Stockwinners Market Radar for September 13, 2019 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:57 EDT DBV Technologies falls 2% after FDA panel votes in favor of Aimmune drug

17:39 EDT Zayo Group CEO sells 1M common shares - In a regulatory filing, Zayo CEO Daniel Caruso disclosed the sale of 1M common shares of the company on September 11 at a price of $33.78 per share.

17:22 EDT Disney CEO Bob Iger resigns from Apple board of directors - In a regulatory filing, Apple (AAPL) disclosed that on September 10, Disney (DIS) CEO Bob Iger resigned from the board of Apple.

17:17 EDT Raytheon awarded $427.3M Army procurement contract - Raytheon was awarded a $427.3M contract for procurement of common sensor payload systems, spare parts and engineering and system support services. One bid was were solicited with one bid received. Work locations and funding will be determined with each order, with an estimated completion date of September 12, 2024. U.S. Army Contracting Command is the contracting activity.

16:44 EDT Cardlytics CEO sells 250K shares and COO sells 200K shares of common stock - In a regulatory filing, Cardlytics disclosed that its CEO Scott Grimes sold 250K shares of common stock on September 13th. The total transaction size was $8.08M. The company's COO Marie Laube sold 200K shares of common stock on September 13th. The total transaction size was $6.46M.

16:34 EDT FDA panel votes 8-1 saying Aimmune peanut allergy drug Palforzia is safe - A panel of FDA advisers said the safety of Aimmune's drug Palforzia, or AR101, supports approval, according to multiple sources.

16:28 EDT Viper Energy to acquire interest from Santa Elena Minerals for 5.2M units - Viper Energy (VNOM), a subsidiary of Diamondback Energy (FANG) announced it has entered into a definitive purchase and sale agreement to acquire certain mineral and royalty interests from Santa Elena Minerals for approximately 5.2M common units representing limited partner interests in Viper, subject to certain adjustments. The transaction is valued at $150M and will have an effective date of October 1 with closing anticipated in Q4, subject to continued diligence and closing conditions. The transaction includes 1,358 net royalty acres across two ranches primarily in Glasscock and Martin counties; over 65% of acreage is operated by Diamondback. Acreage has a 5.6% average NRI that will provide concentrated exposure to contiguous leasehold which Diamondback plans to actively develop. Combined Q2 production of 1,400 boepd with multiple years of active development ahead on current Diamondback drilling and completion schedules; further upside provided by third-party operators not included in underwriting assumptions. Assuming no purchase price adjustments, Viper will issue common units to Santa Elena valued at $150M based on the $29.02 volume weighted average sales price of common units for the five-trading day period ended September 5, or approximately 5.2M common units. The effective date is October 1 with anticipated closing in Q4, subject to continued diligence and closing conditions. At closing, Viper will issue to Santa Elena common units as consideration for the assets, and Viper Energy Partners LLC, Viper's operating subsidiary will issue to Viper an equal number of new units of the operating company, in each case in a number equal to the quotient of $150M divided by $29.02, which represents the volume weighted average sale price as traded on Nasdaq of the common units calculated for the five-trading day period ended September 5. With respect to the common units it receives under the purchase and sale agreement, Santa Elena has agreed to waive its right to receive any distributions for which the record date falls in Q4. Santa Elena has also agreed to a restriction on transfer, sale, pledging, hedging and certain other transactions in the common units it receives in the pending acquisition, subject to certain limited exceptions, during a period beginning on the closing date of the pending acquisition and ending on the 180 day after such closing. Viper has granted to Santa Elena certain piggyback registration rights during the restricted period. The common units will be issued in reliance upon the exemption from the registration requirements of the Securities Act of 1933, as amended, provided by Section 4 of the Securities Act as sales by an issuer not involving any public offering.

16:21 EDT McClatchy discloses NYSE listing compliance notice - McClatchy announced that on September 9, 2019, it received a notice from NYSE indicating that the company is not currently in compliance with certain listing standards, and has approximately 18 months to become compliant under a plan that is subject to approval by NYSE American. McClatchy is below compliance with Sections 1003(a)(i) and 1003(a)(ii) of the NYSE American continued listing standards since it reported stockholders' deficit of $372.5 million as of June 30, 2019 and net losses in each of the four most recent fiscal years ended December 30, 2018. The company intends to submit a plan to NYSE American by October 9, 2019 advising how the company plans to regain compliance with the continued listing standards by March 9, 2021.

16:16 EDT Noble Corp CFO Adam Peakes resigned effective September 9th - Noble Corp announced that Adam Peakes, Senior Vice President and CFO resigned effective September 9, 2019. A search for Mr. Peakes' replacement has begun. In the interim, Mr. Peakes' direct reports, including those individuals responsible for the company's Treasury and Financial Reporting activities, will report directly to Julie J. Robertson, Chairman, President and CEO of Noble Corporation plc.

16:01 EDT Hancock Whitney gets regulatory approval to acquire MidSouth - Hancock Whitney (HWC) has received regulatory approval from the Federal Reserve System, the Federal Deposit Insurance Corporation, and the Mississippi Department of Banking and Consumer Finance to complete its previously announced proposed acquisition of MidSouth Bancorp (MSL), parent company of MidSouth Bank N.A. The proposed acquisition was announced on April 30, 2019, is expected to close on or about September 20, 2019, and remains subject to approval by MidSouth's shareholders at a special meeting scheduled for September 18, 2019 and other customary closing conditions.

16:00 EDT Xynomic Pharmaceuticals doses first patient in phase 3 kidney cancer trial - Xynomic Pharmaceuticals Holdings announced the dosing of the first Chinese patient in its on-going global pivotal Phase 3 trial of Xynomic's abexinostat combined with pazopanib as a first- or second-line therapy against renal cell carcinoma at Peking University Cancer Hospital & Institute. A global randomized pivotal Phase 3 trial is underway of abexinostat + pazopanib as a first- or second-line therapy in patients with locally advanced or metastatic RCC. Currently, this trial is being conducted in the United States, Europe and South Korea. The U.S. Food and Drug Administration has granted Fast Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of RCC in Q1 of 2019.

13:17 EDT Curaleaf Holdings reports approval for five adult-use licenses in Massachusetts - Curaleaf Holdings announced that it was granted approval for its three final and two provisional adult-use licenses by the Massachusetts Cannabis Control Commission. "Following today's approval of all five licenses, the next step in the process is to schedule Post Final inspections for the three final licenses, which will then be followed by Commence Operation inspections. The process is expected to be completed in the coming months," the company stated.

13:12 EDT Walmart announces opening of 'first-ever' Walmart Health Center - Walmart, in a post to its corporate site, announced that "families in the Dallas, Georgia, area can now experience a remodeled Walmart Supercenter that's offering customers new ways to save money, while living better -and healthier- lives. Located at 3615 Marietta Hwy., the community will celebrate the new store features during a grand opening Friday, Sept. 13, along with the opening of the first-ever Walmart Health center...By partnering with local providers, the new Walmart Health center will deliver services including primary care, labs, X-ray and EKG, counseling, dental, optical, hearing, community health (nutritional services, fitness) and health insurance education and enrollment all in one facility, conveniently located outside the store with a separate entrance for customers. The clinic will provide low, transparent pricing for key health services for local families, regardless of insurance status." Reference Link

12:55 EDT Bleichroeder reports 13.59% passive stake in Cassava Sciences - In a regulatory filing, Bleichroeder LP disclosed a 13.59% stake in Cassava Sciences, which represents about 2.4M shares. The filing does not allow for activism.

12:01 EDT Cars.com subsidiary announces OEM agreement with General Motors - Dealer Inspire, a Cars.com (CARS) company, announced a new OEM agreement with General Motors (GM). The company has been selected as a website provider for GM's more than 4,000 U.S.-based Chevrolet, Buick, GMC, and Cadillac dealerships.

12:00 EDT Telaria falls -11.5% - Telaria is down -11.5%, or -$1.07 to $8.20.

12:00 EDT Owens & Minor falls -13.6% - Owens & Minor is down -13.6%, or -97c to $6.13.

12:00 EDT Medallia rises 20.3% - Medallia is up 20.3%, or $5.34 to $31.60.

11:47 EDT CBR acquires Evercord newborn stem cell business from Natera - Natera and CBR -- Cord Blood Registry -- announced the acquisition by CBR, a California Cryobank Life Sciences company, of Natera's Evercord cord blood and tissue banking business. "This divestiture will allow Natera to focus squarely on its core genetic testing business in reproductive health, oncology and organ transplantation," said Steve Chapman, Natera's CEO. "We are proud of what we've accomplished with Evercord and believe that CBR, as the recognized industry leader in newborn stem cells, is the best partner for cord blood services moving forward." CBR will work closely with Natera to ensure a smooth transition for customers and ordering clinics. Convergence Healthcare Advisors LLC served as exclusive strategic advisor to Natera, Inc. on the sale of the Evercord business.

11:13 EDT Lumber Liquidators founder reduces stake, believes stock no longer undervalued - In a regulatory filing, Thomas Sullivan of F9 Investments, the founder of Lumber Liquidators, disclosed that on trade dates September 11 and 12, he sold shares of the company common stock and the beneficially owned options contracts exclusively on the open market, lowering his stake in the company to 1.61%, or 461,895 shares. Sullivan "previously wanted to explore various options and to propose transactions," but "due to the significant price appreciation of the stock price since the initial Schedule 13D was filed, [Sullivan], as of September 11, 2019, believes that the common stock is no longer undervalued. Furthermore, discussion regarding potential actions...are now less prudent at these elevated levels. [He] reserves the right to revisit potential options and propose transactions at a later time," the filing stated. Earlier, in an interview, Sullivan told Bloomberg that he will not seek a buyout of the company after the price "got too high."

11:05 EDT ORIX Corp appoints Yoshiteru Suzuki as president, CEO - ORIX Corporation announced that Yoshiteru Suzuki will become the company's next president and CEO, effective Sept. 15, 2019. Suzuki succeeds current President and CEO, Hideto Nishitani, who will return to the Tokyo headquarters of ORIX Corporation to assume a new role assistant to the CEO of ORIX. The transition is a carefully planned succession that follows Suzuki's promotion to Executive Officer for ORIX and Deputy President of ORIX USA in 2018 and Managing Executive Officer for ORIX earlier this year.

10:34 EDT Lumber Liquidators sinks after founder says he won't seek buyout - Lumber Liquidators shares moved lower after its founder Tom Sullivan told Bloomberg in an interview that he will not seek a buyout of the company. The stock in morning trading is down 12% to $9.85. Sullivan said that while he will "keep watching the situation," the price of the company "got too high." Sullivan also said that he plans to sell some of his shares in the flooring retailer he founded.

10:00 EDT Parker Drilling falls -5.6% - Parker Drilling is down -5.6%, or -$1.23 to $20.78.

10:00 EDT Telaria falls -7.1% - Telaria is down -7.1%, or -66c to $8.62.

10:00 EDT Mallinckrodt rises 12.5% - Mallinckrodt is up 12.5%, or 37c to $3.36.

09:55 EDT FDA opens probe into ranitidine medicines after finding carcinogen traces - The Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine at low levels, the agency said in a statement. Zantac is marketed by Chattem, a Sanofi company. NDMA is classified as a probable human carcinogen, or a substance that could cause cancer, based on results from laboratory tests, the FDA added. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables, it adds. The FDA said, "The agency is working with international regulators and industry partners to determine the source of this impurity in ranitidine. The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation. The agency will provide more information as it becomes available." The European Medicines Agency also announced this morning in investigation into some ranitidine medicines. Reference Link

09:47 EDT McDermott falls -3.8% - McDermott is down -3.8%, or -23c to $5.89.

09:47 EDT Telaria falls -9.2% - Telaria is down -9.2%, or -86c to $8.41.

09:47 EDT Mallinckrodt rises 10.8% - Mallinckrodt is up 10.8%, or 32c to $3.31.

09:45 EDT Genmab reports Phase 3 CANDOR study met primary endpoint - Genmab A/S (GMAB) announced topline results from the Phase 3 CANDOR study, sponsored by Amgen (AMGN), of daratumumab in combination with carfilzomib and dexamethasone versus Kd alone in patients with multiple myeloma who have relapsed after one to three prior therapies. The study met the primary endpoint of improving progression free survival. The regimen resulted in a 37% reduction in the risk of progression or death in patients with relapsed or refractory multiple myeloma treated with daratumumab in combination with Kd. The median PFS for patients treated with daratumumab in combination with Kd had not been reached by the cut-off date compared to a median PFS of 15.8 months for patients who received Kd alone. There was a higher frequency of adverse events reported with daratumumab plus Kd, a three-agent regimen, than with Kd, a two-agent regimen. The types of observed adverse events were consistent with the known safety profiles of the individual agents. The most frequently reported treatment-emergent adverse events in the daratumumab plus Kd arm were thrombocytopenia, anemia, diarrhea, hypertension, upper respiratory tract infection, fatigue and dyspnea. The CANDOR data will be submitted to a future medical meeting and Amgen will discuss the data with health authorities in preparation for regulatory submissions. In August 2012, Genmab granted Janssen Biotech (JNJ) an exclusive worldwide license to develop, manufacture and commercialize daratumumab, the company noted.

09:24 EDT Moen contracts Liquidity Services to conduct auction for manufacturing assets - Moen contracted Liquidity Services to conduct an online auction for manufacturing assets no longer needed in daily operations. The equipment sale promotes the sustainable disposition of its surplus assets including stamping presses, machine tools, plant support equipment and other machinery from Moen's metal stamping facility in Pine Grove, PA.

09:12 EDT Caterpillar reports retail machines sales up 4% in three months end August - Caterpillar reported in a regulatory filing that its total retail machines sales were up 4% on a three month rolling basis in August. For reference, retail sales of machines were up 4% in the period ending in July and up 5% int he period ending in June. The company reported world Resources Industries sales were up 25% in the August-end period, compared to a July-end period increase of 24% and a June-end period increase of 23%. Construction Industries world sales were down 1% in the August-end period, versus down 1% in the prior three-month period ending in July. Total Energy & Transportation Retail Sales were up up 4% in the August-end period, and were up 6% in the July-end period.

09:03 EDT Four Points Technology teams with Leidos on NASA NEST contract - Four Points Technology has partnered with Leidos on their awarded NASA End-User Services & Technologies, NEST, contract. NASA's End-User Services & Technologies contract is a single award, firm-fixed-price, indefinite delivery/indefinite quantity contract estimated in value of $2.9B if all options are exercised. Work will be performed at ten NASA centers nationwide. "Four Points is pleased to provide Leidos and NASA with managed print services across all the NASA centers, working with HP Inc. As a small business focused exclusively in serving our government customers, we are excited to continue that service with strategic partnerships including Leidos," stated David Gilchrist, Chief Executive Officer at Four Points Technology.

09:02 EDT Auris Medical receives FDA, EMA guidance for Keyzilen development program - Auris Medical Holding announced that it has obtained advice on the development plan and regulatory pathway for its investigational tinnitus treatment Keyzilen from the U.S. Food and Drug Administration and from the European Medicines Agency.The Company had reached out to the two agencies in order to discuss and validate the design of a new Phase 2/3 trial for the Keyzilen program. The advice was provided in the context of a Type C meeting and a Scientific Advice procedure, respectively. In their feedback, both the FDA and EMA supported the use of the Tinnitus Functional Index questionnaire as the primary efficacy outcome measure. The TFI captures the impact of tinnitus on the patient's day-to-day functioning. Furthermore, the two agencies agreed on a less frequent collection of patient-reported tinnitus loudness than in the previous Keyzilen trials, where daily ratings had turned out to be problematic. The FDA considers the improvement in tinnitus loudness as a co-primary efficacy endpoint, whereas the EMA endorsed it as a secondary efficacy endpoint. In addition, the two agencies endorsed the planned sample size for the trial and provided important guidance on the regulatory path forward. The planned Phase 2/3 trial shall, in two stages, reaffirm and confirm the efficacy of Keyzilen in the treatment of acute tinnitus following traumatic cochlear injury. It will incorporate learnings from the previous four late-stage trials, TACTT2, TACTT3, AMPACT1 and AMPACT2, notably with regard to the collection of patient reported outcomes and certain elements of study conduct. In addition, the trial will explore the use of a novel method for objective tinnitus diagnosis and measurement. The Company aims to further develop Keyzilen with the aid of non-dilutive funding. The funding options which are currently under consideration include: strategic partnering, special purpose vehicle financing, grant funding or a combination thereof.

09:01 EDT House requests information from Alphabet, Amazon, Apple, Facebook - Reps. Doug Collins, Ranking Member of the House Judiciary Committee, Jerrold Nadler, Chairman of the House Judiciary Committee, Jim Sensenbrenner, Ranking Member of the Subcommittee on Antitrust, Commercial and Administrative Law,, and David Cicilline, Chairman of the Subcommittee on Antitrust, Commercial and Administrative Law, today issued requests for information to Alphabet (GOOG, GOOGL), Amazon (AMZN), Apple (AAPL) and Facebook (FB). "Committee members will use this information as they continue their bipartisan investigation into competition in the tech sector," the House Judiciary Committee said in a statement. Each requests for information seeks emails from company executives pertaining to matters raising specific competition concerns; Documents from any government investigations into the company; A list of all cases filed against the company alleging anticompetitive behavior; Documents provided to the Justice Department's Antitrust Division, the Federal Trade Commission or any other government entity within the last 10 years relating to the Clayton Act; Organizational charts for the company and each of its U.S. divisions; A list of the company's competitors in markets for the company's products and services and accompanying reasons each entity listed is considered a competitor; Financial statements or reports for the company's products and services. Reference Link

08:53 EDT House Committee asks Facebook, Amazon, Alphabet, Apple for documents - The House Judiciary Committee today sent letters to Facebook (FB), Amazon.com (AMZN), Alphabet (GOOG) and Apple (AAPL), requesting the companies provide documents and executive communications. The Committee says the focus of its "bipartisan investigation" is to examine competition problems in digital markets, whether "dominant firms" are engaging in anti-competitive conduct online, and whether existing antitrust laws, competition policies, and current enforcement levels are "adequate to address these issues." Reference Link

08:38 EDT Discover says John Thomas Greene succeeds R. Mark Graf as CFO - In a regulatory filing, Discover Financial (DFS) said its board has elected John Thomas Greene as EVP, CFO and an Executive Committee Member of the company, effective September 18, 2019. Prior to Greene's election, R. Mark Graf served as the company's EVP and CFO. Prior to joining Discover, Greene was employed by Bioverativ, a biopharmaceutical company dedicated to helping patients with rare blood diseases that was acquired by Sanofi (SNY) in March 2018, where he served as Executive Vice President, Chief Financial Officer and Treasurer.

08:33 EDT Carnival's cruise line brands resume trips to The Bahamas - Carnival announced the company's cruise brands are returning to The Bahamas and resuming regular guest sailings for the first time since Hurricane Dorian arrived earlier this month. Three Carnival Corporation brands - Carnival Cruise Line, Princess Cruises and Holland America Line - are expected to make over 250 sailings to The Bahamas through the end of 2019, helping to support the country's tourism industry and its vital economic impact on local businesses and people.

08:31 EDT iFresh board of directors authorizes share repurchase program up to 2M shares - iFresh announced that its Board of Directors has authorized a new share repurchase program of up to 2M shares of iFresh common stock between certain price range in the open market. The Company expects to put the program into place within the next twelve months and will issue a further release when the program has been established.

08:18 EDT Varian Medical partners with Oncora Medical - Varian announced it is investing in Oncora Medical and partnering to accelerate the development of software tools to enable precision medicine in radiation oncology. Oncora is a privately-held digital health company using software and data to equip doctors and scientists with analytics tools to develop the optimal cancer treatment plan for each patient.

08:09 EDT Nuance launches expanded pediatric portfolio ar AHIMA conference - Nuance Communications launched a portfolio of pediatric-specialized solutions in an effort to simplify and streamline how pediatricians capture and communicate patient stories, access real-time clinical intelligence to improve care, and use metrics to assess and document care quality. Included in the pediatric-specialized portfolio are: Dragon Medical One: allows physicians and care teams to dictate pediatric notes directly into the electronic health record. Dragon Medical Advisor with Pediatric Guidance: offers in-workflow advice to improve documentation accuracy and quality. Nuance Surgical CAPD: provides surgeons with pediatric documentation guidance to meet regulatory and billing requirements. CDE One: delivers CDI workflow management and pediatric strategies for documentation improvement. Nuance Performance Analytics: helps organizations accurately track and measure improved pediatric quality scores, including Pediatric Quality Indicators.

08:07 EDT Alnylam presents new results from UK Biobank study on V122I mutation - Alnylam presented new results from an analysis of the UK Biobank, a prospective cohort study with genetic, physical and health data on approximately 500,000 individuals across the United Kingdom, demonstrating a significant association of the V122I mutation. These results were presented at the Heart Failure Society of America, or HFSA. The V122I variant is the most common pathogenic TTR mutation implicated in hereditary ATTR, or hATTR, amyloidosis in the U.S. Historically, the V122I variant has been associated with a predominantly cardiac phenotype. The company presented findings from a phenome-wide association study demonstrating a significant association of the TTR V122I genotype with a clinical diagnosis of polyneuropathy in the black subpopulation of the UK Biobank. Among the 6,063 unrelated black participants, 243 subjects were carriers of the TTR V122I mutation, equating to an allele frequency of 2%. Among the carriers, polyneuropathy was significantly associated with the V122I genotype. The significant association of V122I with polyneuropathy was further replicated in the Penn Medicine Biobank from 5,737 black participants with 190 subjects who were V122I carriers. In addition, there was nominally significant evidence that carriers of V122I were at an increased risk for other signs and symptoms of hATTR amyloidosis, including carpal tunnel syndrome and urinary retention. There was no association of V122I with cardiomyopathy, potentially due to the younger age of the carriers in the UK Biobank at the time of analysis as compared to the age at which hATTR amyloidosis with cardiomyopathy typically presents.

08:06 EDT Weight Watchers to change legal name to WW International - WW announced that it will be changing its legal name from Weight Watchers International to WW International effective September 29, 2019. In September 2018, the Company rebranded as WW to reflect the broadened role it plays in helping people lead healthier lives. W

08:04 EDT AerCap signs lease agreement with Air Macau for three A321neos - AerCap (AER) has announced that it has signed long-term lease agreements with Air Macau for three new Airbus (EADSY) A321neo aircraft. The agreement was signed during a ceremony in Macau to celebrate the airline's 25th anniversary. The first aircraft is scheduled to deliver in November 2020 with the two remaining units delivering through October 2021.

08:03 EDT Salarius appoints Scott Jordan as CBO, Mark Rosenblum as interim CFO - Salarius Pharmaceuticals announced the appointment of Scott Jordan to the new role of chief business officer and the appointment of Mark Rosenblum to the position of EVP Finance and interim CFO. These changes are intended to enhance Salarius' focus on financial operations and strategic value creation while its lead clinical programs in Ewing sarcoma and advanced solid tumors continue to advance toward potential data milestones in 2020. Jordan first joined the company as CFO in 2016. In his new role as CBO, Jordan will lead Salarius' strategic and business development initiatives, public relations, communications and capital markets activities. As the company's interim CFO, Rosenblum is responsible for the company's financial and operating activities. Rosenblum first joined Salarius as a financial consultant to assist in the recent merger of Flex Pharma and Salarius Pharmaceuticals.

08:03 EDT Biogen, Eisai to discontinue Phase 3 studies of elenbecestat - Eisai Co. (ESALY) and Biogen (BIIB) announced the decision to discontinue the Phase III clinical studies on the investigational oral BACE inhibitor elenbecestat in patients with early Alzheimer's disease. The decision is based on the results of a safety review conducted by the Data Safety Monitoring Board, which recommended to discontinue these trials due to unfavorable risk-benefit ratio. Detailed data of these studies will be presented at future medical meetings. Investigators are being informed of the decision and they will be contacting their study participants to discontinue the investigational treatment. As part of this decision, the long-term extension of the Phase II clinical trial of elenbecestat will also be discontinued. This determination does not impact the program of the anti-amyloid beta protofibril monoclonal antibody BAN2401, and the Phase III Clarity AD trial of BAN2401 will continue.

07:29 EDT London Stock Exchange rejects HKEX acquisition proposal - The board of London Stock Exchange Group plc, together with its financial and legal advisers, has now considered the "unsolicited, preliminary and highly conditional proposal" from Hong Kong Exchanges and Clearing Limited, or "HKEX," to acquire the entire share capital of LSEG. "The Board has fundamental concerns about the key aspects of the Conditional Proposal: strategy, deliverability, form of consideration and value. Accordingly, the Board unanimously rejects the Conditional Proposal and, given its fundamental flaws, sees no merit in further engagement. LSEG has today sent a letter to HKEX setting out the reasons for its rejection...LSEG remains committed to and continues to make good progress on its proposed acquisition of Refinitiv Holdings Ltd. Regulatory approval processes are under way and a circular is expected to be posted to LSEG shareholders in November 2019 to seek their approval of the transaction. The transaction remains on track to close in H2 2020," the company said. The Refinitiv business is currently owned by private equity funds managed by Blackstone (BX) and by Thomson Reuters (TRI).

07:10 EDT Helius announces addition of a new PoNS clinic in Quebec City - Helius Medical Technologies reported that Clinique Cortex has been authorized to provide PoNS Treatmen in Quebec City Canada, giving Canadians living in Quebec City local access to the PoNS Treatment. Clinique Cortex joins the current roster of existing clinics authorized to provide the PoNS Treatment, including Neurotherapy Montreal, Surrey Neuroplasticity Clinic, Advantage 4 Athletes Training Centre and Therapy Clinic in Markham, Ontario; Synaptic Spinal Cord Injury and Neuro Rehabilitation Centre in Calgary, Alberta; and Apollo South Physical Therapy Centre in Ottawa, Ontario. Clinique Cortex will operate as a satellite clinic in partnership with Neurotherapy Montreal. Neurotherapy Montreal will be responsible for the initial in-clinic patient treatment and formal treatment assessments while Clinique Cortex will be working with patients locally in Quebec City on their ongoing physical therapy programs to ease the travel burden. "We are very impressed with the customer centric innovation displayed by these two clinics to bring PoNS Treatment to the people of Quebec City," said Philippe Deschamps, Helius Company CEO. The PoNS Treatment is an innovative, non-invasive treatment which combines the use of the PoNS device with targeted physical therapy. The PoNS device is authorized in Canada for the acute treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury, and is to be used in conjunction with physical therapy.

07:08 EDT Applied Therapeutics to present data highlighting AT-001 at HFSA meeting - Applied Therapeutics announced presentation of data at the Heart Failure Society of America 23rd Annual Scientific Meeting in Philadelphia on AT-001, a novel, potent and selective aldose reductase inhibitor in Phase 3 clinical development for Diabetic Cardiomyopathy. The presentation, titled "Preclinical and Clinical Proof of Concept for Metabolic Intervention in Diabetic Cardiomyopathy," further supports the development rationale and clinical proof of concept for AT-001 in DbCM. Preclinical and Clinical Proof of Concept for Metabolic Intervention in Diabetic Cardiomyopathy: AT-001 significantly reduced cardiac damage in a relevant mouse model of DbCM; AT-001 potently inhibited AR within a favorable safe dosing range; In humans, single and multiple ascending doses were well-tolerated with no safety concerns identified, and proof of biological activity was obtained in all patients dosed.

07:05 EDT Orchard Therapeutics says chief commercial officer Jason Meyenburg - Orchard Therapeutics announced that chief commercial officer Jason Meyenburg is leaving the company to take on a chief executive role in the industry. In the interim Mark Rothera, the company's president and chief executive officer, will assume global commercial leadership responsibilities. Rothera has driven the transition of multiple emerging biotechnology companies from R&D stage to commercialization, with a special focus on bringing novel therapies to market for patients with rare diseases, having launched seven orphan drugs over the course of his 30-year career in the biopharmaceutical industry. Orchard has initiated a global search for Mr. Meyenburg's permanent replacement.

07:04 EDT Carrier appoints Timothy McLevish as new CFO, effective October 1 - Carrier announced the appointment of Timothy McLevish as CFO, effective October 1. McLevish will help lead Carrier into its future as it prepares to become a public company after completing its separation from United Technologies Corp. (UTX), expected in the first half of 2020. As a member of Carrier's executive leadership team, McLevish will report to Dave Gitlin, Carrier's President & CEO. McLevish most recently served as senior advisor to the CEO at Walgreens Boots Alliance (WBA).

06:51 EDT Mallinckrodt announces retrospective analysis of Acthar Gel cost per response - Mallinckrodt announced findings from a retrospective analysis of Acthar Gel that showed the cost per response of Acthar Gel when used as a late-line treatment was lower than other late-line treatments, including plasmapheresis, or PMP, and intravenous immunoglobulin, or IVIg, for multiple sclerosis, or MS, relapses in adults. In the analysis, response was defined as no additional relapse treatments or procedures within 30 days, and cost of care was defined to include MS-related inpatient and outpatient treatment and medication costs. Acthar Gel is FDA-approved for the treatment of acute exacerbations of MS in adults. Controlled clinical trials have shown Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease. The objective of the analysis was to estimate the cost per response of MS relapse treatment with Acthar Gel versus PMP/IVIg among patients with acute exacerbations of MS from a payer perspective. The findings were presented as a poster at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, or ECTRIMS and 24th Annual Conference of Rehabilitation in Multiple Sclerosis. Although average annual cost of late-line treatments for all patients is similar, the cost per response of Acthar Gel is lower than other late-line treatments. The base case annual cost per response among those treated with Acthar Gel at $141,970 was lower than that with PMP/IVIg at $253,331. Patients who took Acthar Gel had a response rate of 86.6% compared to a response rate of 49.9% among patients who took PMP/IVIg. Relapses were identified based on treatment-seeking behavior across two databases using an established claims-based algorithm; treatment received outside a healthcare visit was not addressed. Unrestricted enrollment could underestimate unresolved relapses. PMP and IVIg may be administered as courses of therapy, which would also lead to an underestimation. The total annual cost of care did not account for treatment convenience and compliance and the safety profile associated with each therapy.

06:46 EDT VAALCO Energy commences 2019/2020 drilling campaign at Etame - VAALCO announced that the company has commenced its 2019/2020 drilling campaign and spud the Etame 9P appraisal wellbore at the Etame field offshore Gabon. Drilling of the Etame 9P appraisal wellbore is expected to take approximately four weeks, after which the company will commence drilling the Etame 9H development well targeting the Gamba reservoir. The objective of the Etame 9P appraisal wellbore is to test the Dentale reservoirs beneath the Etame field. The company estimates that there could be up to 4.6M gross barrels of recoverable oil present in the Dentale reservoirs beneath the Etame field. If these resources are present in the Dentale, the company will need to drill additional wells to exploit these reservoirs. As previously announced, VAALCO contracted the Vantage Drilling International Topaz jackup drilling rig to execute the 2019/2020 drilling campaign, which will include two appraisal wellbores and up to three development wells.

06:28 EDT Pyxus CEO issues statement on e-cigarette products - Pieter Sikkel, president, CEO and chairman of Pyxus, said, "As manufacturers and marketers of e-liquids, an adult-use product, our subsidiaries and affiliates recognize the unique responsibility in bringing nicotine products to market and are committed to responsible marketing practices. Our companies recognize the seriousness of youth access to e-liquid products and have long supported responsible efforts to address this issue. Bans and outright restrictions of an adult's use of flavors in e-liquid products are misguided and not based on scientific research. The fact is, e-liquids are intended only for responsible adult consumption and, like other adult products, the effort should be focused on educating and preventing underage access to all e-liquids rather than restricting the types of products legal age adults can and do enjoy today."

06:14 EDT Achieve Life Sciences: Final Phase 2b ORCA-1 data to be presented at SRNT-E - Achieve Life Sciences announced that two presentations featuring final data from the Phase 2b ORCA-1 trial will be conducted at the SRNT-E Annual Conference on Friday, September 13th in Oslo. ORCA-1 was designed to evaluate cytisinicline efficacy and safety across various dosing and administration schedules in 254 smokers in the United States. Topline results, reported in June, have led to the selection of 3.0 mg, three times daily dosing for future Phase 3 development. The 3.0 mg TID treatment arm demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo and a 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline compared to 8% for placebo. Continuous abstinence for 4 weeks is the relevant endpoint for regulatory approval. Final data included in the oral presentations at SRNT-E indicate statistically significant end-of-treatment abstinence rates of 50%-54% for all cytisinicline treatment arms compared to 16% for placebo. Subjects had smoked on average for over 30 years. There were no differences observed in treatment outcomes based on subject demographics, clinical site location, number of prior smoking cessation treatments, or previous quit attempts. Overall adherence to study treatment was greater than 94% across all treatment arms and 98% in the 3.0 mg TID arm, specifically. Cytisinicline was well-tolerated with no serious or severe adverse events reported. Overall, in subjects treated with cytisinicline, all individual AE's reported were below a rate of 10%. Minimal rates of abnormal dreams, insomnia, upper respiratory tract infections, and nausea were reported compared with placebo.

06:11 EDT InterCure: Canndoc signs strategic distribution agreement with Teva's S.L.E. - InterCure announced that subsidiary Canndoc has entered into a strategic distribution agreement with Salomon, Levin, Elstein, which is owned by Teva Pharmaceuticals. Under terms of the agreement, S.L.E. will distribute Canndoc's GMP products to pharma clients, including hospitals, health maintenance organizations and all pharmacies in Israel, including pharmacy chains. In the future, as regulatory approvals allow, S.L.E. will provide logistics capability for exporting Canndoc's products to countries that support regulations for the sale and distribution of cannabis products for medical use.

06:05 EDT Microsoft, Walt Disney Studios announce five-year content creation partnership - Microsoft (MSFT) and Walt Disney Studios (DIS) announced a five-year innovation partnership to pilot new ways to create, produce and distribute content on the Microsoft Azure cloud platform. Through The Walt Disney Studios' StudioLAB, a technology hub designed to create and advance the future of storytelling with tools and methods, the companies will deliver cloud-based solutions to help accelerate innovation at The Walt Disney Studios for production and post-production processes, or from "scene to screen." Building on Microsoft's cloud alliance with Avid, the companies have already produced several media workflows running in the cloud , including collaborative editing, content archiving, active backup and production continuity.

06:01 EDT Genentech presents new six-year Ocrevus data - Genentech, a member of the Roche Group, announced longer-term data from the Phase III open-label extension studies of OPERA I, OPERA II and ORATORIO showed that patients who were treated with Ocrevus continuously for six years or more had reduced risk of disability progression in relapsing MS and primary progressive MS. These results suggest earlier treatment with Ocrevus reduced the risk of disability progression and this effect was sustained over time. Additionally, new safety data as of January 2019 were announced, representing 4,611 patients with RMS and PPMS and 14,329 patient years of exposure to Ocrevus, across all Ocrevus clinical trials, and remain consistent with the medicine's favorable benefit-risk profile. Findings were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Stockholm.

05:57 EDT Halozyme: Genentech's Phase III FeDeriCa study met primary endpoint - Halozyme Therapeutics (NHALO) announced that the global phase III FeDeriCa study conducted by Genentech, a member of the Roche Group (RHHBY), met its primary endpoint. The FeDeriCa study investigated a fixed-dose combination of pertuzumab and trastuzumab for subcutaneous administration using Halozyme's ENHANZE drug delivery technology in combination with intravenous chemotherapy. The study results demonstrated non-inferior levels of Perjeta in the blood compared to standard intravenous infusion of Perjeta plus Herceptin and chemotherapy in patients with HER2-positive early breast cancer.