included Global 500 enterprises such as AstraZeneca, Toyota, and UPS. Bridgeline sold over 500 subscriptions through its new partnership with Duda, a leading Content Management Platform. The partnership, signed in January 2023, makes WooRank available to over 10,000 websites through the Duda App Store. WooRank allows Duda users to increase traffic to their sites by improving their ranking on search engines such as Google.

08:43 EDT Titan Medical continuing to evaluate options for the business - Titan Medical provided an update on its annual filings and certain other corporate and operational matters. On March 22, 2023, the Company announced that it would not be filing its annual financial statements, the related management's discussion and analysis and annual information form, and the accompanying chief executive officer and chief financial officer certification for its financial year ended December 31, 2022 within the time period prescribed by National Instrument 51-102 - Continuous Disclosure Obligations and National Instrument 52-109 - Certification of Disclosure in Issuers' Annual and Interim Filings. The Company also announced that it had applied to the Ontario Securities Commission, as its principal regulator, under National Policy 12-203 - Cease Trade Orders for Continuous Disclosure Defaults requesting that a management cease trade order be imposed in respect of the late filing of its Annual Filing Documents. The Company has the necessary financial and human resources to remedy the default and file its Annual Filing Documents by May 19, 2023. Titan's management has prepared a work plan to prepare and finalize the Annual Filing Documents by the Anticipated Filing Date and is actively preparing the filing documents and working to that end. Additionally, the Company plans to engage its existing auditor, BDO Canada LLP, to work with the Company to complete an audit of the Company's 2022 annual financial statements. The Company continues to evaluate options for the business including the sale and/or licensing of all or a portion of the Company's assets, including its intellectual property. The Company retains 14 employees who are focused on supporting a potential strategic transaction, including a sale and/or licensing of the Company's assets; maintaining its intellectual property portfolio; continuing to complete deliverables pursuant to certain contractual development and supply obligations; preparing and filings its Annual Filing Documents; and continuing corporate administrative and compliance obligations. The Company confirms that it is not subject to any insolvency proceedings at this time and that there is no other material information concerning its affairs that have not been generally disclosed.

08:43 EDT Ascendis Pharma falls 38% after disclosing FDA notice of deficiencies in NDA - Shares of Ascendis Pharma are down 38% or $40.96 in pre-market trading at $66.26 after disclosing that the FDA has notified the company regarding deficiencies in its New Drug Application, NDA, for TransCon PTH in hypoparathyroidism.

08:40 EDT Siyata Mobile receives order from U.S. school district for SD7 Handset - Siyata Mobile announced it has received its largest order for the SD7 Handset from a single customer in the education market. A school district located in the Southwest U.S. has placed an order at a gross purchase price of more than $600,000 for the Company's SD7 Handsets and related accessories. These devices will be used by the schools' safety staff, custodial staff, administration staff, selected teachers, and by their school bus drivers.

08:38 EDT HBT Financial announces executive officer transition plans - HBT Financial announced that Fred Drake, Chairman and CEO of the Company and Chairman of Heartland Bank, will transition to the newly created role of Executive Chairman of the Company and Heartland Bank effective May 24, 2023. At that time, J. Lance Carter, President and Chief Operating Officer of the Company and Heartland Bank, will assume the role of President and CEO of the Company and Heartland Bank.

08:36 EDT Maris-Tech completes its share repurchase program - Maris-Tech announces that its previously announced share repurchase program was completed on March 31, 2023. The Company repurchased 120,715 of its ordinary shares, no par value per share (the "Ordinary Shares"), representing approximately 1.5% of its issued and outstanding Ordinary Shares, at an average price of $0.987 per Ordinary Share.

08:34 EDT Sypris awarded contract for side-by-side drivetrain components, no terms - Sypris Technologies announced that it was awarded a new program to supply drivetrain components for use in the production of a new model of side-by-side utility-terrain vehicles. Production is expected to begin in 2024. Terms of the multi-year agreement were not disclosed. The new program award provides Sypris with the opportunity for further growth in this burgeoning market. The finished components produced by Sypris to exacting specifications will be incorporated into the differentials of these vehicles. The all-terrain vehicle market is reported to grow at a compound annual growth rate of 16.8% between 2020 and 2025, according to Technavio Research. Commenting on the announcement, Federico Aviles, Vice President & General Manager of Sypris Technologies Mexico, S. de R.L. de C.V., stated, "We are pleased to have the opportunity to extend and expand our support for this important customer, a relationship which has grown substantially over the past 20 years. We will continue to support them with advanced manufacturing systems to ensure that this valued customer continues to benefit from world-class quality, on-time delivery and cost-competitive products." Sypris Technologies, Inc. is a premier manufacturer and supplier of drivetrain and other critical components for the commercial vehicle, automotive, recreational vehicle, mining, agriculture, industrial and energy markets. Sypris is headquartered in Louisville, Kentucky. Through its operations in North America, Sypris continues to meet the needs of the industries it serves after more than 90 years of service.

08:32 EDT Akebia announces 'positive' results from vadadustat alternative dosing study - Akebia Therapeutics announced positive top-line results from FO2CUS, a study evaluating the efficacy and safety of vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in hemodialysis patients who were converted from a long-acting erythropoiesis-stimulating agent to three times weekly oral vadadustat dosing for the maintenance treatment of anemia. The data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA in the treatment of anemia due to chronic kidney disease in patients on hemodialysis when used three times a week at the time of dialysis and with a comparable safety profile to the current standard of care. Data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA as a treatment for anemia due to chronic kidney disease when administered three times a week at the time of dialysis. Vadadustat demonstrated a similar safety profile to long-acting ESA when used three times a week.

08:32 EDT WWE falls 6% in pre-market to $86 after confirming acquisition by Endeavor Group

08:28 EDT Glatfelter announces milestone anniversary for Sontara - Glatfelter Corporation is celebrating the 50th year anniversary of Sontara by commemorating past successes and embracing the possibilities of the future. "Today's anniversary marks a significant milestone in the evolution of the Sontara brand and represents Glatfelter's commitment to providing sustainable, innovative nonwoven technologies and advanced fiber-based solutions to support our customers' growing global demand," said Thomas Fahnemann, President and Chief Executive Officer of Glatfelter. "Sontara products are important components of Glatfelter's nonwovens portfolio and we are excited to celebrate the brand's success with the many dedicated and talented employees who continue to champion its unique qualities and ensure that our products enhance consumers' lives around the world. At Glatfelter, we are proud of our long history of innovation and excellence and look forward to continuing to provide Sontara high-quality nonwoven fabrics for years to come"

08:27 EDT Perspective Therapeutics appoints Andrew Bright as EVP, brachytherapy - Perspective Therapeutics names Andrew Bright as Executive Vice-President of Brachytherapy. Bright brings to this role over 30 years in leadership roles within the medical device industry, including over 20 years in brachytherapy.

08:24 EDT Wejo targets under $3M in cash burn by end of 2023 - John Maxwell, Chief Financial Officer, said, "We are making significant progress on our efforts to capitalize the business to reach our projected cash flow breakeven point. In addition to strong progress on our PIPE efforts with strategic investors, we are working to raise capital that will bridge us to these transactions. We reduced our monthly cash burn by 40% from the start to the end of 2022, and we are targeting another 50% reduction in our cash burn to get to under $3 million by the end of 2023. Our focus on reduced cash burn, the deployment of our long-term capital strategy and continued strong revenue performance are key steps to fully funding Wejo to cash flow breakeven in mid-2024."

08:24 EDT Kiromic BioPharma submits IND for Deltacel trial for NSLC treatment - Kiromic BioPharma announces the submission of an Investigational New Drug application to the U.S. Food and Drug Administration for a Phase 1 clinical trial to evaluate KB-GDT-01, or Deltacel, in combination with an anti-tumor therapy for the treatment of non-small cell lung cancer, NSCLC. Deltacel is the Company's allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cell herapy. The Company is seeking to address the significant unmet need of applying cell therapy to treat solid malignancies, which comprise 90% of all cancers, including NSCLC. "Submitting this IND brings us one step closer to beginning human clinical testing with this incredible science and providing a promising treatment option to the tens of thousands of patients living with non-small cell lung cancer. While this is the second most common type of cancer, lung cancer is the leading cause of cancer deaths in the United States, accounting for about 1 in 5 of all cancer deaths," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "This milestone, achieved on March 31, 2023, is a tremendous accomplishment by our team, and we look forward to initiating clinical testing upon IND acceptance by the FDA."

08:22 EDT Oportun Financial announces new study on its loan products - Oportun released findings from the latest True Cost of a Loan Study conducted by the Financial Health Network. The new study found that Oportun's loan products on average are eight times less expensive than other alternatives for a typical borrower. The 2022 analysis compares Oportun unsecured installment loans of $500, $1,500, and $3,000 to alternative products for Oportun borrowers based on the most likely options that a hypothetical subprime borrower might access. "Providing affordable and inclusive loan products that help our members integrate into the financial mainstream by establishing a FICO score is an important part of our mission to put their financial goals within reach and help them build a better financial future," said Matt Jenkins, Chief Operations Officer for Oportun. "The True Cost of a Loan study clearly demonstrates that Oportun is an affordable alternative for hardworking people who would otherwise be denied by other lenders or would have to pay a much higher cost for a similar loan product."

08:20 EDT StoneCo announces completion of CEO transition - StoneCo announced that on March 31, 2023, the Company completed the transition of leadership roles, by which Pedro Zinner assumed the position of CEO of Stone. Thiago Piau, former CEO, joined the Company's Board as a director and member of the Finance and Risk committee on February 15, 2023, as previously announced.

08:18 EDT Corcept Therapeutics announces preliminary results of tender offer - Corcept Therapeutics announced the preliminary results of its previously announced tender offer to purchase up to 7,500,000 shares of its common stock, par value $0.001 per share, at a price not greater than $22.00 nor less than $19.25 per share, in cash, less any applicable withholding taxes and without interest, which expired one minute after 11:59 p.m., New York City time, on March 31, 2023. Based on the preliminary count by Continental Stock Transfer & Trust Company, the depositary for the Tender Offer, 6,630,151 shares of Corcept's common stock were validly tendered and not properly withdrawn at or below a purchase price of $22.00 per share, including 2,040,587 shares tendered by notice of guaranteed delivery. In accordance with the terms and conditions of the Tender Offer, based on these preliminary results, Corcept expects to purchase 6,630,151 shares of common stock at a purchase price of $22.00 per share, for an aggregate cost of $145,863,322, excluding fees, any excise taxes and expenses relating to the Tender Offer. The number of shares that Corcept expects to purchase in the Tender Offer represents approximately 6 percent of the total number of shares of common stock outstanding as of March 30, 2023. Corcept expects to have 101,435,180 shares of common stock outstanding immediately following payment for the shares of common stock purchased in the Tender Offer.

08:17 EDT PDS Biotechnology supports Oral, Head & Neck Cancer Awareness Month - PDS Biotechnology announced its support for Oral, Head & Neck Cancer Awareness Month in April and Oral, Head & Neck Cancer Awareness Week, April 16-22, both of which are organized by the Head & Neck Cancer Alliance. PDS Biotech recognizes the important role and dedication of patient organizations, such as the HCNA and the U.K.-based Swallows Head & Neck Cancer Support Group in not only raising awareness of oral, head and neck cancer, but also in providing advice, information and education to those impacted by the disease. PDS Biotech recently announced it is planning to initiate a randomized, controlled Phase 3 trial of the company's lead clinical candidate, PDS0101, in combination with KEYTRUDA for the potential treatment of human papillomavirus 16-positive head and neck cancer. A growing number of head and neck cancers are caused by HPV and 90% of HPV-associated head and neck cancers in the US are reported to be caused by HPV16, as reported in a study published in the Journal of Clinical Medicine. PDS Biotech is currently running - VERSATILE-002 - a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 in combination with KEYTRUDA in adults with HPV16 recurrent or metastatic head and neck squamous cell carcinoma. Data reported at the American Society for Clinical Oncology Annual Meeting in 2022 indicated the combination therapy achieved an objective response rate of 41%, a clinical benefit rate of 77%, and an overall survival rate of 87% at nine months in 17 evaluable patients. Following the release of these data, the U.S. Food and Drug Administration granted the combination of PDS0101 and KEYTRUDA Fast Track designation.

08:14 EDT Transcode Therapeutics enters agreement with Triton Funds - TransCode Therapeutics announced that it has entered into a definitive securities purchase agreement with Triton Funds, LP for the sale of 60 shares of the Company's Series A Convertible Preferred Stock, each with a stated value of $10,000 per share, for an aggregate purchase price of $500,000 in a registered direct offering. Each share of Series A Preferred Stock is convertible at any time after issuance at the option of the holder into a number of shares of Common Stock equal to the Stated Value of $10,000 per share of Series A Preferred Stock divided by the conversion price of $0.60, subject to certain conversion price adjustments based on share price performance.

08:13 EDT Enphase Energy launches IQ batteries in France, Netherlands, Switzerland - Enphase Energy announced that it has started shipping IQ Batteries to customers in France, the Netherlands, and Switzerland, further expanding the product's availability in the European market. SolarPower Europe released its latest European Market Outlook for residential battery storage and is predicting significant growth across the continent in the coming years. The report predicts up to 11 GWh of residential battery storage could be installed by the end of 2026, which is nearly 5x growth from the 2.3 GWh installed in 2021. "We're excited to work with our growing installer network across Europe to deliver Enphase's industry-leading home energy systems," said Marco Krapels, vice president of international sales at Enphase Energy. "Enphase is committed to delivering high-quality products and services that will help installers and customers maximize the value of the systems from start to finish in these important solar and storage markets."

08:12 EDT Akari Therapeutics presents case study from Phase 3 Part A trial of nomacopan - Akari Therapeutics announced the upcoming presentation of a case study, Clinical Response to Nomacopan in the Paediatric HSCT-TMA Setting, on Sunday, April 23rd at 8:30 am. The poster presentation will take place at The European Society for Blood and Marrow Transplantation in Paris, France. Nomacopan is an investigational bispecific inhibitor of both complement C5 and leukotriene B4 currently in Phase 3 clinical trials for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy advancing into pivotal Part B later this year.

08:10 EDT Greenbrook TMS amends master sales agreement with Neuronetics - Greenbrook TMS (GBNH) announced that the company has amended its amended and restated master sales agreement between the company and Neuronetics (STIM), pursuant to which the company and Neuronetics have agreed to convert the company's outstanding account balance payable to Neuronetics for the supply of TMS devices and treatment sessions to the company from Neuronetics in the amount of approximately $5.7M, together with Neuronetics' out-of-pocket transaction costs, into a $6M secured promissory note. The Neuronetics Note, together with the company's recently-announced restructuring plan and $8.25M equity and debt financings, is expected to provide additional cash flow relief to the company.

08:09 EDT Pacira announces repayment, termination of Term Loan B Facility - Pacira BioSciences announced the repayment on March 31, 2023 of $287.5 million in Term Loan B debt, which represented all outstanding principal under the facility, using net proceeds from a new $150 million 5-year Term Loan A Facility and existing cash resources. After the debt repayment, the company expects to finish the first quarter of 2023 with approximately $180 million in cash and investments. The $150 million Term Loan A Facility was placed with high-quality commercial banks. JPMorgan Chase Bank, N.A. acted as Sole Lead Arranger / Bookrunner and Administrative Agent.

08:08 EDT Global Crossing Airlines enters ACMI wet lease agreement with TUI Airlines - Global Crossing Airlines Group announced the signing of an ACMI wet lease agreement to operate twoAirbus A320 aircraft for TUI Airlines Netherlands, for use in its European summer programs. GlobalX will provide the Aircraft and qualified crews to TUI for peak season flying in July and August, 2023 as well as in 2024 and 2025. From a base of operations in Amsterdam, GlobalX will provide daily flights throughout Europe.

08:07 EDT Procept BioRobotics announces United Healthcare coverage of Aquablation therapy - PROCEPT BioRobotics Corporation announced that United Healthcare published an update to its Prostate Surgeries and Interventions Policy Bulletin that states Aquablation therapy is proven and medically necessary for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia when performed according to the FDA labeled indications, contraindications, warnings and precautions. The updated policy follows Aquablation's FDA label and is effective June 1, 2023. "We are very excited to announce the updated policy from United Healthcare and believe this will greatly improve accessibility of Aquablation therapy for men suffering from BPH." said Reza Zadno, President and CEO. "With the addition of United Healthcare, we estimate approximately 95% of all men in the United States now have access to Aquablation therapy."

08:06 EDT NeuroBo Pharmaceuticals submits NDA to FDA for Phase 2a trial of DA-1241 - NeuroBo Pharmaceuticals announced that it has submitted an Investigational New Drug application to the U.S. FDA. The IND application supports a Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 agonist, in development for the treatment of nonalcoholic steatohepatitis.

08:06 EDT Enlivex, BeiGene collaborate to evaluate Allocetra with Tislelizumab - Enlivex Therapeutics (ENLV) announced a clinical collaboration with BeiGene (BGNE). to evaluate the safety and efficacy of Allocetra, an investigational macrophage-reprogramming cell therapy, in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor, for the treatment of patients with advanced-stage solid tumors. Under the terms of the clinical collaboration agreement, Enlivex has agreed to amend its ongoing Phase I/II trial in patients with advanced-stage solid tumors to include evaluation of Allocetra in combination with tislelizumab. The Phase I/II trial is a multicenter, open-label, dose escalation trial that is expected to enroll up to 48 patients with advanced solid tumors across two trial stages. Stage 1 of the trial will examine escalating doses of Allocetra monotherapy administered intravenously or intraperitoneally once a week for three consecutive weeks. Stage 2 will evaluate escalating doses of Allocetra administered IV or IP and combined with anti-PD1 therapy. BeiGene will provide the clinical supply of tislelizumab for the trial.

08:05 EDT Raytheon Technologies awarded $1.2B contract from U.S. Army - Raytheon Technologies was awarded a $1.2B foreign military sales contract from the U.S. Army to provide Switzerland with the Patriot air defense system. With the sale, Switzerland becomes the 18th global Patriot partner and the eighth European country to choose the system as the backbone of their air defense. The contract includes five Patriot fire units and a quantity of Guidance Enhanced Missiles, known as GEM-T. The missile is proven to defeat tactical ballistic missiles, cruise missiles and enemy aircraft.

08:03 EDT Mars to acquire Heska for $120.00 per share - Mars and Heska announced that they have entered into a definitive agreement under which Mars will acquire Heska for $120.00 per share. The transaction price represents a premium of approximately 38% over Heska's 60-calendar day volume weighted average price and a premium of approximately 23% over Heska's closing stock price as of March 31. The agreement has been unanimously approved by the boards of directors of both companies. Upon transaction close, Heska will join Mars Petcare, a purpose-driven global business serving pets and pet owners through products and services within veterinary health and diagnostics, nutrition, innovation, and technology. This acquisition will enable the Science & Diagnostics division of Mars Petcare to expand its diagnostic offerings and broadly promote point-of-care veterinary diagnostics to the global pet healthcare community. The transaction includes customary closing conditions, including Heska shareholders' and regulatory approvals, and is anticipated to close in the second half of 2023.

08:01 EDT Mars to acquire Heska for $120.00 per share

07:45 EDT Novartis' Sandoz announces EC approval for HCF Hyrimoz - Sandoz, a Novartis division, announced that the European Commission granted marketing authorization in the European Union for a citrate-free high concentration formulation, or HCF, of its biosimilar Hyrimoz. The approval includes all indications covered by the reference medicine: rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. Rebecca Guntern, Head of Region Europe, Sandoz, said: "With eight marketed biosimilars Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe with more than two decades of experience. Today's approval brings Sandoz one step closer to providing European patients with chronic conditions an additional treatment option that offers increased convenience and a reduction in injection volume."

07:42 EDT Windtree Therapeutics expects cash to fund operations into 2Q23 - As of December 31, 2022, the Company reported cash and cash equivalents of $6.2 million, which is expected to be sufficient to fund operations into the second quarter of 2023.

07:40 EDT Entourage Health issues deferred share units, enters shares-for-debt agreements - Entourage Health announced that, in accordance with the provisions of its omnibus equity incentive compensation plan, the Company has authorized the issuance of an aggregate of 1,600,000 deferred share units to non-management directors of the Company as compensation for their services. The DSUs will vest on March 31, 2024 and are granted in lieu of cash compensation for services rendered during the first quarter of 2023. The Company's board of directors has approved a cap on the number of DSUs payable to each director as part of their quarterly fee payment at 400,000 DSUs. By capping the number of DSUs issuable to directors, the Board is providing the Company with more flexibility to grant equity awards to management, creating greater incentives to drive improvements in shareholder value. The purpose of the Omnibus Plan is to promote greater alignment of interests between the Company's shareholders and directors and management while reducing the cash expense of compensating its directors. Further details regarding the Omnibus Plan are available in the Company's management information circular dated May 8, 2022, which is available on SEDAR. The Company is also pleased to announce it has entered into shares-for-debt agreements with certain senior employees of the Company, under which the Company will, subject to the approval of the TSXV, issue up to an aggregate of 1,423,057 common shares of the Company at a deemed price of $0.03 per share in satisfaction of approximately $91,522.56, less required employer deductions and withholdings, owing to such senior employees. By entering into these agreements, the Company is preserving cash while also promoting share ownership within the leadership ranks of the business, further incentivizing management to deliver value back to the Company's shareholders over the long term.

07:38 EDT Enovix receives UL1642, a global safety certification for its wearable cells - Enovix Corporation announced it received UL1642 certification for its first wearable lithium-ion battery cells. UL1642 is a voluntary certification from Underwriters Laboratories, UL, a global leader in applied safety science. Enovix battery cells underwent stringent, 3rd party testing including impact, overcharge, vibration, crush, shock and short-circuit tests in order to receive UL1642 certification. The tests demonstrate that Enovix cells are designed to withstand harsh conditions. "UL1642 certification provides the assurance to our customers that they are receiving not only a product with high energy density and capacity, but also one that meets strict safety standards for use in various electronic products," said Jesse Griggs, Vice President, Quality. "Our commitment to safety, quality and reliability is at the forefront of every cell we design, and we take great pride in delivering products that exceed our customers' expectations." Additionally, Enovix received IEC62133 certification for its wearable cells, one of the most important standards for exporting lithium-ion batteries into global markets.

07:37 EDT Arrowhead earns $30M milestone payment from GSK through GSK4532990 trial - Arrowhead (ARWR) announced that it earned a $30M milestone payment from GSK (GSK) following the start of GSK's Phase 2b trial of GSK4532990, formerly called ARO-HSD, an investigational RNA interference (RNAi) therapeutic for the treatment of patients with non-alcoholic steatohepatitis (NASH). GSK4532990 is being developed under the November 2021 exclusive license agreement between Arrowhead and GSK. GSK received an exclusive license to develop and commercialize GSK4532990 in all territories except Greater China, which was retained by Arrowhead. GSK is wholly responsible for further clinical development and commercialization, outside of Greater China. GSK4532990 targets HSD17B13, a member of the hydroxysteroid dehydrogenase family involved in the metabolism of hormones, fatty acids, and bile acids. Published human genetic data indicate that a loss of function mutation in HSD17B13 provides strong protection against alcoholic hepatitis, cirrhosis, and NASH, with approximately 30-50% risk reduction compared to non-carriers. The double-blind, placebo-controlled Phase 2b HORIZON trial will evaluate the efficacy and safety of GSK4532990 in adults with pre-cirrhotic NASH. It will enroll up to 246 participants.

07:36 EDT American Hotel Income Properties announces support agreement with securityholder - American Hotel Income Properties REIT announced that the annual meeting of unitholders of AHIP will be held in Vancouver on June 8, 2023 and that AHIP and its general partner, American Hotel Income Properties REIT, have entered into a support agreement with K2 Principal Fund L.P. and K2 & Associates Investment Management. The K2 Group is a significant securityholder of AHIP. The Support Agreement provides for, among other things, the right of the K2 Group to nominate one individual for election to the board of directors of AHIP GP at the Meeting. For purposes of the Meeting, the K2 Group has identified Josef Vejvoda as its nominee. Vejvoda acts as a special advisor to K2. The Support Agreement also provides the K2 Group with the right to nominate one individual for election to the Board for the purposes of the 2024 annual meeting of AHIP's unitholders and sets out customary standstill restrictions and voting covenants which the K2 Group will be bound by until the later of the day immediately after the 2024 Meeting or June 30, 2024 and thirty days after the K2 Group ceases to have a nominee serving on the Board.

07:35 EDT Cyclerion enters negotiation period, binding equity investment agreement - Cyclerion Therapeutics announced that the Board of Directors of the Company, acting solely by all of its independent and disinterested members, has reviewed a non-binding proposal received on March 17, 2023 from an entity formed by investors that include the Company's Chief Executive Officer, CEO, to purchase the Company's zagociguat and CY3018 assets. After consultation with its legal and financial advisors, the Independent Board has concluded that the proposal merits further pursuit. Cyclerion has entered an exclusive negotiation arrangement for a limited period to allow the parties to negotiate binding documentation. In addition, Cyclerion has entered into a binding agreement with CEO Peter Hecht for him to make an equity investment in Cyclerion of $5M in cash for common stock or nonvoting convertible preferred stock of Cyclerion, the purchase price, consistent with Nasdaq rules, to be at or above the market price at the time of signing that agreement. The closing of the equity investment is contingent upon negotiation and completion of definitive documentation associated with the above transaction and would take place six business days after the signing of these documents. The proceeds are intended to support ongoing operations. The transaction remains subject to approvals by the Board of Directors and Cyclerion shareholders.

07:33 EDT OpGen's Curetis meet milestones in research project with InfectoGnostics - OpGen reported that it has completed two interim milestones as part of its collaboration project with InfectoGnostics under the PREPLEX grant. The InfectoGnostics Research Campus Jena is a public-private partnership breaking new ground in the diagnosis of infections. Following sample collection over the course of one year, various testing methods to detect carbapenemase resistance were evaluated during this phase of the collaboration. Novel markers were identified for phenotypic carbapenemase resistance in Klebsiella pneumoniae and Pseudomonas aeruginosa, two of the pathogens of concern on the World Health Organization's list. These markers were also confirmed and validated using the proprietary ARESdb database at OpGen's subsidiary Ares Genetics in Vienna, Austria. The Ares team applied its unique machine learning and AI capabilities to support the research project. Dr. Gerd Luedke, Director Innovation, Technology and IP at OpGen's subsidiary Curetis commented: "We are excited to complete several key milestones in this joint research collaboration. We believe that the discovery of novel biomarkers for antimicrobial resistance will be crucial in developing novel cutting-edge tools to fight the ever-growing threat of antimicrobial resistance and enhance antibiotic stewardship in our hospitals. And seeing the AI that our colleagues at Ares have developed successfully validate the research work is extremely gratifying. This success could open up the potential for additional collaborative work being conducted under the PREPLEX project which could provide additional funding of a few hundred thousand dollars to OpGen's Curetis research team in the coming years."

07:28 EDT Western Digital provides information on network security incident - In a regulatory filing, Western Digital provided information regarding a network security incident involving some of its systems and the company's active response to this matter. "On March 26, 2023, Western Digital identified a network security incident involving Western Digital's systems. In connection with the ongoing incident, an unauthorized third party gained access to a number of the Company's systems. Upon discovery of the incident, the Company implemented incident response efforts and initiated an investigation with the assistance of leading outside security and forensic experts. This investigation is in its early stages and Western Digital is coordinating with law enforcement authorities. The Company is implementing proactive measures to secure its business operations including taking systems and services offline and will continue taking additional steps as appropriate. As part of its remediation efforts, Western Digital is actively working to restore impacted infrastructure and services. Based on the investigation to date, the Company believes the unauthorized party obtained certain data from its systems and is working to understand the nature and scope of that data. While Western Digital is focused on remediating this security incident, it has caused and may continue to cause disruption to parts of the Company's business operations. The Company will provide updates as appropriate."

07:20 EDT Electrovaya completes purchase of industrial site in Jamestown, NY - Electrovaya closed the previously announced purchase of its planned manufacturing site in Jamestown, New York as of March 31 2023. The site includes 52 acres of land, including a building previously utilized for the manufacturing of electronic components. Electrovaya expects to start battery system assembly at the Jamestown facility later in calendar year 2023 and is planning significant investments at the site to enable production of its proprietary lithium ion ceramic cells. Electrovaya's battery products have best in class safety and cycle life and the company sees growing demand in electric heavy duty vehicles and energy storage applications utilizing its technology. The Jamestown site has access to low cost renewable energy as agreed with the New York Power Authority. The site is well connected to transportation, has excellent room for expansion, and has close proximity to the company's existing facilities in Ontario in addition to current and prospective OEM customer manufacturing facilities.

07:16 EDT Smart for Life releases Chairman's video report - Smart for Life announced the release of a video report provided by the Company's Founder and Chairman. The unscripted and candid video report provides an overview of the Company's activities during the past year, including significant developments and achievements, as well as updated information on the Company's most recent acquisitions and products. In addition, the video report will delve into the Company's future initiatives, including its acquisition pipeline, engagement of buyside professionals, and anticipated breakeven metrics. As a result, the video report will contain various forward-looking statements on the Company's future prospects and growth opportunities.

07:15 EDT ABM announces Momentum Support rebrand - Momentum Support has officially rebranded as ABM, following the company's acquisition in April 2022 by ABM. ABM's acquisition of Momentum represented ABM's entry into the Irish market. Along with providing access to Momentum's blue-chip customer base, the acquisition is providing the opportunity to cross sell to legacy ABM clients who have a footprint in Ireland. "With Momentum, we long recognized a terrific business led by a strong leadership team and an experienced and dedicated workforce, with shared values and a culture that aligned with ABM. This belief has been proven by the seamless and collaborative integration over the past year that led us to this exciting moment," said Rene Jacobsen, ABM's Chief Operating Officer. "While the name of the business is changing, customers and team members can rest assured that the award-winning service and outstanding culture will remain the same. We look forward to continuing to work with our team in Ireland to expand the business and grow the solutions and services we can offer our clients."

07:14 EDT Arvinas appoints Page as SVP, Global Head of Oncology Strategy, Program Leader - Arvinas (ARVN) announced that Kelly Page has joined the company as Senior Vice President, SVP, Global Head of Oncology Strategy and Program Leadership. Page has over 25 years of global pharmaceutical industry experience from the research setting through global commercialization, with nearly 20 years of experience in oncology therapeutics. She recently served as Vice President, Head of Global Commercial, Hematology at AstraZeneca (AZN), where she was responsible for ensuring the successful commercialization of CALQUENCE.

07:12 EDT Stratasys board rejects proposal received from Nano Dimension - Stratasys (SSYS) announced that its Board of Directors has unanimously rejected the revised unsolicited proposal received from Nano Dimension (NNDM) on March 29 to acquire Stratasys for $19.55 per share in cash. Consistent with its fiduciary duties, and in consultation with its independent financial and legal advisors, the Stratasys Board of Directors carefully reviewed and evaluated the revised proposal. Following its review, the Stratasys Board concluded that Nano's proposal continues to substantially undervalue Stratasys in light of its standalone prospects and is not in the best interests of Stratasys and its shareholders. The Stratasys Board and management team are confident that Stratasys' standalone plan will create significantly greater value for its shareholders than the Nano proposal. In addition, Stratasys believes it is important to set the record straight on the many misleading statements made by Nano's CEO, Mr. Yoav Stern, including the following: Contrary to statements made by Mr. Stern, Stratasys' CEO Dr. Yoav Zeif has met with Mr. Stern only once, on March 9, 2023. This meeting was at Mr. Stern's request. Dr. Zeif did not indicate any support for the proposal and made it clear that Stratasys would respond once the Board's review of Nano's proposal was completed. Other than this one meeting, there has been no contact or substantive discussion between Dr. Zeif and Mr. Stern, any directors or any other representatives from either company. The composition and authority of Nano's board and management, generally, and hence their authority to submit and follow through on a bona fide acquisition proposal, remain unclear due to Nano's pending court litigation with its largest shareholder, Murchinson Ltd. Murchinson requisitioned a meeting of Nano shareholders to, among other things, remove Mr. Stern and three other Nano directors and elect two new directors, with the goal of "reporting out to shareholders within 60 days of new directors being seated a cohesive strategy for enhancing value." Murchinson announced that the Nano shareholder meeting was held on March 20 and that all of the changes regarding the composition of Nano's board, including the removal of Mr. Stern, were approved. Thus, Nano's revised proposal, in addition to substantially undervaluing Stratasys, is also subject to significant uncertainty as to the composition, leadership and decision-making authority of Nano's board. Pending the Israeli Court's ruling on the March 20, Nano shareholder meeting and hence on the composition of its board, Nano's authority to make and follow through on an acquisition proposal remains in question.

07:12 EDT Ascendis announces FDA notified it of deficiencies in NDA for TransCon PTH - Ascendis Pharma announced that the U.S. Food & Drug Administration, FDA, has notified the Company that, as part of their ongoing review, the FDA has identified deficiencies in the Company's New Drug Application, NDA, for TransCon PTH in hypoparathyroidism that at this time precludes them from holding further discussions about labeling and post-marketing requirements/commitments. The deficiencies were not disclosed in the letter. The FDA also stated that this does not reflect their final regulatory decision on the Company's application. "This notification from FDA relates to their review of our NDA, and since the NDA deficiencies were not disclosed in the letter, we are eager to work with FDA to learn, understand, and address them. This development a month from the agency's PDUFA action date may lead to a delay in the FDA's final regulatory decision on the TransCon PTH NDA," said Jan Mikkelsen, Ascendis Pharma's President and Chief Executive Officer. "The safety of patients remains our highest priority and, since our NDA submission, no new safety signals have been observed to date in our ongoing TransCon PTH Phase 2 and Phase 3 clinical trials or in our Expanded Access Program program and these programs continue unchanged." To date, 145 out of 154 clinical trial participants continue to be treated with TransCon PTH in Phase 2 and Phase 3 clinical trial open label extensions, including 57 patients in the Phase 2 PaTH Forward Trial, 76 in the Phase 3 PaTHway Trial, and 12 in the Phase 3 PaTHway Japan. In these studies, TransCon PTH has been generally well tolerated, with no discontinuations related to study drug.

07:10 EDT Macau reports March casino revenue up 246.9% to 12.734B patacas - Macau's gaming bureau reported March gross revenue from games of fortune in the region was up 246.9% year-over-year to 12.74B patacas. Publicly traded companies in the Macau gaming space include Las Vegas Sands (LVS), MGM Resorts (MGM), Wynn Resorts (WYNN) and Melco Resorts (MLCO). Reference Link

07:08 EDT Entera Bio provides guidance from FDA Type D meeting related to EB613 - Entera Bio announced feedback from its Type D Meeting with the U.S. Food and Drug Administration related to EB613's proposed registrational program for the treatment of postmenopausal women with osteoporosis. Entera submitted a draft phase 3 study protocol and requested the FDA's written responses to two questions. On the first question, "Based on the FDA's feedback provided in the Type C meeting written response August 19, 2022, and subsequent teleconference held on September 27, 2022, the Sponsor has updated the Phase 3 protocol design including the use of Total Hip Bone Mineral Density as the primary endpoint. Does the FDA concur that the revised protocol meets its expectations?" the FDA responded that it is not opposed to the use of BMD as a surrogate for fracture, including initiating a study under the proposed Foundation for the National Institutes of Health Bone Quality Project pathway, which is undergoing review. The FNIH-BQP approach to BMD as a surrogate endpoint for fracture was first discussed with Entera during its End of Phase 2 Meeting with the FDA. In the Type D meeting responses, the FDA confirmed to Entera that a 24-month placebo-controlled phase 3 trial with the primary efficacy analysis at 24 months is acceptable and provided some guidance on the statistical evaluation of the study. On the second question, "Does FDA agree that the design of the population PK and exposure response evaluation incorporated in the draft Phase 3 study protocol meets FDA expectations?" FDA responded that the Company's proposed PK sampling scheme in the phase 3 study seems reasonable. "We thank the FDA for our Type D Meeting and their ongoing support for our EB613 program. We are very pleased that the agency has re-affirmed its acceptance of BMD as an endpoint and our placebo-controlled design. We will continue our dialogue with the FDA and we will be ready to initiate our study once the FDA provides us with final guidance on their review of the FNIH-BQP. The ethical concerns associated with placebo-controlled fracture endpoint studies in osteoporotic patients at high risk of fracture is a critical barrier to new drug development for this common disorder. Entera is proud to be part of this incredibly significant process with FDA, which is also sponsored by the ASBMR. Our conviction that EB613, as the first potential oral osteoanabolic treatment, may help millions of women globally is unwavering; and we look forward to initiating our pivotal Phase 3 study under this critical initiative. Meanwhile, we are preparing to start the PK study for our next generation platform, which may enable us to advance our EB612 program for the treatment of hypoparathyroidism into Phase 2 in 2024," stated Miranda Toledano, CEO.

07:07 EDT FibroGen completes patient enrollment in ZEPHYRUS-2 - FibroGen announced the completion of patient enrollment for ZEPHYRUS-2, a Phase 3 clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis, a chronic, progressive, and fatal lung disease."We are pleased to announce the completion of enrollment for our second Phase 3 study of pamrevlumab in IPF," said Mark Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen. "The ZEPHYRUS program consists of two phase 3 clinical trials that will evaluate the ability of pamrevlumab to attenuate fibrosis and lung function decline in patients with idiopathic pulmonary fibrosis. IPF is a fatal progressive disease, and patients need new treatment options to improve their clinical outcomes."

07:06 EDT Ovintiv to acquire PetroLegacy Energy, Piedra Resources for $4.28B - Ovintiv announced it has entered into a definitive purchase agreement to acquire substantially all leasehold interest and related assets of Black Swan Oil & Gas, PetroLegacy Energy and Piedra Resources, which are portfolio companies of funds managed by EnCap Investments, in a cash and stock transaction valued at approximately $4.28B. Upon closing, the acquisition will add approximately 1,050 net 10,000 foot well locations to Ovintiv's Permian inventory and approximately 65,000 net acres in the core of the Midland Basin, strategically located in close proximity to Ovintiv's current Permian operations. The transaction has been unanimously approved by Ovintiv's board of directors. Under the terms of the agreement, the NMB sellers will receive approximately 32.6M shares of Ovintiv common stock and $3.13B of cash. The cash portion of the transaction is expected to be funded through a combination of cash on hand, cash proceeds received from the company's pending sale of its Bakken assets located in North Dakota to Grayson Mill Bakken, a portfolio company of funds managed by EnCap, totaling approximately $825M, as well as borrowings under the company's credit facility and/or proceeds from new debt financing. Ovintiv has received fully committed bridge financing from Goldman Sachs Bank USA and Morgan Stanley. Ovintiv remains committed to its capital allocation framework which returns at least 50% of post base dividend non-GAAP free cash flow to shareholders through buybacks and/or variable dividends. At March 30, 2023 strip pricing, the company expects the transactions to drive more than 25% higher cash returns per share over the next twelve months following the close of the transactions and more than 40% higher cash returns per share in 2024.

07:05 EDT Genenta announces extension of license agreement with OSR - Genenta Science announced that the license agreement with Ospedale San Raffaele, OSR, has been amended and restated to provide access to all solid tumor indications, subject to governmental consent as described below. "We are pleased to reaffirm Genenta's collaboration with OSR by expanding our license agreement and providing our platform access to all solid tumor indications," said Pierluigi Paracchi, Chief Executive Officer of Genenta. "This agreement will strengthen the breadth of our IP position and confirm options for combination treatments and other potential payloads. Promising preliminary clinical data generated in the ongoing study of our first solid tumor indication in glioblastoma supports our decision to expand the license to cover all solid tumors and primes our ability to impact other hard-to-treat cancer types." The amended and restated license agreement reinforces Genenta's long-term strategic relationship with OSR, who contributes unique and valuable expertise to the development of cell-based therapies. Genenta has exclusive worldwide commercial rights to Temferon, which was originally developed by a team led by Genenta co-founder Luigi Naldini in the SR-Tiget laboratories, a world-leading cell and gene therapy research institution formed in a joint venture between OSR and Fondazione Telethon.

07:04 EDT Tango Therapeutics announces FDA clearance of IND application for TNG260 - Tango Therapeutics announced that the U.S. Food and Drug Administration, FDA, has cleared the Company's Investigational New Drug, IND, application for TNG260, a first-in-class inhibitor of the CoREST complex, for the treatment of STK11-mutant cancers. "FDA clearance of our IND application to initiate the TNG260 phase 1/2 trial is an important milestone in the development of this novel treatment for STK11-mutant cancers. STK11 mutations drive resistance to standard of care immunotherapy and are a major challenge in treating many cancers, including non-small cell lung cancer," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "We expect that TNG260 will be among the first oncology molecules to leverage the benefits of genetically-based patient selection with checkpoint inhibitor therapy. We look forward to initiating the Phase 1/2 clinical trial of TNG260 in the second half of 2023."

07:03 EDT OncoSec announces results from Phase 2 KEYNOTE-695 clinical trial - OncoSec Medical (ONCS) announced primary endpoint data from the Phase 2 KEYNOTE-695 clinical trial. This global, open-label single-arm trial is evaluating TAVO-EP, OncoSec's proprietary interleukin 12 encoding plasmid delivered by intratumoral electroporation, in combination with KEYTRUDA, Merck's (MRK) anti-PD-1 therapy, in patients with unresectable or metastatic melanoma who had confirmed disease progression after at least 12 weeks exposure to immediate prior anti-PD-1 antibody therapy. The last patient started treatment in December 2020; clinical database lock occurred in October 2022. The primary endpoint of overall response rate per RECIST v1.1 assessed by blinded independent central review (BICR) was not met. Among 98 efficacy evaluable patients with at least one post-baseline tumor assessment, the confirmed ORR per RECIST v1.1 by BICR assessment is 10.2%, which did not achieve the pre-specified clinically meaningful ORR of greater than or equal to17%. The BICR results for 98 efficacy evaluable patients are lower than the ORR per RECIST v1.1 by investigator assessment of 18.8% for the 101 patients previously reported as the key secondary endpoint of the KEYNOTE-695 trial. BICR assessment, i.e., review of the available images of treated and non-treated lesions by radiologists and oncologists, blinded to investigator assessments, showed that 4 patients had a complete response, 6 patients had a partial response, and 25 patients had stable disease as a best response, for a disease control rate of 35.7%. The durable response rate of greater than or equal to24 weeks is 8.2% and the median duration of response is 25.5 months.

06:58 EDT Ryder to add BrightDrop's electric vehicles to lease and rental fleet - Ryder System announced its plan to introduce 4,000 BrightDrop Zevo 600 and Zevo 400 electric vans to its lease and rental fleet through 2025, with the first 200 to be ordered this year. This announcement underscores the company's ongoing efforts to meet rising demand across the transportation and logistics industries for commercial electric vehicles. The expanded offering will enable Ryder customers to test and broaden their EV footprint, enhance the driver experience, and accelerate their sustainability initiatives.

06:55 EDT Endeavor Group, WWE to form global live sports, entertainment company - Endeavor Group Holdings (EDR) and World Wrestling Entertainment (WWE) announced that they have signed a definitive agreement to form a new, publicly listed company consisting of two complementary, global sports and entertainment brands: UFC and WWE. Upon close, Endeavor will hold a 51% controlling interest in the new company and existing WWE shareholders will hold a 49% interest in the new company. Together, UFC and WWE will have global reach, impressive scale and omnichannel distribution. On a combined 2022 fiscal year-end basis, UFC and WWE achieved revenue of $2.4B and a 10% annual revenue growth rate since 2019. The new company will be led by Ariel Emanuel CEO, who will also continue in his role as CEO of Endeavor, McMahon, Executive Chairman of the Board, and Mark Shapiro, who will be President and COO of both Endeavor and the new company. Dana White will continue in his role as President of UFC and Nick Khan will serve as President of WWE. The Board of Directors will consist of 11 members who will be appointed at a later date, six of whom will be appointed by Endeavor and five of whom by WWE. Together, UFC and WWE expect to deliver an estimated $50M to $100M in annualized run rate cost synergies by leveraging, among other things, Endeavor's back office and robust infrastructure. Endeavor also expects significant growth across revenue areas including domestic and international media rights, ticket sales and yield optimization, event operations, sponsorship, licensing and premium hospitality. Endeavor's success at UFC, including increasing commercial opportunities that have driven more than 2x Adjusted EBITDA growth since its acquisition in late 2016, demonstrates the significant value creation opportunity and upside potential of having UFC and WWE under one roof. The transaction values UFC at an enterprise value of $12.1B and WWE at an enterprise value of $9.3B. The transaction represents a contribution price of WWE of approximately $106 per share. Additionally, UFC and WWE will each contribute cash to the new company so that it holds approximately $150M. At closing, Endeavor intends to sweep all excess cash at UFC, and shareholders of the new company are expected to receive a post-closing dividend. Under the terms of the transaction, existing WWE shareholders will roll all existing equity into the new entity that will be the parent company of UFC and WWE and intends to list on the New York Stock Exchange under the ticker symbol "TKO". The listing of NewCo will expand the collective investor base to allow for broad market participation across Endeavor and NewCo. The transaction has been unanimously approved by the Executive Committee of the Board of Directors of Endeavor and by the Board of Directors of WWE. The transaction is subject to the satisfaction of customary closing conditions, including receipt of required regulatory approvals. The transaction is expected to close in the second half of 2023. This marks the conclusion of WWE's strategic alternatives review process.

06:55 EDT Spire Global awarded contract by the National Reconnaissance Office - Spire Global was awarded a contract by the National Reconnaissance Office for commercial radio frequency remote sensing. Spire won a contract as part of the NRO's Strategic Commercial Enhancements Broad Agency Announcement program in September 2022. Spire is proud to announce two options were exercised extending the performance period through March 1, 2025. The agency will continue to use Spire's data to evaluate how commercial radio frequency will be integrated into its overhead architecture. The contract demonstrates the agency's commitment to expand the acquisition and integration of commercial space-based data for situational awareness and to address new intelligence challenges.

06:50 EDT CNX Resources announces multi-billion-dollar clean ammonia production facility - A multi-billion-dollar clean ammonia production facility is advancing in Mingo County, West Virginia, with anticipated construction beginning in 2024, Adams Fork Energy, CNX Resources and other partners announced. The Adams Fork Energy clean ammonia project, jointly developed by Adams Fork Energy, LLC and the Flandreau Santee Sioux Tribe, is expected to have initial annual ammonia production capacity of 2,160,000 metric tons, with optional additional production capacity. Project developers have entered into a strategic partnership with CNX, one of the lowest carbon intensive natural gas producers in the lowest emissions basin in the United States, to provide fuel and carbon sequestration services. The project is expected to support 2,000 well-paying construction jobs, including pipefitters and electrical workers, as well as generate significant tax revenues and capital investment for underserved Mingo County in Southern West Virginia. The planned facility is also located on a reclaimed coal mining site near Gilbert Creek, West Virginia, further aligning the project with the White House's Justice40 Initiative.

06:47 EDT BioNTech, DualityBio form global strategic partnership - BioNTech and Duality Biologics announced that the companies have entered into exclusive license and collaboration agreements for two ADC assets to develop, manufacture and commercialize the two assets globally, excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region. With this collaboration, ADCs will become an additional drug class in BioNTech's oncology portfolio with the aim to further support BioNTech's mission of developing highly efficacious therapies for cancer patients at every stage of disease. As part of the collaboration, BioNTech will gain access to DualityBio's lead candidate, DB-1303, which is a topoisomerase-1 inhibitor-based ADC directed against Human Epidermal Growth Factor Receptor 2, a target that is overexpressed in a variety of cancers, which contributes to the aggressive growth and spread of cancer cells. Antibody therapy targeting HER2 has been shown to be an effective treatment strategy for HER2-expressing cancers. The DB-1303 program received the Fast Track designation from the U.S. FDA and is currently in a Phase 2 clinical trial for HER2-expressing advanced solid tumors. BioNTech will also gain access to a second topoisomerase-1 inhibitor-based ADC candidate, DB-1311. Under the terms of the agreements, DualityBio will receive upfront payments for both asset licenses totaling $170M, and additional development, regulatory and commercial milestone payments for both assets, potentially totaling over $1.5 billion. DualityBio will be eligible to receive single-digit to double-digit tiered royalties on net sales for both ADC assets. BioNTech will hold commercial rights globally (excluding Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region), while DualityBio will retain commercial rights for Mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region. As part of the agreement for DB-1311, DualityBio has the right to exercise a co-development cost and profit/loss sharing option for DB-1311 for the U.S. market, as well as a co-promotion option for the U.S. market.

06:39 EDT Coinbase lists Signature Bank as option for customer funds - Coinbase disclosed on its website: "To the extent U.S. customer funds are held as cash, they are maintained in pooled custodial accounts at one or more banks insured by the FDIC. Our custodial accounts have been established in a manner to make pass-through FDIC insurance available up to the per-depositor coverage limit then in place. FDIC pass-through insurance protects funds held on behalf of a Coinbase customer against the risk of loss should any FDIC-insured bank(s) where we maintain custodial accounts fail. FDIC insurance coverage is contingent upon Coinbase maintaining accurate records and on determinations of the FDIC as receiver at the time of a receivership of a bank holding a custodial account. Below is a list of the insured depository institutions at which Coinbase may deposit customer funds: Signature Bank, JPMorgan Chase, Cross River Bank, Pathward (previously known as MetaBank). *Note: All Silvergate Bank accounts closed as of March 8, 2023." Reference Link

06:35 EDT Extra Space Storage to acquire Life Storage in an all-stock transaction - Extra Space Storage (EXR) and Life Storage (LSI) announced that the two companies have entered into a definitive merger agreement by which Extra Space will acquire Life Storage in an all-stock transaction. The combined company is expected to have a pro forma equity market capitalization of approximately $36B and total enterprise value of approximately $47B. Under the terms of the agreement, Life Storage shareholders will receive 0.8950 of an Extra Space share for each Life Storage share they own, representing a total consideration of approximately $145.82 per share based on Extra Space's share price close on March 31. At closing, Extra Space and Life Storage shareholders are expected to own approximately 65% and 35% of the combined company, respectively. The respective boards of directors of both Extra Space and Life Storage have unanimously approved the transaction. The transaction will increase the size of Extra Space's portfolio by more than 50% by store count with the addition of Life Storage's 1,198 properties, including 758 wholly-owned, 141 joint venture, and 299 third-party managed stores. In total, the transaction adds over 88M square feet to the portfolio. The combined portfolio represents the largest storage operation in the country with over 3,500 locations, over 264M square feet and serving over two million customers. Extra Space will retain its name and continue to trade on the NYSE under the ticker (EXR). Kenneth Woolley will remain chairman of the board and Joseph Margolis will remain as CEO and director. The Extra Space board will be expanded from 10 to 12 directors and will consist of nine directors from Extra Space's board and three directors from Life Storage. The transaction is currently expected to close in the second half of 2023, subject to the approval of Extra Space and Life Storage shareholders and satisfaction of other customary closing conditions.

06:31 EDT nVent Electric to acquire ECM Investors for $1.1B - nVent Electric announced that it has entered into a definitive agreement to acquire ECM Investors, the parent of ECM Industries, for a purchase price of $1.1B, subject to customary adjustments. ECM Industries is a provider of high-value electrical connectors, tools and test instruments, and cable management. nVent will conduct an investor teleconference at 9:30 a.m. ET today to provide more details about this acquisition. nVent expects the acquisition to be accretive to adjusted earnings per share in 2023 following completion of the transaction. On a GAAP reported basis, nVent estimates the acquisition to be accretive to earnings per share in 2024. The effective enterprise value multiple is approximately 10.6 times trailing twelve month ECM Industries' adjusted EBITDA. The transaction is expected to close in the second quarter of 2023, subject to customary conditions, including regulatory approval. nVent expects to fund the acquisition with a combination of available cash on hand and new debt.

06:02 EDT Cummins to invest more than $1B across its U.S. manufacturing network - On Monday, April 3, President Biden will visit Cummins in Fridley, Minnesota as part of his Administration's Investing in America tour. During the visit, President Biden will discuss how his Investing in America agenda is supporting manufacturing, innovation and a clean energy economy, as well as creating good-paying jobs in communities like Fridley and across the country. Coinciding with the visit, Cummins has announced that in addition to recent investments in Fridley, the company is investing more than $1B across its U.S. engine manufacturing network in Indiana, North Carolina and New York. The investment will provide upgrades to those facilities to support the industry's first fuel agnostic engine platforms that will run on low carbon fuels, including natural gas, diesel and eventually hydrogen, helping decarbonize the nation's truck fleets today.

05:55 EDT Apple wins appeal over U.K. mobile market competition probe - The U.K.'s Competition Appeals Tribunal ruled on Friday that the Competition and Markets Authority failed to stick to established statutory timeframes for an investigation of Apple's mobile browser and cloud gaming service. Reference Link

05:19 EDT Innate Pharma enters exclusive license agreement with Takeda - Innate Pharma (IPHA) announced that it has entered into an exclusive license agreement with Takeda (TAK) under which Innate grants Takeda exclusive worldwide rights to research and develop antibody drug conjugates, or ADC, using a panel of selected Innate antibodies against an undisclosed target, with a primary focus in Celiac disease. Takeda will be responsible for the future development, manufacture and commercialization of any potential products developed using the licensed antibodies.

05:12 EDT Paysafe appoints Nicole Carroll as chief strategy, innovation officer - Paysafe has appointed Nicole Carroll as its first ever chief strategy and innovation officer. Carroll joins the company and reports into Paysafe CEO, Bruce Lowthers. Carroll joins Paysafe from Experian where she was chief product officer for the company's Decisions Analytics business.