Stockwinners Market Radar for January 13, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:58 EST CVS Health CEO: We are very excited about the HealthHubs - In an interview on CNBC's Mad Money, CVS Health CEO Larry Merlo said, "We are seeing great utilization of the HealthHub services and are committed to have about 600 Hubs by end of the year." When asked about the Aetna acquisition, Merlo said, "We've repaid about $8B of debt from the Aetna deal. We have ample cash to pay back the debt. We are comfortable with the trajectory we're on."

18:47 EST GlaxoSmithKline CEO: I'm pleased with our progress and momentum - In an interview on CNBC's Mad Money, GlaxoSmithKline CEO Emma Walmsley said, "Innovation is the first of our three priorities. We're hopeful for six new approvals for medications in 2020 and we're investing in our pipeline." She noted, "We love the vaccines business and are proud to be world leaders with vaccinations. We have lots of room to grow with Shingrix." Walmsley thought the Tesaro acquisition was a "smart risk" and added, "Our commitment to our dividend remains strong." When asked about China she noted that,"The Chinese market has very high potential and it's exciting as they open up more to innovation."

18:01 EST Starboard Value confirms 9% activist stake in Merit Medical - In a regulatory 13D filing, Starboard Value disclosed taking a 9.0% activist stake in Merit Medical. Starboard indicates that it "may in the future take such actions with respect to their investment as they deem appropriate including, engaging in communications with management and the Board of Directors of the Issuer, engaging in discussions with stockholders of the Issuer or other third parties about the Issuer and the Reporting Persons' investment, including potential business combinations or dispositions involving the Issuer or certain of its businesses, making recommendations or proposals to the Issuer concerning changes to the capitalization, ownership structure, board structure, potential business combinations or dispositions involving the Issuer or certain of its businesses, or suggestions for improving the Issuer's financial and/or operational performance."

17:02 EST RTI Surgical surges 85% after sale of OEM business and guidance - Shares of RTI Surgical are up 85% in after-hours trading to $5.10 per share.

16:59 EST GameStop falls 8.8% after cutting FY19 SSS outlook - Shares of GameStop are down 8.8% or 48c at $4.95 per share after the company lowered its FY19 comparable store sales outlook to down 19%-21% from its prior forecast of a decline in high teens issued on December 10th.

16:55 EST MagnaChip up 10.5% after raising Q4 revenue guidance - Shares of MagnaChip are up 10.5% or $1.32 at $13.90 per share after the company raised its Q4 revenue guidance to $198M-$200M from $181M-$191M.

16:52 EST Saint Joe Co. to build, own self-storage facility in Santa Rosa Beach, FL - The St. Joe Company announced its plans to build and own a self-storage facility in Santa Rosa Beach, Florida. Plans call for the proposed facility to be built in South Walton Commerce Park near the corner of US Hwy 98 and Serenoa Road. The proposed location of the facility is in close proximity to the Scenic Highway 30-A corridor and the communities of Watersound Origins, WaterColor, WaterSound Beach and several other growing residential communities. Current plans include a facility of approximately 90,000 square feet featuring more than 600 storage units ranging in size from 25 square feet to as large as 300 square feet. St. Joe intends to make the units available for rent on a monthly or annual basis to residents and businesses. Proposed features of the three-story facility include seven-day-a-week access, a covered loading area and climate-controlled storage units. St. Joe intends to begin construction this spring. Plans call for the facility to be complete with storage units available for rent in the spring of 2021.

16:47 EST Copa Holdings reports December traffic down 2.2% y/y - For the month of December 2019, Copa Holdings' capacity decreased 5.9%, while system-wide passenger traffic decreased only 2.2% year over year. As a result, system load factor for the month was 85.4%, 3.3 percentage points higher than December 2018.

16:42 EST IAC's subsidiary begins tender offer to acquire shares of Care.com - IAC/InterActiveCorp (IAC) and Care.com (CRCM) announced that IAC's wholly-owned subsidiary, Buzz Merger Sub, has commenced its previously announced tender offer to acquire all of the outstanding shares of common stock of Care.com at a price of $15.00 per Common Share and all outstanding shares of Series A Convertible Preferred Stock of Care.com at a purchase price equal to 150% of the liquidation preference per Preferred Share plus accrued and unpaid dividends, in each case, net to the holder in cash, without interest and less any applicable withholding taxes. The tender offer is being made in connection with the Agreement and Plan of Merger, dated December 20, 2019, by and among IAC, Merger Sub and Care.com. The board of directors of Care.com has determined that the offer is fair, advisable and in the best interest of Care.com and its stockholders and recommends that the stockholders of Care.com tender their shares. The tender offer is scheduled to expire at one minute after 11:59 p.m., Eastern Time, on February 10, 2020, unless extended or earlier terminated.

16:39 EST Ethan Allen announces Rodney Hutton appointed Chief Marketing Officer - Ethan Allen announced that Rodney Hutton has recently joined Ethan Allen as Chief Marketing Officer. Rodney has previously held senior marketing leadership roles in a number of leading enterprises including Karl Lagerfeld, Ann Klein, Ralph Lauren and Giorgio Armani.

16:36 EST Ethan Allen increases share repurchase authorization to 3M shares

16:35 EST Cigna, Oscar announce strategic partnership over small businesses - Cigna and Oscar announced an exclusive partnership to jointly provide commercial health solutions to small businesses. The companies will provide affordable, seamless, fully insured health benefits under the Cigna + Oscar brand to the small group market. Services will include: Integrated medical, behavioral, and pharmacy services; Broad access to high-performing networks of doctors and hospitals; Support from a dedicated concierge team assigned to individual members to help them understand their benefits and find care; Digital-first support, featuring 24/7 telemedicine at no charge, easy ID card access, an overview of copay details and benefits, deductible tracking, lab results and individual health history; Easy-to-use search tools to help review health care providers, book appointments, find facilities and check prescriptions; Leading broker, business and provider portals for seamless enrollment and management. Cigna and Oscar plan to share risk equally under a reinsurance agreement for solutions offered through this strategic partnership. Pending regulatory approvals, the companies will launch in select markets in 2020 and plan to expand the partnership over time.

16:33 EST Lone Pine Capital reports 6.7% passive stake in Under Armour - In a regulatory filing, Lone Pine Capital disclosed a 6.7% stake in Under Armour, which represents about 12.7M common shares. The filing does not allow for activism.

16:31 EST MetaBank names Kathi Winter chief people officer - MetaBank, a wholly-owned subsidiary of Meta Financial Group, Inc., announced that Kathi Winter has joined Meta as Executive Vice President, Chief People Officer. Kathi Winter joins Meta after having held the Chief Human Resources Officer position at UnitedWeb Nextiva Sitelock, a global privately-held technology organization with over 1000 employees. Winter's career includes over six years at iMortgage Loan Depot, as well as over eleven years at Honeywell, serving in a variety of global Human Resources and Organizational Development roles. Winter holds a Master's degree in Instructional Technology from Arizona State University, where she also received a Bachelor's Degree in Psychology and Education.

16:31 EST Leidos and Clarify Health announce strategic alliance - Leidos announced a strategic alliance with Clarify Health Solutions, a leader in advanced healthcare analytics, that will facilitate improved healthcare operations and impact through world-class and governance-based digital solutions. Under the agreement, Leidos will enable its customers to deliver Clarify-generated observed and predictive insights directly into healthcare operations through its careC2 platform. "Both our companies share a mission to improve health and access to high value healthcare," said Todd Gottula, co-founder and chief product officer of Clarify Health. "We are excited to collaborate with Leidos to create innovative and unprecedented offerings in advanced predictive analytics for our partners that ultimately improve value and increase performance transparency in healthcare."

16:31 EST JetBlue reports December traffic up 5.7%, capacity up 4.4% - Load factor for December 2019 was 82.4%, an increase of 1.0 points from December 2018. JetBlue's preliminary completion factor for December 2019 was 99.3% and its on-time performance was 66.7%.

16:23 EST Amgen announces strategic collaborations with Guardant, Qiagen - Amgen announced strategic collaborations with leading diagnostic companies Guardant Health (GH) and Qiagen (QGEN) to develop blood- and tissue-based companion diagnostics, or CDx, respectively, for investigational cancer treatment AMG 510. AMG 510 is the first KRASG12C inhibitor to advance to the clinic for investigation in treatment of multiple tumor types. KRAS G12C is one of the most frequently mutated oncogenes in human cancers. The agreements with both companies will initially focus on CDx tests for non-small cell lung cancer but allow for further development of the diagnostic tests for Amgen's other oncology clinical development programs.

16:20 EST Stemline reports preliminary Q4 Elzonris revenue $11.8M - Robert Francomano, chief commercial officer of Stemline, stated, "We are very pleased with the solid uptake seen in the first year of the ELZONRIS launch, as we continue to successfully create, penetrate and grow a new market in BPDCN. Given the orphan nature and unique features of this disease, we believe patient starts were subject to significant quarterly variance - a phenomena that will likely continue throughout 2020. We are actively implementing a host of tactics to expand and further penetrate this emerging market."

16:19 EST RingCentral names Anand Eswaran as new COO - RingCentral (RNG) announced that Anand Eswaran, former Corporate Vice President for Microsoft's (MSFT) Global Enterprise Business, has joined the company as its President and COO, reporting to CEO Vlad Shmunis. Eswaran will be responsible for leadership and execution across products, engineering, sales, marketing, services, customer care, operations, and human resources. Eswaran was most recently responsible for Microsoft's Enterprise Commercial and Public Sector business globally.

16:18 EST Merit Medical jumps 17% after report of Starboard building stake - Shares of Merit Medical Systems have jumped 17% to $40.50 in after-hours trading after Bloomberg's Scott Deveau reported, citing people familiar with the matter, that activist investor Starboard Value has built a roughly 9% stake in the device maker. The hedge fund thinks shares are undervalued but it is unclear what changes it might push for, the report said.

16:16 EST Cloudera names Robert Bearden as CEO - Cloudera announced the appointment of Robert Bearden as President and CEO. Bearden is an experienced enterprise software executive. He was co-founder and CEO of Hortonworks, a publicly traded open-source company that merged with Cloudera in 2019. He also served as President and COO of SpringSource, a leading provider of open-source developer tools, until its acquisition by VMWare in 2009. Before joining SpringSource, Bearden served as Entrepreneur in Residence at Benchmark Capital. He also served as COO of JBoss, a leading open-source middleware company, until its acquisition by Red Hat in 2006. In connection with the announcement, Cloudera also reaffirmed the guidance for the fourth quarter of fiscal 2020 and the full year fiscal 2020 that it provided in the December 5, 2019 press release.

16:16 EST Five Point Holdings to sell 781 homesites in Valencia for $135M - Five Point Holdings announced the sale of 781 homesites at Valencia in Q4 of 2019. The company closed on 711 of these homesites, and the balance is anticipated to close in the first half of this year. The proceeds from the closed homesites were approximately $135M.

16:12 EST ICF International to acquire Incentive Technology Group for $255M - ICF announced that it has entered into a definitive agreement to acquire Incentive Technology Group, one of the leading and fastest growing providers of cloud-based platform services to the U.S. federal government. ITG had revenues of approximately $90M in 2019 and ended the year with a revenue run-rate in excess of $100M. The purchase price is $255M, funded by ICF's existing credit facility. The closing of this transaction, subject to regulatory approval and customary closing conditions, is expected to occur in the first quarter of this year and to be accretive on a non-GAAP EPS basis in 2020. ICF expects the net present value of the tax benefit of this transaction to be approximately $33M. ITG's EBITDA margin is in the mid-teens. Following the completion of this acquisition, the company's leverage ratio is expected to be less than 2.7.

16:11 EST GameStop now sees FY19 comparable store sales down 19%-21% - Comparable store sales are now expected to decline in the range of 19%-21% for FY19. The company, while not updating earnings per share guidance at this time, now expects an adjusted net loss for the fiscal year, with adjusted earnings per diluted share impacted by the further deceleration in sales in December. Despite the sales results, the company continues to manage inventory and anticipates ending FY19 with inventory down approximately 26% as compared to FY18. The company now expects capital expenditures for FY19 to be in the range of $75M-$80M, and forecasts total cash and liquidity, including availability under the revolving line of credit, at the end of the fiscal year to be approximately $900M.

16:09 EST GameStop reports holiday period sales of $1.83B, down 27.5% - GameStop reported sales results for the nine-week holiday period ended January 4. Total global sales from continuing operations for the holiday period were $1.83B, a 27.5% decrease compared to the 2018 nine-week holiday period ended January 5, 2019. Total comparable store sales for the nine-week period decreased 24.7%, following a 1.5% increase in comparable store sales for the similar period in fiscal 2018. Sales results during the holiday period are indicative of overall industry trends impacting the video game industry and driven by an accelerated decline in new hardware and software sales, particularly in the month of December.

16:07 EST ICF International to acquire Technology Group for $255M - ICF announced that it has entered into a definitive agreement to acquire Incentive Technology Group, one of the leading and fastest growing providers of cloud-based platform services to the U.S. federal government. ITG had revenues of approximately $90M in 2019 and ended the year with a revenue run-rate in excess of $100M. The purchase price is $255M, funded by ICF's existing credit facility. The closing of this transaction, subject to regulatory approval and customary closing conditions, is expected to occur in the first quarter of this year and to be accretive on a non-GAAP EPS basis in 2020. ICF expects the net present value of the tax benefit of this transaction to be approximately $33M. ITG's EBITDA margin is in the mid-teens. Following the completion of this acquisition, the company's leverage ratio is expected to be less than 2.7.

16:06 EST Everspin Technologies to cut workforce by 15%, targeting $5M in annual savings - Everspin Technologie announced a restructuring plan designed to reduce annual operating expenditures and achieve quarterly cash flow breakeven this year under the existing revenue outlook. Headcount reductions will be enacted January 31, 2020. As a result, Everspin will take a one-time restructuring charge in the fourth quarter of 2019. The restructuring will result in an approximately 15% reduction of the workforce and is designed to maximize long-term sustainability, operational health and financial controls, while prioritizing the company's long-term roadmap expansion and associated R&D for MRAM products and technology.

16:06 EST Qiagen announces strategic collaboration with Amgen over AMG 510 - Qiagen (QGEN) announced a strategic collaboration to develop tissue-based companion diagnostics for Amgen's (AMGN) investigational cancer treatment AMG 510 to identify patients with cancers that have the KRAS G12C mutation. The agreement focuses initially on companion diagnostics for non-small cell lung cancer but allows for further development of the tests for Amgen's other oncology clinical development programs. "We are pleased to support Amgen by building on the success of our therascreen platform to develop a tissue-based companion diagnostic to identify patients who would benefit from AMG510. QIAGEN's Sample to Insight workflows and experience in developing diagnostic solutions for Precision Medicine are well-suited to help aid in evaluating patients with non-small cell lung cancer," said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area. "The success of our long-standing collaboration with Amgen is a demonstration of QIAGEN's capabilities as a preferred partner of pharmaceutical and biotech companies for the creation of companion diagnostics."

16:04 EST Zumiez up 1.3% after raising Q4 EPS, SSS guidance

16:03 EST Capital Southwest supports Cotton Creek Capital's acquisition of Landpoint - Capital Southwest announced that it supported Cotton Creek Capital's recent acquisition of Landpoint and all of the Company's subsidiaries, which include King Surveyors, and West Company of Midland with a senior secured first lien term loan. Capital Southwest led the financing and will act as the sole administrative agent on the credit facility."We are excited to partner with Cotton Creek on its acquisition of Landpoint. Cotton Creek brings deep experience in the infrastructure services sector and an extensive network of industry relationships that will bolster the Company's next phase of growth," said Douglas Kelley, Managing Director of Capital Southwest.

16:02 EST Zumiez raises Q4 comparable sales guidance to 6% from 2%-4%

16:01 EST Zumiez reports holiday 2019 comparable sales increase of 6.8% - Zumiez announced that the company's comparable sales increased 6.8% for the nine-week period ended January 4, 2020 compared to the nine-week period ended January 5, 2019. In the prior year, comparable sales increased 4.0% for the nine-week period ended January 5, 2019.

15:34 EST EQT sees taking up to $1.8B impairment charge during Q4 - In a regulatory filing from earlier, EQT Corp said it sees Q4 net sales volumes to be between 370 Bcfe and 375 Bcfe, which is towards the high end of its previously announced guidance range of 355 Bcfe to 375 Bcfe. Average realized price, including the impact of cash settled derivatives, for the fourth quarter of 2019 is expected to be between $2.51 and $2.56 per Mcfe. In addition, average differential is expected to be between $(0.45) and $(0.40) per Mcf, which is within the company's previously announced guidance range of $(0.45) to $(0.25) per Mcf. EQT sees Q4 capital expenditures of $340M-$360M, which is within its previously announced guidance range of $320M-$370M. During the fourth quarter of 2019, EQT also expects to incur a non-cash impairment charge between $1.4B and $1.8B, principally related to the following: reducing the carrying value of certain proved and unproved properties as a result of management's potential monetization of select, non-core exploration and production assets and depressed natural gas prices and the write-down of unproved properties which are primarily the result of changes to our development strategy and renewed focus on a refined core operating footprint. This estimated non-cash impairment charge for the fourth quarter of 2019 is subject to a number of assumptions and judgments and may change as the company finalizes its financial results for the year ended December 31, 2019. "It is also possible we may incur additional impairment charges in future periods as a result of the above factors or otherwise," the company said.

15:21 EST Twinlab names Dan DiPofi as new CEO - Twinlab announced it has appointed Dan DiPofi as its new CEO. Prior to this new position, DiPofi served as the executive vice president and COO of the Buffalo Sabers of the National Hockey League and has held senior executive positions within the sports and entertainment industry for over 20 years.

15:00 EST Welltower, Jefferson announce framework for joint venture - Welltower (NYSE: WELL) and Thomas Jefferson University and Jefferson Health announced their intention to create a long-term strategic partnership that will transform Jefferson's real estate portfolio and "open new opportunities to address social determinants of health for aging populations across their shared geographic footprint." Under the terms of a Memorandum of Understanding signed by both parties, Welltower and Jefferson would create a joint venture whereby Welltower would acquire a stake in certain real estate assets of Jefferson, enabling Jefferson to reduce some of its fixed asset investments and redeploy the capital to other clinical and academic strategic areas. In addition to the joint venture, Welltower would help Jefferson accelerate its ambulatory care growth strategy.

14:21 EST Cigna sees 2020 full year medical customer growth of 150,000-250,000 customers - Cigna disclosed earlier that officials expect to participate in meetings with investors and analysts on January 13 and 14, 2020 at the J.P. Morgan Healthcare Conference, including a presentation with David Cordani, Cigna's President and CEO. During these meetings, Cigna officials expect to disclose expectations for growth in 2020, including total full year medical customer growth of 150,000 to 250,000 customers over Cigna's year-end 2019 total medical customer base, including individual Medicare Advantage growth of 60,000 to 70,000 customers, representing 13% to 16% growth over year-end 2019. In addition, Cigna management also intends to disclose the company's expectations for 2020 Health Services' adjusted pharmacy scripts in the range of 1.47B to 1.50B, representing growth of 250M to 280M adjusted pharmacy scripts or 20% to 23% over year-end 2019. This outlook includes volumes expected to be insourced from OptumRx and volumes associated with the first year of the Prime Therapeutics LLC collaboration, as well as additional organic growth of 25M to 35M adjusted pharmacy scripts. Cigna's full year 2019 results will be discussed in a press release and investor conference call scheduled for February 6, the company noted.

13:40 EST Neptune Wellness says sold 1.96M Acasti Pharma shares for net proceeds of $4M - Neptune Wellness Solutions (NEPT) provided an update on its non-core investments. In recent months, Neptune said it sold 1,964,695 shares of Acasti Pharma(ACST) for net proceeds of $4M as part of a monetizing process for the company's non-core investments. Neptune still owns 1M shares in Acasti. The net proceeds are intended to be channeled towards the deployment of Neptune's cannabis 2.0 products, it said in a statement.

13:05 EST Kimball International appoints Mark Johnson as chief legal, governance officer - Kimball International (KBAL) will consolidate its manufacturing operations and implement a company-wide approach to all corporate business practices including legal, compliance, and Environmental, Social and Governance. The company created two new roles to support these changes. Greg Meunier has been promoted to EVP, Kimball International Global Operations and Mark Johnson will join the company as Chief Legal, Governance Officer and Corporate Secretary. The Global Operations team will include manufacturing, supply chain, engineering, logistics, R&D, safety, and environmental. To lead the corporate business practices and legal affairs, Kimball International recruited Johnson, who was previously Deputy General Counsel at Newell Brands (NWL). Johnson's role will support the company's shift to a centralized structure and the Kimball International Connect strategy; he will also develop company-wide Environmental, Social and Governance policies.

13:03 EST Driver urges Community Bankers Trust to immediately initiate a sale process - Driver Management Company issued an open letter to shareholders of Community Bankers Trust Corporation, which is the holding company for Virginia-based Essex Bank. The letter said, "In recent months, Driver has sought to initiate a productive dialogue with the Board of Directors and management of Community Bankers Trust Corporation about the best approach for enhancing shareholder value. Like many of you, we are concerned about the Company's standalone prospects and dismayed that the actions of Rex Smith, Chief Executive Officer, may have deterred numerous potential suitors. It appears to us that Mr. Smith has maintained unrealistic sale price expectations and has conditioned potential transactions on remaining a fixture in the upmost levels of senior management at any combined company. We expressed these concerns to Senator John C. Watkins, Chairman of the Board, but have only received perfunctory and formulaic responses. In light of this, we feel compelled to make you aware that we believe the Board has fallen into the trap of remaining overly-deferential to a CEO whose interests appear to conflict with those of shareholders. As we have outlined in great detail to the Company's leadership, ESXB faces significant challenges - compounded by today's extremely competitive environment - when it comes to lowering deposit costs, prudently growing loans, continuing to rationalize costs, and sustaining long-run profitability. This leads us to seriously question the Company's ability to consistently deliver shareholder value on a standalone basis. Conversely, we do believe that ESXB could obtain a significant premium to its current market value now through a sale to one of the many logical acquirers in the marketplace. We further contend that a value-maximizing sale can be reached expeditiously if Mr. Smith is not an impediment and the Board is able to explore all alternatives without being colored and influenced by a conflicted gatekeeper. We are calling on the Board to immediately hire experienced investment bankers to initiate and run a sale process. To this end, we hope that those of you who share our concerns and views will join in this call for a sale by contacting the Board through John M. Oakley III, the Company's Corporate Secretary. In closing, Driver intends to continue engaging with the Board about the importance of objectively assessing a sale and putting the best interests of shareholders first. "

12:00 EST Tilly's falls -19.5% - Tilly's is down -19.5%, or -$2.28 to $9.40.

12:00 EST At Home Group rises 9.1% - At Home Group is up 9.1%, or 46c to $5.54.

12:00 EST Garrett Motion rises 9.7% - Garrett Motion is up 9.7%, or 88c to $9.91.

11:37 EST Illumina shares fall 6% to $316.45 after issuing 2020 sales growth outlook

11:37 EST Thermo Fisher, PerkinElmer slip after Illumina issues guidance at JPMorgan event

11:10 EST Lowe's expanding work with Google Cloud - Google Cloud (GOOG, GOOGL) and Lowe's (LOW) announced the two companies are expanding their work together "to create a best-in-class technology foundation to help Lowe's deliver exceptional customer experiences and empower store associates with tools to better serve customers, regardless of how they shop." This technology foundation for the home improvement company includes new investments toward modernizing Lowes' e-commerce, merchandising, supply chain management, and pricing systems-ultimately providing a more fluid, "channel-less" customer experience spanning from product discovery to return visits. Lowe's is in the early stages of a large-scale, multiyear technology transformation, investing more than $500 million annually through 2021 and hiring up to 2,000 engineers to continue to build out future retail experiences. "We are making substantial investments in technology to modernize our platforms and advance our digital capabilities to better serve customer needs and deliver the best service and value across every channel," said Seemantini Godbole, executive vice president and chief information officer of Lowe's. "Partners like Google Cloud provide the innovative tools and support we need to execute our digital transformation."

10:58 EST Allele, Astellas Pharma enter into expanded license for iPSC lines - Allele Biotechnology and Pharmaceuticals, a San Diego-based private company, and Astellas Pharma, through its Massachusetts-based subsidiary Astellas Institute for Regenerative Medicine, entered into a licensing agreement to expand Astellas' access to Allele's induced pluripotent stem cell technologies for various cell therapy programs. Under the terms of the new license agreement, Astellas will pay Allele upfront and milestones, product-based royalties, and potentially manufacture fees.

10:25 EST BioCardia 8F Morph DNA Deflectable Guide Catheter granted premarket notification - BioCardia received 510(k) premarket notification for its 8F Morph DNA Deflectable Guide Catheter on January 7, according to a post to the FDA's website. Reference Link

10:15 EST Blueprint Medicines announces 2020 corporate goals - Blueprint Medicines announced corporate goals for 2020, which provide a path to achieve the company's "2020 Blueprint" strategy for launching its global commercial business. The 2020 goals are: Report top-line data from the Phase 3 VOYAGER trial of avapritinib in third-line GIST in Q2; Gain regulatory approval and launch avapritinib in fourth-line GIST in the U.S. in Q2; Gain regulatory approval and launch avapritinib in PDGFRA D842V GIST in Europe in the Q3; Present the registration dataset from the VOYAGER trial of avapritinib in third-line GIST; Submit a supplemental new drug application, or NDA, to the FDA for third-line GIST in the second half of the year. "2020 is off to a great start for Blueprint Medicines with the recent FDA approval of our first medicine and a U.S. launch now underway. As we complete our evolution into a fully-integrated biopharmaceutical company this year, we will also aim to bring a second product to market, expand across multiple indications and extend our global commercial footprint with our first anticipated regulatory approval in Europe," said Blueprint Medicines CEO Jeff Albers. "In addition, our future growth will be fueled by an expanded strategic focus on systemic mastocytosis and related mast cell disorders, which represent a large population of underserved patients with significant medical needs. This focus is anchored by avapritinib, which is now FDA-approved for the treatment of PDGFRA exon 18 mutant GIST. Avapritinib was specifically designed to treat the underlying cause of systemic mastocytosis and has demonstrated remarkable and consistent clinical activity across the spectrum of the disease."

10:05 EST Ally appoints Sathish Muthukrishnan as chief information, data, digital officer - Ally Financial (ALLY) announced that Sathish Muthukrishnan has joined the company as chief information, data and digital officer. Muthukrishnan will lead Ally's technology, data and digital transformation teams, with a focus on advanced technical capabilities, including cyber security and infrastructure, as well as accelerating Ally's growth as a leading digital financial services provider. Muthukrishnan reports to Ally's CEO Jeffrey Brown, and is based in Charlotte, N.C. Muthukrishnan has held a number of senior technology leadership roles with substantial scale and global reach, most previously serving as the chief digital and information officer for Honeywell Aerospace (HON).

10:00 EST Zymeworks falls -13.3% - Zymeworks is down -13.3%, or -$5.99 to $38.93.

10:00 EST Stage Stores falls -58.1% - Stage Stores is down -58.1%, or -$4.26 to $3.06.

10:00 EST Hexcel rises 9.9% - Hexcel is up 9.9%, or $7.20 to $80.11.

09:55 EST PAVmed receives formal notification of Nasdaq continued listing compliance - PAVmed announced it has received formal notification from the Nasdaq Stock Market of compliance with Nasdaq Listing Rule 5550(a)(2) after 10 consecutive days with a closing bid price of at least $1 per share.

09:52 EST Kiniksa reiterates 2020 clinical data readouts - Kiniksa Pharmaceuticals announced recent pipeline progress and upcoming 2020 clinical milestones. Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa will provide further detail in a corporate presentation at the 38th Annual J.P. Morgan Healthcare Conference today, Monday, January 13, 2020 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time at the Westin St. Francis Hotel in San Francisco, California. Recent Pipeline Progress and Expected 2020 Clinical Data Readouts: Rilonacept: Kiniksa has achieved its enrollment target for RHAPSODY, a global, randomized-withdrawal design, pivotal Phase 3 trial of rilonacept in patients with recurrent pericarditis. The company expects top-line data in the second half of 2020. Kiniksa recently announced the U.S. Food and Drug Administration granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis. Kiniksa's Breakthrough Therapy application was based on final data from an open-label Phase 2 clinical trial of rilonacept in a range of recurrent pericarditis populations. Mavrilimumab: Kiniksa has achieved its enrollment target for a global Phase 2 proof-of-concept trial of mavrilimumab in patients with giant cell arteritis. The company expects top-line data in the second half of 2020. Kiniksa and Kite, a Gilead company, recently announced a clinical collaboration evaluating the investigational combination of Yescarta and mavrilimumab in relapsed or refractory large B-cell lymphoma. The objective of the study is to determine the effect of mavrilimumab on the safety of Yescarta. Preclinical evidence shows the potential for interruption of granulocyte macrophage colony stimulating factor signaling to disrupt chimeric antigen receptor T cell-mediated inflammation without disrupting anti-tumor efficacy. KPL-716: Kiniksa expects top-line data from a Phase 2a clinical trial of KPL-716 in patients with prurigo nodularis in the first half of 2020. Kiniksa expects interim data from cohorts of a Phase 2 clinical trial of KPL-716 in diseases characterized by chronic pruritus in the first half of 2020. KPL-404: Kiniksa is enrolling and dosing subjects in a single-ascending-dose Phase 1 clinical trial of KPL-404 in healthy volunteers. The first-in-human trial will provide safety data and pharmacokinetics as well as receptor occupancy and T-cell Dependent Antibody Response. Top-line data are expected in the second half of 2020. KPL-045: Based on preclinical data in the context of Kiniksa's portfolio, the company no longer plans to progress KPL-045 into clinical development.

09:49 EST MediWound expands distribution agreement with GENFA MEDICA - MediWound announced the expansion of its agreement with GENFA MEDICA SA, granting it the exclusive right to market and distribute NexoBrid in Ukraine, Lithuania, Latvia and Estonia adding to its current rights to distribute NexoBrid in Russia. NexoBrid, currently approved in the European Union and other international markets, is a topically-administered biologic product that removes eschar in patients with deep partial and full-thickness thermal burns and is already approved for marketing in Lithuania, Latvia and Estonia. Commercialization of NexoBrid in Ukraine will commence after receipt of local marketing authorization, which is expected within 2 years.

09:47 EST Tabula Rasa HealthCare retains 99.1% of PACE clients to start 2020 - Tabula Rasa HealthCare announced a client retention rate of 99.1% in the PACE market to begin 2020. PACE organizations nationwide rely on TRHC's PACE division, CareVention HealthCare, for technology, services, and consulting to optimize outcomes and maintain regulatory compliance. CareVention's lead offering for PACE providers is medication safety and pharmacy services, which features proprietary medication risk mitigation software and pharmacists who are board-certified in geriatrics to improve medication outcomes, increase adherence, and reduce participant hospitalizations.

09:47 EST Granite Construction falls -4.1% - Granite Construction is down -4.1%, or -$1.13 to $26.55.

09:47 EST Stage Stores falls -55.1% - Stage Stores is down -55.1%, or -$4.03 to $3.29.

09:47 EST Jumei rises 8.8% - Jumei is up 8.8%, or $1.54 to $18.97.

09:46 EST Tetra Bio Pharma receives letter of advice from FDA for QIXLEEF - Tetra Bio-Pharma announced that it has received a favorable Letter of Advice from the US Food and Drug Administration for QIXLEEF. "We are extremely excited to have received this letter from the FDA for QIXLEEF. Once again, it demonstrates the FDA's commitment to approve this botanical drug for chronic pain if the quality, non-clinical safety and human clinical data are positive. This Letter of Advice clearly shows that QIXLEEF can be developed for chronic pain conditions beyond pain in patients with advanced cancer. It also reconfirms FDA's previous position on the development and commercialization of QIXLEEF for pain management including indications, such as second- or third-line therapy for uncontrolled cancer and non-cancer pain," said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. On January 26, 2017, FDA had previously provided in-depth guidance to Tetra on the development of QIXLEEF. This Letter of Advice provides Tetra new guidance based on our clinical and safety progress with the quality of QIXLEEF and lays out the requirements for marketing approval for cancer and non-cancer pain indications. "FDA collaboration has been excellent and continues to show that Tetra develops prescription drugs in accordance with FDA regulatory standards, in place for pharmaceutical products," commented Dr. Chamberland. According to Allied Market Research, the global drug market for pain management was about $60 billion in 2016 and is estimated to reach $130 billion by 2023. This includes pain medications for indications such as Arthritic Pain, Neuropathic Pain, Cancer Pain, Chronic Back Pain, Postoperative Pain, Migraine, and Fibromyalgia. First line pain medications include acetaminophen and NSAIDs whereas second- and third-line drugs include Lyrica, Cymbalta and opioids. Chamberland added, "With this letter we are confident that we can develop QIXLEEF for pain indications beyond cancer. Indeed, QIXLEEF can be developed all the way to an indication for use as a second- or third-line drug for use in pain relief. Tetra will be continuing to develop QIXLEEF for advanced cancer pain but will now evaluate the best market opportunity within this large potential multi-billion dollar market of second- or third line pain medications. If clinical trials are successful, this will significantly shift the opioid battle."

09:45 EST Biofrontera AG (ADS) trading halted, volatility trading pause

09:42 EST Rubius Therapeutics announces 2020 objectives - Rubius Therapeutics announced 2020 objectives and operational updates. Pablo J. Cagnoni, M.D., chief executive officer, will present these updates and review 2019 accomplishments today at 9:00 a.m. PST / 12:00 p.m. EST at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California. RTX-134 for the Treatment of Phenylketonuria: RTX-134 is an allogeneic cellular therapy product candidate that is genetically engineered to express the enzyme phenylalanine ammonia-lyase inside RTX-134 to degrade toxic levels of phenylalanine that accumulate due to a deficiency in the phenylalanine hydroxylase enzyme. Rubius plans to announce when the first patient has been dosed in the Phase 1b clinical trial evaluating RTX-134 in adults with PKU and expects to provide an update on timing for reporting of initial clinical results at that time. The initial clinical results expected are preliminary safety, longevity of RTX-134 in circulation and proof-of-mechanism as measured by the production of trans-cinnamic acid, a metabolite of phenylalanine when degraded by PAL. RTX-240 for the Treatment of Solid Tumors: RTX-240 is an allogeneic cellular therapy product candidate engineered to replicate the human immune system by broadly stimulating the adaptive and innate immune systems to generate an immune response. RTX-240 expresses 4-1BBL and IL-15TP, a fusion of IL-15 and IL-15 receptor alpha, on the cell surface with the goal of improving anti-tumor activity and overcoming resistance to immunotherapy in patients with solid tumors. Rubius has filed an IND with U.S. FDA for RTX-240 for the treatment of cancer and plans to announce when the first patient has been dosed. GMP grade RTX-240 is expected to be manufactured at Rubius' fully-owned manufacturing facility. RTX-321 for the Treatment of HPV-Positive Tumors: RTX-321 is an allogeneic artificial antigen-presenting cellular therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses an HPV peptide antigen bound to MHC I, 4-1BBL and IL-12 on the cell surface to mimic human T cell-APC interactions. Rubius plans to file an IND for RTX-321 by year-end. GMP grade RTX-321 is expected to be manufactured at Rubius' fully-owned manufacturing facility. Additional Manufacturing Update: Rubius has the potential to significantly expand its manufacturing capabilities at its Smithfield, RI site and plans to stage additional investments based on future supply needs.

09:38 EST PetIQ reaffirms 2019 guidance - PetIQ provided an update on its 2019 wellness center openings and reaffirmed its 2019 guidance ahead of a conference presentation today. In December, the Company opened 20 new wellness centers for a total of 80 wellness centers across 22 states and 5 host retail partners in 2019.

09:36 EST Cytokinetics announces expected 2020 milestones - Expected 2020 Milestones: Cardiac Muscle Programs: Omecamtiv mecarbil: Second interim analysis of GALACTIC-HF, the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil, in Q1 2020. Topline results from GALACTIC-HF in Q4 2020. Complete enrollment in METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil, in 2020. Conduct commercial readiness and develop co-promotion plan in collaboration with Amgen in 2020. AMG 594: Complete Phase 1 SAD/MAD study of AMG 594 in 2H 2020. CK-3773274: Conduct REDWOOD-HCM, the Phase 2 clinical trial of CK-274 designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy, in 2020. CK-3772271: File IND and initiate Phase 1 study in 1H 2020. Skeletal Muscle Programs: Reldesemtiv: Engage with regulatory and reimbursement authorities in 2020 to prepare for a potential Phase 3 clinical trial and registration program for reldesemtiv in patients with ALS. CK-3762601: Advance CK-601 in IND-enabling studies in 2020. Ongoing Research: Continue research activities directed to the cardiac and skeletal sarcomere and our other muscle biology research programs. Expect to continue research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators through 2020, subject to current negotiations.

09:34 EST Cytokinetics announces Vision 2025 - Cytokinetics announced its Vision 2025 and provided guidance for corporate milestones expected to occur in 2020. The company's Vision 2025: "Leading with Science, Delivering for Patients," articulates its five-year key imperatives enabling Cytokinetics to be the leading muscle biology biopharmaceutical company that meaningfully improve the lives of patients with diseases of impaired muscle function through access to novel medicines arising from its research. Key imperatives for Vision 2025 include: Achieve regulatory approvals for at least two drugs arising from our pipeline. Build commercial capabilities to market and sell our medicines reflective of their innovation and value. Generate sustainable and growing revenues from product sales. Double our development pipeline to include ten therapeutic programs. Expand our discovery platform to muscle energetics, growth and metabolism. Be the science-driven company people want to join and partner with.

09:31 EST SK Telecom, Sinclair Broadcast announce joint venture, Cast.era - SK Telecom (SKM) and Sinclair Broadcast Group (SBGI) announced Cast.era, a joint venture located in Arlington, Virginia focused on cloud infrastructure for broadcasting, ultra-low latency over-the-top broadcasting, and targeted advertising. With the aim to launch next-generation transmission services using both mobile and fixed broadcasting networks for the first time in the U.S., Cast.era plans to provide ATSC 3.0 broadcast solutions to Sinclair stations deploying the new standard beginning in 2020.

09:29 EST Universal Logistics names Tim Phillips as CEO, succeeding Jeff Rogers - Universal Logistics announced that its Board of Directors appointed Tim Phillips as the company's new CEO, President, and member of the Board, effective January 10. He has over 30 years of experience in numerous leadership positions, including most recently serving as the company's Executive Vice President of Transportation. Phillips has also served as the President of Universal's intermodal division since 2009. Phillips succeeds Jeff Rogers, who separated from service with the company as CEO, President and a director effective January 10.

09:28 EST Natera filed suit against CareDx for patent infringement - Natera filed suit against CareDx for infringing its U.S. Patent 10,526,658. The U.S. Patent Office most recently recognized Natera's innovation in cell-free DNA, or cfDNA, when it awarded the '658 patent on January 7th, 2020. The '658 patent covers cfDNA-based diagnostic methods, including those for transplant. Natera now has over 200 patents issued and pending, including more than twenty in the field of transplant. In recent studies separately evaluating Prospera and Allosure, Prospera had an 89% sensitivity for rejection, compared with a 59% sensitivity for Allosure.1 Natera's NPV was 95%, compared with 84% for Allosure, in a similar incidence cohort.1,2 Additionally, Prospera detected 10/10 T Cell-Mediated Rejection samples while Allosure could only identify 3/11.2

09:25 EST Sarepta appoints John Martin to board of directors - Sarepta Therapeutics announced that it has appointed John C. Martin, Ph.D., to its Board of Directors. Martin brings decades of executive leadership to Sarepta's board, having played an instrumental role in building one of the world's foremost biotechnology companies. During his 20-year tenure as chief executive officer of Gilead Sciences, he oversaw the growth of the company and development of its scientific portfolio into 24 marketed products. Martin served as the Executive Chairman and Chairman of Gilead Sciences.

09:22 EST ClearOne says Shure's redesigned MXA910 infringes on ceiling tile patent - ClearOne announced that Shure's redesigned MXA910, the MXA910W-A released in December 2019, infringes ClearOne's U.S. Patent No. 9,813,806 and has been added as an accused product to its currently pending lawsuit against Shure in Illinois. Shure began shipping the MXA910W-A just over four months after Judge Edmond E. Chang of the U.S. District Court of the Northern District of Illinois granted ClearOne's request for a preliminary injunction preventing Shure from "manufacturing, marketing, and selling" the original MXA910 for use "in its drop-ceiling mounting configuration." Shure claimed that it "specifically designed the new MXA910W-A to provide a drop-ceiling mounting configuration that fully complies with the Court's rulings in the ongoing litigation in U.S. District Court of Northern Illinois." After careful review, ClearOne believes that any installation of the MXA910W-A in a drop-ceiling mounting configuration infringes ClearOne's Graham Patent. "In our view, Shure did not put in the time or effort necessary to ensure that its new product respects ClearOne's intellectual property rights", said Zee Hakimoglu, ClearOne Chair and CEO. "ClearOne is disappointed in Shure's ongoing infringement and its refusal to compete fairly in the market."

09:20 EST Turning Point Therapeutics announces 2020 milestones - Key milestones anticipated in 2020 include: Additional TPX-0131 preclinical data during the first half of the year; Present preclinical repotrectinib combination data; Early interim data from initial patients in some of the registrational cohorts of the repotrectinib TRIDENT-1 Phase 2 study during the second half of the year; Early interim data from initial patients treated with TPX-0022 during the second half of the year; and Submitting the IND for TPX-0131 by early 2021.

09:18 EST Livongo Health, DexCom partner for G6 CGM system integration - Livongo (LVGO) has partnered with Dexcom, Inc. (DXCM) to offer Livongo Members the ability to synch data from their Dexcom G6 Continuous Glucose Monitoring System with the Livongo platform, providing access to key insights and Health Nudges from Livongo's Applied Health Signals platform based on their CGM data. The Dexcom G6 system accurately measures glucose levels just beneath the surface of the skin and sends data wirelessly every five minutes. The G6 includes a slim, water-resistant sensor that is discreet, easy to insert, and is FDA-cleared to make diabetes treatment decisions without confirmatory fingersticks or calibration. The system features customizable alarms and alerts to warn users of dangerous glucose levels, even while they are asleep. Through the partnership, Livongo can now aggregate data from the Dexcom G6, cross-reference with proprietary blood pressure and weight data from its connected devices, and then use advanced data science to interpret that data and offer Members personalized health insights, or Health Nudges, based on their comprehensive health profile. Joint Livongo and Dexcom Members will also have access to 24/7 support from Livongo's certified health coaches.

09:16 EST Applied DNA Sciences signs licensing agreement with LifeSensors - Applied DNA Sciences announced that LineaRx, its majority-owned subsidiary focused on next-generation biotherapeutics and cancer diagnostics, has signed a licensing agreement with LifeSensors, to incorporate LifeSensors' high expression SUMO-fusion technologies into the Company's linear DNA amplicons designed and produced for therapeutic applications. LifeSensors' SUMO-fusion technologies enable the attachment of the C-terminus of SUMO, or Small Ubiquitin Like Modifier, to the N-terminus of a protein of interest that can dramatically improve protein solubility, achieve native protein folding, and increase total yield by improving expression and decreasing degradation. Under the terms of the Agreement, LineaRx will have a worldwide license to the applicable LifeSensors intellectual property to make, have made, use, and sell DNA constructs incorporating the SUMO-fusion technologies for therapeutic and diagnostic applications.

09:15 EST Radius Health announces major objectives over next three years - Radius' major objectives and anticipated business outlook over the next three years include the following: TYMLOS Revenue greater than 20% compound annual growth rate; Financial strength and flexibility to support ongoing business and existing pipeline and achieve profitability; Top-line data readouts from abaloparatide-SC male osteoporosis, abaloparatide-patch and elacestrant Phase 3 studies; Potential approval, pre-launch preparation and market launch of abaloparatide-patch; Strategic exit from oncology; and Expansion of clinical pipeline in bone health and targeted endocrine diseases.

09:13 EST Nexstar subsidiary enters into multiyear partnership with Mediaocean - Nexstar Digital, a wholly owned subsidiary of Nexstar Media Group, announced that it has entered into a multiyear partnership with Mediaocean and its Connect Partner Program. The partnership enables advertisers to use Mediaocean's Spectra Platform to access Nexstar's OTT, digital video, display, streaming audio and linear broadcast inventory. For the first time, advertisers can now shape multi-channel, multi-market media buys across OTT, linear television and all other digital channels, resulting in comprehensive cross-platform reach and frequency control to generate a greater return on their marketing spend. The partnership is effective immediately, with Nexstar Media's advertising inventory available through Spectra. As part of this partnership, Mediaocean has fully integrated Nexstar Digital's video and OTT inventory into its Spectra Platform, which supports advertising agencies with tools and technologies.

09:12 EST HealthEquity announces partner growth at JPMorgan Healthcare conference - HealthEquity announced significant growth in its health plan / administrator network partners and employers served. HealthEquity also announced it will provide final sales results for its fiscal year 2020, on February 18, 2020, while providing estimates of HSA members, HSA assets and Total Accounts for its fiscal year ending on January 31, 2020. The Company also provided yield expectations on HSA cash assets for fiscal year 2021. The number of HealthEquity network partners reached 164, up from 141 last year. The number of employer clients served by HealthEquity increased to approximately 100,000 up from approximately 45,000 last year. Estimated HSA members are expected to grow to approximately 5.3 million by January 31, 2020, up from 4.0 million a year earlier. HSA assets are expected to grow to approximately $11.6 billion, up from $8.1 billion a year earlier. HSA cash assets on the HealthEquity platform are expected to grow to approximately $7.4 billion by January 31, 2020, up from $6.4 billion a year earlier. HSA cash assets with legacy WageWorks banking partners will be approximately $1.4 billion by fiscal year-end 2020. HSA invested assets are expected to be about $2.8 billion, excluding the potential impact from market volatility for the remainder of the month of January 2020. HealthEquity estimates it will close fiscal year 2020 with approximately 12.8 million Total Accounts. The Company estimates yields on HSA cash assets on the HealthEquity platform will be approximately 2.40% for fiscal year 2021 based upon current indications provided by its bank deposit partners.

09:11 EST Boston Private Financial appoints Allison Baird as Chief Marketing Officer - Boston Private announced the appointment of Allison Baird as Chief Marketing Officer. In this role, Ms. Baird will be responsible for all aspects of marketing, advertising, branding, public relations and client development programs across the firm. Baird joined Boston Private in 2016 as Senior Vice President of Marketing and Client Development to lead strategic programs designed to drive awareness and affinity among Boston Private clients and prospects.

09:11 EST AMIH subsidiary executes lease agreement to open Novopelle Med Spa location - American International Holdings announce that its newly formed subsidiary, Novopelle Tyler has entered into a Lease Agreement with Asher Park, LLC to lease and occupy approximately 1,900 square feet of commercial retail space located in Tyler, Texas with the plan to open and operate a Novopelle Med Spa at such location. The new Novopelle Med Spa location will be located in Asher Park, which is one of Tyler's newest and most impressive commercial developments. Located at the entrance to Hollytree Golf and Country Club, Asher Park provides easy access to south Tyler's main arteries and is surrounded by high-end residential development. The Lease Agreement has a term of five (5) years and commences 120 days from the later of the fully executed lease, delivery of premises, and delivery of construction permit from the City of Tyler.

09:08 EST NortonLifeLock announces sale of ID Analytics business to LexisNexis for $375M - NortonLifeLock announced LexisNexis Risk Solutions, part of RELX, has entered into an agreement to acquire ID Analytics, or IDA, a trusted provider of credit and fraud risk solutions for enterprises, for a purchase price of $375M. Based in San Diego and founded in 2002, ID Analytics technology delivers risk insights to enterprises through the combination of proprietary data, patented analytics, and near real-time cross-industry consumer identity behavior.

09:05 EST Inphi completes acquisition of eSilicon - Inphi Corporation announced that it has completed the acquisition of eSilicon, as announced on November 11, 2019, in a transaction valued at approximately $216 million in both cash and the assumption of debt.

09:04 EST QuickLogic regains Nasdaq compliance - QuickLogic announced that it received notice from The Nasdaq Stock Market on January 9 indicating that the company has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) for continued listing on The NASDAQ Capital Market. Accordingly, the company has regained compliance with the Bid Price Rule and NASDAQ considers the matter closed.

09:03 EST Qualys appoints Dan Barahona as CMO - Qualys announced that Dan Barahona has joined as Chief Marketing Officer, or CMO, to lead the organization through its next phase of growth. Dan will direct the company's worldwide marketing team and oversee strategy, brand, corporate communications, demand generation, and other go-to-market initiatives. Dan's career includes more than 20 years of cybersecurity industry experience and deep business acumen. He previously served as Chief Marketing Officer for Anomali, a leader in threat intelligence solutions, and before that, he was EVP Worldwide Field Operations for Qualys. Dan has significant experience leading business and product development for organizations such as ArcSight (acquired by Hewlett Packard) and WatchDox. He holds a bachelor's degree in mechanical engineering from Rensselaer Polytechnic Institute, a master's degree in mechanical engineering from Cornell University, and an MBA in finance from the University of Michigan.

09:02 EST Instructure urges shareholders to vote for Thoma Bravo transaction - The Lead Independent Director of the Board of Directors of Instructure, Lloyd "Buzz" Waterhouse, sent an open letter on behalf of the Board of Directors to the company's shareholders regarding the previously announced definitive merger agreement with Thoma Bravo, LLC. The letter says, in part: "we believe a certain activist investor is attempting to deprive all Instructure stockholders of the opportunity to realize this substantial return by deliberately perpetuating a false and misleading narrative about the Board's deliberations, intentions and strategic transactions process, despite having publicly pushed for a sale process. The Board urges our stockholders to reject the opportunistic tactics being employed by this investor to derail the Thoma Bravo transaction by voting your shares in favor of the $47.60 per share Thoma Bravo merger proposal at the February 13, 2020 Special Meeting of Instructure stockholders. Your vote is extremely important to realizing this value; no matter how many shares you hold, please make sure your voice is heard by voting in favor of the merger proposal at the Special Meeting."

09:02 EST Sellas Life Sciences announces 2020 clinical milestones - Expected 2020 Clinical Milestones First patient dosed in the Phase 3 registration-enabling study of GPS in AML patients in February 2020. First patient dosed in the Phase 1 open-label study of GPS with nivolumab in MPM patients in January 2020. Interim analysis of the Phase 1/2 basket study of GPS with pembrolizumab in multiple tumor types in the second half of 2020. Guidance from the FDA on the regulatory and development pathway for NPS in TNBC patients in the first quarter of 2020. Initial data from Phase 2 trial of NPS in DCIS in the first quarter of 2020.

08:59 EST Ferroglobe appoints Marco Levi as CEO - Ferroglobe announced that Dr. Marco Levi has been appointed as its CEO, effective immediately. Dr. Levi will be based with the Company's management team in Madrid, Spain. Levi has over thirty years of executive management and board level experience spanning the chemicals, plastic, rubber and paper industries. Dr. Levi is recognized for his track record in turning around multinational companies and transforming business units. Levi succeeds Pedro Larrea Paguaga, who has stepped down from the Company to pursue other opportunities, having served as CEO of Ferroglobe since its inception in 2015 and formerly as CEO of Grupo FerroAtlantica since 2011.

08:56 EST Xenon Pharmaceuticals announces 2020 milestone opportunities - XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. A Phase 2b double-blind, placebo-controlled, multicenter clinical trial is underway to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Patient enrollment for this XEN1101 Phase 2b clinical trial is ongoing in the United States, Canada and Europe. Long term six-and nine-month toxicology studies have now been completed, providing support for the 12-month open label extension for patients enrolled in the Phase 2b clinical trial. Depending upon the rate of enrollment, top-line results are anticipated in the second half of 2020. Xenon continues to explore the development of XEN1101 in other neurological indications. XEN496 is a Kv7 potassium channel modulator being developed by Xenon. The U.S. Food and Drug Administration has granted orphan drug designation for XEN496 as a treatment of KCNQ2 developmental and epileptic encephalopathy. A pharmacokinetic study testing Xenon's proprietary pediatric formulation of ezogabine in healthy adult volunteers is expected to complete in the first quarter of 2020. The FDA previously indicated that it is acceptable to study XEN496 in infants and children up to four years old, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496's efficacy in KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication. After completion of the XEN496 PK study and discussions with the FDA on a Phase 3 clinical trial design in the first quarter of 2020, Xenon expects to initiate a Phase 3 clinical trial in KCNQ2-DEE. XEN007 is a CNS-acting calcium channel modulator that modulates Cav2.1 and T-type calcium channels. Other reported mechanisms include dopamine, histamine and serotonin inhibition. A physician-led, Phase 2 proof-of-concept study has recently been initiated to examine the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy. Results from this Phase 2 investigator-led proof-of-concept study are expected in 2020. Depending on the results from the study, CAE may represent a potential orphan indication for future development of XEN007. In December 2019, Xenon entered into a license and collaboration agreement with Neurocrine Biosciences to develop first-in-class treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor for epilepsy. In addition, Neurocrine Biosciences gained an exclusive license to pre-clinical compounds for development, including selective Nav1.6 inhibitors and dual Nav1.2/1.6 inhibitors. The agreement also included a multi-year research collaboration to discover, identify and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors. Neurocrine Biosciences anticipates filing an IND application with the FDA in mid-2020 in order to start a Phase 2 clinical trial in SCN8A developmental and epileptic encephalopathy patients in the second half of 2020. Xenon is eligible to receive up to $25 million upon the FDA acceptance of an IND for NBI-921352, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time. In September 2019, Xenon entered into an agreement with Flexion Therapeutics that provides Flexion with the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor. Flexion's pre-clinical program, known as FX301, consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion has indicated that it anticipates initiating FX301 clinical trials in 2021. Effective immediately, Dr. Clarissa Desjardins has been appointed to Xenon's Board of Directors and will also serve on the Compensation Committee. An award-winning entrepreneur with over 25 years of biotechnology experience, Dr. Desjardins has a doctorate in neurology and neurosurgery from McGill University's Faculty of Medicine. In 2011, Dr. Desjardins founded Clementia Pharmaceuticals, a publicly traded biotechnology company focused on rare bone disorders that was acquired by Ipsen S.A. in 2019 for up to $1.3 billion. Dr. Richard Scheller will resign from Xenon's Board effective January 14, 2020 after serving as an independent director since 2015.

08:54 EST Five Below down 18% after cutting Q4 guidance following Holiday period update - Shares of Five Below are down over 18% or $22.25 at $99 per share after the company cut its Q4 and FY19 earnings, revenue, and same-store sales expectations following its announced Holiday Period sales performance.

08:52 EST Delcath Systems completes enrollment in FOCUS registration trial - Delcath Systems announced it has completed patient enrollment in its FOCUS registration trial intended to confirm the potential of its investigational combination treatment for patients with unresectable hepatic-dominant metastatic ocular melanoma. A total of 80 patients have been enrolled in the trial. Delcath expects to announce top-line results of the FOCUS trial by the middle of 2020. Because of a lack of effective treatments for patients with unresectable hepatic-dominant ocular melanoma, Delcath will continue to enroll eligible patients in the trial until Delcath determines the feasibility of an Expanded Access Program and subsequent commercial availability.

08:48 EST Health Insurance Innovations announces strategic alternatives review extension - Health Insurance Innovations announced that as a result of its in-progress strategic transformation and successful development and growth of its Medicare business, the Company is extending its process for exploring, reviewing, and evaluating alternative strategies focused on maximizing shareholder value that commenced in July 2019. These alternatives could include, among other things, a sale of the Company or a portion thereof, a strategic business combination, changes in the Company's operations or strategy, or continuing to execute on the Company's current business plan. "The Board of Directors believes that the best path for enhancing value for our shareholders is to allow additional time for potential strategic and financial partners to review the Company's strategy and recent and projected operating results," said Paul Gabos, Chairman of the Board. "We are encouraged by our recent Medicare sales volume success and the level of interest that this has garnered in the marketplace. Since the announcement of our Medicare results in early December, we have received additional inquiries from multiple new strategic parties expressing an interest in participating in our process. We believe it is prudent to allow these parties more time to complete their assessment of the Company in light of the business transformation in progress." The Company's Board of Directors has not set a timetable for completing the strategic review nor has it made any decisions related to strategic alternatives at this time, and there can be no assurance that the Board's exploration of strategic alternatives will result in changes in strategy or any transaction or, if a transaction is undertaken, as to its terms, structure or timing. The Company does not expect to make further public comment regarding these matters unless and until the Board has approved a specific transaction or alternative or otherwise concludes its review of strategic alternatives.

08:47 EST Five Below reports Holiday Period sales up 13.4% at $596.6M, SSS down 2.6% - Five Below announced net sales results for the quarter-to-date period from November 3, 2019 through January 4, 2020 . The company announced that net sales for the Holiday Period increased by 13.4% to $596.6 million from $526.1 million in the comparable nine-week period from November 4, 2018 to January 5, 2019. Comparable sales for the Holiday Period decreased by 2.6%. CEO Joel Anderson states: "While our comparable sales during key holiday selling periods were positive, they were not strong enough to overcome the headwind of six fewer shopping days between Thanksgiving and Christmas, and overall sales did not meet our expectations. Despite the sales shortfall, strong inventory management and disciplined cost control has us on track to end the quarter with gross margin in line with our expectations and to deliver earnings per share near the low end of our previous guidance range. Looking ahead, we are pleased to announce 180 planned new stores for 2020. As we continue to innovate, we will incorporate a Ten Below zone in the majority of these new stores as well as our remodels. We are also excited to announce the acquisition of a robust e-commerce platform, fulfillment operation and certain other assets of Hollar.com, which will expand our digital capabilities."

08:46 EST Guardant Health announces collaboration with Amgen to develop companion test - Guardant Health (GH) announces a strategic collaboration to develop and help support commercialization of a blood-based companion diagnostic test for Amgen (AMGN) AMG 510, an investigational oral therapy that inhibits KRAS G12C mutant protein, globally. Under the agreement, Guardant Health will pursue U.S. Food and Drug Administration Pre-Market Approval, Japan Pharmaceutical and Medical Device Agency Approval, and European CE-Mark for Guardant360 CDx as a companion diagnostic for AMG 510 in metastatic non-small cell lung cancer patients with the KRAS G12C mutation. AMG 510 is the first-in-class KRAS G12C inhibitor to advance to the clinic, and Amgen is currently enrolling patients in a potentially registrational Phase 2 study. AMG 510 is designed to selectively and irreversibly target a specific mutant form of KRAS called G12C that is present in nearly 13 percent of all NSCLC patients1 and for whom limited targeted treatment options have existed to date. The FDA granted Orphan Drug Designation to AMG 510 for previously treated metastatic NSCLC and colorectal cancer with KRAS G12C mutation and Fast Track Designation for previously treated metastatic NSCLC with KRAS G12C mutation.

08:41 EST Healthpeak executes long-term lease with Janssen BioPharma at Sierra Point - Healthpeak Properties (PEAK) announced that it has executed a long-term lease with Janssen BioPharma, part of the Johnson & Johnson (JNJ) Family of Companies, for approximately 60% of Phase II at The Shore at Sierra Point. The lease is expected to commence in January 2022, upon completion of construction. Janssen BioPharma has expansion rights under the lease that can be exercised over the course of 2020. Phase II of The Shore at Sierra Point includes two Class A purpose-built life science buildings within a larger five-building campus. Healthpeak has designed and entitled an addition to Phase II of The Shore at Sierra Point, which will link the two buildings across three of the four floors, adding connectivity and increased functionality for both the Janssen BioPharma, Inc. team and future tenants. Phase II of The Shore at Sierra Point will now represent approximately 298,000 square feet, an increase from the initial 266,000 square feet planned.

08:39 EST Charles River, Takeda Pharmaceutical announce drug discovery collaboration - Charles River (CRL) announced a multi-year drug discovery collaboration with Takeda Pharmaceutical (TAK). Together, Charles River and Takeda will launch multiple integrated programs across Takeda's four core therapeutic areas-oncology, gastroenterology, neuroscience, and rare disease-with the ultimate goal of delivering preclinical candidates that Takeda can advance into clinical development. The alliance combines Charles River's integrated drug discovery expertise and deep scientific bench with Takeda's investments in human data and translation to deliver medicines for patients aligned with Takeda's therapeutic strategies in oncology, gastrointestinal disease, neuroscience and rare disease. Charles River will leverage its end-to-end drug discovery and safety assessment platform to explore potential therapeutic approaches and progress these programs towards candidate status. Takeda will then have the option to advance the preclinical candidates through their clinical development pipeline. Under the terms of the agreement, Takeda will pay Charles River a one-time, upfront fee to establish the collaboration. Charles River will be eligible to receive development payments with a potential value of over $50M per program in preclinical and clinical milestones for candidates that progress to registration. The agreement also includes additional potential commercial milestones of up to $120M plus royalties on launched products.

08:38 EST Calithera Biosciences announces 2020 milestones - Calithera expects to achieve the following milestones in 2020: Announce topline data from randomized CANTATA trial of telaglenastat with cabozantinib in advanced renal cell carcinoma. The CANTATA trial is a global, randomized, double-blind clinical trial of telaglenastat combined with cabozantinib, in patients with advanced or metastatic RCC who have received one or two prior treatments. The CANTATA trial enrolled 445 patients at multiple centers globally. The primary endpoint is progression-free survival. Calithera plans to report top-line efficacy and safety data from the trial in the second half of 2020. Initiate Phase 2 trial of telaglenastat in non-small cell lung cancer patients with genetic mutation NRF2/KEAP1. The NRF2/KEAP1 pathway is known to drive the development of certain cancers, including a significant proportion of NSCLC through the regulation of reactive oxygen species in a manner that is dependent upon glutaminase activity. Recently presented clinical data demonstrate that activation of this pathway, either through the loss of KEAP1 function or activation of NRF2, results in very poor outcomes in NSCLC patients. The clear mechanistic rationale, strong preclinical data, and high unmet medical need in the NSCLC population have led Calithera to design a clinical study that will evaluate telaglenastat in combination with chemo-immunotherapy in first line NSCLC patients with tumors that harbor mutations in either KEAP1 or NRF2 that activate this pathway. This trial is expected to begin in the first half of 2020. Enroll telaglenastat combination trials in collaboration with Pfizer. Calithera and Pfizer have two clinical trial collaborations to evaluate Pfizer's CDK4/6 inhibitor palbociclib, also known as IBRANCE, and the dual-mechanism poly polymerase inhibitor talazoparib, also known as TALZENNA, each in combination with glutaminase inhibitor telaglenastat. Continue enrollment of multiple clinical trials evaluating Calithera's arginase inhibitor INCB001158. INCB001158 is a small-molecule immuno-oncology therapeutic being evaluated in multiple clinical trials as a single-agent and in combination with immunotherapies and chemotherapy for the treatment of patients with cancer. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Enroll clinical dose escalation trial evaluating CB-280, an oral arginase inhibitor, in cystic fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. A Phase 1b clinical study in people with CF, which is expected to start enrollment in the first half of 2020, will test multiple doses of CB-280 compared to placebo in approximately 30 adults with CF to determine a safe dose range, and pharmacodynamics effects of arginase inhibition in this population. Patients with any CF transmembrane conductance regulator mutational status will be eligible for the study.

08:37 EST Orchard Therapeutics expects cash, investments to fund operations into 2H21 - The company ended 2019 with approximately $325 million of cash and investments. The company expects that its cash, cash equivalents and marketable securities as of December 31, 2019 will enable the company to fund its currently anticipated operating expenses and capital expenditure requirements into the second half of 2021, which includes the capital investment required to build-out a new manufacturing facility operated by Orchard in Fremont, CA.

08:36 EST T. Rowe Price reports preliminary AUM $1.21T at December 31, 2019 - Client transfers from mutual funds to other portfolios, including trusts and separate accounts, were $2.3B in December 2019, and $3.7B for the quarter-ended December 31, 2019. This brings total client transfers for 2019 to $23.2B.

08:35 EST Horizon Therapeutics announces Krystexxa, pipeline updates - Horizon Therapeutics announced that it is increasing the peak U.S. annual net sales expectations for its key growth drivers Krystexxa and teprotumumab, as well as providing several pipeline updates. Based on current strong performance, the company is increasing its peak U.S. annual net sales expectation for Krystexxa to more than $1B, from the previous expectation of more than $750M. The company continues to project Krystexxa FY19 net sales growth of more than 25%. The company also announced topline results from its MIRROR open-label pilot study, which evaluated the use of the immunomodulator methotrexate with Krystexxa to increase the response rate of Krystexxa. The results of the study demonstrated that 79%, or 11 of 14 patients, achieved a complete response, defined as the proportion of serum uric acid, or sUA, responders at Month 6. The combination was also well tolerated. Detailed results from the study will be presented at a future medical meeting. The 79% response rate is significantly higher than the 42% response rate in the Krystexxa Phase 3 clinical program, which evaluated Krystexxa alone. Krystexxa has demonstrated rapid reduction in sUA levels for people with uncontrolled gout; however, treatment with biologic medicines can, in some patients, trigger the body's immune system to develop anti-drug antibodies. These anti-drug antibodies can reduce the effectiveness of the biologic therapy. Immunomodulators such as methotrexate, which is commonly used by rheumatologists, can help reduce this reaction. The MIRROR open-label pilot study follows other studies that showed an improved response rate when Krystexxa is co-administered with methotrexate. There is a growing body of data supporting the potential of Krystexxa plus immunomodulation to become the standard therapy opposed to Krystexxa therapy alone. The company is currently conducting a separate, placebo-controlled MIRROR trial evaluating the use of Krystexxa and methotrexate. The trial, with 135 randomized patients, is designed to enable the potential for submission of results to the FDA for update to the label. In addition, the company is planning to evaluate the impact of administering Krystexxa over a significantly shorter infusion duration. The initial proof-of-concept work will begin mid-2020. Currently, Krystexxa is infused over a two-hour or longer timeframe. A shorter infusion duration could meaningfully improve the experience and convenience for patients, physicians and sites of care. Additionally, the company is evaluating additional indications for teprotumumab and is initiating an exploratory study in diffuse cutaneous scleroderma, a rare fibrotic disease with no treatment options. Diffuse cutaneous scleroderma is a subtype of scleroderma in which excess collagen production causes skin thickening and hardening, or fibrosis, over large areas of the body, usually the fingers, hands, arms, anterior trunk, legs and face. There can be significant associated organ damage, including to the gastrointestinal tract, kidneys, lungs and heart. Literature suggests that the mechanism of action of teprotumumab, which is to block the IGF-1 receptor, could have an impact on fibrotic processes, such as those that are relevant to diffuse cutaneous scleroderma. The company expects to conduct an exploratory trial beginning in the first half of 2020 to evaluate objective biomarker and clinical endpoints to inform potential subsequent larger and longer duration clinical trials.

08:33 EST Amyris reports record production in Q4 - Amyris reported record production for the Q4. In addition, the company's Clean Beauty business continued its breakout performance. The company executed very well operationally during Q4 toward meeting its customer product requirements and delivered record recurring sales in 2019 that more than doubled prior year performance. These product volume results were driven by strong market and consumer demand for clean and natural products that are sustainably sourced from fermentation as well as the competitively differentiated high performance of the company's ingredients and products. The company said, "We are off to an excellent start for 2020 and are particularly pleased by our Clean Beauty performance which is tracking to again more than double sales in 2020. Our January 2019 Biossance results were very strong and, on a comparative basis, already in the first 12 days of January 2020 we are delivering more than 190% growth over last year."

08:31 EST BioMarin receives IND from FDA and MHRA for BMN 307 - BioMarin announced that both the FDA and the Medicines and Healthcare Products Regulatory Agency, or MHRA, in the U.K. have granted the Company Investigational New Drug, or IND, status and approved its Clinical Trial Application, CTA, respectively, for its investigational gene therapy candidate BMN 307. BMN 307 is an AAV5-phenylalanine hydroxylase, or PAH, gene therapy designed to normalize blood phenylalanine, or Phe, concentration levels in patients with PKU. BMN 307 will be evaluated to determine whether a single dose of treatment can restore natural Phe metabolism, normalize plasma Phe levels, and enable a normal diet in patients with PKU. The Company expects to start dosing patients in PHEARLESS, a Phase 1/2 study, in the first quarter of 2020 with product made at commercial scale from its award-winning gene therapy manufacturing facility. The Company is actively preparing regulatory submissions to open additional clinical sites in other countries.

08:31 EST Replimune Group CEO says company had 'very productive 2019' - "Replimune had a very productive 2019 where a key highlight included the presentation of initial clinical data with RP1 as monotherapy and combined with Opdivo at the 34th Annual Meeting of the Society for Immunotherapy of Cancer," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "We believe the data provides strong support for our ongoing registration-directed trial in our lead indication of CSCC as well as the decision to initiate a new clinical trial in organ transplant recipients who have developed the disease. Similarly, the data in melanoma led to the decision to expand the clinical trial to include a registration-directed cohort of melanoma patients who are refractory to prior treatment with anti-PD1 therapy. We also initiated our first clinical trial of RP2, the next therapy in our pipeline. Overall we are thrilled with our progress and are excited for the year ahead as we release further data sets, bring our third product into the clinic to address less immune-responsive tumors and as we continue to execute upon our mission to make our oncolytic immuno-gene therapies a cornerstone of cancer treatment."

08:30 EST Ameri Holdings Inc trading resumes

08:27 EST Gamida Cell provides cash runway guidance - The company expects that its current cash, cash equivalents and available-for-sale securities will support the company's ongoing operating activities into Q4. This cash runway guidance is based on the company's current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.

08:22 EST AMERI Holdings to merge with Jay Pharma - AMERI Holdings announced it entered into an amalgamation agreement with Jay Pharma, a Canadian company dedicated to developing innovative, evidence-based cannabinoid products and combination therapies to address unmet needs in cancer care, pursuant to which the shareholders of Jay Pharma will become the majority holders of Ameri's outstanding stock by way of an amalgamation. In connection with the Amalgamation, Ameri will spin-off its existing IT services business to a private entity founded by Ameri management in partnership with Ameri's current Series A Preferred Equity Holders. The Transactions are expected to close in the first half of 2020, subject to Ameri shareholder approval, approval of the Nasdaq Stock Market, and other customary closing conditions. On a pro forma basis and based upon the number of shares of Ameri common stock to be issued in the Amalgamation, current Ameri shareholders will own approximately 16% of the combined company and current Jay Pharma shareholders will own approximately 84% of the combined company. The Boards of Directors of both Ameri and Jay Pharma have unanimously approved the transaction. Jay Pharma is primarily focused on developing over-the-counter cannabinoid-based palliative and wellness products to address the side effects of cancer and cancer treatment, including skin reactions, pain, nausea, and anxiety. Jay Pharma holds the exclusive rights to Israel-based Tikun Olam proprietary cannabinoid genetics and data for oncology, including for the development of over-the-counter and pharmaceutical products. Tikun Olam has amassed one of the world's largest patient treatment databases in the field of medical cannabis, with over 20,000 patient records noting strains used and symptoms treated. Use of Tikun Olam strains were analyzed in 2,970 cancer patients seeking assistance with sleep problems, pain, nausea, and lack of appetite; treatment was found to be a well-tolerated, effective, and safe option to help patients cope with the malignancy related symptoms. Jay Pharma plans to bring leading oncology clinicians and researchers, together with academic and industry partners to enhance clinically proven products to patients. In addition, Jay Pharma has an experienced management team led by Dave Johnson who will assume the Chairman & CEO role upon the closing of the Transactions.

08:20 EST Verso Board sends letter to stockholders recommending to vote FOR - Verso announced that the Verso Board of Directors has sent a letter to stockholders in connection with the Company's upcoming 2019 Annual Meeting of Stockholders, to be held on January 31. As previously disclosed, the Annual Meeting will include proposals related to the sale of Verso's Androscoggin and Stevens Point mills to Pixelle Specialty Solutions Verso stockholders of record at the close of business on December 16, 2019 are entitled to attend and vote at the Annual Meeting. Verso's Board of Directors unanimously recommends that stockholders vote "FOR" ALL seven of Verso's nominees, "FOR" the approval of the Pixelle Transaction, and "FOR" Company Proposals 3 - 8 on the WHITE proxy card TODAY. Letter to stockholders included: Our Annual Meeting for Stockholders to be held on January 31, 2020, is rapidly approaching, and your vote is critical to the future of the Company, no matter how many shares you own. The Board of Directors unanimously recommends that you vote "FOR" ALL seven of Verso's nominees and "FOR" the approval of the Pixelle Transaction on the WHITE proxy card TODAY."

08:18 EST ContraFect partners with European orthopedic center for use of exebacase - ContraFect Corporation announced that it has extended early access to exebacase to individual named patients with chronic post-operative prosthetic joint infections under Temporary Authorizations for Use from the French National Agency for Medicines and Health Products Safety in collaboration with Dr. Tristan Ferry at the Hopital de la Croix Rousse in Lyon, France. Four patients with longstanding, treatment-refractory PJIs have been treated with direct administration of exebacase to the affected joint under ATUs. Based on promising clinical signals in these exebacase-treated patients, temporary authorization for use of exebacase has now been extended to patients with Staphylococcal PJI occurring early in the postoperative period, to potentially avoid significant loss of function.

08:17 EST Fate Therapeutics announces expansion of FT516 clinical investigation - Fate Therapeutics announced that the U.S. Food and Drug Administration has allowed its second Investigational New Drug application for FT516, the Company's off-the-shelf natural killer cell product candidate derived from a clonal master induced pluripotent stem cell line engineered to express a novel CD16 Fc receptor. This is the Company's fourth IND from its proprietary iPSC product platform cleared by the FDA, and enables the clinical investigation of FT516 in combination with monoclonal antibody therapy across a broad range of solid tumors. FT516 expresses a novel high-affinity, non-cleavable variant of CD16 that enhances its binding to therapeutic antibodies and prevents its down-regulation, which can significantly inhibit anti-tumor activity. A publication by scientists from the Company, the University of Minnesota, and the University of California, San Diego in the journal Blood, entitled "Pluripotent stem cell-derived NK cells with high-affinity non-cleavable CD16a mediate improved anti-tumor activity," highlights preclinical proof-of-concept data for FT516. In the published studies, iPSC-derived NK cells expressing hnCD16 were shown to have superior therapeutic properties in vitro, including maintenance of CD16 expression and increased levels of cytokine production upon activation, compared to peripheral blood NK cells sourced from healthy donors. In an in vivo systemic tumor model of human lymphoma, treatment with iPSC-derived hnCD16 NK cells plus anti-CD20 mAb resulted in a significant improvement in survival compared to treatment with anti-CD20 mAb alone or in combination with peripheral blood NK cells sourced from healthy donors. Additionally, iPSC-derived hnCD16 NK cells plus anti-HER2 mAb also conveyed a survival benefit in a xenograft model of SKOV-3 ovarian carcinoma. FT516 is the first-ever cell therapy in the world derived from a genetically engineered pluripotent stem cell cleared for clinical testing. The Company intends to initiate clinical investigation of FT516 in combination with tumor-target antibody therapy in solid tumors later this year. The Company is currently conducting an open-label, multi-dose Phase 1 clinical trial of FT516 as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-directed mAbs for the treatment of advanced B-cell lymphoma.

08:16 EST Akero Therapeutics announces expansion of Phase 2a BALANCED study of AKR-001 - Akero Therapeutics announced that the ongoing Phase 2a BALANCED study of AKR-001 is being expanded to include an additional cohort of subjects with NASH who have compensated cirrhosis, Child-Pugh Class A. Thirty NASH subjects, demonstrated at baseline by liver biopsy to have cirrhosis with a fibrosis score of 4, will be randomized 2:1 to receive either 50 mg of AKR-001 or placebo for 16 weeks. The primary objective of the expansion cohort is to assess safety and tolerability of treatment with AKR-001 in NASH patients at greatest risk of progressing to end-stage liver disease. The selection of the 50 mg dose for this cohort is based on modeling of data from the Phase 1b trial in Type 2 diabetes as well as availability of drug product.

08:15 EST Magenta Therapeutics provides update across several programs - Magenta Therapeutics highlighted recent progress across several programs and outlined goals for 2020. Current methods to condition patients before transplant and gene therapy are dependent on toxic, non-specific chemotherapy or radiation. These pre-transplant treatments are associated with significant side effects, including infertility, cancer, organ damage and death. Magenta is developing targeted, disease-modifying ADCs that are designed to precisely and rapidly remove the disease-causing cells in the body and enable immune system reset without the need for chemotherapy or radiation. Magenta's new clinical candidate, MGTA-117, is a CD117 antibody conjugated to amanitin. Results published in an abstract for the Transplant and Cellular Therapy annual meeting show that MGTA-117 depleted stem and progenitor cells and demonstrated a wide tolerability: potency ratio of 30 fold. This program is advancing to the clinic and further validates Magenta's antibody drug conjugate-based conditioning platform. MGTA-117 was developed under a partnership with Heidelberg Pharma that grants Magenta exclusive worldwide development and marketing rights for ADCs using an amanitin payload and targeting CD117. Magenta is scaling up manufacturing of MGTA-117 and completing IND-enabling studies in 2020. The company intends to move this new product candidate into the clinic with initial clinical data expected in 2021. Magenta has identified a lead antibody and has progressed this program into IND-enabling studies, which the company plans to further advance in 2020. Magenta intends to complete the Phase 1 study and move this program into multiple Phase 2 studies in patients in 2020. The Phase 2 studies will include both allogeneic and autologous transplant settings and will evaluate mobilization and collection of high-quality cells and engraftment of the cells after transplant. Magenta intends to complete enrollment in the Phase 2 in 2020 and continue dialogue with the FDA under the RMAT designation, and to discuss with the European Medicines Agency for development in Europe

08:14 EST Allscripts, Northwell Health extend Managed Services agreement through 2026 - Allscripts Healthcare Solutions announced that Northwell Health, New York State's largest health system, has extended its engagement with Allscripts Managed Services through 2026. The health system has used the Allscripts services offering since 2004 and currently employs it enterprise-wide, which includes 23 hospitals and more than 700 physician practices. The Managed Services extension had a modest impact on 2019 fourth-quarter bookings and is expected to add approximately $500 million to contract backlog as of December 31, 2019.

08:13 EST R1 RCM to acquire SCI Solutions for $190M in cash - R1 RCM announced a definitive agreement to acquire SCI Solutions for approximately $190M in cash. SCI's platform streamlines the patient and provider experience, creating efficient care networks where health systems' capacity is digitally and conveniently accessible to all market constituents. With consumer self-scheduling and provider order facilitation, SCI's EHR-agnostic patient access and care coordination solutions support more than 94,000 providers and 1,200 sites of care that comprise $225B of potential net patient revenue across the country. R1 expects to deliver enhanced value for its customers by enabling providers to expand digital front door strategies for their patients, improve operating efficiency, and increase capacity utilization, among other benefits. SCI's digital patient experience platform allows patients to search for physicians, schedule appointments and complete their onboarding across all care settings, resulting in an improved experience for patients and streamlined workflows for patient scheduling and access teams. The transaction is expected to close in the second quarter of 2020, subject to regulatory approval and other closing conditions. R1 intends to fund the transaction with a combination of cash from its balance sheet and debt.

08:12 EST MRI Interventions to change corporate name to ClearPoint Nuero - MRI Interventions announced plans to change its corporate name to ClearPoint Neuro, Inc. As part of the name change, the Company will release a new logo and launch a new website at www.clearpointneuro.com, and its common stock will commence trading under the symbol "CLPT" upon completion of the name change, which is expected to occur on February 14, 2020. The new name was chosen to better reflect the Company's expanded strategic focus as the medical device extension of its biologics and drug delivery partners.

08:11 EST Enzo Biochem responds to 'misleading' statements from activist hedge fund - The Board of Directors of Enzo Biochem responded to a "series of misleading and inaccurate statements" in an investor presentation and press release filed by activist investor Harbert Discovery Fund regarding the company's accomplishments. The Board believes that Harbert's campaign of disinformation is designed to divert attention from its inferior slate of underqualified nominees and weak arguments bereft of any true understanding of Enzo's business or market. With Harbert steadfastly seeking to change 40% of the Board -- which would result in only a single independent director remaining with more than a few weeks of experience on our Board -- it is critical that the company set the record straight so shareholders can make a fully informed decision at the upcoming Annual Shareholder meeting. Enzo said: "With alarming frequency, Harbert's assertions demonstrate a lack of understanding of the nature of Enzo's business, the complexity of its uniquely integrated model and the industry-wide headwinds created by today's challenging reimbursement environment. Most importantly, Harbert fails to comprehend the compelling business case behind Enzo's strategic plan and the significant long-term value it is designed to create... We urge shareholders to see through Harbert's uninformed attacks and misleading statements and to vote the WHITE proxy card FOR the election of Enzo's director nominees: Dr. Bruce Hanna, Ph.D., Barry Weiner and Rebecca Fischer."

08:10 EST Veru announces interim data from Phase 2 trial of Zuclomiphene - Veru announced positive top line data interim results from its Phase 2 clinical study of Zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist, for the treatment of androgen deprivation hormone therapy induced hot flashes, also known as vasomotor symptoms, in men who have advanced prostate cancer. The Phase 2 clinical study is a double-blind randomized placebo-controlled dose finding study evaluating daily oral doses of Zuclomiphene in men with advanced prostate cancer who have ADT induced moderate to severe hot flashes. The clinical study has a treatment duration of 12 weeks and is being conducted in 24 clinical centers in the United States. A topline interim analysis was performed in which 93 men with ADT-induced hot flashes were enrolled. The objectives of the study were to evaluate the estrogenic activity of Zuclomiphene on hot flashes, to confirm a no-effect dose and to evaluate the effect of a higher dose of Zuclomiphene on the frequency of moderate to severe hot flashes at Day 42. The topline interim clinical results demonstrate that a statistically significant decrease in moderate to severe hot flashes from baseline was observed in the 50mg treatment group. The 10mg treatment group, as expected, did not show a statistically significant reduction in hot flashes from baseline. Based on this result, the 10mg dose group is established as a no-effect dose as was planned for in the study. Furthermore, when comparing the 50mg treatment group versus the 10mg treatment group, a statistically significant reduction in the frequency of moderate to severe hot flashes at Day 42 is observed. Moreover, the observed estrogenic activity of the 50mg group was statistically different from 10mg and placebo group. Zuclomiphene appears to be well tolerated as there have been no reports of drug related serious adverse events nor drug related severe adverse events and no observations of adverse events of special interest, such as breast enlargement or pain, or venothromboembolic events in the safety database for the Phase 2 clinical study. Adverse events of special interest are side effects commonly seen with off label use of steroidal estrogens and progestins for hot flashes. The 50mg treatment group shows statistical and clinically meaningful reductions in moderate to severe hot flashes from baseline without any clinically relevant safety findings. The Company plans to meet with FDA for an End of Phase 2 meeting and following this discussion with FDA, advance Zuclomiphene into a pivotal Phase 3 clinical trial for the treatment of ADT-induced moderate to severe hot flashes in men with prostate cancer in the first half of 2020.

08:09 EST Greenland Technologies and Goog enter into MOU - On December 18, 2019, Greenland Technologies Holding Corporation and Goog Intelligent Machinery Changxing, a technology service and product provider in China, entered into a non-binding Memorandum of Understanding, or MOU. Under the terms of the MOU, Greenland or its affiliates will acquire up to 75% ownership of Goog. Greenland will pay Goog's shareholders their original paid-in capital with cash and a 20% premium with newly issued shares of Greenland. Greenland will conduct due diligence on Goog regarding its financials, operating results, technology, and intellectual property. The transaction is subject to the approval by the Boards of Directors of Greenland and Goog. Goog has been developing the AMT technology, created a few working prototypes with the AMT technology, and tested them on buses and heavy-duty trucks. AMT is an automated gearbox system, which enables the decision to perform a gearshift and the actuation of clutch/gears to be done by computer.

08:08 EST electroCore sees cash, cash equivalents funding operations into 2021 - The Company expects to reduce its cash burn gradually as revenues increase and reductions in operating expenses take effect. Based on the company's current operating plan, electroCore expects its current cash and cash equivalents to fund operations into the beginning of 2021.

08:06 EST Matrix Service selected by Eagle LNG for construction of Florida LNG facility - Eagle LNG announced that it has selected Matrix Service Inc., a subsidiary of Matrix Service (MTRX), for the engineering, procurement, fabrication and construction of a liquefied natural gas, or LNG, export facility, to be built in Jacksonville, Florida. Eagle LNG's Jacksonville LNG Export Facility, which will require an investment of $500M based on final design, will also utilize Chart Industries' (GTLS) IPSMR technology and liquefaction equipment technology. The facility will have a production capacity of approximately 1.65M LNG-gallons per day with 12M LNG-gallons of storage plus a marine terminal and truck-loading capabilities. LNG offers environmental and economic benefits for industries that include marine and power generation. The Jacksonville LNG Export Facility will serve as the Caribbean's most cost-effective, proximal LNG source loading LNG onto small, ocean-going vessels for export to countries currently using heavy fuel oil or diesel for power generation.

08:05 EST Eldorado Resorts to divest Eldorado Shreveport Resort for $230M in cash - Eldorado Resorts (ERI) announced that it has entered into a definitive agreement to sell the Eldorado Resort and Casino in Shreveport, Louisiana to Maverick Gaming LLC for $230M in cash, subject to a working capital adjustment. The transaction is subject to regulatory approvals, the prior or concurrent closing of Eldorado's previously announced merger with Caesars Entertainment (CZR), and other customary closing conditions and is expected to close in 2020.

08:05 EST 3D Systems, CollPlant sign joint development agreement - 3D Systems (DDD) and CollPlant Biotechnologies (CLGN), announced signing a joint development agreement intended to play a pivotal role in advancing and accelerating breakthroughs in the biomedical industry. The collaboration brings together two industry pioneers--3D Systems, renowned for its 3D printing technologies and healthcare expertise; and CollPlant, the developer of proprietary recombinant human collagen BioInk technology currently used for 3D bioprinting of tissues and organs. The two companies plan to jointly develop tissue and scaffold bioprinting processes for third party collaborators.

08:03 EST Legg Mason reports preliminary AUM $803.5B as of December 31, 2019

08:02 EST INTL FCStone subsidiary acquires Giroxx - INTL FCStone announced that its London-based subsidiary, INTL FCStone, executed a sale and purchase agreement to acquire GIROXX in Frankfurt, Germany. Closing is conditional upon the approval of the Bundesanstalt fur Finanzdienstleistungsaufsicht. Through its digital platform, GIROXX GmbH provides online payment and foreign exchange hedging services to small and medium sized enterprises in Germany, Austria and Switzerland. INTL FCStone offers a wide range of financial services including advisory and execution services in commodities, which will be offered to GIROXX's corporate client base. This purchase completes a series of acquisitions and company restructuring to ensure that all clients of INTL FCStone are secure with their continuity of service and market access, and are 100% unaffected by Brexit.

07:59 EST Assertio sees FY neurology franchise net sales above upper end of guidance - The Company is also pleased to announce a strong finish to the year with 2019 Neurology Franchise net sales expected to be above the upper end of the company's previously expressed guidance of $102 million to $105 million.

07:57 EST BioNTech appoints Ryan Richardson as CSO - BioNTech announced that the Supervisory Board has appointed Ryan Richardson to the Management Board as Chief Strategy Officer and managing Director. In his new role he will support and contribute to the creation and implementation of the Company's long-term growth strategy in collaboration with the management team. Ryan has previously served as Senior Vice President, Corporate Development & Strategy after joining the Company in 2018. The appointment took effect on January 12, 2020. In his new role, Ryan will work closely with the Management Board to develop and execute BioNTech's global growth strategy. As Chief Strategy Officer, he will be responsible for evaluating new business opportunities and developing BioNTech's portfolio management function to support an advancing pipeline of more than 20 product candidates. In addition, Ryan will continue to play a leadership role in the development and execution of BioNTech's capital markets strategy and will oversee investor relations and external communications functions.

07:56 EST Ameri Holdings Inc trading halted, news pending

07:52 EST EbixCash, MoneyGram sign exclusive strategic agreement for India - EbixCash, a wholly-owned subsidiary of Ebix (EBIX), together with MoneyGram International (MGI) announced a strategic partnership to bring enhanced services to millions of consumers across India. Details of the strategic partnership include: MoneyGram chose EbixCash as its exclusive partner in India; MoneyGram will now be able to reach additional consumers through Ebix's 320,000 distribution outlets spread across 768 districts, 4,000 cities, and more than 75,000 villages - significantly increasing coverage in rural areas; EbixCash customers in these locations can now access the MoneyGram platform to affordably and quickly send or receive money to family and friends across over 200 countries and territories; The strategic partnership aims to service inward remittance volumes of $3 Billion annually by targeting remitters in key sending markets outside India; EbixCash expects net revenues for EbixCash to be between $20 million to $35 million annually from this partnership once fully rolled out.

07:47 EST Mesa Air reports 39,212 block hours in December - Commenting on the results, Brad Rich, Executive Vice President and Chief Operating Officer said, "In December we saw several positive developments compared to the same period last year. Most notable is the increase in our controllable completion factor year to date."

07:44 EST Autolus Therapeutics expects to start Phas 1 trial of AUTO1NG in 1H20 - Autolus Therapeutics is presenting at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 5:00 pm Pacific Time where Christian Itin, the chairman and chief executive officer of Autolus, will provide an outlook for 2020. Autolus is advancing its lead program, AUTO1 in relapsed/refractory adult acute lymphoblastic leukemia patients, into a potential pivotal trial in the United Kingdom and the United States. During the year, the company also expects to report further clinical data across several programs at key medical conferences, including AUTO1 in adult ALL, AUTO1 in pediatric ALL, AUTO3 in diffuse large B cell lymphoma and AUTO4 in Peripheral T cell lymphoma. Additionally, Autolus expects to commence a Phase 1 clinical trial of AUTO1NG in pediatric ALL in the first half of 2020, plans for a go/no-go decision on Phase 2 initiation of AUTO3 in DLBCL in the middle of 2020, and expects to initiate two new Phase 1 clinical trials with next generation programs, AUTO6NG across certain solid tumor settings and AUTO8 in multiple myeloma, both in the second half of 2020. Autolus will continue in 2020 to progress additional next generation programs through pre-clinical development and expand its suite of cell programming technologies to include programming modules designed for allogeneic applications. A first novel allogeneic application is expected to enter the clinic in the fourth quarter of 2020.

07:41 EST Mereo BioPharma, Oncologie enter licensing agreement for Navicixizumab - Mereo BioPharma Group and Oncologie announced a global license agreement for the development and commercialization of navicixizumab, an anti-DLL4/VEGF bispecific antibody currently being evaluated in an ongoing Phase 1b study in combination with paclitaxel in patients with advanced heavily pretreated ovarian cancer. Navicixizumab previously completed a Phase 1a monotherapy study in patients with various types of refractory solid tumors and is one of two product candidates Mereo acquired through its 2019 merger with OncoMed Pharmaceuticals, Inc. In October 2019, the U.S. Food and Drug Administration granted Fast Track designation to navicixizumab and has agreed in principle on the design of a study that could potentially support accelerated approval for navicixizumab in a heavily pretreated, platinum-resistant ovarian cancer patient population. Under the terms of the License Agreement, Oncologie will receive an exclusive worldwide license to develop and commercialize navicixizumab. Mereo will receive an upfront payment of $4 million with an additional payment of $2 million conditional on a CMC milestone. Oncologie will be responsible for all future research, development and commercialization of navicixizumab. Additionally, Mereo will be eligible to receive up to $300 million in future clinical, regulatory and commercial milestones, tiered royalties ranging from the mid-single-digit to sub-teen percentages on global annual net sales of navicixizumab, as well as a negotiated percentage of sublicensing revenues from certain sublicensees. As a consequence of the License Agreement with Oncologie, and in accordance with the terms and conditions of the Contingent Value Rights Agreement for former stockholders of OncoMed Pharmaceuticals, dated April 23, 2019, by and among Mereo and Computershare Inc., as rights agent, holders of contingent value rights pursuant to the Mereo CVR Agreement will be entitled to receive certain eligible cash milestone payments made to Mereo under the License Agreement relating to navicixizumab. Details of the amount payable to holders of CVRs from the upfront payment will be announced within thirty days of the effective date of the License Agreement. Pursuant to the terms of the Mereo CVR Agreement, if a milestone occurs prior to the fifth anniversary of the closing of Mereo's merger with OncoMed, then holders of CVRs will be entitled to receive an amount in cash equal to 70% of the aggregate principal amount received by Mereo after deduction of costs, charges and expenditures set out in detail in the Mereo CVR Agreement. Such milestone payments are also subject to a cash consideration cap, pursuant to which the aggregate principal amount of all cash payments made to holders of CVRs under the Mereo CVR Agreement shall in no case exceed $79.7 million.

07:39 EST Infinity Pharmaceuticals sees cash runway extended into second half of 2021 - Infinity Pharmaceuticals announced 2020 milestones for IPI-549, a first-in-class, oral, immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma inhibition and provided financial guidance for 2020 ahead of the company's plans to present at 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16. "Our recently announced non-dilutive financing with BVF Partners has provided Infinity with the financial resources to fully fund all of our ongoing IPI-549 trials to key data readouts throughout 2020 and into 2H 2021. 2020 will be a very exciting and important year for Infinity as we continue our efforts to expand the development of IPI-549 across earlier lines of therapy and broader indications, leveraging a safety profile that enables innovative combination therapy approaches. We continue to see growing recognition of the importance of MDSC-directed and tumor macrophage-directed immuno-oncology therapies among the medical and scientific communities, and we are well positioned to solidify our leadership in the field with expected clinical and translational data from IPI-549 studies in 2020 to mid-2021," stated Adelene Perkins, CEO and Chair of Infinity Pharmaceuticals.

07:39 EST Starboard says GCP Applied Technologies 'deeply undervalued' - Starboard announced that it has delivered a letter to the Board of GCP Applied Technologies. The letter states: "Starboard Value LP, together with its affiliates, currently owns approximately 8% of the outstanding shares of GCP Applied Technologies, making us one of the cxompany's largest shareholders. We continue to believe that GCP is deeply undervalued and significant opportunities exist within the control of management and the Board of Directors to unlock substantial value for all shareholders. As you know, we have been shareholders of GCP for over a year. We invested in the company because we believe that GCP has a strong product portfolio with differentiated capabilities and strong end market positioning. Furthermore, our research indicates that the company has significant opportunities to improve revenue trends, operating margins, and free cash flow generation. However, despite this untapped potential, GCP has suffered from a prolonged period of disappointing operating and financial results, poor corporate governance, and excessive executive compensation. It has been approximately one year since we first highlighted our concerns to you regarding the operating and financial performance, governance, and compensation issues that are plaguing the company. Despite our efforts to engage constructively, very little progress has been made to put GCP on a better path. Although we were pleased to reach agreement on the appointment of two new independent and highly-qualified director candidates last year, it is clear now that those appointments have not created enough change to address these very serious issues. For that reason, and as described in our formal nomination notice delivered to the company today, we are nominating nine highly-qualified director candidates for election at the 2020 Annual Meeting, whom we believe can ensure that GCP takes the correct actions to improve performance and enact best-in-class corporate governance. This slate of directors, if elected, would represent a change in a majority of the Board, which we think is needed and appropriate given the severe issues at GCP. Despite its recent problems, GCP is fundamentally a great company with promising future prospects. The Specialty Construction Chemicals business should be a market leader. Our research indicates that SCC has industry leading products with differentiated technology that should result in above market growth and profitability. We believe that with the appropriate focus and execution SCC can drive meaningful profitability improvements while continuing to drive improved revenue trends. Throughout our research process, we have not heard any feedback that indicates there is any structural reason for this business not to achieve higher operating profits. Similarly, in the company's Specialty Building Materials segment, GCP is also a market leader and frequently designed into some of the largest and most visible construction projects globally. Our diligence has indicated that there is significant untapped potential in this business through further product line expansion and development. If the company can merely achieve historical levels of profitability in SBM, we believe significant value will be created by winning new business. We believe that GCP needs a new plan, with improved execution and greatly enhanced board oversight. Starboard has significant experience in these areas with a long, successful track record of driving operational, financial, strategic, and governance changes that benefit employees, customers, and shareholders. We firmly believe that with the right Board in place, GCP can be a best-in-class company in its industry and generate significant value for all shareholders. We are confident you will find the slate of professionals we are nominating to be incredibly well-qualified to serve as directors of GCP. As you can see from our nominees' detailed biographies in the following pages, this group of extremely impressive director candidates has backgrounds spanning operations, finance, private equity, mergers and acquisitions, restructuring, strategic transformation, and public company governance. As a group, they have substantial and highly successful experience in the chemical, construction, and broader industrial industries. Collectively, they have decades of experience as CEOs, senior executives, chairmen and directors of well-performing industrial companies. Our goal is to represent the best interests of all shareholders, and we believe that our nominees have the experience and track record to drive the much needed change at GCP that will put the company on a path to significant shareholder value creation. We remain available to discuss this - and other topics - with you, and, of course, remain open-minded about reaching a mutually agreeable solution to put GCP on a better course."

07:37 EST T2 Biosystems promotes Tony Pare to CCO - T2 Biosystems announced that its CEO John Sperzel, has promoted Tony Pare to the newly created position of CCO, effective immediately. Mr. Pare previously served as Vice President and General Manager - International at T2 Biosystems.

07:35 EST Enterprise Products begins service at iBDH plant in Mont Belvieu, Texas area - Enterprise Products announced that its isobutane dehydrogenation, or iBDH, plant in the Mont Belvieu, Texas area recently began service, with volumes expected to continue ramping up during the next two weeks. The facility, which is supported by long-term, fee-based contracts with investment grade customers, will ultimately have the capability to process approximately 25,000 barrels per day of butane into nearly 1 billion pounds per year of isobutylene.

07:33 EST New Age Beverages appoints David Vanderveen as COO - NewAge Beverages Corporation announced that David Vanderveen has joined NewAge as the newly appointed chief operating officer effective immediately. He was the founder and chief executive officer of XS Energy.

07:32 EST Biogen to acquire novel clinical stage asset PF-05251749 from Pfizer - Biogen Inc. (BIIB) announced an agreement to acquire from Pfizer Inc. (PFE) PF-05251749, a novel CNS-penetrant small molecule inhibitor of casein kinase 1 for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases. In particular, Biogen plans to develop the Phase 1 asset for the treatment of Sundowning in Alzheimer's disease and Irregular Sleep Wake Rhythm Disorder in Parkinson's disease. The purchase will include an upfront payment of $75M with up to $635M in potential additional development and commercialization milestone payments, as well as tiered royalties in the high single digits to sub-teens. CK1 is a key regulator of the 'central clock,' the suprachiasmatic nucleus of the hypothalamus, that controls circadian rhythm and impacts nearly all vital physiology and metabolism. The disruption of circadian rhythm is associated with various psychiatric and neurological diseases, including certain important symptoms of AD and PD. Sundowning is a symptom that impacts 20% or more of AD patients who become confused, anxious, aggressive, agitated or restless later in the day. ISWRD is a circadian rhythm disorder where patients experience fragmented nighttime sleep leading to daytime sleepiness, severe fatigue and difficulty with activities of daily living. It is one of the non-motor symptoms of PD, and usually increases in frequency over the course of the disease and disability progression. Biogen will explore the potential of PF-05251749 to improve behavioral disturbances of Sundowning in AD by correcting circadian rhythm, as well as its potential to treat symptoms of ISWRD to improve daytime wakefulness, sleep quality, behavior and daily function. PF-05251749 has previously demonstrated an acceptable safety profile and proof of mechanism in a Phase 1a clinical study. Biogen aims to initiate a Phase 1b study in Q4 2020. This transaction will be accounted for as an asset acquisition and is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart Scott Rodino Antitrust Improvements Act of 1976 in the United States. Biogen expects the transaction to close in the first quarter of 2020.

07:31 EST Accenture says no change to outlook for Q2, FY20

07:30 EST Chiasma announces FDA acceptance of MYCAPSSA NDA resubmission - Chiasma announced that the U.S. Food and Drug Administration accepted for review the New Drug Application resubmission for its oral octreotide capsules investigational product candidate, conditionally trade named MYCAPSSA. Chiasma is developing MYCAPSSA for the maintenance treatment of adults with acromegaly. The FDA assigned a Prescription Drug User-Fee Act target action date of June 26, 2020, which is a six-month review.

07:28 EST Stage Stores down 45% to $4.05 after lowering FY19 earnings guidance

07:26 EST Fiesta Restaurant closes 19 Taco Cabana restaurants in Texas - Fiesta Restaurant announced that it will close 19 Taco Cabana restaurants in Texas, effective immediately. Nearly all employees impacted by the closures will be offered positions at other Taco Cabana locations. The 19 Taco Cabana restaurants contributed approximately $24.5M in restaurant sales and an estimated $4.2M in restaurant level pre-tax operating losses, including $2M in depreciation expense, for the twelve months ended December 29, 2019. The company expects to recognize estimated non-cash long-lived asset impairment charges of approximately $7M-$8M and estimated lease right-of-use asset impairment charges of approximately $1M-$3M related to these 19 Taco Cabana restaurants in Q4. The company also expects to recognize costs associated with de-imaging and removing equipment related to these restaurants in Q1, but it does not expect these additional closure related costs to be material.

07:21 EST Bayer, Dare Bioscience announce licensing agreement for U.S. rights to Ovaprene - Bayer (BAYRY) and Dare Bioscience (DARE) announced that the companies have signed a license agreement under which Bayer may commercialize Dare's investigational contraceptive product, Ovaprene in the United States once approved by the FDA. Ovaprene is an investigational hormone-free monthly vaginal contraceptive currently in clinical development for the prevention of pregnancy. If approved, it could be the first monthly non-hormonal contraceptive product. Under the agreement, Dare will receive an upfront payment and access to Bayer's clinical and market capabilities while retaining control over Ovaprene's development and regulatory approval process. Bayer receives the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Dare. If Bayer, in its sole discretion, makes payment to Dare of $20M, which Dare intends to apply to reimbursement of clinical study costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective. Dare will also be entitled to receive commercial milestone payments potentially totaling $310M, in addition to double digit tiered royalties on net sales. Dare plans to file an investigational device exemption, or IDE, for Ovaprene in the first half of 2020 and, pending the FDA's review and clearance of the IDE, to initiate a pivotal contraceptive effectiveness and safety clinical study of Ovaprene in the second half of 2020. If successful, Dare expects that study to support marketing approvals of Ovaprene in the U.S., Europe and other countries worldwide.

07:19 EST Sientra appoints Caroline Van Hove to board of directors - The Board of Directors has appointed Caroline Van Hove as a director of Sientra, effective January 10, 2020. Ms. Van Hove recently served as Chief Commercial Officer of Sienna Biopharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on therapies in immunology and inflammation.

07:15 EST KalVista provides update on oral HAE franchise - KalVista provided an update on its franchise of oral plasma kallikrein inhibitors for treatment of hereditary angioedema, or HAE. In developing the strategy for its oral HAE franchise, KalVista has conducted patient, physician and payer research to identify the key needs in the market. Oral therapy remains the highest unmet need according to all stakeholders, with 93% of patients surveyed by KalVista expressing a willingness to switch to oral therapy for both on-demand and prophylactic usage. However, the survey data shows that patients are not prepared to accept significantly reduced efficacy with a switch to oral therapy. The survey also indicated that twice-daily dosing would have little impact on willingness to switch compared to once-daily. KalVista anticipates that KVD824 can meet the efficacy and safety needs of patients as an oral prophylactic treatment. KVD824 is a highly potent and selective plasma kallikrein inhibitor which achieved high exposures and a favorable safety and tolerability profile in a first-in-human study. KalVista intends to investigate twice-daily dosing in the planned Phase 2 trial to maximize efficacy while maintaining the convenience of an oral therapy.

07:14 EST Mereo BioPharma, Oncologie enter licensing agreement for navicixizumab - Mereo BioPharma and Oncologie announced a global license agreement for the development and commercialization of navicixizumab, an anti-DLL4/VEGF bispecific antibody currently being evaluated in an ongoing Phase 1b study in combination with paclitaxel in patients with advanced heavily pretreated ovarian cancer. Navicixizumab previously completed a Phase 1a monotherapy study in patients with various types of refractory solid tumors and is one of two product candidates Mereo acquired through its 2019 merger with OncoMed Pharmaceuticals. In October 2019, the U.S. FDA granted Fast Track designation to navicixizumab and has agreed in principle on the design of a study that could potentially support accelerated approval for navicixizumab in a heavily pretreated, platinum-resistant ovarian cancer patient population. Under the terms of the License Agreement, Oncologie will receive an exclusive worldwide license to develop and commercialize navicixizumab. Mereo will receive an upfront payment of $4M with an additional payment of $2M conditional on a CMC milestone. Oncologie will be responsible for all future research, development and commercialization of navicixizumab. Additionally, Mereo will be eligible to receive up to $300M in future clinical, regulatory and commercial milestones, tiered royalties ranging from the mid-single-digit to sub-teen percentages on global annual net sales of navicixizumab, as well as a negotiated percentage of sublicensing revenues from certain sublicensees.

07:12 EST Denny's reports Q4 domestic system-wide same-store sales up 1.7% - Denny's fourth quarter domestic system-wide same-store sales increased 1.7%, including a 0.5% increase at company restaurants and a 1.8% increase at domestic franchised restaurants. Fiscal year domestic system-wide same-store sales grew 2.0%, including 1.9% growth at company restaurants and 2.0% growth at domestic franchised restaurants. On a two-year basis, this represents domestic system-wide same-store sales growth of 2.8%, comprised of 3.7% growth at company restaurants and 2.6% growth at domestic franchised restaurants.

07:11 EST Staar Surgical receives CE Mark approval for use of ICL as supplemental lens - Staar Surgical announced the company has gained CE Mark approval for use of its ICL as a supplemental or "piggyback" lens in post-cataract IOL surgery patients. A supplemental EVO ICL is placed in front of the cataract IOL lens in post-cataract patients just like the EVO ICL is placed in front of the human crystalline lens in refractive patients. The EVO ICL in the post-cataract patient is supplemental to the cataract IOL. The approval is for STAAR's EVO/EVO+ and Visian Implantable Collamer Lenses for myopia and hyperopia, and EVO/EVO+ and Visian Toric Implantable Collamer Lenses for myopia and hyperopia with astigmatism.

07:11 EST Amicus sees cash position funding operations 'well into' 2022 - Cash, cash equivalents, and marketable securities totaled over $450M at December 31, 2019. The current cash position is anticipated to fund ongoing operations well into 2022.

07:08 EST Zynerba provides update on pivotal CONNECT-FX trial of Zygel - Zynerba provided an update on the pivotal CONNECT-FX trial of Zygel in children and adolescents with Fragile X syndrome, or FXS, in advance of this week's investor meetings in San Francisco. Enrollment is nearing completion in CONNECT-FX, a pivotal, multi-national, randomized, double blind, placebo-controlled trial evaluating the efficacy and safety of Zygel in treating common behavioral symptoms of FXS in three through 17-year old patients with FXS. As of January 10 178 patients of the 204 targeted for enrollment in the trial have been randomized into the trial. There are also 15 patients who have been screened but not yet randomized. The Company anticipates that screening for the trial will close near the end of January.

07:07 EST Zynerba completes enrollment for Phase 2 BRIGHT trial of Zygel - Zynerba Pharmaceuticals announced the achievement of its enrollment target for the 14-week Phase 2 BRIGHT trial of Zygel for the treatment of pediatric and adolescent patients with autism spectrum disorder, or ASD. The Company expects to announce topline results from this study in the Q2. The 14-week exploratory Phase 2 BRIGHT trial has enrolled 36 patients with ASD at a single clinical site in Australia. The trial is designed to evaluate the efficacy and safety of Zygel in children and adolescents with ASD as confirmed by DSM-5 diagnostic criteria for ASD. Enrolled patients are receiving weight-based initial doses of 250 mg daily or 500 mg daily of Zygel. The efficacy assessments include the Aberrant Behavior Checklist, or ABC, Parent Rated Anxiety Scale - Autism Spectrum Disorder, or PRAS-ASD, Autism Impact Measure, or AIM, the Children's Sleep Habit Questionnaire (CSHQ), and Clinical Global Impression - Severity and Improvement, or CGI-S, CGI-I. After completing dosing in the 14-week period, participants may enroll in a six-month extension trial.

07:05 EST Destination XL reports nine-week holiday sales $103.1M vs. $102.7M last year - Destination XL Group announced that total sales for the 9-week holiday sales period ended January 4, 2020 increased 0.4% to $103.1 million as compared to $102.7 million for the 9-week holiday sales period ended January 5, 2019. Comparable sales in our omni-channel retail business for the same period increased 0.4%. Included in total sales are sales from our wholesale business of $3.4 million for the 9-week holiday sales period compared to $0.9 million for the same period last year. Sales in our direct business comprised 27.4% of retail sales for the holiday period compared to 24.8% of retail sales in the prior year holiday period. Based on the holiday sales results and expectations for the remainder of the fourth quarter, the Company expects comparable sales in our omni-channel retail business for the full year to be flat and free cash flow for the full year to be approximately break-even. Harvey Kanter, President and CEO, commented, "Although our comparable sales performance was not to the level we expected, we delivered a net positive comparable sales result for the holiday season. Management's efforts and investment drove greater inflection over our third quarter trends in the direct business and meaningful growth in wholesale. However, our store business struggled as we continued to observe a downtrend in store traffic that resulted in a low single-digit decrease in store comparable sales."

07:04 EST Actinium Pharmaceuticals announces collaboration with UC Davis - Actinium Pharmaceuticals announced that it has entered into an agreement with the University of California, Davis to utilize Actinium's Antibody Radiation-Conjugate or ARC apamistamab-I-131 for targeted conditioning and replace the chemotherapy conditioning being used in an ongoing Phase 1/2 stem cell gene therapy clinical trial. In the trial, patients with relapsed or refractory HIV-related lymphoma are being treated with autologous stem cell gene therapy. This is the first gene therapy clinical trial that will utilize ARC based conditioning. The clinical trial will be conducted at UC Davis and may be expanded to additional sites in the future.

07:02 EST Biomica enters pact with Biose Industrie for production of BMC121 & BMC127 - Biomica, a subsidiary of Evogene, announced that it has entered a service agreement with Biose Industrie, a France based CDMO, for the scale-up production of its drug candidates, microbial consortia BMC121 & BMC127 for its Immuno-Oncology program. This agreement will accelerate the company's Immuno-Oncology program which is currently planned to enter the clinic in 2021 for proof of concept studies.

06:59 EST Eagle Pharmaceuticals, UPenn in pact to develop dantrolene sodium - Eagle Pharmaceuticals announced that Eagle and the University of Pennsylvania have agreed on terms of a new exclusive worldwide license agreement for the development of dantrolene sodium for the potential treatment of people living with Alzheimer's disease, including an agreement to fund additional research and provisions regarding commercialization of products developed under the license.

06:57 EST Merck,AstraZeneca: FDA accepts sNDA for LYNPARZA/ bevacizumab - AstraZeneca (AZN) and Merck (MRK) announced that a supplemental New Drug Application for LYNPARZA in combination with bevacizumab has been accepted and granted priority review by the U.S. FDA for the maintenance treatment of women with advanced ovarian cancer whose disease showed a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. A Prescription Drug User Fee Act date is set for the second quarter of 2020.

06:54 EST Citi Trends CFO Stuart Clifford to retire, effective March 29 - The company also announced that Stuart Clifford, Senior Vice President and CFO, plans to retire effective March 29. As part of the succession planning for Clifford's retirement, Jason Moschner has been promoted to Vice President, Finance. Moschner joined Citi Trends in June 2017 and has served in several roles in the company's finance organization, most recently as Director of Finance. The company has initiated a search for a new CFO and will consider both external and internal candidates.

06:52 EST Brookfield Renewable submits offer to buy TerraForm Power in all-stock deal - Brookfield Renewable Partners (BEP) announced that it has made a non-binding, all-share proposal to acquire the outstanding Class A common shares of TerraForm Power (TERP), other than the 62% owned by Brookfield Renewable and its affiliates. Pursuant to the proposed transaction, each Class A common share of TerraForm Power would be acquired, on a tax-deferred basis, for consideration equivalent to 0.36 of a Brookfield Renewable unit. Consideration for the transaction will be in the form of Class A shares of Brookfield Renewable Corporation. The proposal values TerraForm Power at $17.31, representing an 11% premium to the closing share price of TerraForm Power on January 10, 2020. The proposed transaction would strengthen Brookfield Renewable's position as one of the largest publicly-traded, globally-diversified, multi-technology, pure-play renewable power platforms with $50B in total power assets, an equity capitalization of approximately $16B and a 20-year track record delivering 18% annualized returns to unitholders since inception with consistent, stable distribution growth, it said in a statement. "We believe this transaction will create significant value for investors in both companies through a simplified corporate structure and continued sponsorship from Brookfield Asset Management," said Sachin Shah, CEO of Brookfield Renewable. "For Brookfield Renewable unitholders, this transaction is expected to be immediately accretive and further expands our portfolio in North America and Western Europe, all while delivering returns in-line with our targets. Further, the proposed transaction will enhance the liquidity of the BEPC shares." As previously announced, Brookfield Renewable intends to make a special distribution of BEPC shares to its unitholders. The BEPC shares will be structured with the intention of providing an economic return equivalent to Brookfield Renewable units, including identical distributions, and will be exchangeable, at the shareholder's option, for Brookfield Renewable units on a one-for-one basis. As such, the proposed transaction would allow TerraForm Power shareholders to acquire economic exposure to Brookfield Renewable through shares of a corporation. The exchange ratio will be adjusted on a proportional basis to reflect the contemplated special distribution of BEPC shares to Brookfield Renewable unitholders, which we expect to close concurrently with the closing of the proposed transaction. Brookfield Renewable presented its proposal to the Board of Directors of TerraForm Power on January 11, 2020. The proposed transaction is subject to the negotiation and execution of definitive transaction documents and customary approvals, including approval of a committee of the Board of Directors of TerraForm Power consisting solely of independent directors, and the approval of a majority of TerraForm Power's stockholders not affiliated with Brookfield Renewable. Brookfield Renewable will not pursue the proposed transaction without obtaining these approvals.

06:52 EST Citi Trends reports holiday SSS up 3.6% - Total sales in the first two months of the fourth quarter of fiscal 2019 increased 5.4% to $170.5M compared with $161.9M in the same period of 2018. Comparable store sales increased 3.6% during the two-month period. Peter Sachse, Interim CEO, commented, "We were pleased with a 3.6% increase in comparable store sales during the holiday season, as our continued strategic shift towards non-apparel merchandise proved to be successful. We are achieving this sales growth on much less inventory, resulting in very current merchandise levels. We enter the new year well-positioned to grow Citi Trends' business and I look forward to discussing our strategic priorities at the ICR Conference on January 14th."

06:51 EST Brookfield Renewable submits offer to buy TerraForm Power in all-stock deal

06:48 EST Cott Corp. acquires Primo Water for $14.00 per share in cash and stock

06:46 EST Emergent BioSolutions: EMA approves plan for CHIKV VLP vaccine candidate - Emergent BioSolutions announced that it has received agreement from the European Medicines Agency to pursue its proposed development plan for its chikungunya virus virus-like particle vaccine candidate. The company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies as an immune correlate of protection to predict clinical benefit of the vaccine candidate.

06:40 EST AstraZeneca, Merck say Lynparza submission granted priority review in the U.S. - AstraZeneca (AZN) and Merck & Co (MRK) announced that a supplemental New Drug Application for Lynparza in combination with bevacizumab has been accepted and granted Priority Review in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line platinum-based chemotherapy with bevacizumab. A Prescription Drug User Fee Act date is set for the second quarter of 2020. The Priority Review by the US Food and Drug Administration was based on results from the pivotal Phase III PAOLA-1 trial, which were published in The New England Journal of Medicine. The trial compared Lynparza when added to standard-of-care bevacizumab vs. bevacizumab alone in patients with advanced ovarian cancer in the 1st-line maintenance setting, regardless of their biomarker status or outcome from previous surgery. The investigator-assessed results showed Lynparza added to bevacizumab reduced the risk of disease progression or death by 41% based on a hazard ratio of 0.59 and improved progression-free survival to a median of 22.1 months vs. 16.6 months for patients treated with bevacizumab alone. At two years after trial initiation, 46% of patients treated with Lynparza added to bevacizumab showed no disease progression vs. 28% of patients treated with bevacizumab alone. The safety and tolerability profiles of Lynparza and bevacizumab were consistent with previous trials for each medicine and showed no detriment to quality of life. Reference Link

06:37 EST Eli Lilly announces ORIENT-11 trial met primary endpoint in interim analysis - Eli Lilly jointly announced with Innovent Biologics, the results of a Phase 3 study in China; the ORIENT-11 trial of Tyvyt in combination with Alimta and platinum in first-line advanced or recurrent nonsquamous non-small cell lung cancer, or nsqNSCLC, without sensitive EGFR mutation or ALK rearrangement, met the predefined primary endpoint of progression-free survival, or PFS, in an interim analysis. Based on the interim analysis conducted by the Independent Data Monitoring Committee, or IDMC, sintilimab in combination with Alimta and platinum demonstrated a statistically significant improvement in PFS compared with placebo in combination with Alimta and platinum, which met the pre-defined efficacy criteria. The safety profile of sintilimab in this trial was consistent with previously reported studies, and no new safety signals were identified. Relevant data will be presented at an upcoming medical conference. Based on the IDMC recommendations, Lilly and Innovent will initiate regulatory discussions for registration with the National Medical Products Administration, or NMPA, in China in the near future.

06:37 EST Wesco to acquire Anixter in cash, stock deal valued at $4.5B - WESCO (WCC) and Anixter (AXE) announced that their boards of directors have unanimously approved a definitive merger agreement under which WESCO will acquire Anixter in a transaction valued at approximately $4.5 billion. Anixter's prior agreement to be acquired by Clayton, Dubilier & Rice, has been terminated, following CD&R's waiver of its matching rights under the agreement. Under the terms of the agreement, each share of Anixter common stock will be converted into the right to receive $70.00 in cash, 0.2397 shares of WESCO common stock and preferred stock consideration valued at $15.89, based on the value of its liquidation preference. Based on the closing price of WESCO's common stock on January 10 and the liquidation preference of the WESCO preferred stock consideration, the total consideration represents approximately $100 per Anixter share, giving effect to the downside protection described below. Based on transaction structure and the number of shares of WESCO and Anixter common stock currently outstanding, it is anticipated that WESCO stockholders will own 84%, and Anixter stockholders 16%, of the combined company. The combined company will have pro forma 2019E revenues of approximately $17 billion. With an extensive global reach and increased international exposure, approximately 12% of revenues will be generated outside of North America. The increased scale will enable the combined company to accelerate digitization strategies and provide a platform for growth in attractive emerging markets. WESCO expects to realize annualized run-rate cost synergies of over $200 million by the end of year three through efficiencies in corporate and regional overhead, including duplicative public company costs, branch and distribution center optimization, and productivity in procurement, field operations, and supply chain. In addition, WESCO expects incremental sales growth opportunities to result by cross-selling the companies' complementary product and services offerings to an expanded customer base and capitalizing on the enhanced capabilities across both networks. The combination is expected to be accretive to WESCO's earnings in the first full year of ownership and, with the realization of synergies, substantially accretive thereafter. WESCO also expects the transaction to generate significant margin expansion and EPS growth. The combined company will have strong free cash flow generation, supporting continued investments in the business and enabling a return of capital to stockholders in the future. At closing, WESCO estimates that its pro forma leverage on a net debt to EBITDA basis will be approximately 4.5x. WESCO intends to utilize the strength of the combined company's cash flows, including significant synergies, to reduce its leverage quickly and ultimately intends to be within its long-term target leverage range of 2.0x to 3.5x within 24 months post-close. Under the terms of the agreement, each share of Anixter common stock will be converted into the right to receive $70.00 in cash, 0.2397 shares of WESCO common stock, and preferred stock consideration consisting of 0.6356 depositary shares, each whole share representing a fractional interest in a newly created series of WESCO perpetual preferred stock. The common stock consideration is subject to downside protection, such that if the average market value of WESCO common stock prior to closing is between $47.10 per share and $58.88 per share, then the cash consideration paid at closing will be increased commensurately by up to $2.82 per share, such that the reduction in value of the WESCO common stock is offset by an increase in the cash consideration within that range. $2.82 per share will also be paid if the value of WESCO stock is below $47.10. The preferred stock consideration consists of 0.6356 depositary shares, with each whole depositary share representing a 1/1,000th interest in a share of WESCO Series A cumulative perpetual preferred stock, with a liquidation preference of $25,000 per preferred share and a fixed dividend rate calculated based on a spread of 325 basis points over the prevailing unsecured notes to be issued to effect the transaction. The fixed dividend rate will be subject to reset and the Series A preferred stock will have a five year non-call feature. WESCO has agreed to list the depositary shares representing the newly created series of preferred stock on the NYSE, and the security is expected to receive equity treatment from the rating agencies. The 0.6356 depositary share to be issued in the merger per share of Anixter common stock is valued at $15.89 based on the liquidation preference of the underlying interest in the Series A preferred stock represented thereby. Under the terms of the merger agreement, WESCO may elect to substitute additional cash consideration to reduce the amount of the preferred stock consideration on a dollar-for-dollar basis based on the value of the liquidation preference of the preferred stock consideration. WESCO and Anixter currently anticipate completing the transaction during the second or third quarter of 2020.

06:34 EST Wesco to acquire Anixter in $4.5B deal - WESCO (WCC) and Anixter (AXE) announced that their boards of directors have unanimously approved a definitive merger agreement under which WESCO will acquire Anixter in a transaction valued at approximately $4.5B. Anixter's prior agreement to be acquired by Clayton, Dubilier & Rice has been terminated, following CD&R's waiver of its matching rights under the agreement. Under the terms of the agreement, each share of Anixter common stock will be converted into the right to receive $70.00 in cash, 0.2397 shares of WESCO common stock and preferred stock consideration valued at $15.89, based on the value of its liquidation preference. Based on the closing price of WESCO's common stock on January 10, 2020 and the liquidation preference of the WESCO preferred stock consideration, the total consideration represents approximately $100 per Anixter share. Based on transaction structure and the number of shares of WESCO and Anixter common stock currently outstanding, it is anticipated that WESCO stockholders will own 84%, and Anixter stockholders 16%, of the combined company. Under the terms of the merger agreement, WESCO may elect to substitute additional cash consideration to reduce the amount of the preferred stock consideration on a dollar-for-dollar basis based on the value of the liquidation preference of the preferred stock consideration. WESCO has obtained fully committed debt financing from Barclays and intends to offer a combination of debt, equity, and equity-content securities between signing and closing to fund the required cash consideration of the transaction. At closing, WESCO estimates that its pro forma leverage on a net debt to EBITDA basis will be approximately 4.5x. The transaction is subject to Anixter stockholder approval, receipt of regulatory approval in the United States, Canada, and certain other foreign jurisdictions, as well as other customary closing conditions. WESCO and Anixter currently anticipate completing the transaction during the second or third quarter of 2020. Entities associated with Sam Zell, Chairman of the Anixter board, which own approximately 10.8% of the outstanding shares of Anixter common stock, have entered into a voting agreement with WESCO, pursuant to which they have agreed, among other things, to vote their shares of Anixter common stock in favor of the merger.

06:31 EST Wesco to acquire Anixter in cash, stock deal valued at $4.5B

06:31 EST Afya announces CFO transition plan - Afya announced that Luciano Toledo de Campos, its CFO, notified the company of his intention to leave for personal reasons. Campos will remain with the company serving as CFO to ensure a smooth and effective transition of his duties, including through its scheduled FY19 financial results announcement. Afya has already started conducting a search for its next CFO. The company confirm that the transition is not related to any matter regarding the company's financial reporting, accounting or business and that the full year guidance provided by the company remains the same.

06:15 EST Yum!'s Taco Bell to test $100,000 annual salary for managers - Taco Bell will soon begin testing a $100,000 annual salary for general managers in select locations in an attempt to attract and retain talent, the company said last week in a statement about its 2020 plans. "For those who may not want to be in a manager role, the brand is introducing 'Makers,' a program for restaurant team members who want to elevate their passion for the brand and want leadership experience. Additionally, starting January 1, 2020, all nationwide company employees can become eligible to receive at least 24 hours of paid sick time per calendar year. Through these initiatives, Taco Bell aims to enhance restaurant performance, employee satisfaction and support recruitment and retention." Reference Link

06:11 EST Allogene, SpringsWorks Therapeutics announce clinical trial collaboration - Allogene Therapeutics (ALLO) and SpringWorks Therapeutics (SWTX) announced that they have entered into a clinical trial collaboration agreement. This agreement will evaluate ALLO-715, Allogene's investigational anti-B-cell maturation antigen AlloCAR T therapy in combination with SpringWorks' investigational gamma secretase inhibitor, nirogacestat, in patients with relapsed or refractory multiple myeloma. Under the terms of the agreement, Allogene will sponsor and conduct the Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and will assume all development costs associated with the study. Allogene and SpringWorks will form a joint development committee to oversee the clinical study, which is expected to commence in the second half of 2020 pending discussions with regulators. SpringWorks is currently enrolling patients in a global Phase 3, double-blind, randomized, placebo-controlled clinical trial to evaluate nirogacestat in adults with progressing desmoid tumors.

06:06 EST Axsome Therapeutics enters exclusive U.S license agreement with Pfizer - Axsome Therapeutics (AXSM) has entered into an agreement with Pfizer (PFE) for an exclusive U.S. license to Pfizer's clinical and nonclinical data, and intellectual property for reboxetine, the active pharmaceutical ingredient in AXS-12 which Axsome is developing for the treatment of narcolepsy. The agreement also provides Axsome exclusive rights to develop and commercialize esreboxetine, a new late-stage product candidate now referred to as AXS-14, in the U.S. for the treatment of fibromyalgia. Under the terms of the agreement, Axsome will receive from Pfizer an exclusive U.S. license to Pfizer data for reboxetine and esreboxetine encompassing a full range of nonclinical studies, and short-term and long-term clinical trials involving more than five thousand patients. The licensed data includes results of a positive Phase 3 and a positive Phase 2 trial of esreboxetine in the treatment of fibromyalgia. Axsome will have the exclusive right and sole responsibility of developing AXS-14 in the U.S. for the treatment of fibromyalgia and for other indications. Pfizer will receive shares of Axsome common stock having a value of $8M, based on the average closing price of Axsome's common stock for the 10 prior trading days, in consideration for the license and rights. Pfizer will also receive an upfront cash payment of $3M, up to $323M in regulatory and sales milestones, and tiered mid-single to low double-digit royalties on future sales. Pfizer will also have a right of first negotiation on any potential future strategic transactions involving AXS-12 and AXS-14. Axsome recently completed and announced positive results for a Phase 2 trial of AXS-12 in the treatment of narcolepsy and is preparing to advance AXS-12 into Phase 3 trials for the treatment of narcolepsy in 2020, as previously disclosed.

05:52 EST 111, Inc. enters into strategic partnership with Bestyoo - 111, Inc. announced that it has entered into a strategic partnership with Bestyoo. 111 will work with Bestyoo's third-party online prescription information transferring and sharing platform to provide its users with prescription-based online drug purchase and home delivery services. Bestyoo and 111 will also jointly provide online consultation services to patients. This strategic partnership is expected to create a more standardized and feasible process for prescription information sharing and online sales of prescription drugs, bringing easy-to-access healthcare services to more patients in China.

05:45 EST Cnooc reports FY20 CapEx budget RMB 85B-RMB 95B - CNOOC announced its business strategy and development plan for the year 2020. The company's targeted net production for 2020 is 520 million to 530 million barrels of oil equivalent, or BOE, of which, production from China and overseas accounts for approximately 64% and 36%, respectively. The company's net production for 2019 is expected to be approximately 503 million BOE. The company's net production for 2021 and 2022 are estimated to be around 555 million BOE and 590 million BOE, respectively. The company's total capital expenditure for 2020 is budgeted at RMB 85 billion to RMB 95 billion. The capital expenditures for exploration, development, production and others will account for approximately 20%, 58%, 20% and 2% of the total capital expenditure, respectively. In 2020, the company plans to drill 227 exploration wells and collect approximately 27 thousand square kilometers 3-Dimensional seismic data. In 2020, ten new projects are expected to come on stream, namely Penglai 19-3 oil field block 4 adjustment/Penglai19-9 oil field phase II, Qinhuangdao 33-1 South oil field phase I, Bozhong 19-6 gas field pilot area development project, Luda 16-3/21-2 joint development project, Nanbao 35-2 oil filed S1 area, Jinzhou 25-1 oil field 6/11 area, Liuhua 29-1 gas field development project and Liuhua 16-2 oil field/20-2 oil field joint development project in offshore China, Liza oil field phase 1 in Guyana and Buzzard oil field phase II in the UK. Among which, Liza oil field phase 1 in Guyana has already come on stream ahead of schedule.

05:39 EST Adaptimmune SPEAR T-cell platform delivers initial responses - Adaptimmune Therapeutics reported two confirmed Partial Responses, or PRs, - one in a patient with liver cancer and one in a patient with melanoma. There are also two unconfirmed PRs - one in a patient with gastro-esophageal junction cancer and one in a patient with head and neck cancer. These data further confirm the potential of Adaptimmune's SPEAR T-cell platform for patients with multiple solid tumors. Data were previously reported showing compelling efficacy with ADP-A2M4 in synovial sarcoma. "These responses demonstrate that our proprietary SPEAR T-cell platform is clearly active and can overcome the challenges of treating a range of solid tumors with a T-cell therapy product," said Adrian Rawcliffe, Adaptimmune's CEO. "These are early results and we need more patient data and durability information to determine which therapies to develop. Nonetheless, this is a critical demonstration of the value of our SPEAR T-cell therapies for people with cancer and a validation of the importance of our proprietary affinity engineering. I couldn't be prouder of the team at Adaptimmune, and we are grateful to the investigators and patients who have put their faith in our treatment. We look forward to presenting data from these trials at future scientific congresses." There continues to be a favorable benefit:risk profile for all products and indications under study. Most adverse events are consistent with those typically experienced by cancer patients undergoing cytotoxic chemotherapy or other cancer immunotherapies. Adverse events (including cytokine release syndrome, neurotoxicity, and prolonged cytopenias) occur at rates consistent with other T-cell therapies, and are managed in keeping with current guidelines.

05:10 EST ObsEva, Yuyuan announce sublicense agreement to develop, commercialize nolasiban - ObsEva and Yuyuan BioScience Technology announced that they have entered into a sublicense agreement to develop and commercialize nolasiban for improving clinical pregnancy and live birth rates in women undergoing embryo transfer following in-vitro fertilization, or IVF, in the People's Republic of China, or PRC. Nolasiban is a novel, oral oxytocin receptor antagonist, for which two Phase 3 studies have been completed in Europe. Under the terms of the agreement, Yuyuan has the exclusive rights to develop and commercialize nolasiban in the PRC. They will fund all development and registration activities in the PRC starting with the commitment to fund and conduct a Phase 1 study and a Phase 2 Proof-of-Concept study in China. Both companies plan to collaborate on the subsequent global development of nolasiban, but Obseva will retain worldwide rights to the product outside of the PRC. In addition, both companies will seek to expand their collaboration in China on other projects. Financial terms of the deal are not being disclosed.