Stockwinners Market Radar for December 27, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:13 EST Cathie Wood's ARK Investment sold 56.3K shares of Tesla on Monday - Among the sales, ARK Investment also sold 46.5K shares of CoinBase (COIN), 54.0K shares of Roku (ROKU), 184.9K shares of Twitter (TWTR), and 121.1K shares of Teladoc (TDOC), stating: "All transaction activity today was for purposes of raising cash for the 2021 annual ETF distribution. This cash raise activity has been completed."

17:47 EST Flotek gets unsolicited indication of interest - Flotek Industries announced that it "has received an unsolicited indication of interest for a potential transaction for all or part of the Company. To assist in evaluating this unsolicited indication of interest, Flotek's Board of Directors has engaged Piper Sandler & Co. as a financial advisor to assist with the evaluation process. The Company has not set a timetable for the conclusion of its evaluation of the offer."

16:34 EST Travelzoo officer Bartel sells $313K in company shares - Officer of Travelzoo Holger Bartel disclosed in a filing that he had sold 30,668 shares of company stock at $10.20 per share on December 23, for a total transaction amount of $312,814.

16:23 EST Aspen Aerogels, BASF terminate supply arrangement - In a regulatory filing, Aspen Aerogels (ASPN) disclosed that on December 20, the company entered into the First Amendment to the Amended and Restated Supply Agreement and Termination of the Side Agreement with BASF Polyurethanes GmbH and BASF SE. The First Amendment terminates the supply arrangement between the company and BASF pursuant to which the company supplies certain aerogel products to BASF. Pursuant to the First Amendment, effective December 15, BASF no longer sells aerogel products covered under the supply arrangement with the company and the company retains all rights to sell the products. The company's obligations to repay any uncredited prepayment balances pursuant to the amended and restated supply agreement, dated February 16, 2018, by and between the company and BASF SE will remain outstanding and subject to repayment pursuant to the terms of the supply agreement, as amended. In connection with the First Amendment, effective as of the effective date, the company and BASF mutually terminated the side agreement that provided, among other things, the pricing arrangement governing the supply agreement, the filing stated.

16:20 EST KKR increases available amount under repurchase program to $500M - In a regulatory filing, KKR & Co. disclosed that it has increased the available amount under its repurchase program to $500M. "Under its repurchase program, shares of common stock of KKR & Co. Inc. may be repurchased from time to time in open market transactions, in privately negotiated transactions or otherwise. The timing, manner, price and amount of any repurchases will be determined by KKR in its discretion and will depend on a variety of factors, including legal requirements, price and economic and market conditions... KKR expects that the program, which has no expiration date, will be in effect until the maximum approved dollar amount has been used. The program does not require KKR to repurchase or retire any specific number of shares of common stock or equity awards, respectively, and the program may be suspended, extended, modified or discontinued at any time," the filing noted.

16:15 EST Mondelez director Reynolds sells $5.7M in company shares - Mondelez director Fredric Reynolds disclosed in a filing that he had sold 90,000 shares of company stock at $63.29 per share on December 14, for a total transaction amount of $5,696,415.

16:08 EST Broadcom COO Kawwas sells almost $1.3M in company shares - Broadcom COO Charlie Kawwas disclosed in a filing that he had sold 2,000 shares of company stock at $645.53 per share on December 22 for a total transaction amount of $1,291,066.

16:04 EST Middleby completes acquisitions of Kamado Joe, Masterbuilt and Char-Griller - The Middleby Corporation announced that it has finalized the previously announced acquisition of Masterbuilt Holdings, LLC and their residential outdoor brands Kamado Joe and Masterbuilt. Middleby also has completed the acquisition of Char-Griller, which it calls "a leader in residential outdoor charcoal and gas cooking products based in Atlanta." Char-Griller has revenues of approximately $150M in 2021, the company noted. "We continue to make strategic acquisitions that strengthen our three industry leading foodservice platforms. Char-Griller further adds to our product offerings for the outdoor market and the growing number of backyard cooking enthusiasts. With complementary customers and channels of distribution, Char-Griller provides Middleby Residential with added growth opportunities. There are meaningful synergies to leverage supply chain, manufacturing, product development and distribution capabilities. The addition of Kamado Joe, Masterbuilt and Char-Griller outdoor cooking brands expand the revenues of our Middleby Residential platform to more than $1 billion," said Tim FitzGerald, Middleby CEO.

12:00 EST ironSource falls -8.5% - ironSource is down -8.5%, or -69c to $7.50.

12:00 EST Azure Power falls -8.9% - Azure Power is down -8.9%, or -$1.65 to $16.92.

12:00 EST CNFinance rises 18.5% - CNFinance is up 18.5%, or 55c to $3.54.

10:18 EST Vuzix enters agreement with Verizon to leverage 5G, edge computing - Vuzix Corporation announced that the Company has entered into an agreement with Verizon to leverage the power of Verizon's 5G and edge computing technologies to deliver an augmented reality experience for sports and gaming. The agreement between Vuzix and Verizon will focus on the technology advancement and commercialization aspects of delivering immersive augmented reality training experiences powered by Verizon's 5G Ultra Wideband service and edge compute platform and Vuzix Shield smart glasses.

10:06 EST Zhangmen Education Inc (Class A ADS) trading halted, volatility trading pause

10:02 EST Hailiang Education Group trading resumes

10:00 EST Invitae falls -6.4% - Invitae is down -6.4%, or -$1.07 to $15.54.

10:00 EST Bird Global falls -7.1% - Bird Global is down -7.1%, or -52c to $6.78.

10:00 EST Zhangmen Education rises 8.2% - Zhangmen Education is up 8.2%, or 50c to $6.55.

09:52 EST Hailiang Education Group trading halted, volatility trading pause

09:47 EST Carnival falls -5.0% - Carnival is down -5.0%, or -$1.05 to $20.15.

09:47 EST Guild Holdings falls -6.4% - Guild Holdings is down -6.4%, or -91c to $13.20.

09:47 EST CNFinance rises 7.7% - CNFinance is up 7.7%, or 23c to $3.22.

09:46 EST Oncology Institute Inc trading resumes

09:40 EST HealthCor Catalio Acquisition Corp trading halted, volatility trading pause

09:31 EST Cognition Therapeutics Inc trading halted, volatility trading pause

09:27 EST Moderna announces Swiss government exercises option for 7M more booster doses - Moderna announced that the Swiss Federal Government has exercised its option to purchase an additional 7M doses of Moderna's booster vaccine for delivery in the second half of 2022. These doses are in addition to the initial seven million doses of booster vaccine the Swiss Federal Government agreed to purchase for delivery in 2022 and brings Switzerland's order commitment to a total of 27.5M doses.

09:18 EST Terreno Realty acquires Washington industrial property for $33.5M - Terreno Realty acquired an industrial property located in Woodinville, Washington on December 23 for a purchase price of approximately $33.5M.

09:09 EST Wrap Technologies announces international shipment of BolaWrap devices - Wrap Technologies announced the first international shipment of its next-generation technology, the BolaWrap 150 remote restraint device. The order follows the live demonstrations showcasing the benefits and features of the device that were given in October 2021.

09:05 EST FuelCell jumps over 6% to $6.87 per share after settling with POSCO Energy

09:01 EST Sorrento Mexico executes second contract for sale of 10M COVISTIX tests - Sorrento Therapeutics announced its subsidiary, Sorrento Therapeutics Mexico, has executed a second contract with a large distributor for the sale and distribution of up to 10M COVISTIX tests for the Mexican market. Sorrento previously announced that Sorrento Mexico had signed a contract with a leading local distributor for up to 5M COVISTIX tests in Mexico, bringing the total number of tests to 15M to date.

08:41 EST Gladstone Commercial acquires Crossville, Tennessee industrial space for $29M - Gladstone Commercial acquired a 300,000 square foot industrial facility, located on 16.3 acres in Crossville, Tennessee, for $29.M on December 21.The property is Gladstone Commercial's second industrial acquisition along the I-40 corridor in Tennessee. The property is 100% leased to CoLinx with 11.0 years of remaining absolute NNN lease term. The property serves as a mission critical distribution building as a part of CoLinx's central Crossville distribution network and is utilized for packaging, warehousing, and distribution of ball bearings and other mechanical parts on behalf of SKF, Timken, and Schaeffler. The acquisition of the industrial property is consistent with Gladstone Commercial's growth strategy of acquiring functional assets, leased to credit-worthy tenants in strong industrial locations.

08:34 EST Harbor Custom Development closes sale on 30 developed lots for $6.045M - Harbor Custom Development announced that it has closed on the sale of 30 developed lots in the Summit Rock golf course development in Horseshoe Bay Texas to Modern Homestead, LLC for $6,045,000.

08:32 EST Infobird enters into equity transfer agreement with Shanghai Qishuo - Infobird announced it had entered into an equity transfer agreement to acquire a 51% equity interest in Shanghai Qishuo Network Technology. Qishuo is a provider of consumer product and retail store digitalization solutions in the retail footwear industry and leading clothing brands. Infobird believes the acquisition of a 51% equity interest of Qishuo is an "important complimentary and synergistic strategic initiative and is expected to enable Infobird to accelerate its expansion into the consumer products and retail industry," the company said. Yimin Wu, Chief Executive Officer and Chairman of Infobird, commented: "We believe that China's consumer products and retail industry continues to have significant growth potential... Qishuo's product, Retail Rubik's Cube, provides an ideal solution for retailers that want to optimize the customer experience at their physical stores. By having a deep understanding of client store operations in China's consumer products and retail industry, Qishuo aims to empower companies with easy-to-use SaaS products that can provide deep insights of how to improve store performance and operations."

08:27 EST Microbot Medical up 75% to $9.45 after entering Robotic System deal with Stryker

08:19 EST Cenntro delivers first 200 Logistar 200 vehicles to European markets - Cenntro Automotive announced that it produced and shipped 628 the newly launched model Logistar 200, or LS200, a light urban delivery vehicle purpose-built to navigate European streets. The Company has experienced strong demand from its European and American customers for its new models. The company today also reaffirmed its 2022 guidance to deliver a minimum of 20,000 vehicles.

08:13 EST Moleculin announce preliminary interim results in Phase 1b/2 trial of annamycin - Moleculin Biotech reported preliminary interim results from its U.S. Phase 1b/2 clinical trial as it concluded the safety review of the third cohort and opens the fourth cohort in a dose escalation trial evaluating Annamycin for the treatment of soft tissue sarcoma, STS, lung metastases, which continues to document preliminary clinical activity for this drug. The Phase 1b/2 study is a U.S. multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose, MTD, or the recommended Phase 2 dose, RP2D, and safety of Annamycin. The Phase 2 portion of the study will explore the efficacy of Annamycin as a single agent for the treatment of subjects with STS with lung metastases for whom prior chemotherapy has failed, and for whom new chemotherapy is considered appropriate. The summary of interim data from the first three cohorts of the study are as follows: First Cohort: Two subjects had stable disease up to 6 cycles but were then discontinued due to progressive disease; One subject discontinued after the first cycle. The End of Study scan was performed, and stable disease was observed. However, the subject discontinued from the study because the initiation of the second cycle was delayed greater than 6 weeks from the previous dose. Second Cohort: In one subject, the scan at the end of the second cycle showed that there was a partial response and this was stable when the subject was scanned at the end of cycle 4. The subject subsequently discontinued from the study due to that subject electing to undergo surgical resection to potentially eradicate disease; One subject was discontinued from the study after 2 cycles after the end of cycle 2 scan revealed progressive disease; One subject received 1 cycle of treatment but discontinued treatment for reasons unrelated to Annamycin. The End of Study scan revealed progressive disease. Third Cohort: Efficacy data for the third cohort is incomplete as not all patients have received their scans. One subject received 1 cycle, without exhibiting any dose-limiting toxicities. An interim, unscheduled scan revealed progressive disease and the subject was discontinued from the study. One subject was discontinued from the study after 2 cycles after the end of cycle 2 scan revealed progressive disease. One additional subject was treated, also without evidence of any dose-limiting toxicities, and CT scans are scheduled in the near term.The statements above are based on interim data and should be considered preliminary and subject to change.

08:10 EST Cenntro delivers first 200 Logistar 200 vehicles to European markets - Cenntro Automotive announced that it produced and shipped 628 the newly launched model Logistar 200, or LS200, a light urban delivery vehicle purpose-built to navigate European streets. The Company has experienced strong demand from its European and American customers for its new models. The company today also reaffirmed its 2022 guidance to deliver a minimum of 20,000 vehicles.

08:09 EST S&P Global to sell CGS business to FactSet for $1.93B - S&P Global (SPGI) and IHS Markit (INFO) announced agreements to sell IHS Markit's Base Chemicals business to News Corp (NWS) and S&P Global's CUSIP Global Services, or CGS, business to FactSet Research Systems (FDS). These agreements represent progress toward completing the pending merger of S&P Global and IHS Markit. News Corp agreed to purchase the Base Chemicals business for $295M, and FactSet Research Systems has agreed to acquire CGS for $1.93B, with each agreement subject to customary purchase price adjustments. Each of these divestitures is dependent on closing the S&P Global-IHS Markit merger and other customary conditions. S&P Global and IHS Markit currently anticipate the combined company will receive aggregate net sale proceeds of approximately $1.3B from these transactions, of which proceeds are net of taxes and payments to CGS's industry partner. The divestitures remain subject to further review and approval by antitrust regulators. S&P Global and IHS Markit continue to expect to close their merger in the first quarter of 2022, subject to the satisfaction of closing conditions.

08:08 EST Metracrine CMO Hubert Chen resigns - Metacrine announced that Hubert Chen, M.D., chief medical officer, has resigned to pursue a new opportunity. Dr. Chen's resignation is effective December 31, 2021. Preston Klassen, M.D., MHS, CEO, is expected to assume responsibility for Metacrine's ongoing clinical trials and future clinical operations.

08:06 EST News Corp. to acquire Base Chemicals from IHS Markit for $295M in cash - News Corp. (NWS) announced that it has entered into an agreement to acquire the Base Chemicals business from S&P Global (SPGI) and IHS Markit (INFO). Base Chemicals will become part of Dow Jones' Professional Information Business, alongside OPIS, the energy and renewables data and information business. The OPIS acquisition, also from S&P Global and IHS Markit, was announced in August. The addition of Base Chemicals and OPIS will further enhance Dow Jones' information services business. News Corp is acquiring Base Chemicals for $295M in a cash transaction, subject to customary adjustments. The agreement was reached following the UK Competition and Markets Authority request that IHS Markit divest Base Chemicals as part of the S&P Global and IHS Markit merger plans. News Corp's acquisition of Base Chemicals is subject to customary closing conditions, including regulatory approvals and the completion of the S&P Global and IHS Markit merger. In addition, News Corp expects to receive a step up in tax basis resulting in an annual deduction over the next 15 years with an estimated tax benefit of approximately $46M on a present value basis. In its most recent fiscal year, ended November 30, Base Chemicals was expected to generate approximately $65M in revenues. Base Chemicals' revenues are geographically diverse, with more than 1700 customers across a wide range of industries, and approximately 185 employees. Its main products include Market Advisory Services, which provide pricing, insights and weekly/monthly reports; and World Analysis, which produces annual reports and maintains a database of trends and long-term forecasts. The total addressable market is expected to increase, with new demand anticipated for pricing data and insights and analysis resulting from the transition to renewables and related structural changes in the broader chemical industry. In the first quarter of FY22, Dow Jones recorded a 15% increase in revenues, compared to the same quarter last year, with segment EBITDA surging 32% that profitability was a record for a first quarter. Dow Jones' Professional Information Business experienced a 13% increase in revenues in the quarter.

08:05 EST Celularity receives Fast Track Designation for CYNK-001 - Celularity announced the U.S. Food and Drug Administration has granted Fast Track Designation for its non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy, CYNK-001, in development for the treatment of acute myeloid leukemia.

08:04 EST FuelCell reaches settlement agreement with POSCO Energy - FuelCell Energy (FCEL) announced that POSCO Energy (PKX) and its subsidiary, Korea Fuel Cell have entered into a settlement agreement with FuelCell Energy. Pursuant to the Agreement: FuelCell Energy confirms its exclusivity to sell its differentiated platform technology throughout Asia; All licenses previously granted to POSCO Energy are amended such that POSCO has the right to service the existing installed POSCO customer base, but enjoys no other rights to FuelCell Energy technology in South Korea or broader Asian markets; and All claims between the parties are fully and finally settled with the exception of two small claims being negotiated by the parties that have no impact on market access. Having reached an agreement, the parties are cooperating to ensure that existing customers are fully aware of the settlement and that a framework exists for POSCO to deliver module replacements per the service and support design specifications in the agreement. The parties are also communicating to the broader market that FuelCell Energy has the exclusive right to pursue new fuel cell projects in Asia.

08:02 EST Envista announces Novel Biocare N1 implant system receives FDA clearance - Envista announced that the U.S. Food and Drug Administration, FDA, has cleared the Nobel Biocare N1 implant system. The N1 implant system represents a "significant step forward in patient-centric implant solutions," the company said. N1 is a system of instruments, prosthetic components, and surgical protocols. New features of the system include an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance. Amir Aghdaei, Chief Executive Officer, Envista, stated, "For over 50 years, Nobel Biocare has been a pioneering force behind implantology. The demand for high quality patient-centric solutions is higher than ever, and the Nobel Biocare N1 system enables clinicians to set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can offer patients."

08:01 EST FactSet to acquire CUSIP Global Services from S&P Global for $1.925B

07:47 EST Capital Bancorp appoints Jerome Bailey to board of directors - Capital Bancorp announced new board member Jerome Bailey. Bailey is a member of the Bank's board and managing member of Bailey Real Estate Holdings. Since 2013, Bailey has held the position of Vice Chairman of the Board of the Bank as well as Chairman of the Board Loan Committee. Retiring from the board is Stephen Ashman.

07:32 EST Servotronics announces Trbovich resigns as CEO, removed as Chairman of Board - Servotronics announced that Kenneth Trbovich has resigned as Chief Executive Officer and President and was removed as Chairman of the Board, after a nearly six-month-long internal investigation identified grounds for his termination. While the Board of Directors conducts a search for a permanent replacement, the responsibilities of the CEO and President will continue to be carried out by other personnel, led by Chief Operating Officer James Takacs. Today's announcement follows a previously disclosed internal investigation, authorized by the Board on June 8 when Trbovich was placed on administrative leave, one day after a then-employee filed a civil complaint making allegations regarding the executive's conduct. The investigation was undertaken by independent, outside counsel. On Dec. 1, Mr. Trbovich was informed that grounds for termination were identified during the investigation and a Dec. 22 meeting was scheduled for the Board to hear from the executive and consider the matter. On Dec. 21, Trbovich resigned as CEO and President. At its Dec. 22 meeting, the Board accepted his resignation, removed him as Chairman, and based on the findings of the investigation determined that he committed willful malfeasance that would have justified termination. The Company has not disclosed other findings of the investigation, as they relate to personnel matters. While the former executive remains a director, the Company does not intend to renominate him for election to the Board at the 2022 annual meeting of shareholders.

07:25 EST BridgeBio Pharma trading halted, news pending

07:13 EST Microbot Medical collaborates with Stryker to develop LIBERTY Robotic System - Microbot Medical (MBOT) announced that it has entered into a strategic collaboration agreement with Stryker (SYK). The company will collaborate with Stryker's Neurovascular division to integrate its neurovascular instruments with Microbot's LIBERTY Robotic System to develop the world's first dedicated robotic procedural kits for use in certain neurovascular procedures. The company will continue to develop the LIBERTY Robotic System independently for use in peripheral and coronary procedures. The animal feasibility studies to date support the company's assertion that it will potentially allow physicians to safely and efficiently conduct remote catheter-based vascular procedures, and reduce the risk for radiation exposure, physical strain on the user and Hospital Acquired Infections, without the need for cumbersome and expensive capital equipment.

07:12 EST Talos Energy releases 2021 ESG report - Talos Energy published its second annual environmental, social and governance, ESG, report to stakeholders, highlighting the Company's continued environmental, health and safety focus, impacts on communities and employees and solid governance practices. Key highlights of this year's report include: Established a long-term target of 30% greenhouse gas emissions intensity reduction by 2025 from the 2018 baseline, and more recently added a 40% reduction stretch target; Zero hydrocarbon releases of greater than one barrel and less than three-fourths of one barrel released from over 23 million gross operated barrels of oil equivalent produced; ~3 million man hours worked with a 50% and 9% reduction in total recordable incident rates and lost time incident rates, respectively, from the 2018 baseline; Enhanced and renamed the Board of Directors' Safety Committee to the Safety, Sustainability and Corporate Responsibility Committee; Increased the weighting of ESG-related performance on management's annual incentive plan to 20% of total.

07:11 EST Orange Belgium enters deal with Nethys to acquire 75% in VOO SA - The company states: "Following the period of exclusive negotiations that began on 22 November and the approval of the board of directors of Enodia, Orange Belgium and Nethys have today signed an agreement for the acquisition by Orange Belgium of 75% less one share of VOO SA. The transaction is based on an enterprise value of EUR 1.8 billion for 100% of the capital."

07:09 EST Joyy announces results of annual general meeting - JOYY announced that the following proposed resolution submitted for shareholder approval has been duly adopted as a special resolution at its annual general meeting of shareholders held in Guangzhou: THAT the Company's Second Amended and Restated Memorandum and Articles of Association be amended and restated by the deletion in their entirety and by the substitution in their place of the Third Amended and Restated Memorandum and Articles of Association.

07:08 EST MAG Silver, Fresnillo provide Juanicipio commissioning update - Fresnillo plc (FNLPF) and MAG Silver Corp. (MAG) provide a commissioning update on the Juanicipio Project. The Juanicipio Project team delivered the Project for plant commissioning on schedule despite the recent changes to labour contracting legislation and having successfully mitigated most COVID-19 related issues over the past two years, a testament to the dedication of the operational and development teams on the ground. However, the 'Comision Federal de Electricidad', the state-owned electrical company, has just notified Fresnillo, the Juanicipio Project operator, the approval to complete the tie-in to the national power grid cannot yet be granted and the mill commissioning timeline will therefore be extended by approximately six months. This is directly related to knock-on effects of the pandemic on the CFE's operations, predominantly related to a lack of CFE staff which limits its ability to oversee three key tasks to: review the existing installation; supervise physical connection to the active power grid; and approve required blackout prevention devices. As operator, Fresnillo will continue to engage closely with the CFE and 'El Centro Nacional de Control de Energia' to do all that it can to expedite these necessary approvals. Although there remains uncertainty regarding the timing for connecting the Juanicipio Project to the power grid, the current estimate, which continues to be subject to potential COVID-19 related realities, is that full load commissioning activities will be approved sometime after the first week of May 2022. Stoping and mineralized mine development at Juanicipio will continue. In order to minimize any potential adverse effect, Fresnillo will make available any unused plant capacity at its Minera Fresnillo and Minera Saucito operations to process mineralized material produced at Juanicipio during this period, and if possible matching commissioning and ramp up tonnages that were previously expected. The effect on cashflow generation from Juanicipio therefore will also be mitigated while CFE approvals are pending.

07:06 EST BridgeBio 'well-capitalized' through completion of ATTRibute-CM - BridgeBio is well-capitalized through the completion of ATTRibute-CM and remains on track to deliver on additional catalysts in 2022 and 2023. "With the financing announced in November 2021, we currently have approximately $800 million in cash, cash equivalents and marketable securities with access to up to $300 million on achieving portfolio milestones through year-end 2022. We have ongoing clinical trials in multiple genetic diseases, including achondroplasia, autosomal dominant hypocalcemia type 1, limb-girdle muscle dystrophy type 2i and dystrophic epidermolysis bullosa, and we believe we are well-positioned to deliver in 2022," said Brian Stephenson, Ph.D., chief financial officer of BridgeBio.

07:05 EST BridgeBio says Phase 3 ATTRibute-CM study does not meet primary endpoint - BridgeBio Pharma announced topline results from Month 12 of ATTRibute-CM, an ongoing global Phase 3 study investigating acoramidis for the treatment of symptomatic transthyretin amyloid cardiomyopathy. The mean observed decline in 6MWD at Month 12 in participants receiving acoramidis or placebo with baseline eGFR greater than or equal to 30 mL/min/1.73m2 were 9 meters and 7 meters, respectively. Decline observed in both arms of ATTRibute-CM was similar to expected functional decline in healthy elderly adults.1 The declines were also substantially less than the greater than40 meter annual declines observed in previous untreated arms reviewed by the company.2 The decline in the ATTRibute-CM placebo group was more than 70% lower than the decline observed in the ATTR-ACT treatment group. The ATTRibute-CM independent data monitoring committee recommends continuing the study based on unblinded data reviews. Despite the unexpected performance of the six-minute walk test, the trial's steering committee co-chairs and the Company agree that there is potential for acoramidis to demonstrate benefit on the Month 30 endpoint which includes all-cause mortality and cardiovascular hospitalizations. "Although these results were not what we hoped, the most important moment in this trial will be the Part B readout at 30 months, where we will see the effects of acoramidis on all-cause mortality and cardiovascular hospitalizations. From what I've seen so far, I remain enthusiastic about getting to that endpoint," said Daniel Judge, M.D., professor in the Division of Cardiology at the Medical University of South Carolina, and co-chair of the ATTRibute-CM Steering Committee. ATTRibute-CM enrolled 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR, with New York Heart Association Class I-III symptoms. The study is designed as a two-part study with Part A comparing change from baseline in 6MWD and Part B utilizing a hierarchical comparison including all-cause mortality and cardiovascular hospitalizations. ATTRibute-CM enrolled a similar patient population as ATTR-ACT, excepting a smaller proportion of U.S. participants and TTR variant carriers. Participants were randomized 2:1 between treatment and placebo twice daily. Based on data available after 12 months of treatment, the Company observed: In the primary analysis, change from baseline in 6MWD was not improved in the acoramidis arm relative to the placebo arm. Key differences in NYHA class, geographic distribution, and TTR variant status compared to the ATTR-ACT population do not appear to have affected the primary outcome of ATTRibute-CM. The only participant sub-population the company has reviewed to date that exhibited substantial placebo decline in 6MWD by Month 12 was the variant population. In that population, observed decline in placebo and acoramidis was -40 meters and -2 meters, respectively. Acoramidis improved Kansas City Cardiomyopathy Questionnaire Overall Summary Score relative to placebo. Acoramidis improved NT-proBNP relative to placebo. Median percent change from baseline at Month 12 in acoramidis-treated and placebo-treated participants were +0.6% and +24.3%, respectively. Acoramidis increased serum TTR levels relative to placebo. Mean percent change from baseline at Month 12 in acoramidis-treated and placebo-treated participants were +38.5% and -0.7%, respectively. Acoramidis was generally well-tolerated with no safety signals of clinical concern identified. To protect the integrity of Part B, the Sponsor's access to unblinded adverse event data for Part A excludes AEs leading to a cardiovascular hospitalization excepting events with the outcome of death. Adverse events occurred in 85.3% of placebo-treated participants and 91.9% of acoramidis-treated participants. Serious adverse events occurred in 23.2% of placebo-treated participants and 20.2% of acoramidis-treated participants/ Adverse events with outcome of death occurred in 6.2% of placebo-treated participants and 4.5% of acoramidis-treated participants.

07:03 EST BrainStorm announces FDA authorizes further NurOwn dosing under EAP - BrainStorm Cell Therapeutics announced plans for a dosing extension of NurOwn for participants who completed the Expanded Access Protocol, EAP. The U.S. Food and Drug Administration recommended that BrainStorm submit an EAP protocol amendment to provide additional dosing for these participants. Under the original EAP protocol, participants who had completed the Phase 3 NurOwn trial and who met specific eligibility criteria had the opportunity to receive 3 doses of NurOwn. Under the amended EAP protocol, these eligible participants will receive up to 3 additional doses. Data collected from the original EAP treatments informed the decision to move forward with additional doses for participants who completed it. Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics, commented, "We are pleased to be able to provide additional treatments to these patients. This program is an outcome of a fruitful collaboration between the FDA, Patient Advocacy groups and Brainstorm. We look forward to continuing this dialogue with the FDA for the best path forward."

07:02 EST Pluristem says Phase II studies of ARDS do not meet primary efficacy endpoint - Pluristem Therapeutics announced topline results from its Phase II dose escalation studies evaluating the safety and efficacy of intramuscular injections of PLX-PAD cells for the treatment of Acute Respiratory Distress Syndrome associated with COVID-19. The analysis is based on 89 patients enrolled in two Phase II studies in the U.S. and in Europe and Israel. The primary efficacy endpoint was the number of ventilator free days from day 1 through day 28 of the Studies. VFD at day 60 and all-cause mortality at days 28 and 60 were part of the secondary efficacy endpoints in the Studies. The Studies did not meet the primary efficacy endpoint of statistically significant improvement of VFD at 28 days. Taking into consideration the baseline risk factors of the ARDS patients, no differences in the safety profile were observed between PLX-PAD and placebo. In July 2021, Pluristem announced its decision to bring the Studies to early clinical readout based on 89 patients enrolled, instead of the originally planned 180 patients. The decision came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients. These changes in the evolution of COVID-19 raised a major concern about the potential variability in the patient population in the Studies. The early termination of recruitment led to a significant reduction in the statistical power of the Studies. Efficacy trends from the Studies included: A single administration of 300 million PLX-PAD cells demonstrated overall better results, compared to other treatment groups Patients in the U.S. study treated with a single dose of 300 million PLX-PAD cells showed an increased survival rate by 40% at day 60 compared to placebo group. Patients in the EU Study treated with a single dose of 300 million PLX-PAD cells showed an increased survival rate by 27% at day 60 compared to control group. In the EU Study, patients treated with a single dose of 300 million PLX-PAD cells showed increased VFD at day 28 by 3.6 days, from 0.2 days in the control group to 3.8 days in the treated group. In the EU Study, patients treated with a single dose of 300 million PLX-PAD cells showed increased VFD at day 60 by 112% or 6.6 days, from 5.9 days in the control group to 12.5 days in the treated group. Pluristem's CEO and President, Yaky Yanay said: "Pluristem joined the global effort to fight the evolving and unexpected COVID-19 pandemic. We chose to focus on the most severe intubated patients suffering from ARDS associated with COVID-19, that have no viable treatment to date and are challenging healthcare systems worldwide. With the new coming wave of the Omicron variant, we intend to explore the opportunities based on the efficacy trends obtained from the Studies. I would like to thank everyone who has been involved in the Studies including the patients and their families, our investigators and study personnel, and the team at Pluristem for making extraordinary efforts to conduct these important studies during very challenging times."

06:56 EST Church & Dwight completes purchase of TheraBreath - Church & Dwight has completed its previously announced acquisition of TheraBreath, the #2 brand in the alcohol-free mouthwash category in the United States. The transaction was completed under the original terms announced on November 29, 2021, which called for Church & Dwight to pay $580M in cash at closing.

06:54 EST Japanese MHLW approves combination of KEYTRUDA plus LENVIMA - Merck (MRK) and Eisai (ESALY) announced that the Japanese Ministry of Health, Labour and Welfare has approved the combination of KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy. This approval marks the first time the combination of KEYTRUDA plus LENVIMA has been approved in Japan. KEYTRUDA plus LENVIMA is now approved in Japan, the U.S. and Europe for certain types of advanced endometrial carcinoma. The approval is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival, reducing the risk of death by 38%, and progression-free survival, reducing the risk of disease progression or death by 44%. The median OS was 18.3 months for KEYTRUDA plus LENVIMA versus 11.4 months for chemotherapy. The median PFS was 7.2 months for KEYTRUDA plus LENVIMA versus 3.8 months for chemotherapy. The Japanese package inserts for KEYTRUDA and LENVIMA note that in the KEYNOTE-775/Study 309 trial, adverse reactions were observed in 395 patients out of the safety analysis set of 406 patients receiving KEYTRUDA plus LENVIMA. The most common adverse reactions were hypertension in 249 patients, hypothyroidism in 222 patients, diarrhea in 171 patients, nausea in 158 patients, decreased appetite in 151 patients, fatigue in 113 patients, proteinuria in 105 patients, vomiting in 98 patients, weight decreased in 91 patients, arthralgia in 87 patients and palmar-plantar erythrodysesthesia syndrome in 84 patients.

06:33 EST Dogness International GPS pet tracker rises to top of category after three weeks - Dogness International announced its Discover Smart GPS Pet Tracker has become the second most popular product in its category in China after only three weeks on the market. Silong Chen, chairman and CEO of Dogness, commented, "Our traditional and intelligent pet products have had successful launches in the past but nothing can compare to the success of our new state-of-the-art Discover Smart GPS Pet Tracker. Clearly, pet safety is as important to pet owners as it is to Dogness."

06:12 EST Velo3D ships first Sapphire XC to aerospace customer - The company states: "Velo3D has announced its first Sapphire XC delivery. The Sapphire(R) XC, or "Extra Capacity," is Velo3D's newest and largest metal 3D printer that delivers both faster production and larger parts. The Sapphire(R) XC is a scale up version of the Sapphire(R) printer, utilizing the same Flow(TM) print preparation software, the same Assure(TM) quality control software, and the same Intelligent Fusion(R) manufacturing process. Sapphire(R) XC is built to enable a seamless transition of parts that were developed and qualified on Sapphire(R) to the larger, more productive Sapphire(R) XC, reducing the cost of producing parts by up to 75%. Sapphire(R) XC also expands the use of Velo3D's production solution to parts that are up to 400% larger in volume than the largest parts possible to produce with Sapphire(R). The customer receiving the new Sapphire(R) XC will use it to scale up production of its product that is built using the Sapphire(R) fleet of metal 3D printers they already have. Velo3D currently has a backlog of firm bookings for 17 additional Sapphire(R) XC systems as well as 19 additional reservations. The demand is primarily driven by the lower production costs Sapphire(R) XC can enable for customers who have adopted the original Sapphire(R) printers and its ability to produce much larger parts."

05:50 EST Apple appeals Netherlands order over App Store payment policies - Apple spokesperson Marni Goldberg told media outlets that the company disagrees with the order issued by the Netherlands Authority for Consumers and Markets and has filed an appeal." Apple "does not have a dominant position in the market for software distribution in the Netherlands, has invested tremendous resources helping developers of dating apps reach customers and thrive on the App Store, and has the right under EU and Dutch law to charge developers of these apps a fee for all the services and technologies Apple provides them," the company said in a statement.

05:12 EST Tuniu executives to purchase up to $2M of ADSs - Tuniu announced that certain senior management members of Tuniu, consisting of Donald Dunde Yu, founder, chairman and chief executive officer, Wei Zhang, executive vice president, and Anqiang Chen, financial controller, as well as certain employees of Tuniu, intend to use their personal funds to purchase the company's American depositary shares, or ADSs, on the open market for an aggregate amount up to a maximum of $2M within the next six months, pursuant and subject to the restrictions of, and consistent with, the applicable laws and regulations and the company's securities trading policy.

05:07 EST CooTek invested game studio announces top ranking of 'Hotties Up' mobile game - Recently, the hyper-casual game "Hotties Up" has reached the top three of the U.S. iOS game ranking a few days after release. The dress-up parkour game is published by Smillage, the game studio CooTek invested in.