Stockwinners Market Radar for February 11, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:11 EDT Amicus, WuXi sign exclusive manufacturing partnership - WuXi Biologics and Amicus Therapeutics announced that the companies have entered into an exclusive commercial manufacturing partnership for Amicus' Pompe biologic ATB200. Per the strategic agreement, WuXi Biologics will be the exclusive commercial drug substance manufacturing partner and key commercial drug product supplier. WuXi Biologics will enable and support Amicus with its "Global Dual Sourcing within WuXi Biologics" strategy and manufacture both the drug substance and drug product, each at two sites across its global commercial supply network in EU, China and US. This approach effectively ensures a global and robust supply chain while at the same time minimizes the intra-company technology transfer risk associated with traditional approaches of using different suppliers. The contract has an initial five-year term and then automatically renewed every two years until cancelled. This agreement showcases the strong commercial manufacturing expertise and global premier quality system of WuXi Biologics as well as its powerful "Follow-the-Molecule" strategy that enables a global client base from discovery to commercial manufacture. The ATB200 program was initiated at WuXi Biologics in 2012 and now progresses through a pivotal study enabled by the global leading technology platform and unparalleled manufacturing capacity at WuXi Biologics. "This long-term supply agreement is another significant step forward in our relationship with WuXi Biologics," said Mr. Bradley L. Campbell, President and Chief Operating Officer of Amicus Therapeutics, Inc. "Over the past five years we have successfully collaborated in the scale up of our Pompe biologic from research to commercial scale while maintaining all key quality attributes. We look forward to continuing this important manufacturing partnership as we advance our Pompe program in a pivotal study to support global regulatory approvals, and we are confident in our ability to supply patients around the world."

18:45 EDT S&P Global CEO: 'We are not just a ratings agency' - In an interview on CNBC's Mad Money, S&P Global CEO Doug Peterson said: "We are not just a ratings agency... We also have subscription businesses with market intelligence... We plan to increase women in management positions by 50% by 2030."

18:23 EDT Norfolk Southern CEO: 'We're in a great growth environment' - In an interview on CNBC's Mad Money, Norfolk Southern CEO Jim Squires said: "We're in a great growth environment... We think we have secular and cyclical growth opportunities ahead... Intermodal has been our growth engine and we remain bullish on it... Our growth plan is aggressive but achievable... We started re-engineering operations in the field last year and we've been picking up speed ever since... We have a diversified coal franchise."

18:13 EDT EA's 'Apex Legends' reaches 25M players after one week - EA's Respawn Entertainment said that since it launched "Apex Legends" last week, it has seen "the creation of an Apex Legends community that is excited, thriving, and full of great feedback and ideas." The developer announced that since last Monday, more than 25M players have jumped into the game, and over the weekend it had well over 2M concurrent players at its peak. Respawn noted that it is looking at changes to the game based on player feedback and experiences and that Season One kicks off in March. Reference Link

17:41 EDT Latam Airlines reports January system passenger traffic increased by 5.1% - LATAM Airlines Group S.A. and its subsidiaries reported its preliminary monthly traffic statistics for January 2019 compared to January 2019. System passenger traffic increased by 5.1%, while capacity rose 6.1%. As a result, the Company's load factor for the month fell 0.8 percentage points to 85.5%. International passenger traffic accounted for approximately 57% of the month's total passenger traffic.

17:23 EDT Amcor, Bemis receive approval from European Commssion on transaction - Amcor (AMCRY) and Bemis (BMS) announce an important step toward closing their all-stock transaction, with approval received from the European Commission on 11 February 2019. A condition of this approval is an agreement to divest three Bemis plants located in the United Kingdom and Ireland. Combined, these plants generate approximately $170M of annual revenue from the sale of flexible packaging for certain healthcare products. This approval preserves Amcor's European healthcare packaging business which is substantially larger and participates in attractive, high value end markets. The transaction remains subject to regulatory approval in the United States and Brazil, and the companies are in advanced discussions with regulators in both countries. Those advanced discussions include the potential for required remedies. Inclusive of remedies required by the European Commission, collective potential remedies would represent an immaterial proportion of the total sales for the combined company and would not impact the $180M of net cost synergies expected to be delivered by the end of the third year following completion. The transaction is expected to close in the second quarter of calendar year 2019.

17:16 EDT Naked Brand Group received non-compliance notice from Nasdaq - Naked Brand Group received a letter from the Listing Qualifications Department of The Nasdaq Capital Market notifying the company that the minimum bid price for the company's common stock was below $1.00 per share for a period of 30 consecutive business days, and that the company did not meet the minimum bid price requirement set forth under Nasdaq Listing Rule 5550(a)(2). The Nasdaq notification has no effect at this time on the listing of the company's common stock, and the stock will continue to trade uninterrupted under the symbol "NAKD". Naked management intends to actively monitor the bid price for its common stock and will consider all available options to regain compliance with the Nasdaq minimum bid price requirement. The company has a compliance period of 180 calendar days until August 5, 2019 to regain compliance with the minimum bid price requirement.

17:10 EDT Chegg up 10% to $38.35 after Q4 results, FY19 guidance top estimates

17:04 EDT PDC Energy sees Q1 production down slightly from Q4 - Due to the timing of expected turn-in-lines in the Delaware, as well as the timing of planned third party gas processing expansions in Wattenberg, the company expects Q1 production to decrease slightly compared to Q4 before showing steady sequential growth through the rest of the year. Similarly, the company expects to outspend cash flows in the first half of 2019 before generating its expected free cash flow in the latter half of the year. Oil production for FY19 is expected to grow approximately 20% compared to 2018 volumes while accounting for 41%-45% of total production.

17:02 EDT Bristol-Myers says Opdivo-Yervoy combo showed improved ORR in Phase 3 study - Bristol-Myers Squibb Company announced new results from the Phase 3 CheckMate -214 study, showing that therapy with Opdivo plus low-dose Yervoy continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic renal cell carcinoma. With a minimum follow-up of 30 months, intermediate- and poor-risk patients randomized to Opdivo plus low-dose Yervoy continued to show a significant overall survival benefit compared to those randomized to sunitinib. Additionally, at 30 months, the objective response rate per investigator for intermediate- and poor-risk patients with Opdivo plus low-dose Yervoy improved compared to the previous analysis at a minimum of 17.5 months. The overall safety of the combination was consistent with that observed in the 17.5-month minimum follow-up analysis and with previously reported studies of these medicines in patients with RCC. No new safety signals or drug-related deaths occurred with extended follow-up. "The results from this 30-month follow-up from the CheckMate -214 study are meaningful as they continue to demonstrate that in patients with advanced renal cell carcinoma, a population with considerable unmet treatment needs, there is potential for long-term survival benefits with the combination of nivolumab and ipilimumab," said CheckMate -214 investigator Nizar M. Tannir, M.D., FACP, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

16:58 EDT Amkor Technology says inventory correction underway in the smartphone market - "We expect first quarter 2019 revenues to be around $880M . Our first quarter revenue guidance reflects the inventory correction currently underway in the smartphone market," said said Steve Kelley, Amkor's (AMKR) president and CEO. Companies that may be impacted include Apple (AAPL) and Samsung (SSNLF).

16:51 EDT Alico and Remy Trafelet reach 'amicable' resolution - Alico announced that it has entered into a settlement agreement with Mr. Remy W. Trafelet and certain of his affiliates, along with certain members of the Alico Board of Directors, to dismiss the pending litigation in the Circuit Court of the Thirteenth Judicial Circuit in and for Hillsborough County, Florida captioned 734 Agriculture, LLC v. Brokaw, Case No. 18-CA-011294. Separately, Mr. Trafelet and certain of his affiliates have entered into a settlement agreement with certain members of 734 Investors, LLC, the Company's largest shareholder, to dismiss related pending litigation in Delaware. In accordance with the settlement agreement, which was unanimously approved by the Board, Mr. Trafelet has resigned from his roles as president and chief executive officer and a director of the Company. Mr. Trafelet remains one of the largest individual beneficial holders of the Company's stock. The parties to the settlement jointly determined that such an agreement was in the best interests of Alico and its shareholders and was beneficial for all parties. Mr. Trafelet has agreed to provide consulting services to the Company following his departure, so that Alico can continue to benefit from his input, in particular regarding the Alico 2.0 modernization program, which has transformed three legacy businesses into a single efficient enterprise, Alico Citrus - one of the leaders in the U.S. citrus industry.

16:50 EDT FMC Corporation sees FY19 adjusted EBITDA $1.165B-$1.205B - Up 7% at the midpoint versus recast 2018.

16:44 EDT Titan International enters agreement with RDIF regarding settlement put option - Titan International announced that the company and an affiliate of the Russian Direct Investment Fund, one of the three shareholders of Voltyre-Prom, have entered into a definitive agreement relating to the previously announced settlement put option that was exercised by RDIF. The Agreement provides, among other things, that in full satisfaction of the put option, within ten business days following the date of the Agreement, Titan will pay to RDIF $25M in cash and, subject to the completion of regulatory approval, will issue to RDIF in a private placement $25M in shares of restricted Titan common stock, with RDIF being required to hold such shares for three years from the date of the definitive agreement. Immediately following the closing, RDIF will continue to own the same interest in Voltyre-Prom, subject to the terms of the Agreement and the Shareholders' Agreement. Titan has retained the right to buy back the Titan shares from RDIF for $25M during such three-year period and, if the stock buyback is consummated within one year, at the time of such buyback RDIF would be required to convey to Titan, based on current ownership, a 10.71% interest in Voltyre-Prom, resulting in RDIF reducing its interest in Voltyre-Prom from 35.71% to 25%. Closing of the transaction is expected to occur on or about February 25.

16:42 EDT Truett-Hurst announces extension of tender offer to purchase up to 1M of shares - Truett-Hurst announced that it has extended the expiration of its previously announced self tender offer to purchase up to 1M shares of its Class A common stock, including shares issued upon exchange of limited liability company interests of its subsidiary H.D.D., LLC, or such lesser number of shares of its Class A common stock as are properly tendered and not properly withdrawn, at a price of $2.40 per share of Class A common stock, to the seller in cash, less any applicable withholding taxes and without interest. The Offer was previously scheduled to expire at 12:00 midnight, New York City time, at the end of the day on February 11, and will instead expire at 12:00 midnight, New York City time, at the end of the day on February 22. Truett-Hurst is extending the Offer to provide stockholders with sufficient time to consider supplemental disclosures that it anticipates making in a filing with the SEC. Truett-Hurst intends to issue a press release promptly following such disclosures to notify stockholders when such supplemental disclosures are available.

16:40 EDT Bristow Group files Form 12b-25 notification of late filing with SEC - Bristow Group announced that it filed a Form 12b-25 notification of late filing with the SEC and released preliminary results for the three and nine months ended December 31, 2018. The company intends to hold its investor conference call to discuss its fiscal year 2019 third quarter after it has filed its Form 10-Q with the SEC, and will not be commenting until the Form 10-Q has been filed. Management has concluded that the company did not have adequate monitoring control processes in place related to non-financial covenants within certain of its secured financing and lease agreements, and this control deficiency identified represents a "material weakness" in internal controls over financial reporting. Accordingly, the company's internal control over financial reporting was ineffective at March 31, 2018 and the reporting periods thereafter. As such, both management's assessment and the report of KPMG on internal control over financial reporting as of March 31, 2018 should no longer be relied upon. In addition, because of the material weakness described above, in February 2019, the company's management has determined that the company's disclosure controls and procedures were not effective at a reasonable assurance level as of March 31, 2018 and the reporting periods thereafter. The company is evaluating whether this material weakness in internal controls over financial reporting resulted in a misstatement in the company's financial statements included in the Annual Report on Form 10-K for the fiscal year ended March 31, 2018 and the impact on the financial statements of the company as of December 31, 2018, including disclosures. The company is specifically evaluating whether certain debt balances should be reclassified from long-term to short-term in those financial statements, whether related waivers can be obtained from lenders, if necessary, and the resulting impact on the assessment of the company's ability to continue as a going concern. Further discussion of the material weakness and any financial statement implications, including any related revisions to the company's previously issued financial statements, if required, will be included in the Quarterly Report on Form 10-Q for the three months ended December 31, 2018 and in an amendment to the Annual Report on Form 10-K for the fiscal year ended March 31, 2018. The company intends to file the Form 10-Q no later than February 19, 2019.

16:38 EDT Gilead drops 5% to $64.01 after Phase 3 NASH study fails

16:37 EDT PDC Energy sees FY19 production 46-50 MMBoe - Sees FY19 anticipated capital investments of $810M-$870M. Operating plan designed around the prioritization of delivering strong debt-adjusted per-share metrics and free cash flow generation utilizing a flat $50 WTI oil and $3 NYMEX gas price deck.

16:35 EDT Bristow Group, Columbia Helicopters terminate proposed merger transaction - Bristow Group and Columbia Helicopters announced that Bristow and Columbia have mutually agreed to terminate Bristow's agreement to acquire Columbia. In connection with the termination, Bristow has paid $20M to Columbia. Bristow, Columbia and Columbia's shareholders have agreed to release each other from all claims in connection with the purchase agreement and the related transactions. Thomas Knudson, the Chairman of the Board of Directors of Bristow, stated, "The decision to enter into a mutual termination of the purchase agreement was based on a number of developments following the entry into the agreement, which led both Bristow and Columbia to conclude that it was not possible to combine the two companies at this time. We continue to value our relationship with Columbia and look forward to having the opportunity to work together in the future." Steve Bandy, the President and Chief Executive Officer of Columbia, stated, "We continue to believe in the potential for collaboration between Bristow and Columbia, and the companies are actively considering mutually beneficial opportunities to work together."

16:34 EDT RingCentral signs cloud communications provider contract with Columbia - RingCentral has signed an agreement with Columbia University for a cloud communications platform to support 44,000 faculty and students. Columbia University needed to replace its legacy on-premises communications systems to provide greater mobility and enhanced student to student and student to faculty collaboration. The University will deploy 14,000 seats of RingCentral Office to faculty, which includes voice, video, team messaging, online meetings, SMS, and fax, and will roll out team messaging to 30,000 students. "The need to support an increasingly mobile faculty and student base while keeping pace with younger generational preferences for collaboration is fueling the demand for cloud communications solutions," said Ryan Azus, EVP of global sales and services, RingCentral.

16:34 EDT PDC Energy reports Q4 production 11.8 MMBoe - Reports Q4 production of approximately 11.8 MMBoe with a December exit rate of approximately 130,000 Boe per day. Reports FY18 oil production increased 32% year-over-year to approximately 17M barrels. Year-end 2018 proved reserves of 545 MMBoe, an approximate 20% increase over year-end 2017 levels with an estimated all-sources reserve replacement of 330%.

16:33 EDT FMC Corporation expects to repurchase up to $500M of shares in 2019 - Company expects to repurchase up to $500M of FMC shares, including $100M already purchased in 2019. Company set to spin remaining Livent stake on March 1.

16:32 EDT Gilead says selonsertib did not meet primary endpoint in Phase 3 study - Gilead Sciences, Inc. announced that STELLAR-4, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of apoptosis signal-regulating kinase 1, in patients with compensated cirrhosis due to nonalcoholic steatohepatitis, did not meet the pre-specified week 48 primary endpoint of a greater than or equal to 1-stage histologic improvement in fibrosis without worsening of NASH. In the study of 877 enrolled patients who received study drug, 14.4 percent of patients treated with selonsertib 18 mg and 12.5 percent of patients treated with selonsertib 6 mg achieved a greater than or equal to 1-stage improvement in fibrosis according to the NASH Clinical Research Network classification without worsening of NASH after 48 weeks of treatment, compared with 12.8 percent of patients who received placebo. Selonsertib was generally well-tolerated and safety results were consistent with prior studies. "While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments. Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases. Data from this large study of patients with compensated cirrhosis due to NASH, including the extensive set of biomarkers collected, will further advance our understanding of the disease and inform our broader NASH development programs," said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead. "We are grateful to the patients and investigators who participated in the STELLAR-4 study, and we now await the upcoming results from the Phase 3 STELLAR-3 trial of selonsertib in patients with bridging fibrosis due to NASH and the Phase 2 ATLAS combination trial of selonsertib, cilofexor and firsocostat in patients with advanced fibrosis due to NASH later this year."

16:26 EDT Artisan Partners reports AUM as of January 31 totaled $105.4B - Artisan Partners reported that its assets under management, or AUM, as of January 31 totaled $105.4B. Separate accounts accounted for $54.7B of total firm AUM, while Artisan Funds and Artisan Global Funds accounted for $50.7B.

16:24 EDT DCP Midstream sees FY19 adjusted EBITDA $1.15B-$1,29B - Sees FY19 distributable cash flow $700M-$800M.

16:22 EDT Construction Partners appoints Steven Meehan CFO - Kadmon Holdings announced the appointment of Steven Meehan as executive VP, CFO. Meehan, who has served as a member of the board at Kadmon since 2017, has over 25 years of financial leadership experience spanning corporate strategy, mergers and acquisitions, capital raising and financial planning and analysis. Meehan previously served as a partner in the Healthcare Group of Moelis & Company.

16:20 EDT Gladstone acquires industrial property in Philadelphia area - Gladstone Commercial Corporation announced that it completed the acquisition of a 26,050 square foot industrial building in Moorestown, NJ for $2.7M. The initial capitalization rate for the acquisition was 7.8%, with an average capitalization rate of 8.8%. The property is 100% occupied by Shields Business Solutions.

16:20 EDT Invesco reports preliminary AUM $930.6B as of January 31 - Invesco reported preliminary month-end assets under management of $930.6B, an increase of 4.8%. The increase was driven by favorable market returns, foreign exchange, higher money market AUM and reinvested distributions, partially offset by net long-term outflows and non-management fee earning AUM outflows. FX increased AUM by $4.9B. Preliminary average total AUM for the quarter through January 31 were $910.3B, and preliminary average active AUM for the quarter through January 31 were $683.3B.

16:17 EDT A-Mark Precious Metals CEO 'cautiously optimistic' - "A-Mark's vertically-integrated structure, and especially our minting capabilities through SilverTowne Mint, gives us a key competitive advantage by enabling us to meet surges in demand during more volatile market environments. Our financial success in the first half of the fiscal year was primarily due to higher sales volumes on both gold and silver products at our Wholesale Trading & Ancillary Services segment and sustained reductions of selling, general and administrative expenses at our Direct Sales segment over the prior year period. Additionally, we further strengthened our balance sheet by paying off the credit facility which we had used to finance our acquisition of Goldline, and which had been our highest interest rate debt instrument. "Looking forward to the second half of the fiscal year, we have seen a 3% increase in both gold and silver prices since the end of December and have continued to experience increased volatility in the market and robust demand for A-Mark's physical products. Moreover, the price of gold exceeded $1,300 per ounce in January for the first time in over six months. We remain cautiously optimistic about our prospects, especially given the macro backdrop and geopolitical environment, and will continue to act opportunistically to capitalize on attractive near-term trading opportunities while strategically scaling our business for long-term success."

16:13 EDT Mimecast appoints Rafe Brown CFO - Mimecast Limited announced the appointment of Rafe Brown to the position of CCFO, effective March 18. Rafe will oversee global financial strategy and operations, including accounting, tax, treasury, investor relations and real estate. Prior to joining Mimecast, Rafe served as the senior VP, CFO and treasurer of SevOne.

16:12 EDT Flir Systems to acquire Endeavor Robotic Holdings, for $385M in cash - FLIR Systems announced that it has entered into a definitive agreement to acquire Endeavor Robotic Holdings, Inc., a developer of battle-tested, tactical unmanned ground vehicles for the global military, public safety, and critical infrastructure markets, from Arlington Capital Partners for $385M in cash. Endeavor's highly-mobile and easy to operate ground robots utilize advanced sensing and actuation in providing explosive ordnance disposal, reconnaissance, inspection, and hazardous materials support for troops, police, and industrial users at stand-off range. Along with the recent acquisition of Aeryon Labs, FLIR has significantly expanded its unmanned systems capabilities. Upon closing of the acquisition, which is expected in the first quarter of 2019, Endeavor will be part of the FLIR Government and Defense Business Unit's Unmanned Systems and Integrated Solutions division. The transaction is expected to be 3c dilutive to FLIR Systems' 2019 adjusted earnings per share due to borrowing costs associated with funding the transaction, and accretive thereafter.

16:11 EDT Huntington Ingalls awarded $78.4M contract - Huntington Ingalls Industries announced that the U.S. Army Product Manager Force Protection Systems recently awarded a contract to HII's Technical Solutions division to provide maintenance, repair, supply support, fielding, engineering, configuration management and training for Non-Intrusive Inspection System Support systems. The three-year task order has a value of $78.4M.

16:10 EDT Amkor Technology sees FY19 CapEx of around $475M

16:00 EDT Multi Color trading halted, news pending

15:39 EDT Vanguard reports 8.08% passive stake in Marcus & Millichap - In a regulatory filing, Vanguard disclosed an 8.08% stake in Marcus & Millichap, which represents over 3.1M shares. The filing does not allow for activism.

14:47 EDT Vanguard reports 7.28% passive stake in Hilton - In a regulatory filing, Vanguard disclosed a 7.28% stake in Hilton Worldwide, which represents about 21.6M shares. The filing does not allow for activism.

14:27 EDT Ericsson, Intel announce multi-year 5G collaboration - Ericsson (ERIC) and Intel (INTC) announced that they have begun a multi-year collaboration to align ongoing development efforts in software-defined infrastructure and Intel Rack Scale Design. "The resulting next-generation infrastructure management platform will deliver a new level of cloudlike agility, transparency and efficiency required for Network Functions Virtualization, distributed cloud, and 5G...Ericsson and Intel are teaming up to deliver a next-generation hardware management platform that extends the agility of the cloud to the hardware infrastructure layer. For service providers, the new infrastructure management solution will help speed time-to-market, maximize utilization, and reduce total cost of ownership. As part of the multi-faceted agreement, the companies will align development efforts of Ericsson SDI Manager software and Intel Rack Scale Design and extend these solutions with advanced management capabilities. These unified development efforts will allow operators to leverage multi-vendor hardware options, Ericsson's end-to-end software solutions, and Intel's latest architectural innovations," the companies stated.

14:21 EDT Vanda Pharmaceuticals denies allegations, 'pleased' government not intervening - Contacted by The Fly after Aurelius Value disclosed a short position in Vanda Pharmaceuticals, the company said that, "On February 4, 2019, a qui tam lawsuit against the company was unsealed. Vanda denies the allegations and we are pleased that the U.S. Government has declined to intervene." In a report, Aurelius Value said it is short Vanda Pharmaceuticals, highlighting a recently unsealed whistleblower complaint that included "detailed allegations that Vanda has engaged in a series of fraudulent schemes, some personally orchestrated by [CEO Mihael] Polymeropoulos himself, to defraud government payors."

14:19 EDT Zayo Group dip attributed to new CTFN report - CTFN, an M&A focused news service that has published several prior reports regarding Zayo Group, has a new article from Sarah Cohen that was published on February 11 at 2:08 pm ET. As of time of writing, Zayo shares are down $1.02, or 3.9%, to $25.29. Reference Link

14:16 EDT Great Panther Silver shareholders approve acquisition of Beadell resources - Great Panther Silver reports that at its special meeting of shareholders held earlier today the company's scheme resolution and the name change resolution were approved, pursuant to which Great Panther will acquire Beadell Resources Limited and change its name to Great Panther Mining Limited. Beadell shareholders will meet later today in Perth to vote on the acquisition. Should Beadell shareholders vote in favor, the acquisition is expected to close the first week of March, following satisfaction of customary closing conditions and receipt of regulatory approvals. The name change to Great Panther Mining Limited will become effective upon closing of the acquisition. The common shares of the company will continue to trade on the Toronto Stock Exchange under the symbol GPR and NYSE American under the symbol GPL.

13:50 EDT BAE Systems receives $114.5M contract to modernize USS Bulkeley - BAE Systems has received a $114.5M contract from the U.S. Navy to perform maintenance and modernization of the guided-missile destroyer USS Bulkeley in its Norfolk shipyard. The value of the competitively awarded contract could reach $136.2M if all options are exercised. The USS Bulkeley is the 34th ship of the Arleigh Burke class. Named for Medal of Honor recipient Vice Admiral John Bulkeley, the ship was commissioned in December 2001. Following its arrival in March, BAE Systems will perform extensive hull, mechanical, and electrical repairs, and upgrade the combat systems suite aboard the 509.5-foot-long Bulkeley. The Bulkeley's depot maintenance period is expected to be completed in June 2020. BAE Systems' Norfolk shipyard currently employs about 1,200 people and hundreds of subcontractors. The shipyard is expected to hire additional employees and temporary workers to accomplish work on the Bulkeley and other ships in the shipyard.

13:40 EDT FDA Commissioner sends letters to Altria, Juul over youth tobacco use - In a statement, FDA Commissioner Scott Gottlieb said, "I sent letters to the chief executive officers of Altria Group Inc. and JUUL Labs Inc. asking to meet with them to discuss my concerns that they don't seem fully committed to their written promises about the steps they'd take to stop youth use of their products. " Today, the U.S. Centers for Disease Control and Prevention released additional data from its joint FDA/CDC 2018 National Youth Tobacco Survey. "These data are a sobering reminder of the initial results we shared last fall indicating a rampant rise of youth e-cigarette use, which has prompted the FDA to take a series of escalating regulatory actions as part of our Youth Tobacco Prevention Plan. We are advancing those actions, and committing to some new steps. The epidemic use of e-cigarettes among children is one of the biggest public health challenges currently facing the FDA," Gottlieb added.

13:14 EDT Vanguard reports 9.09% passive stake in Apergy - In a regulatory filing, Vanguard disclosed a 9.09% stake in Apergy, which represents roughly 7M shares. The filing does not allow for activism.

12:40 EDT WisdomTree jumps 3.5% after report says explored sale to JPMorgan

12:07 EDT Provectus treatment of ocular melanoma granted FDA orphan status - The FDA granted orphan designation to Provectus BioPharmaceuticals' rose bengal disodium as a treatment of ocular melanoma, according to a post to the agency's website. Reference Link

12:01 EDT NJ Resources unit sells 117 MW wind portfolio to Skyline Renewables - Skyline Renewables has purchased a 117 megawatt wind portfolio from NJR Clean Energy Ventures, the clean energy subsidiary of New Jersey Resources. The US wind farms are located in Iowa, Kansas, Pennsylvania and Wyoming providing clean renewable energy to major population centers across the country.

12:00 EDT VelocityShares 3x Inv Natural Gas ETN falls -9.2% - VelocityShares 3x Inv Natural Gas ETN is down -9.2%, or -$10.74 to $105.52.

12:00 EDT Forum Energy rises 9.5% - Forum Energy is up 9.5%, or 56c to $6.39.

12:00 EDT Insperity rises 16.4% - Insperity is up 16.4%, or $18.20 to $129.10.

11:20 EDT Loews CEO Tisch says CNA's Q4 earnings 'very ugly'

11:03 EDT Sikorsky's AAG, Fly Blade announce agreement for on-demand urban mobility option - Sikorsky's subsidiary Associated Aircraft Group, or AAG, and Fly Blade, announced an agreement to provide a new on-demand urban mobility option in the New York City metro area. AAG is a wholly owned subsidiary of Sikorsky, a Lockheed Martin company. Through the agreement, AAG will provide and operate a dedicated S-76C+ helicopter for BLADE, to be flown and maintained by Sikorsky pilots and maintenance technicians. BLADE also will gain access to AAG's full fleet of Sikorsky helicopters, the largest in the Northeast, as needed. Additionally, the agreement establishes a working group to explore how AAG can best leverage BLADE's consumer, cockpit and operator technology platform.

10:02 EDT Apogee Enterprises enters into confidentiality agreement with Engaged Capital - In a regulatory filing, Apogee Enterprises said that on February 8, it entered into a confidentiality agreement with Engaged Capital, LLC and certain of its affiliates. "Engaged Capital has agreed to abide by certain standstill provisions during a standstill period commencing on the date of the Confidentiality Agreement and ending on the Termination Date. The Company agreed to hold its 2019 annual meeting of shareholders no earlier than 45 days after the Termination Date and will consider any notice from Engaged Capital pursuant to Section 1.09 of the Company's Amended and Restated By-laws with respect to such meeting timely if such notice is received by the Company by 5:30 PM New York City time on the 15th day following the Termination Date. Unless earlier terminated by the Company, the Confidentiality Agreement expires six months after the effective date of the Confidentiality Agreement."

10:00 EDT VelocityShares 3x Inv Natural Gas ETN falls -9.5% - VelocityShares 3x Inv Natural Gas ETN is down -9.5%, or -$11.04 to $105.22.

10:00 EDT Invitae rises 7.1% - Invitae is up 7.1%, or 99c to $14.88.

10:00 EDT Insperity rises 12.1% - Insperity is up 12.1%, or $13.45 to $124.35.

09:32 EDT LTC Properties enters $17M sale-leaseback JV partnership in Virginia - LTC Properties announced it has entered into a real estate joint venture relationship with an affiliate of English Meadows Senior Living Communities to acquire English Meadows Abingdon Campus in Abingdon, Virginia for approximately $17M, at an initial lease rate of 7.4%. LTC has a 95% interest in the joint venture. Opened in 2015, English Meadows Abingdon Campus comprises 74 assisted living and memory care units, with a stabilized occupancy of 90% as of closing. The property will be operated by English Meadows Senior Living Communities, a new operating partner for LTC.

09:26 EDT Alphatec announces stay of court proceedings in NuVasive patent lawsuit - Alphatec (ATEC), or ATEC, announced several developments in its ongoing patent litigation with NuVasive (NUVA). The United States District Court for the Southern District of California granted a stay in the patent litigation proceedings between ATEC and NuVasive and vacated the December 9 trial date. The stay, which was agreed to by both ATEC and NuVasive, halts active litigation in the patent suit while the U.S. Patent and Trademark Office considers challenges recently filed by ATEC to invalidate certain NuVasive patents covering its CoRoent lateral implants. ATEC anticipates that the stay of proceedings announced today will remain in effect until at least July, when it is expected that the patent office will decide whether it will institute a full review of the challenged NuVasive implant patents.

09:18 EDT MongoDB announces Cedric Pech as CRO - MongoDB announced Cedric Pech, who previously lead the company's EMEA sales organization, is promoted to CRO. Pech joined the company to lead Europe, Middle East and Africa sales in July 2017 and since that time has rapidly increased the size of the team, expanded into new markets, implemented a new process that has increased sales productivity and has driven growth. In his new role, Cedric will be responsible for developing and executing MongoDB's global sales strategy.

09:16 EDT Align Technology announces Raj Pudipeddi as CMO - Align Technology (ALGN) announced that Raj Pudipeddi has joined the company as senior VP and CMO reporting to Joe Hogan, Align president and CEO. Pudipeddi will assume responsibility for Align's global marketing organization including product portfolio, product management, commercialization, and global branding for the Invisalign and iTero product brands. Pudipeddi is an accomplished executive with over 24 years of business leadership and brand building experience for companies including Procter & Gamble (PG) and Bharti Airtel, an Indian telecom leader.

09:13 EDT Progenics acquires manufacturing facility for $8M in cash considerations - Progenics announced that it has acquired the Somerset, New Jersey manufacturing facility for Azedra for cash consideration of $8M. Azedra is the first and only FDA-approved radiopharmaceutical indicated for the treatment of pheochromocytoma and paraganglioma, ultra-rare cancers. This Somerset site serves as the launch facility for Azedra and will also provide manufacturing support for the company's development stage radiopharmaceuticals, including 1095. The production of Azedra uses a proprietary Ultratrace process which concentrates the MIBG targeted radiolytic activity by eliminating non-therapeutic "cold" MIBG molecules, giving Azedra uniquely high specific activity.

09:10 EDT Flex appoints Revathi Advaithi as CEO - Flex (FLEX) announced that Revathi Advaithi has been named CEO and appointed to the board at Flex. Prior to Flex, Advaithi was president and COO for the Electrical Sector business for Eaton (ETN).

09:07 EDT Phillips 66 Partners, Kinder Morgan announce joint open season - Phillips 66 Partners (PXSP) and Kinder Morgan (KMI) announced the start of a joint open season by Gray Oak Pipeline and Kinder Morgan Crude & Condensate to provide shippers with long-term crude oil transportation from Gray Oak Pipeline origin points in the Permian Basin to KMCC delivery points at or near the Houston Ship Channel under a binding joint transportation services agreement. Delivery from the Gray Oak Pipeline to the Houston Ship Channel would be achieved through a connection in South Texas.

09:07 EDT Gannett responds to MNG Enterprises - Gannett described the February 7, 2019, meeting where representatives of Gannett, including two of Gannett's independent directors, and its financial and legal advisors met with MNG Enterprises. The objective of the meeting - a meeting Gannett had initially sought two days after receiving MNG's January 14, 2019, unsolicited, public acquisition proposal for the first time - was to give MNG yet another opportunity to answer basic questions about its proposal to acquire Gannett for $12.00 per share in cash, which the Gannett board of directors unanimously rejected on February 4, 2019. Contrary to MNG's claims, and despite MNG having 15 people in attendance, including financial and legal advisors who could have, but did not, address the issues, the presentation made by R. Joseph Fuchs, executive chairman of MNG, and his management team was deficient: MNG described a transaction in which it would invest no new equity, instead relying entirely on debt financing to fund the $1.8 billion implied by its proposal. MNG stated that it had neither secured financing for a potential transaction nor even reached out to potential financing sources. MNG offered vague assurances that it is not concerned about antitrust regulatory issues or pension liabilities in a potential transaction, but provided no specifics for these claims, and further stated that MNG would expect Gannett shareholders to share meaningfully in these risks, as opposed to signaling a willingness to bear these risks itself. MNG framed its proposed transaction as a merger or combination, not the acquisition proposal that MNG had previously put forth. Despite being afforded every opportunity to provide Gannett with specifics related to these important matters, Mr. Fuchs refused to provide any substantive, actionable evidence of a credible proposal. J. Jeffry Louis, chairman of the Gannett board of directors, said, "We are disappointed that at the meeting on February 7, MNG again failed to provide substantive answers to the basic questions Gannett has repeatedly raised. Instead, MNG offered vague and generic statements that further confirmed the board's decision to reject MNG's proposal." MNG delivered notice to Gannett of its intent to nominate six director candidates during a break in the meeting on February 7. All of the individuals it nominated to stand for election to Gannett's board are affiliated with MNG and/or its majority shareholder Alden Global Capital. Gannett believes MNG's clearly conflicted nominees are not in a position to fairly, and in a disinterested way, evaluate and advise Gannett shareholders on MNG's proposed transaction. At least three of MNG's candidates may be legally incapable of serving on the Gannett board under applicable antitrust laws, given their roles with MNG, which is a competitor of Gannett. Several other elements of MNG's notice to Gannett raise additional concerns regarding the credibility of its proposal, including nominating 78-year-old Mr. Fuchs, who exceeds Gannett's mandatory retirement age applicable to all directors, and MNG's statement that it reserves the right to substitute director nominees in direct contravention to Gannett's bylaws. Mr. Louis continued, "MNG's credibility was further undermined by its decision to nominate six director candidates, all of whom are affiliated with MNG and/or its majority shareholder Alden Global Capital, to stand for election to Gannett's board. MNG's acknowledgement that these nominations are indeed intended to advance its efforts to acquire Gannett further underscores the proposed nominees' clear and irreconcilable conflicts of interest and inability to satisfy fiduciary responsibilities to all Gannett shareholders." Gannett will provide notice of the date of the 2019 annual meeting and the board's recommended director nominees in the company's Notice of Annual Meeting of Stockholders, proxy statement and other materials, including a WHITE proxy card, to be filed with the SEC and mailed to all shareholders eligible to vote at the 2019 annual meeting.

09:04 EDT Amgen multiple myeloma treatment granted FDA orphan designation - Amgen's bispecific T-cell engager containing two single-chain variable fragment domains directed against the B cell maturation antigen surface receptor on tumor cells and the cluster of differentiation 3 receptor on T-cells was granted FDA orphan designation as a treatment of multiple myeloma, according to a post to the agency's website. Reference Link

09:02 EDT Inspired Entertainment sees Q1 adjusted EBITDA $13.25M-$14.25M

08:44 EDT Altria to tap European bond market to help fund Juul stake purchase - In a regulatory filing, Altria Group said it will tap the European investment grade corporate bond market to help finance its $12.8B purchase of a stake in e-cigarette maker Juul Labs. Altria will issue the bonds in four tranches in denominations of 100,000 euros as it looks to prepay a term loan arranged by JPMorgan Chase & Co to fund the deal. That loan matures on December 19, 2019.

08:34 EDT Hemispherx reports start of clinical trial combining Ampligen, Merck's Keytruda - Hemispherx Biopharma (HEB) announced the start at the UPMC Hillman Cancer Center in Pittsburgh, PA of a new clinical study supported by Merck that will combine the company's Ampligen with Merck's (MRK) Keytruda for the treatment of recurrent, platinum-sensitive, ovarian cancer. The study will enroll up to 45 participants and be conducted at UPMC, which is sponsoring the study, by Robert Edwards, MD, director of the Ovarian Cancer Program at UPMC Magee Womens Hospital. The overall funding and support for the clinical trial and the supply of Keytruda is based upon a collaboration between Merck and UPMC. Hemispherx is not funding the clinical trial and its collaboration obligation relates to supplying the Ampligen needed for the clinical trial. Over the past year, Hemispherx has produced 16,000 vials of Ampligen, including all of the supply of Ampligen needed for this clinical trial. Hemispherx shipped Ampligen for the clinical trial to UPMC on January 29, 2019 and the first subject was enrolled. The Company believes the study will be an important and more extensive test of Ampligen as an immune system primer that can convert "cold" tumors into "hot" tumors, thereby making the formerly "cold" tumors more responsive to Keytruda. This clinical trial will study how well Ampligen-based combination therapy works when given with Cisplatin and Keytruda in treating participants with recurrent ovarian cancer compared to historical controls. Drugs used in this combination therapy work by either direct antitumor activity, or by unleashing or enhancing the cancer immune responses that already exist. So called "checkpoint inhibitors" such as Merck's Keytruda interfere with the ability of tumor cells to grow and spread when present in a "hot" tumor microenvironment. The clinical trial tests whether the combination therapy will work better than Keytruda alone in treating participants with ovarian cancer. Studies from UPMC and the Roswell Park Comprehensive Cancer Center, in human tumor explants, have demonstrated that Ampligen is a TLR3 restricted and targeted immune modulator that can facilitate the transformation of some "cold" tumor microenvironments into "hot" tumor microenvironments.

08:32 EDT Central Garden & Pet CEO George Roeth set to retire - Central Garden & Pet Company announced that president and CEO George Roeth has announced his intention to retire from his roles, effective at the end of the company's fiscal year on September 28, 2019. Prior to that date, Roeth will continue to lead the Company in his capacity as president and CEO to ensure a smooth transition. The Board of Directors will form a Succession Committee to identify a successor with the assistance of a leading executive search firm.

08:18 EDT FMC Corporation provides details of final separation of Livent - FMC Corporation (FMC) announced that its Board of Directors has approved the distribution of all of its remaining interest in Livent (LTHM) to FMC stockholders, payable on March 1, to shareholders of record as of 5:00 p.m. EST on February 25. Subject to the conditions described below, the FMC Board of Directors has authorized the distribution to FMC stockholders of an aggregate of 123,000,000 shares of Livent common stock on March 1, the distribution date, as a pro rata dividend on shares of FMC common stock outstanding at the close of business on the record date of February 25. Based on the number of shares of FMC common stock outstanding as of December 31, 2018, FMC estimates that each share of FMC common stock will receive approximately 0.9304664 shares of Livent common stock in the distribution. The actual distribution ratio for the Livent common stock to be distributed per share of FMC common stock will be determined based on the number of shares of FMC common stock outstanding on the record date. The Distribution is subject to certain customary conditions, including receipt of a customary tax opinion and confirmation of sufficient capital adequacy and surplus to make the distribution. FMC expects all of these conditions to be satisfied on the distribution date.

08:15 EDT Takeda Pharmaceutical says ADCETRIS with AVD approved in EU - Takeda Pharmaceutical announced that the European Commission, or EC, extended the current marketing authorization of ADCETRIS to include treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with Adriamycin, vinblastine and dacarbazine, or AVD. ADCETRIS is an antibody-drug conjugate, or ADC, directed at CD30, a defining marker of Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on December 13, 2018.

08:10 EDT Kratos Defense awarded $14M in drone system contract - Kratos Defense announced that it has recently received approximately $14M in unmanned aerial drone system related contract awards, including for its newest class of tactical/ISR unmanned aerial system, Aethon. Aethon, which was developed by Kratos and which Kratos owns the system design and data rights, is an intelligence, surveillance, and reconnaissance unmanned aerial system.

08:09 EDT Nasdaq agrees to sell BWise to SAI Global; terms not disclosed - Nasdaq announced that it has entered into an agreement to sell BWise to SAI Global Pty Limited. The closing of this transaction is subject to regulatory approvals, works council and other representative body consultations and notifications in applicable jurisdictions, and customary closing conditions, and is projected to occur in the first half of 2019. Until the closing of the transaction, SAI Global and BWise will continue to operate as independent companies and will remain committed to providing superior service to create value for their customers.

08:08 EDT Active Biotech partner enters collaboration with AstraZeneca for Anyara - Active Biotech (ACTI) announces that their partner NeoTX enters a clinical collaboration with AstraZeneca Group Plc (AZN) global biologics research and development arm, MedImmune, to support Phase 1b/2 studies investigating ANYARA in combination with AstraZeneca's IMFINZI. IMFINZI is a human monoclonal antibody that blocks the immune checkpoint protein programmed death-ligand. Under terms of the agreement, NeoTX and AstraZeneca will collaborate on a non-exclusive basis to evaluate the combination of the two drugs in solid tumors. NeoTX will sponsor the study, while AstraZeneca will supply durvalumab. Up to 195 patients are planned to be enrolled in this multicenter, open-label study, which is planned to start during 2019. Active Biotech has an agreement with NeoTX Therapeutics Ltd since October 2016 for the global development and commercialization of ANYARA for the treatment of cancer.

08:07 EDT Seattle Genetics receives $30M milestone payment for EU approval of ADCETRIS - Seattle Genetics (SGEN) announced that its collaborator, Takeda Pharmaceutical (TKPYY), received approval from the European Commission to extend the marketing authorization for ADCETRIS to include ADCETRIS in combination with AVD in adults patients with previously untreated CD30+ stage IV classical Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on December 13, 2018. As a result, Seattle Genetics will receive a milestone payment from Takeda of $30M. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL that plays a role in tumor growth and survival. The marketing authorization for ADCETRIS is based on positive results from the ECHELON-1 phase 3 clinical trial that were presented in the Plenary Scientific Session at the 59th American Society of Hematology annual meeting in December 2017 with simultaneous publication in the New England Journal of Medicine. In September 2018, the Japanese Ministry of Health, Labour and Welfare approved ADCETRIS in combination with AVD as a frontline treatment option for CD30-positive HL patients in Japan. In March 2018, the U.S. Food and Drug Administration approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL based on the positive results of the ECHELON-1 phase 3 clinical trial.

08:05 EDT Kornit Digital expands partnership with Delta Apparel - Kornit Digital Ltd. (KRNT) announced it has received an order from DTG2Go, a Delta Apparel, Inc (DLA) company and leader in the direct-to-garment printing and fulfillment marketplace. The order follows several months of beta-testing of the recently released Kornit Atlas system by DTG2Go, during which Kornit was able to showcase the enhanced features of the most advanced industrial direct-to-garment solution available on the market. Key features of the Atlas include high volume throughput, attractive cost of ownership and featuring the new NeoPigment Eco-Rapid inkset specifically designed for sustainability and retail-quality digital textile printing. Per the agreement, DTG2Go will take delivery of 10 Atlas systems in 2019, along with a significant number of HD upgrades for DTG2Go's existing Kornit Avalanche systems.

08:05 EDT Jack Henry raises quarterly dividend 8% to 40c per share - Payable on March 18 to stockholders of record as of March 1.

08:04 EDT AbbVie, Teneobio enter global strategic transaction to develop TNB-383B - AbbVie, Teneobio, and its affiliate TeneoOne, that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma. Teneobio is expected to begin the clinical program for TNB-383B in the first half of 2019. Under the terms of the agreement, TeneoOne will receive an upfront payment of $90M and will continue developing TNB-383B through Phase 1. AbbVie will hold the exclusive right to acquire TeneoOne and lead subsequent global development and commercialization of TNB-383B. If AbbVie exercises its right to acquire TeneoOne, the former stockholders of TeneoOne will also be eligible for regulatory and commercial sales milestones.

08:01 EDT SAI Global to acquire BWise from Nasdaq, terms not disclosed - SAI Global announced it has entered into an agreement with Nasdaq to acquire BWise, a recognized leader in internal audit, regulatory compliance management, and operational risk management software. Pending regulatory approvals, works council and other representative body consultations and notifications in applicable jurisdictions, and customary closing conditions, the deal is expected to close in the first half of 2019. Terms of the private transaction will not be released. Until the transaction closes, each company will continue to operate independently.

07:48 EDT Ziopharm completes enrollment of controlled IL-12 monotherapy expansion substudy - Ziopharm Oncology announced that it rapidly completed enrollment and treated a total of 36 patients in less than six months in a substudy to expand a Phase 1 trial evaluating its Controlled IL-12 platform as a monotherapy for the treatment of recurrent glioblastoma. The trial was over enrolled with eleven more patients than the target goal of 25, which the Company attributes to enthusiasm stemming from the trial's encouraging survival and tumor biopsy data. Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, as a drug to control the production of interleukin 12. In the setting for the treatment of rGBM, previously reported Phase 1 data demonstrated an increased survival benefit when using 20mg of veledimex, which is extended further when patients also received low-dose steroids versus higher doses. A majority of the newly enrolled patients in the substudy were treated with low-dose steroids. The company is now evaluating data from 51 patients with rGBM treated with 20mg veledimex dose and assessing the impact of systemic dosing of steroids. The safety profile in the substudy is consistent with the main, Phase 1, dose-escalation study in which patients received varied systemic dosing of steroids, with all adverse reactions being manageable and reversible. Ziopharm anticipates reporting on preliminary data from this substudy at medical meetings this year.

07:38 EDT Valmont acquires 100% of the outstanding shares of United Galvanizing - Valmont Industries announced that it has acquired 100% of the outstanding shares of United Galvanizing located in Houston, Texas. The transaction was funded with cash on hand, and is expected to be accretive to earnings in year one. United's 2018 full-year revenues were approximately $21M. Valmont also announced the construction of a new hot-dip zinc galvanizing facility in Midland, Pennsylvania, approximately 35 miles northwest of Pittsburgh. Construction at the 11-acre site is expected to commence in the first quarter of 2019, and be fully operational by early 2020. As a result of the United acquisition, the 54-foot kettle currently at Valmont's Brenham, Texas galvanizing facility will be redeployed to the Midland location, as part of retrofitting the existing building site. When completed, Valmont-Pittsburgh Galvanizing's 120,000 square-foot facility will serve multiple market verticals throughout the region.

07:35 EDT Avaya appoints Kieran McGrath SVP, CFO - Avaya Holdings announced that Kieran McGrath will assume the role of SVP and CFO of Avaya effective February 15, 2019 and Pat O'Malley will transition to serve as SVP, Growth Initiatives. McGrath and O'Malley will both report to Jim Chirico, Avaya President and CEO. McGrath has thirty-plus years of technology industry financial, operational and transformational experience in software as a service, cloud computing, and technology services. He most recently served as Executive Vice President and CFO at CA Technologies from July 2016 until the company's acquisition in November 2018. In his new role, O'Malley will be responsible to accelerate strategic, cross-functional initiatives that are fundamental to Avaya's primary objective of revenue growth in fiscal 2019. In addition to its CFO transition, Avaya announced that Laurent Philonenko, SVP, Innovation, will be departing the company this month to assume the role of CEO for a customer experience management organization that is a business partner to Avaya.

07:32 EDT Precigen announces FDA clears IND application for PRGN-3005 - Precigen, a wholly-owned subsidiary of Intrexon, announced that the U.S. FDA has cleared the Investigational New Drug application for Precigen's PRGN-3005, a first-in-class investigational therapy using autologous chimeric antigen receptor T cells to treat advanced-stage platinum-resistant ovarian cancer patients.

07:18 EDT Myriad Genetics subsidiary enhances Prequel Prenatal Screen - Myriad Genetics announced that its Myriad Women's Health subsidiary has enhanced the Prequel Prenatal Screen to include all 23 chromosome pairs rather than just the standard five chromosomes previously tested. Aneuploidies refer to extra or missing chromosomes that can lead to poor reproductive health outcomes. The expanded Prequel screen will be available to clinicians and patients starting February 19. Prequel Prenatal Screen with expanded aneuploidy analysis can potentially improve birth outcomes by identifying more pregnancies at risk for birth defects and syndromes, as well as those at risk for pregnancy complications due to these chromosome changes in the placenta. This improves the opportunity for better monitoring, specialized ultrasounds and targeted prenatal diagnosis.

07:14 EDT Resonant provides update on XBAR technology for 5G devices - Resonant provided an update related to its resonator technology, XBAR, which holds the potential for a new class of high-performance RF filters for 5G devices. First filters using XBAR resonators have been fabricated. XBAR filters are demonstrating greater than 500 MHz bandwidth at 5 GHz. XBAR filters have a significantly smaller form factor than competing dielectric-based filters.

07:12 EDT Apellis announces fast track designation for APL-2 from FDA - Apellis announced that the FDA has granted fast track designation to the company's APL-2, a novel inhibitor of complement factor C3, for the treatment of patients with paroxysmal nocturnal hemoglobinuria, or PNH. APL-2 is currently being studied in a Phase 3 active comparator trial in patients with PNH who remain anemic despite treatment with eculizumab. This new fast track designation for APL-2 for all patients with PNH, supersedes the prior fast track designation granted on December 15, 2016 for APL-2 for the subset of PNH patients who continue to experience hemolysis requiring blood transfusions despite receiving therapy with eculizumab.

07:10 EDT CTI BioPharma receives $10M milestone payment for TRISENOX from Teva - CTI BioPharma (CTIC) announced that it has received a $10M milestone payment from Teva (TEVA) related to the achievement of sales milestones for TRISENOX. TRISENOX was acquired from CTI BioPharma by Cephalon. Cephalon was subsequently acquired by Teva. The milestone was paid pursuant to an acquisition agreement for TRISENOX entered into with Cephalon under which CTI BioPharma is eligible to receive up to an additional $40M in payments upon achievement by Teva of specified sales and development milestones related to TRISENOX.

07:04 EDT BMC Stock Holdings acquires Locust Lumber - BMC Stock Holdings announced that it has acquired Locust Lumber, a supplier of lumber products and building materials primarily to custom homebuilders and professional remodelers in Charlotte, North Carolina. Locust generated $53M in net sales for FY18.

07:03 EDT Recro Pharma reports five-year manufacturing, supply agreement with Novartis - Recro Pharma (REPH) announced that Recro Gainesville LLC, its contract development and manufacturing division, has entered into a five-year manufacturing and supply agreement with Novartis Pharma (NVS), effective January 1, 2019. Under the terms of the agreement, Recro Gainesville will continue to be the exclusive global supplier to Novartis of Ritalin LA and Focalin XR capsules through 2023. The prior Novartis supply contracts for Ritalin LA and Focalin XR were set to expire in late 2019 and mid-2020, respectively, and provided for two revenue components, product manufacturing revenue and royalty revenue. These agreements were consolidated into the 2019 Novartis Agreement, which provides for product manufacturing revenue that is expected to provide similar "total revenue per capsule economics" as did the two prior revenue components combined.

07:02 EDT Sanofi, Regeneron offer Praluent at reduced U.S. list price - Praluent will be made available at a new reduced U.S. list price of $5,850 annually, a 60% reduction from the original price, for both the 75 mg and 150 mg doses, beginning in early March.The new lower-priced Praluent is expected to result in lower patient out-of-pocket costs and represents another step in the companies' efforts to help improve patient affordability and access. This follows an earlier announcement in March 2018, when Sanofi (SNY) and Regeneron (REGN) committed to lower the U.S. net price for payers in return for helping to reduce burdensome access barriers for appropriate patients. With the new lower-priced Praluent, most Medicare Part D patients are expected to pay between $25 to $150 per month, a potential savings of up to $345, depending on their insurance plan. Eligible commercial patients will continue to have access to copay assistance through MyPraluent. The new, lower-priced Praluent is expected to be available for pharmacies to order in early March, and the doses with the original list price will remain on the market at least through 2019. The lower-priced Praluent will be identical to the Praluent currently available, other than the list price.

07:01 EDT EC approves Bristol-Myers' Sprycel, chemotherapy for Ph+ ALL - Bristol-Myers Squibb Company announced that the European Commission has approved Sprycel in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. This is the second pediatric leukemia indication for Sprycel in Europe. The approval includes both the tablet form of Sprycel and, in a first for pediatric patients with ALL in Europe, the powder for oral suspension formulation of Sprycel. The approval is based on data from CA180-372, a Phase 2 trial which evaluated the addition of Sprycel to a chemotherapy regimen modeled on a Berlin-Frankfurt-Munster high-risk backbone in pediatric patients with newly diagnosed Ph+ ALL. Results from the CA180-372 trial presented at the 2017 American Society of Hematology Annual Meeting showed that at three years, the combination of Sprycel and chemotherapy demonstrated an event-free survival rate, the study's primary endpoint, of 65.5%, and an overall survival rate of 91.5%.

06:56 EDT Morgan Stanley to acquire Solium Capital for $900M

06:49 EDT BWX Technologies reaches price agreement on new contracts worth $2.1B - BWX Technologies announced that two of its subsidiaries, BWXT Nuclear Operations Group, and Nuclear Fuel Services, have reached price agreement with the U.S. Naval Nuclear Propulsion Program on new contracts totaling approximately $2.1B, including future-year options, for the manufacture of naval nuclear reactor components and fuel. Initial contract awards are anticipated to occur in the first quarter of 2019 and will constitute the bulk of the $2.1B. The remaining contract option awards are expected in 2020, subject to annual Congressional appropriations. A variety of naval nuclear reactor component manufacturing and material procurement activities performed over the term of these contracts will primarily support Virginia-class and Columbia-class submarine construction at BWXT NOG locations in Lynchburg, Virginia; Barberton and Euclid, Ohio; and Mount Vernon, Indiana. Including future year options, this work is valued at more than $1.7B. The balance of the work - manufacture and delivery of fuel and support activities for the U.S. Naval Nuclear Propulsion Program, as well as development work for future Naval Reactors programs - will be performed at NFS in Erwin, Tennessee. Additional proposal actions are underway for components for the second carrier in the U.S. Navy's plans to procure two Ford-class aircraft carriers in a single purchase. That pricing agreement is anticipated later this year.

06:43 EDT Obsidian Energy lowers FY19 production view to 26,750-27,750 Boepd - Previous guidance for FY19 was 28,000-29,000 Boepd. Sees FY19 operating costs $14.00-$14.50 per boe. Sees FY19 production growth rate flat.

06:39 EDT Obsidian Energy sees Q1 total production 27,000-27,500 Boepd net - Based on preliminary estimates, the company expects Q1 light and heavy oil production to be approximately 15,750-16,250 barrels per day net to Obsidian Energy, which reflects the curtailment requirements for the quarter. Total production for Q1, including natural gas liquids and natural gas is expected to be approximately 27,000-27,500 boe per day net to Obsidian Energy. Currently, the company has approximately 2,200 boe per day behind pipe and if the curtailment requirements were to be lifted or reduced, we would bring those volumes on production.

06:36 EDT Obsidian Energy reports 2018 independent reserves evaluation - Obsidian Energy presented the results of its year-end 2018 independent reserves evaluation. The year 2018 marks the second year in a row that Obsidian Energy has achieved greater than 100% reserve replacement on proved plus probable, or 2P, and total proved reserves, or 1P. This increase is a direct result and recognition of the performance of 2018 Cardium drilling program with a 1P and 2P reserve replacement in the Cardium of approximately 150% and 140% respectively. Cardium assets in Willesden Green continue to perform with 16 additional undeveloped locations added to the book's primary Cardium count. The company also continues to see benefits from its optimization and decline mitigation projects with an average three year proved developed producing decline of 15.8%. All 14 wells of the second half 2018 Cardium program have been drilled and completed with 12 currently on production. Well performance on average is exceeding the updated type-curves presented on November 15, 2018. The company's focus on cost reduction has resulted in an average well cost of $3.6M on the first 14 wells, significantly below forecasted cost estimates. The final two wells off the 5-18 pad have been fractured, with one well setting a record for the company's longest Cardium well drilled to date at 5,290 meters of measured depth with 38 fracture stages. These two wells will be on production by mid-February.

06:34 EDT Bluebird Bio names Chip Baird as CFO - Bluebird bio (BLUE) announced Chip Baird will join the company effective February 11 and assume the role of CFO. Baird joins bluebird from Amicus Therapeutics (FOLD) where he was the CFO for the past seven years and brings a demonstrated track record of successfully leading companies in all phases of discovery, development and commercialization. Jeff Walsh, who has held various roles over the last eight years at bluebird bio - including COO and, most recently, chief financial and strategy officer - will assume the new dedicated role of chief strategy officer to drive corporate development and the company's overall growth strategy. In addition, Jason Cole, who has served as general counsel since 2014 and chief legal officer since 2016, will assume the new and expanded role of chief operating and legal officer overseeing both operations and legal functions for the company.

06:30 EDT Ingersoll-Rand to acquire Precision Flow Systems for $1.45B

06:18 EDT Kemper reports book value per share of $47.10, up 15% y/y - Kemper ended the quarter with a book value per share of $47.10, an increase of 15% from $41.11 at the end of 2017. Book value per share excluding net unrealized gains on fixed maturities was $45.40, up 28% from $35.57 at the end of 2017, driven by the Infinity acquisition and net income, partially offset by dividends paid to shareholders.

06:10 EDT Corcentric to acquire Determine for approximately $32M in cash - Corcentric announced that it signed a definitive purchase agreement with Determine to acquire substantially all the assets of Determine for cash of approximately $32M. This transaction is expected to close within the second calendar quarter of 2019. The purchase agreement, which has been approved by the Board of Directors of both companies, is conditioned upon, among other things, the approval of Determine's stockholders, and other customary closing conditions. In order to accommodate French labor law, the closing is also contingent upon the required prior consultation with Determine's works council. Subject to the satisfaction of these conditions, the transaction is expected to close in the second calendar quarter of 2019.

06:07 EDT AG Mortgage sees Q4 book value declining to an estimated $17.21 - CEO, David Roberts said, "The underperformance in broad risk assets and increased interest rate volatility during the fourth quarter caught most market participants off-guard. During the fourth quarter of 2018, the Agency MBS basis widened and interest rates declined sharply. As a result, we estimate that MITT's book value declined approximately (10.2)% to an estimated $17.21 for the fourth quarter from $19.16 at the end of the prior quarter. Against this backdrop, we were able to deploy capital into a pool of re-performing whole loans and several Non-QM pools alongside other Angelo Gordon funds during the fourth quarter. Through January, there has been a modest recovery in the market for risk assets and the Agency basis, and we estimate that book value increased approximately 2% through January 31, 2019. We continue to hold a favorable outlook on the investment landscape, and we have maintained our overall risk posture in this environment."

06:04 EDT KBR awarded 2 contract modifications by U.S. Navy - KBR announced that its global government services business, KBRwyle, has been awarded two contract modifications to continue providing base operating support services, or BOSS, to the U.S. Navy in Djibouti and the Kingdom of Bahrain. The Naval Facilities Engineering Command, or NAVFAC, Europe, Africa and Southwest Asia, awarded both contract extensions. KBRwyle won a one-year contract modification to continue providing a full spectrum of services at Camp Lemonnier in Djibouti and other locations within Africa. With this extension, KBRwyle will support a base population of thousands of Soldiers, Sailors, Marines, and Airmen. This work will include everything from management and administration to air operations and galley services. The contract modification is the first of a possible seven option years on a $441M firm-fixed-price, indefinite-delivery/indefinite-quantity contract originally won in 2017. The services will primarily be performed at the Naval Support Facility, as well as at two forward operating locations Chabelley Air Field in Djibouti and Camp Simba in Manda Bay, Kenya. KBRwyle has provided base operating support services at Camp Lemonnier, the largest U.S. base in Africa, since 2013. Its work in the region dates back to 2003. KBRwyle also received a one-year contract modification to continue support services at Naval Support Activity Bahrain. KBRwyle will provide a full range of services, including galley, security operations, and facilities, waste and utilities management. This is the first of a possible seven options years on a $91M indefinite-delivery/ indefinite-quantity contract originally won in 2017. These awards follow a recent $62M BOSS contract modification awarded to the company to support Navy Support Facility Diego Garcia in the British Indian Ocean Territory.

06:01 EDT RadNet to acquire outpatient radiology practice of Kern Radiology Medical Group - RadNet reported it has signed a definitive agreement to acquire the outpatient radiology practice of Kern Radiology Medical Group, the owner of five imaging centers in Bakersfield, California. The transaction is expected to close in April. Kern Radiology performs more than 200,000 exams each year and is expected to contribute to RadNet approximately $25M of revenue on an annual basis.

05:33 EDT Embraer delivers 181 total jets in 2018 - Embraer (ERJ) delivered a total of 181 jets in 2018, of which 90 were commercial aircraft and 91 were executive jets, 64 light and 27 large. The deliveries were within the outlook ranges for the year of 85 to 95 for the commercial aviation market, while business aviation market deliveries were below the 105 to 125 outlook, as recently disclosed by Embraer during its recent meeting with investors and analysts at the New York Stock Exchange. In the fourth quarter of 2018, Embraer delivered 33 commercial jets and 36 executive jets. As of December 31, the firm order backlog totaled $16.3B. During the fourth quarter, Embraer confirmed commercial jets sales following the agreements established at Farnborough Airshow, in July 2018. Republic Airways, the world's largest E-Jets operator, signed a firm order for 100 E175 jets. The contract also includes purchase rights for an additional 100 E175s, with conversion rights to the E175-E2, bringing the total potential order up to 200 E-Jets. Azul Linhas Aereas Brasileiras confirmed the firm order for a previously announced 21 E195-E2 jets. This contract is in addition to the 30 E195-E2 jets ordered by the airline in 2015, raising Azul's total order to 51 Embraer E2 aircraft. Azul is the launch operator of the E195-E2 and will receive the first aircraft in 2019. Finalizing the expected deals from the airshow, Embraer signed a firm order contract for three E190 aircraft with Nordic Aviation Capital, the global leader in regional aircraft leasing, and unveiled that Binter Canarias, of Spain, will receive its first E195-E2 jet in the second half of 2019, becoming the first European customer of the E-Jets E2's largest model. The airline signed a firm order with Embraer for three E195-E2s. The contract also includes purchase rights for two additional aircraft of the same model. Embraer also announced in the last quarter that American Airlines Inc. signed a firm order for 15 E175 jets in a 76-seat configuration, as well as the signing of a contract with the Government of Kiribati, in partnership with their national airline, Air Kiribati, for two firm orders for the E190-E2 E-Jets and two purchase rights for the same model. Recently, Embraer unveiled an additional order from SkyWest for nine E175 jets which was included in the last quarter backlog. Since 2013, SkyWest has purchased a total of 158 E175s, in order to expand their large existing fleet of Embraer aircraft. Regarding the business aviation market, Embraer launched in the fourth quarter the new Praetor 500 midsize and Praetor 600 super-midsize business jets, introducing unprecedented range into their categories. The Praetor 600 is expected to be certified and enter service in the second quarter of 2019, followed by the Praetor 500 in the third quarter of 2019. Embraer Defense & Security celebrated an important milestone in the period when its multi-mission airlift KC-390 was granted the Type Certificate from Brazilian aviation authority Agencia Nacional de Aviacao Civil. Also, the company successfully completed the troop unloading, evacuation by hatch and evacuation tests through the front and rear doors of the aircraft in tests supported by the Brazilian Air Force as well as the Brazilian Army. In the fourth quarter, the Services & Support area announced a multi-year contract with airlines around the world. Air Peace, Nigeria's leading private airline, has signed a multi-year Pool Program Agreement for spare parts and support of its six ERJ 145 jets. Trans States Airlines confirmed a contract to implement the Embraer Collaborative Inventory Planning program, a supply chain solution for expendable parts. Besides that, a Flight Hour Pool Program agreement was signed with Western Air, from the Bahamas, to provide repairable component support for the carrier's fleet of ERJ-145 aircraft.

05:27 EDT Boeing to provide Uzbekistan Airways with landing gear services - Boeing reached an agreement with Uzbekistan Airways to provide services that will enable the airline to more efficiently and effectively maintain its 787-8 Dreamliner fleet through the Boeing Landing Gear Exchange program. The flag carrier of the Republic of Uzbekistan will rely on Boeing to support its fleet with quick and reliable landing gear exchanges when and where they need them. This program greatly reduces maintenance time, helps the airline quickly return airplanes to service, and enables the airline to focus its resources on core operations.

05:24 EDT InterDigital sees Q4 operating expenses at top end of the range - InterDigital expects its Q4 operating expenses to be at the top end of the range communicated at our Investor Day held on December 10, 2018. "We expect our fourth quarter 2018 operating expenses will include approximately $9 million related to one-time charges, including $4 million of non-cash charges related to the July 2018 acquisition of Technicolor's licensing business."