Stockwinners Market Radar for March 05, 2018 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:18 EDT LGI Homes reports February home closings 368 - LGI Homes announced 368 homes closed in February 2018, up from 224 home closings in February 2017, representing year-over-year growth of 64.3%. The company ended the first two months of 2018 with 645 home closings, a 62.9% increase over 396 home closings during the first two months of 2017.

18:11 EDT PS Business Parks sells Corporate Pointe Business Park in Orange County, CA - PS Business Parks announced that on March 5, it completed the sale of Corporate Pointe Business Park located in Orange County, California. The park consists of five multi-tenant office buildings comprising approximately 160,000 square feet, which were 97.6% occupied at the date of sale. Net proceeds from the sale, after transaction costs, were approximately $41.7M. The company previously announced that it had 705,000 rentable square feet of office product in Orange County, California, held for sale, including this Corporate Pointe Business Park.

17:30 EDT Fir Tree Capital Management lowers stake in Resolute Energy to 7.2% from 9.0%

17:24 EDT On The Fly: After Hours Movers - UP AFTER EARNINGS: Tintri (TNTR), up 10.8%... Analogic (ALOG), up 7.7%... Tarena (TEDU), up 5.9%... Quanex (NX), up 0.6%. ALSO HIGHER: Quidel (QDEL), up 5% after it received FDA 510k clearance for its Sofia Lyme FIA. DOWN AFTER EARNINGS: Freshpet (FRPT), down 13%... Ascena Retail (ASNA), down 12.4%... Nautilus (NLS), down 9.1%... Syndax (SNDX), down 5.6%... Anthera (ANTH), down 5.2%... Fate Therapeutics (FATE), down 4.9%. ALSO LOWER: GlycoMimetics (GLYC), down 20.4% after it announced its Phase 3 trial design for GMI-1271... Ares Management (ARES), down 10.9% after it launched an offering of common shares... G1 Therapeutics (GTHX), down 3.6% after it filed to sell 3M shares of common stock... Nordstrom (JWN), down 2.5% after its board of directors rejected an indicative proposal to acquire the company... Conagra Brands (CAG), down 2.1% after it said it "disagrees" with the FTC's move to challenge the pending sale of the Wesson oil business to J.M. Smucker (SJM)... TransUnion (TRU), down 0.5% after it offered to sell 19.9M shares of common stock for holders.

17:23 EDT Lockheed Martin awarded $481.2M U.S. Navy contract - Lockheed Martin is being awarded a $481,169,145 not-to-exceed undefinitized contract action for long-lead-time material in support of the construction of four Multi-Mission Surface Combatant ships. The MMSC is a lethal and highly-maneuverable surface combatant capable of littoral and open-ocean operation. This contract involves foreign military sales to the kingdom of Saudi Arabia.

17:17 EDT Aspen REIT to withdraw its common stock from NYSE American - Aspen REIT has issued a notice to the NYSE American of Aspen REIT's determination to withdraw its common stock, $0.01 par value per share, from listing and/or registration on the NYSE American. The stated basis for withdrawal of its common stock from listing are that on February 21, Aspen REIT announced its decision to postpone its initial public offering in order to make certain modifications to the structure of the offering, and in order to continue the offering with the modified structure, Aspen REIT has been asked to withdraw its common stock from listing with the NYSE American. Aspen REIT has not arranged for listing and/or registration on another national securities exchange or for quotation of its Common Stock in a quotation medium as defined by applicable regulations.

17:17 EDT Splendid Days Ltd reports 14.1% stake in The9

17:05 EDT GlycoMimetics dives 19% after announcing Phase 3 trial design for for GMI-1271 - Earlier, GlycoMimetics announced its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in combination with MEC or in combination with FAI in individuals with relapsed/refractory acute myeloid leukemia. The design is aligned with guidance received from the U.S. Food and Drug Administration.The single pivotal trial is planned to enroll 380 adult patients worldwide and is expected to begin in the third quarter of 2018. The primary endpoint will be overall survival, and censoring for transplant in the primary efficacy analysis will not be required. Key secondary endpoints will include incidence of severe mucositis and remission rate, which will be assessed in a hierarchical fashion for potential inclusion in the product labeling, if GMI-1271 is approved by the FDA. In 2017, GMI-1271 received Breakthrough Therapy Designation. "Reaching alignment with the FDA on overall survival as the primary endpoint for the trial, without statistical censoring for transplant, positions GMI-1271 well for a potential successful outcome," said Rachel King, Chief Executive Officer of GlycoMimetics. "Getting more patients to transplant following treatment with GMI-1271 is one of our goals for this therapy. If we accomplish this, we hope GMI-1271 will contribute to prolonged overall survival for relapsed/refractory AML patients. We believe this is a rigorously designed Phase 3 trial that has the potential to bring us one step closer to meeting the significant unmet needs of this patient population. In addition, we believe that our trial design should streamline the path to data on overall survival, considered the 'gold standard' of clinical benefit, and that if this primary endpoint is achieved, it should position GMI-1271 optimally with U.S. and European regulatory agencies, as well as in the marketplace." "Our development strategy now sets us up for multiple, value-creating clinical data readouts, the first of which is topline data from the ongoing Phase 3 trial of rivipansel in sickle cell disease in the second half of 2018," Ms. King added. "In early 2019, we anticipate topline data from our proof-of-concept trial of GMI-1271 in multiple myeloma, and now, by the end of 2020, we expect to have topline data from our pivotal trial of GMI-1271 in patients with relapsed/refractory AML."

17:02 EDT J.M. Smucker 'disappointed' with FTC decision challenging sale of Wesson oil - The J. M. Smucker Company (SJM) issued the following statement in response to the U.S. Federal Trade Commission's announcement that it has filed an administrative complaint challenging the company's proposed acquisition of the Wesson oil brand from Conagra Brands (CAG). The acquisition agreement was previously announced on May 30, 2017. "While we respect the FTC's decision, we are disappointed with this conclusion and strongly believe that the acquisition would benefit all of our constituents," said Mark Smucker, CEO. "We certainly understood this outcome could be possible, and we remain focused on delivering value to our consumers and customers with our Crisco brand and oils business. We are reviewing the complaint and working with Conagra to assess our next steps in this process."

17:00 EDT Frontier Communications names Rob Curtis CMO - Frontier Communications announced that Rob Curtis has joined the company as senior VP and CMO. Curtis reports to John Maduri, executive VP of consumer sales, marketing and product. Most recently, Curtis was a Partner at Bain & Company, and a leader in its customer strategy & marketing practice and its telecommunications practice.

16:56 EDT H&E Equipment president Bradley Barber sells $1.6M in company shares - Bradley Barber, the president of H&E Equipment Services, reported in a filing out after the close that he had sold 40,000 shares of company stock at an average price of $40.49 on March 5.

16:51 EDT Freshpet falls 11% after reporting Q4 results, guidance - The company is down 11.3% after reporting quarterly results. Net loss was $4.3M for the full year ended December 31 compared to net loss of $3.2M for the prior year. The higher net loss was primarily related to the planned increased media spend, partially offset by increased net sales and improved gross profit.

16:46 EDT Tintri jumps 14% after quarterly report, CEO transition, restructuring - The company has implemented a restructuring and reduction in force plan of approximately 20% of the company's global workforce. On February 21, the company also announced an early termination of a facility lease. The restructuring, which consisted of a reduction in force and a termination of a facility lease, is part of an overall plan to optimize the company's operating model. The company expects to substantially complete the restructuring in its first quarter of fiscal year 2019, which ends on April 30, 2018. The company estimates it will incur approximately $4.8 million to $5.8Mof cash expenditures in connection with the restructuring, substantially all of which relate to severance costs and contract termination costs. Total restructuring expenses are estimated at $6.2M to $7.2M, substantially all of which related to severance costs, write-off of net leasehold costs, and contract termination costs. The company expects to recognize most of these charges in the first quarter of fiscal year 2019. Shares Tintri are up 13.7% to $5.81 per shre in after-hours trading.

16:37 EDT Nordstrom down 2% after rejecting indicative acquisition proposal

16:35 EDT AnaptysBio plans to initiate atopic dermatitis Phase 2b study in first half - The company said in its earnings release, "We are poised to continue advancing our ANB020 and ANB019 programs with additional clinical data readouts in serious inflammatory conditions during 2018. We are on-track to report top-line data on ANB020 as a treatment for both severe adult peanut allergy in March 2018 and severe adult eosinophilic asthma during the second quarter of 2018. We plan to initiate a Phase 2b study of ANB020 in moderate-to-severe adult atopic dermatitis during the first half of 2018, as well as Phase 2 studies of ANB019 in generalized pustular psoriasis, or GPP and palmo-plantar pustular psoriasis, or PPP, during 2018. These milestones are significant for the company, and important steps forward in bringing our novel treatments to patients with severe inflammatory diseases." AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan through the end of 2019.

16:35 EDT Ascena Retail trading resumes

16:33 EDT Sito Mobile appoints Bruce Rogers to head of marketing - SITO Mobile announced today that Bruce Rogers has joined SITO as Head of Marketing. In this role, Mr. Rogers will help shape SITO's strategic positioning and guide the Company's clients to make informed business decisions based on direct insight into their target consumers' behavior.

16:31 EDT Nordstrom board receives, rejects indicative proposal to acquire company - The Special Committee of the Board of Directors of Nordstrom, Inc. announced that it has been notified by a group consisting of members of the Nordstrom family - Company Co-Presidents Blake W. Nordstrom, Peter E. Nordstrom, and Erik B. Nordstrom, President of Stores James F. Nordstrom, Chairman Emeritus Bruce A. Nordstrom, and Anne E. Gittinger that the Group intends to submit a proposal to purchase all of the outstanding shares of common stock of the Company not already owned by the Group, and approximately 21% of the shares owned by the Nordstrom family members in the Group, for $50.00 per share in cash. The Special Committee has reviewed the Group's indicative acquisition proposal, in consultation with its financial advisor and legal counsel, and has determined that the price proposed is inadequate. The Special Committee has directed its advisors and management not to provide further due diligence information to the Group. Furthermore, unless the Group can promptly and substantially improve the price it is proposing to pay for the Company, the Special Committee intends to terminate discussions. The Special Committee is committed to protecting the interests of the Company and all of its shareholders. The Special Committee is being advised by Centerview Partners LLC as financial advisor and Sidley Austin LLP as legal counsel.

16:26 EDT Bojangles appoints James Kibler as interim CEO - Bojangles' announced that the board has appointed James "Randy" Kibler as interim president and CEO following the resignation of Clifton Rutledge for personal reasons. The board will also initiate a search for a permanent president and CEO.

16:18 EDT New York REIT announces 1-for-10 reverse stock split - New York REIT announced that its board of directors has approved a reverse stock split of NYRT's common stock at a ratio of 1-for-10. The reverse stock split is expected to take effect at approximately 5:00 p.m. EST on March 15. Accordingly, at the Effective Time, every 10 issued and outstanding shares of common stock will be converted into one share of common stock. In addition, at the market open on March 16, the common stock is expected to be assigned a new CUSIP number.

16:16 EDT Rite Aid provides update on plans to sell stores to Walgreens Boots Alliance - Rite Aid Corporation (RAD) provided an update on the progress of its plans to sell stores to Walgreens Boots Alliance, Inc. (WBA) pursuant to the previously disclosed Amended and Restated Asset Purchase Agreement, dated as of September 18, 2017. As of March 2, 2018, Rite Aid has transferred 1,651 stores and related assets to WBA, and has received cash proceeds of $3.6B, which the company continues to use to reduce debt. Under the Asset Purchase Agreement, WBA will purchase a total of 1,932 stores, three distribution centers and related inventory from Rite Aid for an all-cash purchase price of $4.4B on a cash-free, debt-free basis. Rite Aid expects to complete the store transfer process in the spring of 2018.

16:13 EDT Addus HomeCare reports Q4 same-store revenue growth of 4.1%

16:13 EDT Point72 Asset Management reports 6% passive stake in Agenus

16:10 EDT Anika Therapeutics CEO Charles Sherwood to retire, Joseph Darling to succeed - Anika Therapeutics announced the appointment of Joseph Darling as CEO, succeeding Charles Sherwood, who will retire as CEO and a director of Anika on March 9, after almost 20 years of service. Darling, who succeeded Sherwood as Anika's President in July 2017, will serve as CEO, president and a director of Anika.

16:10 EDT Aeterna Zentaris appoints James Clavijo as CFO - Aeterna Zentaris announced the appointment of James Clavijo as CFO effective March 5. Clavijo joins Aeterna Zentaris from Tri-Source Pharma, where he most recently served as CFO. Tri-Source is a pharmaceutical company focused on procuring pharmaceutical products facing supply issues and supplying pharmaceutical products to veterinary markets.

16:08 EDT Tintri CEO Ken Klein to step down - Tintri announced that its Chairman and CEO, Ken Klein, will transition from his CEO role after a successor is found. Mr. Klein expects to continue to serve as CEO and as a board member until the new CEO is appointed and an orderly transition has occurred. The board has initiated a search for a successor to lead the company in its next stage of evolution and has established a search process and engaged an executive search firm.

16:02 EDT GlycoMimetics to start Phase 3 GMI-1271 study in Q3 - GlycoMimetics announced its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in combination with MEC or in combination with FAI in individuals with relapsed/refractory acute myeloid leukemia. The design is aligned with guidance received from the U.S. Food and Drug Administration. The single pivotal trial is planned to enroll 380 adult patients worldwide and is expected to begin in the third quarter of 2018. The primary endpoint will be overall survival, and censoring for transplant in the primary efficacy analysis will not be required. Key secondary endpoints will include incidence of severe mucositis and remission rate, which will be assessed in a hierarchical fashion for potential inclusion in the product labeling, if GMI-1271 is approved by the FDA. In 2017, GMI-1271 received Breakthrough Therapy Designation. "Reaching alignment with the FDA on overall survival as the primary endpoint for the trial, without statistical censoring for transplant, positions GMI-1271 well for a potential successful outcome," said Rachel King, Chief Executive Officer of GlycoMimetics. "Getting more patients to transplant following treatment with GMI-1271 is one of our goals for this therapy. If we accomplish this, we hope GMI-1271 will contribute to prolonged overall survival for relapsed/refractory AML patients. We believe this is a rigorously designed Phase 3 trial that has the potential to bring us one step closer to meeting the significant unmet needs of this patient population. In addition, we believe that our trial design should streamline the path to data on overall survival, considered the 'gold standard' of clinical benefit, and that if this primary endpoint is achieved, it should position GMI-1271 optimally with U.S. and European regulatory agencies, as well as in the marketplace."

16:00 EDT Ascena Retail trading halted, news pending

15:35 EDT Charter near session highs after Betaville 'RARE Alert' - Shares of Charter Communications are at session highs after the stock was mentioned in a "RARE Alert" issued by Ben Harrington's Betaville blog to its subscribers. As stated on Harrington's site: "Betaville has a wide range of high-level sources but from time to time some intelligence alerts may contain a 'RARE' disclaimer [meaning that it is] market gossip that hasn't been tested through all formal journalistic channels...The rumour might be total codswallop but then again there may be something in it, so it's worth airing on Betaville." Charter shares are up $14.00, or 4.2%, to $346.75 following the report from Betaville. Reference Link

15:11 EDT Senator Cotton says Qualcomm work 'too important' to fall into foreign hands - Republican Senator Tom Cotton of Arkansas released the following statement on the Committee on Foreign Investment in the United States's decision to delay a Qualcomm (QCOM) shareholder meeting to allow for a more extensive review of a takeover bid by Broadcom (AVGO): "Qualcomm's work is too important to our national security to let it fall into the hands of a foreign company-and in a hostile takeover no less. I raised concerns about this proposed takeover to the Treasury Department directly, and I commend the Committee on Foreign Investment in the U.S. for putting it on hold. It's hard to see a good reason why we should hand over one of our leading computer-chip makers, and thereby give Chinese companies a leg-up in the race to develop 5G and the next generation of technology. Better to keep it in American hands and protect American national security." Reference Link

15:02 EDT Travelzoo authorizes repurchase of up to 500,000 common shares - Travelzoo announced that its board of directors has authorized the repurchase of up to 500,000 shares of the company's outstanding common stock. Purchases may be made, from time to time, in the open market and will be funded from available cash. The number of shares to be purchased and the timing of purchases will be based on the level of Travelzoo's cash balances, general business and market conditions, and other factors, including alternative investment opportunities.

14:10 EDT Cheniere Energy commences 20-year LNG contract - Cheniere Energy marked the commencement of their 20-year Sale and Purchase Agreement to supply U.S.-sourced liquefied natural gas to India from Cheniere's Sabine Pass liquefaction facility in Louisiana, with one of GAIL's first shipments departing from the facility. The ship will set sail after today's ceremony to mark the occasion at Sabine Pass in the presence of Cheniere President and CEO Jack Fusco and GAIL Chairman and Managing Director Mr. B.C. Tripathi, who were joined by Consul General Dr. Anupam Ray, as well as representatives from Cheniere and GAIL.

13:57 EDT Square jumps 8% after Cryptona speculates on Bitcoin integration - Shares of payments company Square (SQ) are up over 8% after news site Cryptona published an article earlier that said that Square may be "testing an integration with bitcoin." On January 31, Square founder and CEO Jack Dorsey tweeted "Instant buying (and selling, if you don't want to hold) of Bitcoin is now available to most Cash App customers. We support Bitcoin because we see it as a long-term path towards greater financial access for all. This is a small step." Shares of Square are up more than 9% in afternoon trading to $50.20 per share. Reference Link

13:02 EDT GameStop CEO announces passing of former CEO J. Paul Raines - GameStop CEO Mike Mauler said in a statement: "We are profoundly sad to learn of the passing of our friend and former chief executive officer, J. Paul Raines. His spirit is woven into the fabric of our company and the entire GameStop family mourns this loss. Paul was a brilliant man and remarkable visionary, as well as a compassionate, caring and inspirational community leader who was beloved by many. Paul cared deeply about his work and his GameStop family, but his greatest love was for his family. Our heartfelt sympathies go out to them and all those whose lives and hearts Paul touched during his journey." Previously, GameStop said in a regulatory filing that on January 31, 2018, J. Paul Raines notified the company that, in order to focus on his health and family, he has decided to resign as a director, effective immediately. The filing also noted a "medical event" experienced by Raines.

12:20 EDT Nuance, Partners HealthCare collaborate to accelerate AI adoption - Nuance Communications announced the signing of a multi-year strategic agreement with Partners HealthCare. The two organizations will optimize the process for rapid development, validation and utilization of artificial intelligence for radiologists at the point of care, and Nuance intends to make the new algorithms available through the Nuance AI Marketplace for Diagnostic Imaging. The collaboration will be executed through the recently formed Massachusetts General Hospital and Brigham and Women's Hospital Center for Clinical Data Science and will focus on improving radiologists' efficiency and report quality, as well as patient clinical outcomes. Nuance and Partners HealthCare will work together, and with other key supporters of the Nuance AI Marketplace for Diagnostic Imaging including NVIDIA and the American College of Radiology. The collective will continue to foster the democratization of Imaging AI, with an emphasis on automating many of the mundane and repetitive tasks radiologists face daily. The AI Marketplace is an open platform for developers, data scientists and radiologists to accelerate the development, deployment, and adoption of AI for medical imaging. Leveraging the 70 percent of Radiologists in the U.S. already using Nuance's PowerScribe radiology reporting and PowerShare image exchange network, the AI Marketplace unlocks the power of AI for all radiologists and developers. Specifically, technology partners can now seamlessly deploy their algorithms into Nuance's cloud-based PowerShare Network and users can easily select them through the PowerScribe radiology reporting platform. This enables the algorithms to be accessed within a radiologist's native workflow, eliminating the need to buy new reporting or image sharing systems.

12:07 EDT Amazon acquires GameSparks, terms not disclosed - Video game infrastructure and live operations company GameSparks said in a blog post that it has been acquired by Amazon. "GameSparks has long shared Amazon's passion for helping developers create amazing gaming experiences, so it's a natural fit," GameSparks said. "Being part of Amazon means we'll continue to grow the service, as well as explore new ways to unlock the power of Amazon to help you build, operate, and monetize your games." Reference Link

11:40 EDT Netflix introduces PIN protection, enhancements for 'informed' viewing - Mike Hastings, a director of enhanced content at Netflix, said in a blog post: "At Netflix, we offer a wide variety of series and films catering to an equally broad variety of tastes and sensibilities. With that in mind, we are improving some long-standing Netflix features that provide members with the information and tools they need to make wise decisions about what's right for themselves and for their families. We're rolling out these improvements across the many devices used by Netflix members, and across our global markets, in the coming months. The first change involves introducing a PIN parental control for individual movies and series to give parents and guardians more specific control over what children can watch on the service. We understand that every family is different and that parents have differing perspectives on what they feel is appropriate to watch at different ages. While we already provide PIN protection for all content at a particular maturity level for Netflix accounts, PIN protection for a specific series or film provides families with an additional tool to make decisions they are comfortable with. In addition, we will also begin displaying more prominently the maturity level rating for a series or film once a member hits play on a title. While these maturity ratings are available in other parts of the experience, we want to ensure members are fully aware of the maturity level as they begin watching. We are also continuing to explore ways to make this information more descriptive and easier for our members to understand with just a quick glance. One of the great benefits of internet TV is that it allows for amazing variety and provides viewers with complete control over their experience. At Netflix, we are proud to create and deliver to our members a large catalog of compelling stories crossing many genres from all over the world, while also giving them great control over how and when to enjoy them. These latest steps are part of our continuous efforts to keep members better informed, and more in control, of what they and their families choose to watch and enjoy on Netflix." Reference Link

11:06 EDT The Infatuation confirms plans to acquire Zagat from Google - The Infatuation, a restaurant discovery platform, confirmed that it has entered into an agreement to buy Zagat, the restaurant review brand, from Google. The Infatuation said, "Adding the iconic dining resource brand to The Infatuation's powerful website, mobile app, messaging and social ecosystems will help continue the company's mission to create the largest, most influential, and most useful restaurant discovery platform in the world." The Infatuation and Zagat will operate as two distinct brands, with individual platforms, and distinct purposes and points of view. Specifically, The Infatuation will retain its editorial-first focus, producing high quality, situational reviews and guides, while continuing its groundbreaking work in mobile and social media. Working within The Infatuation's infrastructure and leadership, Zagat will expand user surveys and develop a new tech-driven platform that will create a stronger, more meaningful alternative to other crowdsourced restaurant reviews. "The two brands will work in tandem to provide users quality and diverse options for restaurant recommendations. The Infatuation will introduce Zagat to its highly engaged, millennial audience and will leverage the social capital which they have earned since their launch nine years ago to help grow the Zagat brand. In addition, Zagat's product offerings will be expanded internationally, to connect with communities abroad."

10:24 EDT Shire says FDA accepts NDA for Prucalopride for CIC in adults - Shire announces that the U.S. Food and Drug Administration has accepted the submission of a New Drug Application for prucalopride, or SHP555. Prucalopride is being evaluated as a potential once-daily treatment option for chronic idiopathic constipation in adults. The FDA is expected to provide a decision on or around December 21, 2018, the designated Prescription Drug User Fee Act action date with FDA noting that timelines are flexible and subject to change based on workload and identification of potential review issues. Prucalopride currently is approved and available in the European Union where it is marketed by Shire as Resolor, indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief. It is also available in several other countries outside of Europe.

10:19 EDT Deutsche Bank says buy Valeant after 'significant change' over last two years - Shares of Valeant Pharmaceuticals (VRX) are on the rise after Deutsche Bank analyst Gregg Gilbert upgraded the stock to Buy, saying the company has undergone "significant change" over the last two years under the new management team, and he likes "the set-up from here." BUY VALEANT: In a research note to investors this morning, Deutsche Bank's Gilbert upgraded Valeant Pharmaceuticals to Buy from Hold, with an unchanged price target of $20. The analyst pointed out that the drugmaker has undergone "significant change" over the last two years under the new management team, which he applauds for managing near-term debt maturities, returning the core franchises to growth, and resolving some legacy legal issues. While Gilbert acknowledged that challenges remain, most notably the heavy debt load, he believes Valeant is doing "the right things" to strengthen the business, including investing behind core growth franchises, reducing legal liabilities, and strengthening the balance sheet. He particularly likes that management is now confident enough in the business to have established longer-term revenue and EBITDA targets. Nonetheless, the stock should remain highly volatile, with trading often seemingly disconnected with fundamentals, he added. XIFAXAN GROWTH IMPROVING: Gilbert also highlighted that Xifaxan is Valeant's largest product and an important growth driver. The company's efforts to better access the primary care market appear to be doing well, with volume growth accelerating, the analyst contended, adding that management remains confident in the protectability of the franchise given its IP, technical hurdles for generics, and lifecycle management initiatives. The analyst models a generic cliff in 2025, which may be potentially conservative. PRICE TARGET: In morning trading, shares of Valeant have gained about 4.3% to $15.52.

10:05 EDT Toyota to merge three IT subsidiaries, create comprehensive IT solutions company - Toyota Motor Corporation announces a mutual agreement to merge three of its information technology subsidiaries as of January 1, 2019. The three companies involved in the merger are Toyota Communication Systems Co., Ltd., Toyota Digital Cruise, Inc., and Toyota Caelum Inc. Each of the three companies has its own area of expertise in different fields of IT: TCS in the development of core systems, TDC in the introduction and operation of networks and infrastructure, and TCI in the development of design and manufacturing support systems. The companies all have a long history of providing valuable services to support TMC and Toyota Group companies. This merger is an absorption-type merger of TDC, TCI, and TCS, with the latter acting as the surviving corporation of the merger. The company will be named Toyota Systems Co and will be a wholly-owned subsidiary of Toyota Motor Corporation with about 2,500 employees.

09:55 EDT Glaxo: Nucala improved asthma control in patients uncontrolled on Xolair - GlaxoSmithKline presented positive results from the OSMO study at the American Academy of Allergy, Asthma & Immunology and World Allergy Organization Joint Congress in Orlando. The results showed that severe asthma patients who are uncontrolled despite receiving Xolair, or omalizumab, and who are eligible for treatment with Nucala, or mepolizumab, experience improved asthma control when switched on to mepolizumab. OSMO is an open-label, single-arm study which investigated whether patients who had been receiving omalizumab, for an average of 2.5 years and continued to have uncontrolled severe asthma, gained better asthma control following a switch to mepolizumab. In the study 145 patients, who were documented to have experienced at least two asthma exacerbations in the year prior to enrolment, were switched directly to mepolizumab without a wash-out period and followed for 32 weeks. In this study, mepolizumab data compared with baseline values prior to first dose, unless otherwise stated: Met the primary endpoint of asthma control with clinically significant improvements, as evaluated by the Asthma Control Questionnaire, with a mean change from baseline of -1.45 at week 32; Met all secondary endpoints and other key endpoints, including rate of exacerbations requiring oral steroids reduced by 64% vs prior 12 months.

09:26 EDT Willis Towers Watson appoint Alexis Faber as COO - Willis Towers Watson announced the appointment of Alexis Faber as COO within its Corporate Risk and Broking segment. Faber will transition from her current role as global head of Financial Lines. In this newly created role, Faber will be responsible for delivering the company's operating model within Corporate Risk and Broking as well as implementing a consistent client experience across the segment from sales to claims.

09:19 EDT Golar LNG Partners announces $25M common unit repurchase program - In light of the recent lows in the price of its common units, Golar LNG Partners announced that the Board has authorized the repurchase by the Partnership of up to $25M of its outstanding common units over the next two years. Under the terms of the repurchase program, the Partnership may repurchase common units from time to time, at the Partnership's discretion, on the open market or in privately negotiated transactions. Any repurchases are subject to market conditions, applicable legal requirements and other considerations. Common units will be purchased only during periods where the Partnership is not aware of material inside information that would likely affect a seller's decision to sell. The Partnership is not obligated under the repurchase program to repurchase any specific dollar amount or number of common units, and the repurchase program may be modified, suspended or discontinued at any time. Any common units repurchased by the Partnership under the program will be cancelled.

09:13 EDT Telos Corp awarded $108M NETCENTS-2 task order to support air combat command - Telos announced that the company was awarded a five-year, $108M contract to provide planning, infrastructure systems, networks operations and support for Air Combat Command. Work under the contract will enable ACC's mission defense teams to execute Defensive Cyber Operations for weapon and mission systems across the Command. The work was awarded under the NETCENTS-2 Network Operations & Infrastructure Solutions Small Business contract and will be carried out at 17 Air Combat Command locations throughout the U.S.

09:12 EDT Prudential's PGIM and Citizens Financial's Commercial Real Estate announce deal - Citizens' Commercial Real Estate clients will have an additional source of long-term permanent financing opportunities under a referral agreement with PGIM Real Estate Finance announced. The Citizens Commercial Real Estate team continues to add solutions to deepen its client relationships as it prudently grows its business. In 2017, Citizens' CRE loans grew 15% to $11.2B. Citizens' Commercial Real Estate Finance team provides project finance loans of more than $25M, focusing on building relationships with strong commercial real estate sponsors. Citizens provides loans for multifamily, office, retail, industrial and hospitality properties. Citizens is a trusted strategic and financial advisor, consistently delivering clear and objective advice. The Citizens Commercial Banking approach puts clients first by offering great ideas combined with thorough market knowledge and excellent execution to help our clients enhance their business and reach their potential.

09:04 EDT Emerson and Total announce long-term software agreement - Emerson announced a long-term global agreement with Total to provide all Total geoscientists with access to Emerson's Paradigm exploration and production, or E&P software portfolio to help the global energy leader maximize performance of reservoir subsurface modeling and formation evaluation. In late 2017, Emerson acquired Paradigm, which combined with Emerson's existing portfolio, makes Emerson the largest independent provider of E&P software to the oil and gas industry. The agreement provides Total access to the Paradigm SKUA-GOCAD and Paradigm Geolog software solution suites for full field life cycle subsurface modeling and formation evaluation activities. Additionally, through use of a Paradigm software development kit, Total will continue to integrate the technology into its own proprietary geosciences and reservoir integrated platform.

09:02 EDT Rocky Brands board approves new $7.5M share repurchase program - Rocky Brands announced that its board of directors has approved a new share repurchase program of up to $7.5M of the company's outstanding common stock, no par value per share. This repurchase program replaces the previous repurchase program authorized by the board of directors that expired on March 1.

08:55 EDT Aqua Metals completes first 24 hour run of single Aquarefining module - Aqua Metals announced that it has completed the first 24 hour run of continuous operation of an AquaRefining module. The module, which was retrofitted with the "sticky lead" solution that the company is currently integrating into all modules, operated for 24 continuous hours for the first time. This 24-hour testing run produced approximately 2.4 metric tonnes of AquaRefined lead, which meets the company's objectives. Moreover, the module achieved this output using approximately 13% less energy than its design basis, in part as a result of the modifications developed to resolve the sticky lead issue. The company is working to complete the retro-fit of all 16 AquaRefining modules and ramp up production during 2018.

08:46 EDT On The Fly: Pre-market Movers - HIGHER: XL Group (XL), up 30.5% after AXA (AXAHY) announced that it will acquire XL Group for $15.3B, or $57.60 per share... TrovaGene (TROV), up 16.9%. after the initial patient successfully completed the first cycle 1 of treatment in its Phase 1b/2 multicenter trial of PCM-075 in combination with low-dose cytarabine in patients with Acute Myeloid Leukemia... Vericel (VCEL), up 9% after reporting quarterly results... GTx (GTXI), up 13.5% after announcing the Phase 2 trial of enobosarm met its primary endpoint... AstraZeneca (AZN), up 1.2% after reporting European Medicines Agency approval of the Marketing Authorization Variation for Forxiga. LOWER: Dermira (DERM), down 63.8% after announcing that olumacostat glasaretil did not meet co-primary endpoints... Amag Pharmaceuticals (AMAG), down 2.9% after being downgraded to Hold from Buy at Jefferies.

08:44 EDT RenovaCare: Short sellers spread 'false rumors,' 'innuendos of impropriety'

08:40 EDT On Track Innovations gets new purchase order of 2,000 cashless payment systems - On Track Innovations has received a new purchase order of 2,000 cashless payment systems from Japan via its partner, Billing Systems Cooperation, a leading payment service provider. The systems include OTI's turnkey solution, which is comprised of a new UNO Plus EMV and FeliCa contactless reader and the GoBox Multi-Service Telemetry Gateway. Once complete, OTI will have delivered a total of 7,000 advanced payment systems to Japan to-date. The company expects the purchase order to be delivered in both the first and second quarter of 2018, for which OTI will recognize a one-time sale, followed by a high-margin, recurring revenue stream over the long-term. Due to confidentiality, the terms of the contract cannot be disclosed.

08:36 EDT On Track Innovations gets new purchase order of 2,000 cashless payment systems - On Track Innovations has received a new purchase order of 2,000 cashless payment systems from Japan via its partner, Billing Systems Cooperation, a leading payment service provider. The systems include OTI's turnkey solution, which is comprised of a new UNO Plus EMV and FeliCa contactless reader and the GoBox Multi-Service Telemetry Gateway. Once complete, OTI will have delivered a total of 7,000 advanced payment systems to Japan to-date.

08:36 EDT RenovaCare notes evidence showing 'predatory' trading practices of FINRA firms

08:35 EDT Aqua Metals announces resignation of CFO Mark Weinswig - Aqua Metals announced that Mark Weinswig, CFO, has resigned from his position at Aqua Metals. Weinswig will continue to assist the company during a transition period. Thomas Murphy, a founder and the former CFO of Aqua Metals, will rejoin Aqua Metals as interim CFO effective March 5, 2018, until a replacement can be found. Murphy has a significant amount of knowledge about the company and its operations.

08:33 EDT Methanex announces 10% share repurchase program - Methanex Corporation announced that its Board of Directors has approved a Normal Course Issuer Bid whereby the Company will purchase for cancellation up to 6,590,095 common shares, representing 10% of the public float at the time of the announcement of the NCIB and the maximum number of Shares that may be purchased under the NCIB. Purchases under the NCIB will commence on March 13, 2018 and end no later than March 12, 2019. Purchases will be made from time to time at the then current market price of the Shares and all Shares purchased will be cancelled. Under the NCIB, up to 4,189,185 Shares, representing 5% of the 83,783,704 Shares issued and outstanding at the time of the announcement of the NCIB, will be purchased on the open market through the facilities of the NASDAQ Global Select Market and alternative trading systems in the United States pursuant to Rule 10b-18 under the U.S. Securities Exchange Act of 1934. The remaining Shares under the NCIB will be purchased on the open market through the facilities of the Toronto Stock Exchange.

08:33 EDT Ameren names Bhavani Amirthalingam as chief digital information officer - Bhavani Amirthalingam has joined Ameren as senior vice president and chief digital information officer. In this newly created role, she will focus on accelerating Ameren's customer-centric digital innovation. Amirthalingam comes to Ameren from Schneider Electric.

08:15 EDT FirstEnergy: Davis-Besse Nuclear Power Station begins maintenance outage - FirstEnergy Nuclear Operating Company, a subsidiary of FirstEnergy Corp., announced its Davis-Besse Nuclear Power Station in Oak Harbor, Ohio, shut down at 12:01 a.m. on Saturday, March 3, for scheduled refueling and maintenance. While the unit is offline, about a third of the unit's 177 fuel assemblies will be replaced. Preventative maintenance and safety inspections to ensure continued safe and reliable operations also will be performed on major components including various pumps, valves, reactor vessel, steam generators, turbine generator and the cooling tower. In total, more than 1,200 work activities will be completed during the refueling outage. More than 1,000 temporary contractor workers and FENOC and FirstEnergy employees will supplement the Davis-Besse workforce during the outage.

08:11 EDT Sorrento Therapeutics says CAR-T cell therapy demonstrates therapeutic activity - Sorrento Therapeutics, cellular therapy focused subsidiary TNK Therapeutics and Surefire Medical announced initial results from the Hepatic ImmunoTherapy for Metastases-Surefire, or HITM-SURE, a Phase 1b single arm trial testing its autologous anti-CEA CAR-T cells administered regionally by hepatic artery infusion via pressure directed microvalve infusion technology in heavily pre-treated patients with refractory CEA-positive liver metastases. This Phase 1b trial follows the HITM and HITM-SIR Phase 1 studies we believe demonstrated the safety and biological activity of the anti-CEA CAR-T administered with hepatic artery infusions alone or with selective internal radiotherapy. The data of HITM-SURE were provided by Dr. Steven Katz, the Principal Investigator of the Study and Associate Professor of Surgery at The Roger Williams Medical Center. The study is also open at Colorado University and funded in part by the Colorado Office for Economic Development and International Trade. In total, three patients have completed the ongoing HITM-SURE protocol, two with stage IV pancreatic cancer and one with colorectal cancer. All patients presented with unresectable, chemotherapy refractory CEA+ liver metastases. Patients received three HAI of anti-CEA CAR-T cells along with low dose IL-2 infusion. CAR-T HAI were administered via a Surefire MVI technology. The primary objective of the study was to establish the safety of the CAR-T HAI with the pressure directed MVI device. Secondary objectives included response assessed by modified RECIST, immune-related response criteria, and tumor marker kinetics. Reduction in post-treatment serum CEA was noted in all patients. Two patients have progressive disease, with a pancreatic cancer patient alive at 7 months and a colorectal cancer patient alive at 4.8 months. A patient with stage IV pancreas adenocarcinoma has no evidence of liver metastases 11 months on PET scan following three CAR-T HAIs. In the phase III MPACT study, treatment of stage IV pancreas adenocarcinoma patients with gemcitabine plus albumin-bound paclitaxel resulted in a median overall survival time of 8.7 months. It will be of interest to determine if the results from upcoming phase 2 liver metastasis HITM studies will confirm the encouraging results from our small number of patients. The initial findings from the currently enrolling HITM-SURE trial follows the results of two other trials. In one of the previous trials, a patient survived 51 months following 3 anti-CEA CAR-T HAIs and a patient from another trial is alive 25 months after treatment.

08:09 EDT Endologix announces treatment of first patient in EVAS system clincal study - Endologixs announced that the first patient was treated in the EVAS2 IDE confirmatory clinical study of the investigational Nellix EndoVascular Aneurysm Sealing, or EVAS, System by Sajjad Hussai, Chief of the Department of Vascular Surgery at St. Vincent Health and St. Vincent Heart Center of Indiana. The Nellix System is an endovascular abdominal aortic aneurysm therapy designed to seal the entire aneurysm. Nellix is the first and only EVAS product developed as an alternative treatment approach to traditional EVAR devices. The Nellix System has received a CE Mark and is commercially available in many markets, including the EU. EVAS2 is an IDE-approved confirmatory clinical study, which is designed to evaluate the safety and effectiveness of the second-generation Nellix System and the refined Indications for use. The study is approved to enroll up to 90 primary patients at 28 U.S. centers, with one-year follow-up data required for the pre-market approval application.

08:09 EDT Benitec Biopharma starts Phase 2 clinical study of BB-401 in Australia - Benitec Biopharma announced the start of its Phase 2 clinical study in Australia with BB-401 as a treatment for patients with head and neck squamous cell carcinoma. The Phase 2 open label study has been designed to explore the safety, tolerability and efficacy of BB-401 following intratumoral injections into the lesions of patients with recurrent or metastatic HNSCC. The study will enrol up to 30 patients at 5-8 sites across Australia and Russia.

08:07 EDT Dermira expects to discontinue olumacostat glasaretil Phase 3 program - "We are continuing to analyze the outcome of the olumacostat glasaretil Phase 3 program. However, based on the information we have to date, we expect to discontinue the development program," said Luis Pena, chief development officer of Dermira. "We want to thank our employees, investigators and partners for their commitments to the acne development program and, most importantly, the patients who participated in these trials."

08:06 EDT Trovagene: First patient treated in Phase 1b/2 multicenter trial of PCM-075 - Trovagene announced that the initial patient successfully completed the first cycle 1 of treatment in its Phase 1b/2 multicenter trial of PCM-075 in combination with low-dose cytarabine in patients with Acute Myeloid Leukemia . The patient tolerated the combination well and correlative analyses of blood samples, taken at specified time points, also indicated activity on leukemic blood cells. A significant decrease in the percentage of blood leukemic cells was observed within 24 hours of administering PCM-075 + LDAC. By day 15, within the treatment cycle, the greatest effect was observed with blood leukemic cells showing a decrease from greater than 40% to less than 5%. Additionally, the same tumor DNA mutations (ASXL1 and SRSF2) were detected in the bone marrow and blood, indicating consistency across samples and validity of the analyses. Both DNA mutations appeared to quantitatively track with the decrease in blood leukemic cells.

08:05 EDT Orthofix publishes new data on PEMF stimulation study - Orthofix announced the publication of new data in Bone & Joint Research from a study evaluating the effect of pulsed electromagnetic field, or PEMF treatment for patients who have an increased risk for pseudoarthrosis after anterior cervical discectomy and fusion, or ACDF, procedures. Study findings showed that after ACDF surgery, use of PEMF stimulation significantly increased the fusion rate relative to the control group at six and 12 months for participants who were at risk for pseudoarthrosis.1 Participants included patients who had a risk factor that could impair their cervical spine fusion success; or they had a risk factor and received at least a two- or three-level arthrodesis.The evaluations were conducted with historical data from Orthofix's prospective, randomized, multicenter FDA investigational device exemption PMA study of 323 patients conducted in 2014 and a new multicenter, retrospective cohort study consisting of 274 patients enrolled at three institutions. In the new study, participants were required to have one or more risk factors for pseudoarthrosis. All patients were treated with PEMF following ACDF surgery. The primary endpoint was fusion at six and 12 months as determined by the presence of continuous bridging bone on plain films as assessed by the treating surgeon.

08:04 EDT ReShape Lifesciences announces publication of results from ReShape Balloon study - ReShape Lifesciences announced that results from a study examining real-world safety and efficacy of the ReShape Balloon were published in the February issue of The Journal of Clinical Gastroenterology and Hepatology. The publication, titled "Real-world Safety and Efficacy of Fluid-Filled Dual Intra-Gastric Balloon for Weight Loss" discusses a retrospective, physician-sponsored study of data collected on 202 adults at two academic centers and five private practices in which all patients paid for the ReShape Balloon procedure and follow-up visits out of pocket. All patients had the ReShape Balloon inserted for weight loss therapy and the Balloon was removed from each patient after six months. Patients also received counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss and percent excess weight loss at one, three, six, nine and twelve months after the procedure. Mean %TBWL was 11.4% and 14.7% at six and twelve months, respectively. 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Study investigators concluded that the ReShape Balloon is a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at six months.

08:02 EDT Farmer Bros. receives Safe Quality Food Certification - Farmer Bros. announced that its state-of-the-art Northlake, Texas facility has received Safe Quality Food Certification. Required by many of Farmer Brothers' national customers, SQF Certification marks an important step that will allow Farmer Brothers the production platform to significantly increase volume for national customers as needed.

08:02 EDT Centene to acquire Community Medical Group - Centene announced that it has signed a definitive agreement to acquire Community Medical Holdings Corp., dba Community Medical Group, a leading, at-risk primary care provider, serving over 70,000 Medicaid, Medicare Advantage, and Health Insurance Marketplace program patients in Miami-Dade County, Florida. Under the terms of the purchase agreement, Centene has the ability to fund the purchase with cash, or alternatively, a combination of cash and Centene stock. The transaction is expected to have a neutral impact to GAAP and adjusted EPS in 2018 and to be slightly accretive (low single digits) to GAAP and adjusted EPS in 2019. The transaction is expected to close in the first quarter of 2018, subject to the expiration or termination of the applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions.

07:55 EDT Dermira trading halted, news pending

07:46 EDT Netflix confirms last season of 'House of Cards' to be released Fall 2018 - Reference Link

07:38 EDT Computer Services to give FT employees a one-time $1,300 cash bonus in March - As a result of the reduced corporate tax rate effective with the Tax Cuts & Jobs Act, Computer Services is using its financial savings to reinvest in its employees and infrastructure. Recognizing the opportunity brought about by the TCJA, CSI is investing a portion of its corporate tax savings with its employees. Non-executive full-time employees with the company more than 12 months will receive a one-time $1,300 cash bonus in March. Part-time and other employees with the company less than 12 months will receive a one-time cash bonus of $650 also in March. The company also stated that all eligible employees will receive an additional one-time contribution to their retirement plan. The company also plans to ramp up its investments in infrastructure and facilities in fiscal 2019 just underway. CSI expects to pursue additional stock repurchases as well. The capital expenditures and stock repurchases are expected to be funded by CSI's strong cash flow and tax savings.

07:36 EDT Sparton: DOJ intends to open investigation evaluating ERAPSCO JV

07:36 EDT Sparton and Ultra terminate merger agreement - During the review of the proposed merger by the United States Department of Justice, or DOJ, the United States Navy expressed the view that instead of the parties proceeding with the merger, each of Sparton and Ultra should enhance its ability to independently develop, produce and sell sonobuoys and over time work toward the elimination of their use of Sparton's and Ultra's ERAPSCO joint venture for such activities. The staff of the DOJ then informed Sparton and Ultra that it intended to recommend that the DOJ block the merger. The parties expected that the DOJ would follow this recommendation and seek an injunction in court to block the merger. As a result of the view of the Navy and the position of the DOJ, Sparton and Ultra determined that it was in the best interests of the parties to proceed to terminate the merger agreement. Sparton and Ultra also understand that the DOJ intends to open an investigation for purposes of evaluating the parties' ERAPSCO joint venture. Based on historical practice, Sparton anticipates that the Navy will assist in funding Sparton's transition to independently developing, producing and selling sonobuoys. In addition, as a result of the termination of the merger agreement with Ultra, Sparton will seek to re-engage with parties that previously expressed an interest in acquiring all or a part of Sparton and that are in a position to expeditiously proceed to effect such a transaction. There can be no assurance that any such transaction will occur.

07:36 EDT Sparton: DOJ staff intended to recommend DOJ block Sparton, Ultra merger

07:34 EDT Celgene sees Juno Therapeutics merger closing in the coming days - Following completion of the merger, Juno's common stock will cease to be traded on the NASDAQ Global Select Market.

07:33 EDT Celgene reports expiration of cash tender offer for Juno Therapeutics shares - Celgene Corporation (CELG) announced that its tender offer to purchase any and all issued and outstanding shares of common stock of Juno Therapeutics (JUNO) at a price of $87.00 per share, net to the seller in cash, without interest and less required withholding taxes, expired at 12:00 midnight Edo T, at the end of the day on Friday, March 2.The depositary for the tender offer has advised that, as of the expiration of the tender offer, a total of approximately 90,730,558 shares were validly tendered and not withdrawn in the tender offer, representing approximately 78% of Juno's outstanding shares or approximately 88% of Juno's outstanding shares including the Juno shares already owned by Celgene. Celgene's wholly owned subsidiary will accept for payment all shares that were validly tendered and not withdrawn prior to expiration of the tender offer, and payment for such shares will be made promptly, in accordance with the terms of the tender offer. Celgene expects the merger to close in the coming days, with Juno becoming a wholly owned subsidiary of Celgene.

07:31 EDT Sparton announces termination of merger agreement with Ultra Electronics

07:17 EDT GTx Phase 2 trial of enobosarm meets primary endpoint - GTx announced additional results from a Phase 2 proof-of-concept clinical trial of 3 mg enobosarm administered orally in postmenopausal women with stress urinary incontinence, or SUI, including magnetic resonance imaging, or MRI results from patients' pelvic floor muscle. New data in a subset of women also suggests a positive treatment effect of enobosarm for urge incontinence, or UI, suggesting a possible treatment effect for women with mixed incontinence. Results from a pre-specified analysis of MRI data demonstrate a statistically significant increase in pelvic floor muscle thickness and urethral muscle diameter after enobosarm treatment. Treatment with enobosarm also reduced mean UI episodes by approximately 68 percent in patients who experienced UI as well as SUI, based on a post hoc analysis of a subset of women with both UI and SUI. These results were outlined during a podium presentation which took place at the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction. The presentation included clinical data from all 18 patients completing 12 weeks of enobosarm treatment, which, as previously reported, demonstrated an 81% reduction in the number of mean stress leaks per day, the primary endpoint of the clinical trial, as well as additional data demonstrating duration of response following completion of treatment, including nine patients who have now reached seven months post-treatment. MRI was used to quantitatively measure muscle in the pelvic floor of 17 women at 12 weeks compared to their baseline. The results showed a statistically significant increase in several important measurements and support the mechanism of action of enobosarm on the pelvic floor. While all of the women in the trial had predominant SUI, some also experienced urge incontinence. Eleven of the 18 women completing 12 weeks of treatment were determined to have both SUI and UI at baseline, and these 11 women with mixed incontinence demonstrated a mean reduction in their UI episodes of approximately 68%. Consistent with previous findings, at the end of the 12-week treatment period, all of the 18 enobosarm-treated women showed a clinically meaningful reduction in stress urinary incontinence episodes per day. The reduction in incontinence episodes was sustained, or durable, well beyond the 12-week treatment period. There were no serious adverse events reported and reported adverse events were minimal and included headaches, nausea, fatigue, hot flashes, insomnia, muscle weakness and acne. Mild transient elevations in liver enzymes that were within normal limits were observed, except for one patient with levels greater than 1.5 times the upper limit of normal which returned to normal following her 12-week treatment period. Reductions in total cholesterol, LDL-C, HDL-C and triglycerides were also observed.

07:09 EDT AstraZeneca reports EMA accepts regulatory submission for Forxiga - AstraZeneca announced that the European Medicines Agency has accepted the Marketing Authorization Variation for Forxiga, a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes. Forxiga has the potential to become the first selective SGLT-2 inhibitor approved in Europe for the treatment of T1D as an oral treatment adjunct to insulin, helping to address a significant unmet need in this patient population. Forxiga is not currently licensed for use in T1D, the company stated.

07:07 EDT Americas Silver reports silver production for 2017 of 2.1M silver ounces - Consolidated year-end production was approximately 2.1 million silver ounces and 4.7 million silver equivalent ounces at cost of sales of $10.13 per silver equivalent ounce, by-product cash costs3 of $9.45 per silver ounce, and all-in sustaining costs of $13.29 per silver ounce. Consolidated fourth quarter production was approximately 400,000 silver ounces and 1.4 million silver equivalent ounces at cost of sales of $10.16 per silver equivalent ounce, by-product cash costs of $8.75 per silver ounce, and all-in sustaining costs of $14.20 per silver ounce.

07:06 EDT Oceaneering acquires Ecosse Subsea Limited for approximately GBP50M - Oceaneering announced that one of its wholly owned subsidiaries has acquired Ecosse Subsea Limited, a provider of offshore engineering, seabed preparation, route clearance and trenching services to the renewable energy and oil and gas industries, for approximately GBP50M. Oceaneering intends to report the future financial results of Ecosse through Oceaneering's Subsea Projects segment.

07:04 EDT Ply Gem sees acquisition by CD&R closing during Q2 - "On January 31, 2018, Ply Gem entered into a definitive agreement under which Clayton, Dubilier & Rice will acquire Ply Gem for $21.64 per share in cash, representing a go-private transaction valued at approximately $2.4B," said Gary E. Robinette, Ply Gem's Chairman and CEO. "CD&R also entered into a definitive agreement to acquire Atrium Windows & Doors with the intent of combining Atrium with Ply Gem. The expectation is these two acquisitions will close during the second quarter of 2018, and we believe the new Ply Gem will continue to provide our customers with exceptional value and service while generating long-term growth and value creation for the shareholders of the new combined company." Robinette continued, "In light of the CD&R transaction, Ply Gem will not be holding a quarterly earnings call in conjunction with today's release."

07:03 EDT Vanda: HETLIOZ demonstrates 'significant benefits' in symptoms of jet lag - Vanda announced that HETLIOZ, a circadian regulator, demonstrated significant and clinically meaningful benefits in nighttime and daytime symptoms of jet lag disorder. HETLIOZ is currently approved in the US and Europe for the treatment of Non-24-hour sleep-wake disorder, a rare and chronic circadian rhythm sleep disorder. The clinical efficacy results reported today are from the JET8 Phase-III clinical study. Results from the JET8 study showed significant and clinically meaningful effects of HETLIOZ 20 mg on the primary endpoint of the study as well as multiple secondary endpoints. The pre-specified primary endpoint was the amount of sleep time in the first two thirds of the night. Secondary endpoints included measures of sleep parameters and next day alertness.

07:03 EDT CCUR Holdings announces share repurchase program - CCUR Holdings announced today that its board approved a stock repurchase program that will enable the company to repurchase up to 1M shares of its common stock.

07:03 EDT Clearside Biomedical announces 'positive' topline results in CLS-TA trial - Clearside Biomedical announced positive topline results from its pivotal Phase 3 clinical trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis. Suprachoroidal CLS-TA is Clearside's proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS, which is the space located between the choroid and the outer protective layer of the eye known as the sclera. Clearside enrolled 160 patients in this randomized, controlled, masked Phase 3 pivotal clinical trial. Of the 160 patients enrolled, 96 patients were randomized to the treatment arm to receive two 4.0 mg doses of suprachoroidal CLS-TA 12 weeks apart, and 64 patients were randomized to undergo sham procedures at the same 12-week interval. Patients were evaluated every four weeks for a total of 24 weeks, and a total of 155 patients, or 97% of those enrolled, completed the full evaluation period of the trial. In the PEACHTREE trial, 47% of patients who received suprachoroidal CLS-TA every 12 weeks gained at least 15 letters in best corrected visual acuity, as measured using the Early Treatment of Diabetic Retinopathy Study scale, from baseline at week 24, compared to 16% of patients who underwent a sham procedure. This improvement, which was the primary endpoint of the trial, was statistically significant. Further, in terms of improvements in BCVA, the mean change from baseline was better in the treatment arm than the sham arm at each monthly evaluation. The mean improvement from baseline was maintained throughout the evaluation period, with 9.6 letters gained at week 4 and 13.7 letters at week 24 in the active arm, compared to 1.2 letters at week 4 and 2.9 letters at week 24 in the control arm, respectively. For the other key secondary endpoint, administration of suprachoroidal CLS-TA resulted in a mean reduction from baseline of 157 microns in central subfield thickness at week 24 in the active arm compared to a 19 micron mean reduction in the sham arm, a result that was also statistically significant. Suprachoroidal CLS-TA was generally well tolerated, with no treatment-related serious adverse events reported in the trial. Through 24 weeks, corticosteroid-related elevated intraocular pressure adverse events were reported for approximately 11.5% of patients in the CLS-TA treatment group, compared to no patients in the sham group.

07:02 EDT CCUR Holdings receives Nasdaq listing extension - CCUR Holdings announced that it received an extension for continued listing on The Nasdaq Stock Market through May 15, 2018 to demonstrate to the Nasdaq that the company is not a "public shell" and therefor its continued listing is warranted. During the extension, the company's common stock will continue to be traded on the NASDAQ. While the company continues to evaluate options to maximize the value of its remaining assets, including identifying potential opportunities to invest in or acquire one or more operating businesses that could provide opportunities for appreciation in value, there can be no assurance that the company will be able to demonstrate to the Nasdaq within the 90-day period that it is not a "public shell." Therefore, the company's common stock may be delisted at the end of the 90-day extension.

06:48 EDT Corindus receives FDA 510(k) clearance for 'Rotate on Retract' - Corindus Vascular Robotics announced that it received 510(k) clearance from the U.S. FDA for the first automated robotic movement designed for the CorPath GRX platform. The proprietary software feature, named "Rotate on Retract," is the first automated robotic movement in the technIQ Series for the CorPath GRX platform. It allows the operator to quickly navigate to a targeted lesion by automatically rotating the guidewire upon joystick retraction. Preclinical data presented at the Transcatheter Cardiovascular Therapeutics Conference in October 2017 demonstrated a significant reduction in wiring time among a highly-experienced group of physicians when comparing robotic wiring versus robotic wiring with RoR enabled.

06:33 EDT Nightstar Therapeutics initiates STAR Phase 3 registrational trial for NSR-REP1 - Nightstar Therapeutics announced the initiation of the company's STAR Phase 3 registrational trial to study the safety and efficacy of NSR-REP1 in patients with choroideremia. In data from 32 patients treated with NSR-REP1 across four open-label Phase 1/2 clinical trials, over 90% of treated patients maintained or improved their visual acuity over a one-year follow-up period.

06:31 EDT Axalta Coating acquires manufacturing, distribution facility in Sacramento, CA - Axalta announced that it has acquired a state of the art manufacturing and distribution facility in Sacramento, CA to support growth in its North American Industrial and Refinish businesses. Financial terms of the transaction were not disclosed. The 150,000 square foot facility has production capacity of more than 15M gallons. Axalta will continue to produce products at the site for its Industrial Wood Coatings business and, over time, will expand production to include products for both its Industrial and Refinish coatings businesses.

06:18 EDT Airbus to meet with European Works Council on March 7 - Senior management representatives of Airbus will meet with the European Works Council on March 7 to explain previously announced rate reductions on the A380 and A400M programs and to discuss associated implications for the workforce. Airbus has a policy of first addressing workforce issues with its social partners before any public disclosure. The company will continue to abide by this policy. Airbus deeply regrets that the process on the current subject matter has been disturbed by leaks to the media, which resulted in excessive reporting about alleged job cuts in its four home countries. Airbus is committed to managing any social implications in a responsible manner and has demonstrated its ability to find the best possible solutions for its workforce on various occasions in the past. Only after its initial meeting with the European Works Council on March 7, Airbus will provide further details on the company's plans and considerations.

06:11 EDT Starboard issues statement to Newell Brands holders - Starboard Value, a significant shareholder of Newell Brands, which together with the other participants in its solicitation beneficially owns approximately 4% of the company's outstanding shares, announced that it has issued a public letter to the company's shareholders. In the letter, Starboard reiterated its serious concerns with the company's significant underperformance under the current leadership team, which concerns were exacerbated by the recent resignation of yet another Newell director. Starboard also announced that it has nominated two additional director candidates, Bridget Ryan Berman and Robert A. Steele, for election to the board at the company's 2018 Annual Meeting of Stockholders in response to Newell's unilateral expansion of the Board.

06:07 EDT G1 Therapeutics announces data from Phase 2a trial of trilaciclib - G1 Therapeutics announced positive topline data from its Phase 2a trial evaluating trilaciclib in patients undergoing chemotherapy for first-line small cell lung cancer, or SCLC. Trilaciclib is a potential first-in-class short-acting CDK4/6 inhibitor in development to preserve hematopoietic stem cells and enhance immune system function during chemotherapy. This double-blind, placebo-controlled trial enrolled participants with a confirmed diagnosis of extensive-stage SCLC. The trial randomized 77 treatment-naive participants in a 1:1 ratio, and 75 received trilaciclib or placebo administered intravenously prior to each dose of standard-of-care etoposide and carboplatin chemotherapy. Participants in both arms of the trial were able to receive standard supportive care as recommended by the trial investigator. Growth factors, including granulocyte colony-stimulating factor and erythropoietin, and transfusion support were available to all participants. The statistical analysis plan prospectively defined several clinically-relevant hematologic endpoints. Data from this signal-generating Phase 2a trial demonstrated that trilaciclib reduced clinically relevant consequences of chemotherapy-induced myelosuppression versus placebo. Trilaciclib was well tolerated, with no Grade 3/4 trilaciclib-related treatment emergent adverse events reported. Baseline demographics and disease characteristics were generally well balanced between the two arms. The company plans to share these data with U.S. and European regulatory authorities this year and discuss next steps for the development of trilaciclib. The company also plans to present results from this trial, including updated data from the Phase 1b portion, at a medical meeting later this year.

06:06 EDT Armada Hoffler board approves corporate governance enhancements - Armada Hoffler Properties announced that its Board of Directors unanimously approved and adopted the following corporate governance enhancements: Majority Voting Standard in Uncontested Director Elections - In an uncontested election, each director nominee is now required to receive a majority of the votes cast in order to be elected to the Board. For contested elections, directors will continue to be elected by a plurality of the votes cast. Stockholder Right to Amend the Bylaws - The company's stockholders will now have the concurrent right with the Board to amend the Bylaws, subject to certain conditions.

06:02 EDT G1 Therapeutics announces 'positive' Trilaciclib Phase 2a data - G1 Therapeutics announced positive topline data from its Phase 2a trial evaluating trilaciclib in patients undergoing chemotherapy for first-line small cell lung cancer. Trilaciclib is a potential first-in-class short-acting CDK4/6 inhibitor in development to preserve hematopoietic stem cells and enhance immune system function during chemotherapy. "The data from this trial showed clear evidence that trilaciclib preserved bone marrow and immune system function from the damaging effects of chemotherapy," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. "Moreover, the myelopreservation effects demonstrated by trilaciclib improved patient outcomes. Chemotherapy continues to be a cornerstone of cancer treatment, and trilaciclib has the potential to benefit many of these patients." Data from this signal-generating Phase 2a trial demonstrated that trilaciclib reduced clinically relevant consequences of chemotherapy-induced myelosuppression versus placebo. Trilaciclib was well tolerated, with no Grade 3/4 trilaciclib-related treatment emergent adverse events reported. Baseline demographics and disease characteristics were generally well balanced between the two arms. The trilaciclib arm also showed favorable trends with reduced Grade 3 anemia, red blood cell transfusions, and Grade 3 thrombocytopenia versus placebo. There was no Grade 4 anemia or thrombocytopenia in either arm. In addition to demonstrating myelopreservation benefits across multiple hematopoietic lineages, trilaciclib showed favorable trends versus placebo for overall response rate (ORR), duration of response, and progression free survival. The survival data are still immature.

05:46 EDT Jianpu Technology announces strategic investment - Jianpu Technology announced that it has signed a definitive agreement to acquire 65% of equity interests in a China-based technology company specializing in optimizing data-driven risk management decisions. The target company offers a suite of products and services helping financial service providers to enhance their risk management capabilities by aggregating and analyzing a wide range of data sources using machine learning and AI technology. The consideration of the transaction is in the form of a combination of cash, ordinary shares of the company and options to purchase the company's ordinary shares. The cash portion of the consideration is approximately RMB 110M. The non-cash portion of the consideration will represent approximately 1.5% of the issued and outstanding share capital of the company after giving effect to the issuance. The transaction is expected to close in the second quarter of 2018, subject to the satisfaction of customary closing conditions.

05:38 EDT Anadarko announces approval of Mozambique LNG development plan - Anadarko Petroleum announced it has received official approval from the Government of Mozambique for the Golfinho/Atum Field Development Plan. The Development Plan outlines the integrated onshore project from the reservoir to the LNG market and is a culmination of the substantial progress made to date on the technical and commercial aspects of the Anadarko-operated Mozambique LNG development. The Mozambique LNG project will be Mozambique's first onshore LNG development, initially consisting of two LNG trains with total nameplate capacity of 12.88 MTPA to support the development of the Golfinho/Atum fields located entirely within Offshore Area 1. This foundational project paves the way for significant future expansion of up to 50 MTPA from Offshore Area 1. The Golfinho/Atum Project will also supply initial volumes of approximately 100 million cubic feet of natural gas per day for domestic use in Mozambique.

05:32 EDT XL Group to be acquired by AXA for $57.60 per share - AXA announced that it has entered into an agreement to acquire 100% of XL Group. The merger agreement has been unanimously approved by the boards of AXA and XL Group. Total consideration for the acquisition would amount to $15.3B, to be fully paid in cash. Under the terms of the transaction, XL Group shareholders will receive $57.60 per share. This represents a premium of 33% to XL Group closing share price on March 2, 2018. The opportunity to acquire XL Group has led AXA to review its exit strategy from its existing U.S. operations which AXA now expects to accelerate. Together with the planned IPO of AXA's US operations, expected in 1H 2018 subject to market conditions, and intended subsequent sell-downs, this transaction would gear AXA further towards technical margins less sensitive to financial markets. The strong complementarities between AXA and XL Group provides opportunities for significant value creation, offsetting the planned US IPO earnings dilution as soon as 2018. It also allows for material capital diversification benefits under the Solvency II framework and a strong return on investment. In this context, AXA also reaffirmed its Ambition 2020 targets.