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

18:57 EST Charles River CEO: We are pleased with the demand curve - In an interview on CNBC's Mad Money, Charles River CEO Jim Foster said: Our business is not linear, but we are pleased with our long term growth rates... We'll be in great shape for the year... Biotech is strong and the majority of our revenue is coming from it... We continue to add to our portfolio.

18:23 EST Norwegian Cruise Line CEO: North American consumer is alive and well - In an interview on CNBC's Mad Money, Norwegian Cruise Line CEO Frank Del Rio said: The cruise industry is a leading economic indicator... Our booking window is farther out than ever before... The cruise industry is under-penetrated... Our pasts guests are very engaged with our brands... We were able to overcome the Cuba restrictions... We are taking environmental issues very seriously... We generate a lot of cash... We have the highest net yields in the industry by a wide margin.

18:06 EST Yageo to acquire Kemet for $27.20 per share in cash, or $1.8B

17:56 EST NexPoint Residential acquires three-property portfolio in Las Vegas for $241M - NexPoint Residential Trust entered into an agreement to purchase a three-property portfolio in Las Vegas, Nevada from an unaffiliated third party for approximately $241M. The properties, Bella Solara, a 320-unit property built in 1989; Bloom, a 528-unit property built in 1989; and Torreyana, a 315-unit property built in 1997, are situated on approximately 13.3, 26.9 and 16.3 acres of land, respectively. As of October 16, the portfolio was 94.6% occupied with a weighted average effective monthly rent of approximately $1,200. The purchase of the portfolio will be financed by $132.55M of Federal Home Loan Mortgage Corporation mortgages provided by KeyBank National Association and SunTrust Bank with the remainder funded by borrowings of approximately $110.0M under the company's revolving credit facility.

17:40 EST Fluent drops over 22% after reporting Q3 results, lowers FY19 revenue view - Shares of Fluent are down 22.05% or 56c to $1.98 per share in after-hours trading.

17:34 EST Madrigal announces publication of 'positive' Phase 2 results for resmetirom - Madrigal Pharmaceuticals announced the online publication in The Lancet of the resmetirom Phase 2 multi-center, randomized, double-blind, placebo-controlled clinical trial in patients with non-alcoholic steatohepatitis, or NASH. The 36-week Phase 2 NASH study in 125 patients, and a 36-week extension study in 31 of those patients, are highly supportive of MAESTRO-NASH, an ongoing international Phase 3 registrational clinical trial of resmetirom in patients with NASH and liver fibrosis, that is powered at greater than 90% to achieve the primary endpoint of NASH resolution and key secondary endpoints of LDL cholesterol lowering and reduction in liver fibrosis. Based in part on the results of this study, a multi-center, double-blind, randomized, placebo-controlled Phase 3 registration study, MAESTRO-NASH, is currently enrolling patients with biopsy-proven NASH, randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo.

17:03 EST Franco-Nevada reports 133,219 Gold Equivalent Ounces sold in Q3 - "Franco-Nevada's diversified portfolio performed very well in the third quarter," stated David Harquail, CEO. "Record results were achieved across all our important production and financial metrics. This strong growth has been driven by the start of precious metals deliveries from Cobre Panama and the addition of a new energy royalty in the Marcellus. We expect further growth to come as Cobre Panama continues to ramp-up and our energy assets are further developed. We are also very encouraged by the increased exploration and development activity by many of the operators on our royalty properties. For 2019, Franco-Nevada expects to be close to the high end of its previously announced guidance ranges. Franco-Nevada continues to be the gold investment that works."

16:51 EST Anheuser-Busch to buy remaining Craft Brew Alliance stake for $16.50 per share - Today, Craft Brew Alliance (BREW) and Anheuser-Busch (BUD) jointly announced an agreement to expand their partnership, with A-B agreeing to purchase the remaining CBA shares it does not already own in a merger transaction for $16.50 per share, in cash. The vast majority of CBA's brands are already distributed through A-B's network of independent wholesalers per the companies' existing commercial agreement. A-B currently owns a 31.2% stake in CBA and has offered $16.50 in cash for the remaining shares. The transaction is subject to customary closing conditions, including approval by a majority of CBA's shareholders not affiliated with A-B and certain regulatory approvals. The transaction is expected to close in 2020.

16:35 EST Lonestar sees Q4 production 17,200-17,600 BOE/d - Lonestar has issued production guidance of 17,200 to 17,600 BOE/d for 4Q19. Production rates remain relatively flat quarter over quarter as the pace of capital spending and completions is reduced for the fourth quarter as the company completes its 2019 program. Given current strip pricing for the oil and gas benchmarks, the Company has issued EBITDAX guidance of $32.0 to $34.0 million for 4Q19.

16:33 EST Four Seasons Education appoints Yi Zuo CEO - Four Seasons Education announced the appointment of Yi Zuo as CEO of the company, effective on November 8. Zuo has served as the CFO of the company since March 2017. Peiqing Tian will continue contributing to the company's growth strategies as chairman of the company's board after handing over his duty of the CEO to Zuo. Xun Wang, the company's ViP of Finance, will serve as the company's principal financial and accounting officer.

16:31 EST Franklin Resources reports preliminary AUM $693.1B as of October 31 - Compared to $692.6B at September 30. The increase in assets under management was due to market gains that offset net outflows. Preliminary average assets under management for the quarter, through October 31, were $692.9B.

16:28 EST Kadmon's KD025 met primary endpoint in interim pivotal trial analysis of KD025 - Kadmon Holding announced positive topline results from the planned interim analysis of ROCKstar KD025-213, the fully enrolled pivotal trial evaluating KD025 in patients with chronic graft-versus-host disease, or cGVHD, who have received at least two prior lines of systemic therapy. The trial met the primary endpoint of Overall Response Rate at the interim analysis, which was conducted as scheduled two months after completion of enrollment. KD025 has been well tolerated and adverse events have been consistent with those expected in the patient population. While the ORR endpoint was met at the interim analysis, the primary analysis of the KD025-213 study will occur in the first quarter of 2020, six months after completion of enrollment. This analysis will include updated safety data and efficacy data, including ORRs and secondary endpoints, such as duration of response, changes in corticosteroid dose and changes in quality of life. Kadmon plans to submit results from the KD025-213 study for presentation at an upcoming scientific meeting.

16:22 EST Welltower acquires medical office building portfolio for $787M - Welltower announced that it has entered into a definitive agreement under which Welltower will acquire a 29-property Class-A medical office building portfolio from Hammes Partners for $787M. Separately, Welltower announced an additional gross investment volume of $885M across four separate outpatient medical transactions which are currently under contract at a blended year one cash cap rate of 5.4%. With these announcements, Welltower has closed or announced over $3.5B of outpatient medical acquisitions this year at a blended year one cash cap rate of 5.6%. These acquisitions will contribute 450 properties and over 8M square feet to the company's platform, as it continues to expand through accretive off-market acquisitions.

16:17 EST Welltower, Invesco Real Estate announce $850M medical office building JV - Welltower and Invesco Real Estate announced an $850M joint venture partnership comprising a portfolio of 35 medical office buildings spanning 2.6M square feet. The portfolio was previously wholly owned by Welltower. The properties are 100% affiliated with health systems and have a weighted average lease term of five years. With an average age of 19 years, these properties have experienced strong second generation leasing. Through this partnership, Welltower will retain a 15% economic interest in the portfolio.

16:15 EST Invesco reports preliminary AUM $1.195T as of October 31 - An increase of 0.9% versus previous month-end. The increase was driven by favorable market returns, foreign exchange, and reinvested distributions, partially offset by outflows in long-term AUM, money market, and non-management fee earning AUM.

16:10 EST Cohen & Steers reports preliminary AUM $72B as of October 31 - An increase of $1.1B from assets under management at September 30. The increase in assets under management from September 30 was due to market appreciation of $967M and net inflows of $333M, partially offset by distributions of $186M.

16:07 EST Sandrige Mississippian trading halted, news pending

16:04 EST Reata announces 'positive' results for Phase 3 study of bardoxolone methyl - Reata Pharmaceuticals announced that the Phase 3 portion of the CARDINAL study of bardoxolone methyl in patients with chronic kidney disease, or CKD, caused by Alport syndrome met its primary and key secondary endpoints. After 48 weeks of treatment, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean estimated glomerular filtration rate. After 48 weeks of treatment and a four-week withdrawal period, patients treated with bardoxolone had a statistically significant improvement compared to placebo in mean retained eGFR. Bardoxolone treatment was generally reported to be well-tolerated and showed a similar safety profile to the Phase 2 portion of the CARDINAL study. Based on these positive results, and subject to discussions with regulatory authorities, the company plans to proceed with the submission of regulatory filings for marketing approval in the United States and internationally.

16:00 EST Reata Pharmaceuticals trading halted, news pending

15:01 EST Merck reports ERVEBO vaccine granted conditional approval in EU - Merck announced that the European Commission has granted a conditional marketing authorization to ERVEBO for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease caused by Zaire Ebola virus. The use of ERVEBO should be in accordance with official recommendations. With this approval, the European Commission will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. ERVEBO is currently under Priority Review with the U.S. Food and Drug Administration with a target action date of March 14, 2020, Merck noted.

14:17 EST Alibaba reports 11.11 gross merchandise volume grew 26% year-over-year to $38.4B - Alibaba Group (BABA) confirmed in a press release that it generated RMB268.4B, or $38.4B, of gross merchandise volume, or GMV, on November 11, 2019, an increase of 26% compared to 2018. Total GMV settled through Alipay was RMB268.4B, or $38.4 B in U.S. dollars. There were more than 200,000 participating brands, 1 million new products launched for 11.11, and Cainiao Network processed 1.3 billion delivery orders, the company noted. The top five countries selling to China through its cross-border platforms by GMV were Japan, United States, South Korea, Australia, and Germany. 299 brands surpassed RMB100M, or $14.3M, and 15 of those brands surpassed RMB1B, or $143M in GMV, including Apple (AAPL), Bose, Estee Lauder (EL), Gap (GPS), H&M, L'Oreal (LRLCY), Levi's (LEVI), MUJI, Nestle (NSRGY), Nike (NKE), Philips, The North Face (VFC), Under Armour (UAA) and Uniqlo, according to Alibaba.

12:45 EST T-Mobile drops 2% after WSJ says CEO Legere in talks to run We Company

12:00 EST VelocityShares 3x Long Natural Gas ETN falls -15.1% - VelocityShares 3x Long Natural Gas ETN is down -15.1%, or -$2.81 to $15.78.

12:00 EST Genie Energy rises 10.1% - Genie Energy is up 10.1%, or 73c to $7.93.

12:00 EST Boeing jumps after saying MAX deliveries could resume in December - Boeing, in an emailed statement to media outlets, said, "Boeing continues to target FAA certification of the MAX flight control software updates during this quarter. Based on this schedule, it is possible that the resumption of MAX deliveries to airline customers could begin in December, after certification, when the FAA issues an Airworthiness Directive rescinding the grounding order. In parallel, we are working towards final validation of the updated training requirements, which must occur before the MAX returns to commercial service, and which we now expect to begin in January." Shares of Boeing are up 2%, or $7.06, to $357.61 in midday trading.

11:56 EST Boeing up 1% after clarifying comments on expected return to service of 737 MAX - Boeing has said, according to multiple media reports, that it does not expect the FAA to approve the 737 MAX to return to service until January, but that 737 MAX deliveries could potentially resume in December if the FAA certification comes in the middle of next month.

11:46 EST ForeScout jumps 4% to $32.34 after Bloomberg says exploring potential sale

11:26 EST Beyond Meat falls after CFO sells over $5 million worth of shares - Shares of Beyond Meat are sinking after its Chief Financial Officer Mark Nelson disclosed late Friday the sale of 70,000 shares at a price of $81.11, netting the executive over $5.6M. Beyond Meat in late morning trading is down 4%, or $3.09, to $76.86. Nelson still owns 367,306 shares of the protein-based burger producer. While Beyond Meat CEO Ethan Brown has pledged not to sell any shares, other executives have also been reducing their stakes, including Chief People Officer Cari Soto and Chief Growth Officer Charles Muth, who both sold shares last week, according to regulatory filings.

11:13 EST AstraZeneca says anifrolumab showed superiority on efficacy endpoints in TULIP 2 - AstraZeneca will tomorrow present detailed results from the Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of moderate to severe systemic lupus erythematosus, which demonstrated superiority across multiple efficacy endpoints versus placebo, with both arms receiving standard of care, the company announced. On the primary endpoint, anifrolumab achieved a statistically significant and clinically meaningful reduction in disease activity at week 52, with 47.8% of patients receiving anifrolumab responding compared with 31.5% of patients on placebo, as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment composite measure. The positive BICLA result in TULIP 2 is consistent with results from pre-specified analyses using the BICLA endpoint in the Phase III TULIP 1 and the Phase II MUSE trials, the company said. The TULIP data are being presented at the American College of Rheumatology Annual Meeting 2019 in Atlanta, US. The TULIP 1 data were also published simultaneously in The Lancet Rheumatology. As previously disclosed, TULIP 1 did not meet its primary endpoint based on the SLE Responder Index 4 composite measure. However, analyses of secondary endpoints show efficacy consistent with TULIP 2 on BICLA response, reduction in OCS use, and improvement in skin disease activity, AstraZeneca said.

10:03 EST Cellular Biomedicine receives preliminary 'go private' bid of $19.50 per share - Cellular Biomedicine announced that its board of directors has received a preliminary non-binding proposal letter, dated November 11, from a consortium led by Bizuo Liu, the CEO of the company, certain other senior management members of the company, Hillhouse Bio Holdings and TF Capital Ranok and also including Dangdai International Group, to acquire all outstanding shares of common stock of the company - other than those shares held by the Consortium Members that may be rolled over in connection with the acquisition - for $19.50 per share in cash in a going private transaction. The Board formed a special committee comprised of independent, disinterested directors to evaluate strategic alternatives. The special committee, with the assistance of its advisors will consider the letter and any response thereto in connection with its ongoing review of strategic alternatives. The board cautions the company's shareholders and others considering trading the company's securities that the board has just received the proposal letter and has not had an opportunity to carefully review and evaluate the proposal or make any decision with respect to the company's response to the proposal. "There can be no assurance that any definitive offer will be made, that any definitive agreement will be executed relating to the proposed transaction or that this or any other transaction will be approved or consummated. The company does not undertake any obligation to provide any updates with respect to this or any other transaction, except as required under applicable law," the company stated.

10:00 EST VelocityShares 3x Long Natural Gas ETN falls -14.1% - VelocityShares 3x Long Natural Gas ETN is down -14.1%, or -$2.62 to $15.97.

10:00 EST Medifast rises 6.9% - Medifast is up 6.9%, or $5.14 to $79.50.

10:00 EST VelocityShares 3x Inv Natural Gas ETN rises 14.0% - VelocityShares 3x Inv Natural Gas ETN is up 14.0%, or $13.39 to $109.03.

09:50 EST Galectin Therapeutics, Siemens Healthineers collaborate on NASH, liver fibrosis - Galectin Therapeutics (GALT) announced a collaboration agreement with Siemens Healthineers (SMMNY). This collaboration allows Siemens Healthineers to use Galectin's Phase 2 NASH-CX clinical trial to support regulatory filings of the ADVIA Centaur Enhanced Liver Fibrosis test. This agreement will also provide Siemens Healthineers with access to future clinical and ADVIA Centaur ELF test data from Galectin Therapeutics' planned Phase 3 NASH-RX clinical trial of belapectin in the treatment of NASH liver cirrhosis without esophageal varices. If approved, the ADVIA Centaur ELF test, a simple blood test, would help clinicians better manage patients with chronic liver disease. The ELF test is designed to analyze results from three serum biomarkers, Hyaluronic acid, Procollagen III amino-terminal peptide , and Tissue inhibitor of metalloproteinase 1, in an algorithm that provides a single unitless ELF score, which can help improve the prediction of NAFLD/NASH and chronic liver disease patients at risk of disease progression.

09:47 EST VelocityShares 3x Long Natural Gas ETN falls -13.3% - VelocityShares 3x Long Natural Gas ETN is down -13.3%, or -$2.47 to $16.12.

09:47 EST Britannia Bulk rises 5.1% - Britannia Bulk is up 5.1%, or 23c to $4.75.

09:47 EST VelocityShares 3x Inv Natural Gas ETN rises 13.5% - VelocityShares 3x Inv Natural Gas ETN is up 13.5%, or $12.92 to $108.56.

09:38 EST Uber founder Kalanick sold fifth of stake after lock-up expired - Travis Kalanick sold about 20% of his stake in Uber Technologies last week, according to a regulatory filing from Friday night. Kalanick, who is still a director at the company, sold 20.265M shares worth about $546.9M that were held in a trust. Following the sales, his direct ownership of Uber shares stands at 75,383,808 shares, according to the filing with the SEC. The filing stated: "Form 4s filed on May 13 and May 16, 2019, inadvertently overreported the number of shares of common stock directly beneficially owned by Mr. Kalanick by 270,000 shares. This has been corrected, and the total number of shares of common stock directly beneficially owned by Mr. Kalanick is 75,383,808."

09:21 EST Allegro Merger says TGIF merger filing not posted due to holiday - Privately held TGIF Holdings and Allegro Merger Corp. jointly announced that Allegro's 8-K filing, which describes the business combination transaction between the parties that was announced on Friday, has not yet been posted to the Securities and Exchange Commission's website due to technical difficulties being experienced by the Commission and due to the SEC being closed today for Veteran's Day. Allegro expects the 8-K to be posted by the Commission on Tuesday morning.

09:09 EST Kandi announces inspection of automatic intelligent battery exchange system - Kandi Technologies Group announced that its first automatic intelligent battery exchange system passed the inspection on November 10, 2019. The development was spearheaded by the Company's wholly-owned subsidiary, Jinhua An Kao Power Technology Co. The Kandi automatic intelligent battery exchange system has been successfully developed by its technical team for over a year. The system features automatic functions which perform an intelligent charging and battery exchange. The battery exchanging time for each vehicle is only 90 seconds, which ranks among the current top battery exchange equipment.

09:08 EST Selecta Biosciences presents data from Phase 2 study of SEL-212 - Selecta Biosciences announced new data from their Phase 2 dose-ranging study evaluating SEL-212, a combined therapy of ImmTOR + pegadricase for the treatment of chronic refractory gout. Results reinforce that, in the five monthly combination cohorts, SEL-212 is effective in reducing incidence of gout flares and supports dose selection in the head-to-head COMPARE clinical trial and in future Phase 3 studies. These data are being presented at the 2019 American College of Rheumatology Annual Meeting in Atlanta, GA. Data from the abstract entitled "Monthly Dosing of ImmTOR Tolerogenic Nanoparticles Combined with Pegylated Uricase Enables Sustained Reduction of Acute Gout Flares in Symptomatic Gout Patients" showed that monthly dosing of SEL-212 enables sustained reduction of acute gout flares. In month one, 50% of patients who received pegadricase alone had flares, compared to 35% receiving SEL-212. Further, zero patients receiving SEL-212 had initial flares after the second month of treatment. The abstract entitled "Phase 2 Dose-Ranging Study of SEL-212 in Symptomatic Gout Patients: Selection of Doses for Further Clinical Development" evaluated symptomatic gout patients treated with pegadricase at 0.2 or 0.4 mg/kg alone or combined with 0.05 to 0.15 mg/kg ImmTOR. Results showed that when administered alone at either dose, pegadricase resulted in a rapid reduction in sUA, which was not sustained due to anti-drug antibodies formation in 5 of 6 patients. The addition of ImmTOR at greater than or equal to0.1 mg/kg reduced ADA formation, allowing sustained reduction in sUA, but these responses were attenuated when ImmTOR was removed during cycles 4 and 5. The combination of pegadricase and ImmTOR was given during all 5 cycles in 3 additional cohorts. In these cohorts, 66% of evaluable patients maintained levels below 6 mg/dL at Week 20 after 5 monthly doses of SEL-212, and 100% of patients who had sUA less than6 mg/dL at 12 weeks, maintained control through 20 weeks. Sustained reduction of sUA levels correlated with low or no ADAs. The percentage of patients experiencing flares in these three cohorts declined from 35% during month 1 to 9%-10% during months 3, 4, and 5. These data led to the selection of a combination of pegadricase and ImmTOR in the head-to-head COMPARE study of SEL-212 and pegloticase, a pegylated uricase currently FDA approved for use in patients with treatment-refractory gout. In an abstract entitled "Monthly Dosing of ImmTOR Tolerogenic Nanoparticles Combined with Pegylated Uricase Mitigates Formation of Anti-Drug Antibodies Resulting in Sustained Uricase Activity in Symptomatic Gout Patients" subjects were infused with SEL-212 in 28-day cycles, up to 5 times. Safety, tolerability, sUA, ADAs, and uricase activity were monitored, and data demonstrated that patients taking SEL-212 had titers less than1080, uricase activity AUCs sustained over 5 treatment periods, and low sUA. These results conclude that when anti-uricase titers are less than 1080, patients showed sustained uricase activity, enabling 28-day treatment intervals and further supporting the once-monthly dosing regimen for SEL-212. Further, results showed that SEL-212 was generally well tolerated at clinically active doses following repeated administrations in the trial. SEL-212 is a novel combination product candidate designed to sustain control of sUA in patients with chronic refractory gout, potentially reducing harmful tissue urate deposits which, when left untreated, can lead to debilitating gout flares and joint deformity. SEL-212 consists of pegadricase, the company's proprietary pegylated uricase, co-administered with ImmTOR, designed to mitigate the formation of anti-drug antibodies. ADAs develop due to unwanted immune responses to biologic medicines, rendering these therapies less potent, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout.

09:05 EST Urban Tea regains Nasdaq compliance - Urban Tea announced that it has regained compliance with Nasdaq's minimum stockholders' equity requirements.

09:04 EST Magellan Midstream launches supplemental open season - Magellan Midstream Partners announced a supplemental open season to solicit additional commitments for transportation volume on the western leg of its refined petroleum products pipeline system in Texas. Binding commitments are due from interested customers by 5:00 p.m. Central Time on Dec. 20, 2019. Magellan is in the process of expanding the capacity of its west Texas refined products pipeline system to approximately 175,000 barrels per day (bpd) from its current capacity of 100,000 bpd. In addition, the partnership is currently building a new refined products terminal in Midland, Texas. Based on the timing of current construction activities, Magellan expects both the west Texas refined products pipeline expansion and new Midland terminal to be operational in mid-2020. Magellan's west Texas pipeline system primarily transports gasoline and diesel fuel to demand centers in Abilene, Midland/Odessa and El Paso, Texas as well as New Mexico. The pipeline system also can access markets in Arizona and Mexico via connections to third-party pipelines. Subject to the results of the supplemental open season launched today, Magellan is considering the addition of another 25,000 bpd of capacity on the west Texas pipeline, for a total capacity up to 200,000 bpd, which could be operational by the end of 2021.

09:01 EST TIP, Infinera, Edgecore announces first DCSG commercial deployment - The Telecom Infra Project, Infinera (INFN), and Edgecore Networks announced that they have collaborated to achieve the market adoption of carrier-class Disaggregated Cell Site Gateways technology with the first large-scale commercial deployment by Telefonica (TEF). Initially part of a recently announced nationwide open mobile transport deployment by Telefonica in Germany, the DCSG solution is a white-box cell site gateway device based on an open and disaggregated architecture for existing 3G, 4G, and future 5G mobile infrastructures. As part of an ongoing industry partnership, Infinera and Edgecore Networks advanced DCSG technology with the Infinera DRX-30 and Edgecore AS7315-27X-DCSG hardware platforms. The Infinera Converged Network Operating System. when combined with Infinera or Edgecore Networks' hardware, provides mobile operators with mature IP/MPLS functionality for their cell site gateways. Additionally, the combined CNOS and carrier-class hardware provide a unique stacking capability that delivers simple node expansion and increased resiliency. Multiple gateway elements can be connected to double node capacity while operating as a single routing entity.

08:58 EST CV Sciences announces distribution partnership with Southeastern Grocers - CV Sciences announced a new distribution partnership with Southeastern Grocers with an initial launch at 115 Winn-Dixie stores in Florida and 37 BI-LO stores in South Carolina. PlusCBD Oil products are available at these stores as of November 3, 2019. CV Sciences' new distribution partnership with SEG's Winn-Dixie and BI-LO banners increases distribution and availability of a broad assortment of the Company's PlusCBD Oil products, including ingestible dietary supplements. New distribution at select Winn-Dixie stores in Florida and BI-LO stores in South Carolina includes both topical products, such as PlusCBD Oil Extra Strength and Original Balm and PlusCBD Oil Roll-On, as well as PlusCBD Oil full spectrum hemp extract dietary supplements, including Gold Formula Softgels, Gold Formula Drops and Gummies, and Total Plant Complex Sprays.

08:55 EST eSilicon to be acquired by Inphi, Synopsys, terms not disclosed - eSilicon announced the signing of a definitive agreement with Inphi Corporation (IPHI) to acquire eSilicon. Concurrently, Synopsys, Inc. (SNPS) announced the signing of a definitive agreement to acquire eSilicon's embedded memory and interface IP assets.

08:52 EST Green Plains appoints Phil Boggs as SVP, investor relations and treasurer - Green Plains (GPRE) announced that Phil Boggs, SVP, Finance and Treasurer, will take over as SVP, Investor Relations and Treasurer for Green Plains Inc. and Green Plains Partners (GPP). Boggs' promotion comes as current EVP, Investor and Media Relations Jim Stark, has accepted the position of VP, Investor Relations at Darling Ingredients Inc. located in Irving, Texas. Stark will transition his responsibilities to Boggs over the coming weeks.

08:49 EST Replimune Group says manufacturing build-out remains on schedule - The 63,000-square-foot facility in Framingham, MA is intended to provide multi-product manufacturing capabilities for Replimune's Immulytic product candidates. The capacity of this facility will be sufficient to support full commercialization of the Company's product candidates. An occupancy certificate for the facility has been obtained and technology transfer is underway.

08:47 EST Replimune Group expects to begin enrollment in RP1 trial in 2020 - Based on the clinical efficacy data to date with RP1 in melanoma, the Company has decided to conduct a new clinical trial of RP1 in combination with an anti-PD-1 therapy in anti-PD-1 refectory melanoma patients. Discussions are underway to determine the particular anti-PD-1 therapy to be used. The trial is expected to begin enrollment in 2020.

08:45 EST Diffusion Pharmaceuticals seeking partner to continue TSC development in GBM - Reported news that based on favorable safety data in the TSC dose-escalation run-in study, the Data Safety Monitoring Board recommended continuation of the INTACT trial using the highest dose administered, 1.5 mg/kg of TSC during the adjuvant treatment period. The INTACT trial is comparing SOC radiation therapy and chemotherapy plus TSC, against SOC alone. In Phase 2 testing, TSC demonstrated a nearly four-fold improvement in overall survival at two years for the subset of inoperable GBM patients, compared with the control group of GBM patients. Diffusion is seeking a partner to continue development of TSC in GBM.

08:42 EST Sunworks awarded Northeast region solar project - Sunworks announced it has been awarded an engineering, procurement and construction contract to develop a 370kW ground mount solar system for multi-unit residential project in a Massachusetts suburb located outside of Boston. The project is being developed under the Solar Massachusetts Renewable Target incentive program.

08:39 EST Tetra Bio Pharma appoints Melanie Kelly as CSO, Steeve Neron as COO - Tetra announced that Melanie Kelly will join the team as CSO. Additionally, the company is appointing Steeve Neron as COO. Neron has previously served as SVP of Marketing and Medical Affairs.

08:35 EST Aspen Group reports Q2 student enrollments of 2,217 - Aspen Group announced record new student enrollments of 2,217 for the fiscal 2020 second quarter ending October 31, 2019, an increase of 42% year-over-year. Quarterly bookings increased 92% year-over-year from $16.3 million to $31.3 million. Consequently, total bookings for first half fiscal 2020 was $58.2 million, which on a run rate basis is tracking 31% ahead of the company's full year bookings forecast of $89 million. As a result of these strong bookings, the Company expects fiscal 2020 second quarter revenues to meet or exceed the previous quarter's 43% growth rate.

08:32 EST FTE Networks reports continuing negotiations for possible business combination - FTE Networks announced an amendment to the Debt and Series H Preferred Stock dated October 10, 2019, with Fred Sacramone and Brian McMahon, under which Messrs. Sacramone and McMahon released and discharged the Company and its affiliates from all but $28,000,000 of the indebtedness owed to them by the Company and its affiliates. The Company also announced that negotiations for the previously disclosed possible business combination transaction are continuing. On October 11, 2019, the Company announced that it had received a term sheet concerning a proposed business combination transaction contemplating the contribution of a multi-billion portfolio of real estate related assets in exchange for a combination of common stock, preferred stock and warrants of the Company. As part of the proposed transaction, the Company would also acquire a public non-traded REIT with a portfolio of commercial development assets. The Company is also evaluating a second proposed transaction which involves the contribution of a real estate portfolio of more than 3,000 rental home assets. The proposed transaction has been presented to the Board of the Company. The Company is negotiating the terms and conditions of definitive agreements to carry out the proposed business combination. However, no definitive agreement has been reached concerning either proposed business combination transaction and there can be no assurance that any business combination will result from these negotiations

08:30 EST Carbonite trading resumes

08:26 EST Celldex presents data from CDX-0159, CDX-527 programs - Celldex Therapeutics presented data from the Company's preclinical pipeline this weekend. A review of the CDX-0159 early development program was presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting on November 9, 2019 in the Distinguished Industry Oral Abstract Session. Preclinical data supporting the continued development of the Company's CDX-527 bispecific candidate were also presented at the Society for Immunotherapy of Cancer 34th Annual Meeting, including both a poster presentation on November 9, 2019 and a talk during the preconference program session "Novel Multi-Targeted Therapeutic Platforms" on Wednesday, November 6, 2019. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, and its activation by its ligand SCF regulates mast cell functions including activation and survival. In certain inflammatory diseases, such as chronic idiopathic urticaria, mast cell activation plays a central role in the onset and progression of the disease. In a Phase 1 clinical study with Celldex's KIT antagonist monoclonal antibody, CDX-0158, robust inhibition of mast cell activity was observed supporting the concept that targeting KIT can modulate mast cell activity and potentially provide clinical benefit in mast cell related diseases. CDX-0158 was re-engineered and replaced with CDX-0159, a New Molecular Entity, to ablate Fc receptor interactions and effector function and improve its safety profile, while preserving full KIT inhibitory activity. In addition, CDX-0159 was modified to provide extended half-life following administration. Celldex's Investigational New Drug Application for CDX-0159 has been accepted by the Food and Drug Administration and the Company plans to initiate a Phase 1a study of CDX-0159 by year-end 2019. The study is designed to evaluate the safety profile, pharmacokinetics and pharmacodynamics of single ascending doses of CDX-0159 in healthy subjects. Following completion of this study, Celldex plans to further study CDX-0159 in CIU, a mast cell-related disease. CIU presents as itchy hives, angioedema or both for at least six weeks without a specific trigger; multiple episodes can play out over years or even decades. The prevalence of CIU is estimated to be 0.5% to 1% of the total population or up to 3.2 million cases in the United States. About 50% of patients with CIU achieve symptomatic control with antihistamines or leukotriene receptor antagonists. Omalizumab, an IgE inhibitor, provides relief for roughly half of the remaining antihistamine/leukotriene refractory patients. Consequently, there is a need for more effective later line therapies. Bispecific antibodies that engage two independent pathways involved in controlling immune responses to tumors are a rapidly growing area for the development of next generation PD-1 inhibitors. CDX-527 is the first candidate from Celldex's bispecific platform and uses Celldex's proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. Celldex's prior clinical experience with combining CD27 activation and PD-1 blockade provide the rationale for linking these two pathways into one molecule. The data presented at SITC demonstrate that CDX-527 is more potent at T cell activation and anti-tumor immunity than the combination of parental monoclonal antibodies. Celldex is currently completing CDX-527 GMP manufacturing activities and IND-enabling studies and plans to file an IND in the first half of 2020. The Company believes that CDX-527 supports development of combination studies across the Celldex pipeline without needing to access competitor checkpoint inhibitors, allowing for quicker and more cost-effective studies.

08:21 EST Assembly Biosciences announces data for HBV core inhibitors - Assembly Biosciences announced that data for its first and second generation HBV core inhibitors were highlighted during a late-breaker poster session at the American Association for the Study of Liver Diseases Annual Meeting in Boston, Massachusetts. The posters featured final 24-week results and interim long-term data from the Phase 2 studies of ABI-H0731. Additionally, the company presented initial data from the first dose cohort in the ongoing Phase 1b study of ABI-H2158. This poster included final 24 week data from HBeAg-positive patients in studies ABI-H0731-201 and ABI-H0731-202 in addition to interim data from an ongoing open-label extension study ABI-H0731-211, where all patients receive combination 731+Nrtl therapy. Of the 97 patients completing Study 201 or Study 202, 87 are currently receiving 731+Nrtl and have been treated for at least 16 weeks in Study 211. 731 was well-tolerated when administered in combination with Nrtl therapy. Overall, 26 out of 58 patients reported no adverse events. The remaining patients reported AEs that were Grade 1 or 2 and no serious AEs have been reported to date. As previously reported in the literature, the vast majority of long-term Nrtl treated patients continue to harbor low level infectious virus and this was confirmed in Study 201 patients at the time of enrollment. Final Week 24 results from the HBeAg-positive patients demonstrated that, among those with detectable DNA at baseline, 22/27 of 731+Nrtl treated patients achieved target not detected by Week 24 vs 0/12 Nrtl only treated patients, as measured with a highly sensitive PCR assay. These results indicate that the addition of 731 reduced viral burden to levels not achieved by Nrtl therapy alone. Final Week 24 results from HBeAg-positive patients in Study 202 demonstrated faster and deeper HBV DNA declines in patients receiving 731+entecavir than those receiving ETV alone. Statistically significant reductions of pgRNA were observed by Week 2 with 731+ETV. Longer-term treatment with 731+NrtI resulted in deeper reductions in HBV DNA and pgRNA. The 21 of 25 patients from Study 202 now in Study 211 demonstrated mean HBV DNA and pgRNA declines from baseline of 6.3 logs and 3.0 logs, respectively, at Week 48. A significant finding based on interim data from Study 211 is the observed correlation between the degree of pgRNA reductions and viral antigen declines. Eleven of 21 patients from Study 202 now on Study 211 who have been treated with 731+Nrtl for 16-60 weeks have achieved decreases in pgRNA of greater than3 logs. The results in the tables below demonstrate that these larger declines in pgRNA were strongly associated with observed reductions in viral antigens. Because cccDNA is the only known source of pgRNA, the deeper decline of pgRNA levels may therefore indicate a reduction in cccDNA pools. Of the 27 Nrtl-suppressed HBeAg-positive patients receiving 731+Nrtl for at least 40 weeks in Study 201 and who are now in Study 211, 18 have achieved HBV DNA TND + pgRNA less than35 U/mL, along with significant declines in HBeAg and HBcrAg levels. 731 was well-tolerated in both HBeAg-positive and -negative patients when administered with a Nrtl for 24 weeks with no serious AEs reported. Five patients receiving 731+Nrtl reported a rash. No associated systemic signs or laboratory abnormalities were observed, and all patients continued treatment through Week 24. Overall, laboratory abnormalities observed were of Grade 1 or 2 severity and occurred in similar proportions of patients across the two treatment groups. With longer-term ongoing treatment in Study 211, interim data indicated that the nature, frequency and severity of AEs and laboratory abnormalities observed were similar to the initial 24 week treatment period. The Phase 1b study of 2158 is currently enrolling HBeAg positive patients in sequential dose cohorts of nine patients, with each cohort randomized to receive oral 2158 or placebo once daily for 14 days. The poster details interim safety data and antiviral activity from the initial cohort receiving the lowest dose of 2158 at 100 mg. These interim data demonstrated potent antiviral activity at this initial dose level, reflected by mean declines from baseline to day 15 of 2.3 log10 and 2.1 log10 in HBV DNA and pgRNA respectively. No serious AEs, dose limiting toxicities or premature discontinuations have been reported to date. All treatment emergent adverse events were Grade 1. One patient assigned to placebo and three patients on 2158 reported TEAEs that resolved without intervention: dizziness, fatigue, rash, headache and upper abdominal pain. Observed steady-state exposures were in excess of the EC90's for in vitro antiviral and cccDNA assays. We believe that the safety and pharmacokinetic data and parameters from this interim analysis support once daily administration and the continued evaluation of 2158 across the planned dose cohorts in patients with chronic HBV infection. The Phase 1b study is expected to be completed in the first quarter of 2020.

08:14 EST UroGen Pharma, Agenus enter license agreement to treat urinary tract cancers - UroGen Pharma (URGN) announced that it has entered into an exclusive worldwide license agreement with Agenus (AGEN) to develop and commercialize zalifrelimab via intravesical delivery in combination with UGN-201 for the treatment of urinary tract cancers. This combination is based on encouraging preclinical data utilizing UroGen's proprietary sustained release technology, which is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option while minimizing systemic exposure and potential side effects. UroGen's initial indication for development will be high-grade non-muscle invasive bladder cancer, or HG NMIBC. Zalifrelimab is currently being evaluated by Agenus in combination with Agenus' anti-PD-1 antibody balstilimab, or AGEN2034, in second line cervical cancer with anticipated BLA filing in 2020. UGN-201 is a TLR-7/8 agonist that is in early stage development at UroGen for HG NMIBC. Under the terms of the agreement and in exchange for the worldwide exclusive license to AGEN1884 for the treatment of cancers of the urinary tract via intravesical delivery, Agenus will receive an upfront payment of $10M, in addition to up to $115M for achieving certain clinical development and regulatory milestones, up to $85M upon achieving certain commercial milestones, as well as royalties on net sales of licensed products in the 14%-20% range. UroGen will be responsible for all development and commercialization activities. UroGen's lead investigational candidates, UGN-101 for instillation, and UGN-102 for intravesical instillation, are designed to potentially ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer and low-grade non-muscle invasive bladder cancer, respectively.

08:12 EST UPS, HerdX announce global logistics partnership - At a dinner event Friday evening hosted by HerdX, with the support of the U.S. Embassy in Japan, HerdX and UPS celebrated the announcement of a global logistics partnership at a historic dinner event featuring blockchain verified beef from the United States to Japan. This groundbreaking type of delivery method has huge implications toward the advancement of traceability and quality assurance for the entire food industry worldwide.

08:10 EST Dare Bioscience enters into agreement to acquire Microchips Biotech - Dare Bioscience announced it entered into an agreement to acquire privately-held Microchips Biotech, Inc. Dare entered into the agreement to secure Microchips' innovative, drug delivery technology. The technology, which has been validated in a first-in-human clinical study in osteoporosis patients, is designed to store and precisely deliver hundreds of therapeutic doses over months or years in a single implant. The implant is intended to be operated by the patient to deliver medication on demand or on a pre-determined schedule that can be activated or deactivated wirelessly, as required. The microchip-based implant, originally developed at the Massachusetts Institute of Technology by researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D., is protected by 98 patents granted and 19 patent applications pending. Microchips, with the support of the Gates Foundation in the form of approximately $17.9 million in grant funding to date, has been developing an implantable long-acting, reversible contraceptive application of the technology, which, if successful, will provide women with unparalleled control over the management of their fertility, which can be individually timed to meet her family planning goals and objectives. The device is intended to deliver all the benefits of a traditional long-acting, reversible contraceptive product, utilizing the active pharmaceutical ingredient levonorgestrel, to provide precise dosing and extended implant duration with the added flexibility of wirelessly controlling the duration of ovulatory suppression based on individual user needs. Microchips' cash balance at closing is anticipated to be approximately $6.9M, and approximately $5.7M after payment of one-time transaction related expenses. Microchips is eligible to receive up to $2.5M in additional funding from the Gates Foundation in 2020 to cover the costs of ongoing development activities of its contraceptive program. In the aggregate, at the closing, Dare will issue three million shares of its common stock in consideration of the cash and cash equivalents of Microchips, less liabilities, at the time of closing to the Microchips stockholders, which include Polaris Venture Partners, MS Pace, Intersouth Partners, and Teva Pharmaceuticals. Dare may pay up to $46.5M in contingent consideration for product development, regulatory and funding milestones and up to $55M in contingent consideration for commercial development milestone payments, the amount of which will depend on the extent to which various milestones are achieved, as well as tiered royalty payments. Dare expects that less than $1.3M of the contingent consideration may become payable through 2021. The closing of the merger with Microchips is subject to a number of conditions, including approval of the merger by Microchips' stockholders.

08:08 EST Equinix achieves Binding Corporate Rules compliance from EU regulators - Equinix announced that it has completed the rigorous process of Binding Corporate Rules approval by European Union regulators. In doing so, it becomes the first company to have its BCRs approved by the European Data Protection Board consisting of all 27 Member States set up under the new GDPR regime.

08:07 EST Inphi to acquire eSilicon for $216M in cash, assumption of debt - Inphi Corporation (IPHI) announced that it has signed a definitive agreement to acquire eSilicon for $216M in both cash and the assumption of debt. Inphi has familiarity with the eSilicon team and opportunity through past interactions, investment, and an ongoing board observer seat. Once complete, Inphi expects the acquisition would: Combine Inphi's DSP, TiA, Driver and SiPho disciplines with eSilicon's 2.5D packaging and custom silicon design capabilities and accelerate the roadmap for electro-optics, 5nm advanced CMOS process node, and custom DSP solutions; Augment Inphi's existing SerDes team and resources; Extend Inphi's addressable market in Cloud data center networking and Telecom 5G infrastructure with top tier OEM customers; Expand Inphi's presence into new, strategic geographies for talent acquisition with engineering design centers in Italy, Romania, Vietnam, and Spain and operations in Malaysia; Add between $80M to $120M to 2020 revenue, be accretive to 2020 EPS and both the 2021 revenue and EPS growth rates; Increase Inphi's operational scale with suppliers, lowering costs and resulting in financial leverage; Result in Inphi paying about 2.2X 2020 revenue in a combination of cash and debt assumption. The acquisition is expected to close in the fourth quarter of 2019, subject to US and Vietnamese regulatory approval and customary closing conditions. Concurrent with the signing of the definitive agreement, eSilicon has sold its Embedded Memory IP and Interface IP assets to Synopsys Incorporated (SNPS).

08:04 EST Agenus receives $10M from UroGen Pharma for rights to zalifrelimab - Agenus (AGEN) announced that it received $10M upfront for a License Agreement with UroGen Pharma (URGN). Under the agreement Agenus is providing access to zalifrelimab for use with UroGen's sustained release technology for intravesical delivery in patients with urinary tract cancers. Agenus is conducting clinical trials for zalifrelimab in combination with Agenus' anti-PD-1 antibody balstilimab for a planned BLA filing in cervical cancer. In addition, zalifrelimab is being evaluated as a monotherapy in PD-1 refractory patients. Under the terms of the agreement, in addition to the $10M upfront payment, Agenus is eligible to receive up to $200M in potential development, regulatory and commercial milestones, as well as 14-20% royalties on net sales.

08:03 EST OpenText to acquire Carbonite for approximately $1.42B including cash and debt - OpenText (OTEX) announced that it has entered into a definitive agreement to acquire Carbonite (CARB), a provider of cloud-based subscription data protection, backup, disaster recovery and end-point security to small and medium-sized businesses and consumers. Terms of the agreement include: Tender offer to be commenced for all outstanding Carbonite shares for $23.00 per share in cash; Total purchase price of approximately $1.42B, inclusive of Carbonite's cash and debt; Total purchase price is approximately 2.8x TTM Carbonite GAAP revenues, inclusive of annualized full year reported Webroot GAAP revenues, a significant acquisition which closed in March 2019; Expect significant expansion of cloud revenues, cloud margins, adjusted EBITDA and cash flows in Fiscal 2021; Accretive, and targeting to be on the OpenText operating model by end of Fiscal 2021. OpenText, through a wholly-owned subsidiary, intends to commence the tender offer for all of the shares of common stock of Carbonite within 10 business days. Pursuant to the agreement, the tender offer will be followed by a merger to acquire any untendered shares. The tender offer is subject to the tender of a majority of Carbonite's shares and certain other regulatory approvals and customary closing conditions. The transaction is expected to close within 90 days.

08:02 EST Synopsys to acquire certain IP assets from eSilicon, terms not disclosed - Synopsys announced that it has signed a definitive agreement to acquire certain IP assets from eSilicon. This acquisition will expand Synopsys' DesignWare Embedded Memory IP portfolio with TCAMs and multi-port memory compilers, as well as its Interface IP portfolio with High-Bandwidth Interface IP. The acquisition will also add a team of experienced R&D engineers to further scale Synopsys' IP development in the most advanced process technologies to address customers' evolving design requirements in growing markets such as AI and cloud. The remaining entirety of eSilicon, including its ASIC business and 56/112G SerDes design and related IP, will be acquired by Inphi Corporation. The transaction, which is expected to close during Synopsys' first quarter of fiscal 2020, is not material to Synopsys' financials and is subject to Vietnamese regulatory approval and customary closing conditions. Terms are not being disclosed.

07:59 EST Carbonite trading halted, news pending

07:50 EST Rollins: Orkin establishes new franchise in Bangladesh - Rollins announced that the company, through its wholly-owned subsidiary Orkin, has expanded its presence in Asia with the addition of a new franchise located in Bangladesh. The new Bangladesh franchise will offer commercial and residential pest control, and termite services.

07:42 EST MyoKardia announces Phase 2 MAVERICK-HCM trial achieves primary objective - MyoKardia announced topline data from MAVERICK-HCM, the company's Phase 2 clinical trial of mavacamten in patients with non-obstructive hypertrophic cardiomyopathy. The study achieved its primary objective of establishing safety and tolerability of mavacamten in non-obstructive HCM over a treatment period of 16 weeks. Meaningful reductions in biomarkers of cardiac stress were observed across both mavacamten drug concentration cohorts and clear signals of clinical benefit were noted in a subgroup with elevated cardiac filling pressures and in a pre-specified group of patients at higher risk for morbidity and mortality. Based on the safety and pharmacologic benefits observed in MAVERICK, MyoKardia plans to advance mavacamten into additional studies in defined groups of patients with non-obstructive HCM and heart failure with preserved ejection fraction. For the non-obstructive indication, the company will seek to consult with the U.S. Food and Drug Administration on potential pathways to registration and expects to provide a regulatory update in the first half of 2020. For the targeted HFpEF population, MyoKardia plans to initiate a Phase 2 study in the second quarter of 2020 in a subgroup of patients sharing many characteristics with the subgroups identified in MAVERICK. Further analysis of the findings from MAVERICK is ongoing, and these data will be submitted for presentation at an upcoming scientific conference. Heart failure with preserved ejection fraction is a heterogeneous clinical syndrome, which in many patients is characterized by impairment of the left ventricle's ability to relax and fill during diastole, resulting in insufficient blood flow to meet the body's needs. HFpEF is estimated to affect approximately three million people in the U.S. and is associated with significant morbidity and mortality. There are currently no approved therapies for HFpEF. The subgroup identified for future evaluation of mavacamten is estimated to include approximately 10-20 percent of the broader HFpEF population. Mavacamten was well tolerated and the observed safety data were consistent with prior studies. The rate of adverse events was greater in the mavacamten groups than the placebo group. The majority of AEs reported were mild or moderate in severity and reversible or self-resolving. Serious adverse events occurred twice as frequently in the placebo arm as compared to patients receiving mavacamten. Transient ejection fraction reductions below the protocol-defined threshold of 45% occurred in five participants in the active drug arms. For the intent-to-treat population, there were no statistically significant differences at 16 weeks between active and placebo groups in exploratory endpoints, with the exception of levels of the biomarker NT-proBNP, which were markedly reduced in patients receiving mavacamten across both treatment cohorts, as compared to the placebo group. NT-proBNP is a well-established biomarker of cardiac wall stress, and elevated NT-proBNP levels are associated with reductions in the rate of heart failure-related death or hospitalization, progression to end-stage disease and stroke. In a pre-specified subgroup representing patients believed to be at higher risk of morbidity and mortality, meaningful trends suggesting clinical benefit were observed for patients on treatment versus placebo across multiple endpoints of symptoms, function, biomarkers of cardiac stress and diastolic compliance. Additionally, similar trends were observed in a subgroup of patients with elevated cardiac filling pressures, suggesting improvement driven by reduced left ventricular pressure, consistent with mavacamten's targeted mechanism.

07:38 EST IntercontinentalExchange partners with ADNOC, others to launch futures exchange - Intercontinental Exchange announced that Abu Dhabi National Oil Company and nine of the world's largest energy traders are partnering with ICE on the launch of ICE Futures Abu Dhabi, a new exchange in Abu Dhabi Global Market that will host the world's first Murban crude oil futures contracts. The nine companies supporting the launch of ICE Futures Abu Dhabi are BP, GS Caltex, INPEX, JXTG, PetroChina, PTT, Shell, TOTSA and Vitol.

07:36 EST Invitae to acquire Clear Genetics for approximately $50M in cash and stock - Invitae announced it has entered into a definitive agreement to acquire Clear Genetics, "a leading developer of software for providing genetic services at scale." Using intuitive chatbots, Clear Genetics equips patients with actionable information throughout the genetic testing process and provides guidance for understanding test results. The acquisition will further expand Invitae's ability to scale and deliver genetic information as a part of routine medical care. Under the definitive agreement, Invitae will acquire Clear Genetics for aggregate consideration of approximately $50M, consisting of approximately $25M in cash and the remainder in shares of Invitae common stock, which consideration is subject to adjustment based on the net working capital of Clear Genetics at closing, among other factors. A portion of such consideration will be subject to a hold back to satisfy indemnification obligations that may arise, and securityholders of Clear Genetics will have the right for Invitae to register for resale on Form S-3 shares of Invitae common stock issued in the acquisition. The acquisition is expected to close in the coming days, subject to customary closing conditions.

07:31 EST Allergan: FDA grants QIDP, Fast Track Designation for ATM-AVI - Allergan announced the U.S. FDA has granted Qualified Infectious Disease Product Designation and Fast Track Designation for ATM-AVI for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. ATM-AVI is an investigational, fixed-dose, intravenous combination antibiotic under development globally.

07:13 EST Myriad Genetics announces publication of study on Prequel Prenatal Screen - Myriad Genetics announced that a new study of the Prequel Prenatal Screen was published online in the journal Ultrasound in Obstetrics and Gynecology. The key finding is that Prequel without a fetal-fraction threshold achieves high accuracy, while maintaining a low test-failure rate of one in 1000. The Prequel Prenatal Screen uses a whole genome sequencing approach to identify chromosomal abnormalities including trisomies 21, 18 and 13. To assess the clinical performance of the Prequel Prenatal Screen, the study retrospectively analyzed data from more than 58,000 women, including 572 who tested positive for an aneuploidy or suspected aneuploidy. Pregnancy outcomes were sought for all screen-positive patients and for thousands of patients who screened negative. Whereas some other NIPS offerings attempt to avoid false-negative results at low fetal fraction by failing nearly five percent of all samples, 999 out of every 1,000 women received a result with a single run of Prequel. Importantly, the clinical sensitivity and specificity levels observed with Prequel were high and comparable to those reported for the other commercial NIPS offerings that have the far higher test failure rates.

07:12 EST EVO Payments appoints Tom Panther as EVP, CFO - EVO Payments (EVOP) announced that Tom Panther has been appointed EVP and CFO, effective November 18, 2019. Panther joins EVO after working for over 19 years at SunTrust Banks (STI) where he served in numerous leadership roles including Chief Accounting Officer, Corporate Controller, Director of Corporate Finance, and Head of Capital Planning & Analysis. Panther succeeds Kevin Hodges, who will transition to an operational leadership role at the company, initially directing strategic integration project.

07:07 EST Amicus expects to complete enrollment in Phase 3 PROPEL study in 2019 - The company said, "2019 Key Strategic Priorities: Nearly double annual worldwide revenue for Galafold with over 1,000 Fabry patients on Galafold by year end. Complete enrollment in pivotal Phase 3 PROPEL clinical study in Pompe disease and report additional Phase 2 data. Report additional two-year results from Phase 1/2 clinical study in CLN6 Batten disease and complete enrollment in ongoing CLN3 Batten disease Phase 1/2 study. Establish preclinical proof of concept for Fabry and Pompe gene therapies. Maintain a strong financial position."

07:05 EST Amicus says cash runway projection extends into 1H22 - The company said, "Cash, cash equivalents, and marketable securities totaled $514.2 million at September 30, 2019. Following a diligent review of current and outer year operating and capital expense projections, and robust outlook for Galafold revenue, Amicus now expects to end 2019 with more than $420 million in cash on hand and has extended the cash runway projection from 2021 to well into the first half of 2022. "

06:53 EST Brookfield Renewable announces unit split, creation of exchange corporation - The company said, "Today we announced our intention to create a Canadian corporation in order to provide investors with greater flexibility in how they invest in Brookfield Renewable's globally diversified, multi-technology renewable power portfolio. This entity will be publicly listed on the same exchanges as the current partnership , giving investors the optionality to invest in Brookfield Renewable through either a partnership or Canadian corporation and could therefore lead to increased demand and enhanced liquidity for Brookfield Renewable. Brookfield Renewable intends to distribute to existing unitholders, on a tax-free basis to the majority of unitholders, class A shares of the new corporation, Brookfield Renewable Corporation . From an economic and accounting perspective, the transaction will be analogous to a unit split as it will not result in any underlying change to aggregate cash flows or net asset value except for the adjustment for the number of units/shares outstanding. The class A shares will be structured with the intention of providing an economic return equivalent to BEP units, including identical distributions, and will be exchangeable, at the shareholder's option, for one BEP unit. The class A shares are also intended to provide investors with the ability to have economic exposure to BEP through a more traditional corporate structure. Current unitholders are expected to receive one BEPC class A share for every four BEP units held (i.e. 0.25 BEPC class A shares for each unit held of BEP) in the form of a special distribution. Following completion of the special distribution, the aggregate quarterly distributions and dividends from Brookfield Renewable and BEPC will correspond to the quarterly distributions made on Brookfield Renewable units as if the special distribution did not take place. Holders of Brookfield Renewable's preferred limited partnership units will not receive the class A shares. The majority of the BEPC class A shares will be held by the holders of Brookfield Renewable's units immediately after the effective split. Brookfield Renewable will own all of the BEPC class B and C shares. The class A and class B shares will control 25% and 75%, respectively, of the aggregate voting rights of the shares of BEPC. Brookfield Asset Management, as a unitholder of Brookfield Renewable, is expected to hold approximately 60% of the BEPC class A shares, which is equivalent to its effective ownership of Brookfield Renewable units. BEPC intends to apply to list its class A shares in the United States on the NYSE and in Canada on the TSX. Subject to the receipt of normal course regulatory approvals, Brookfield Renewable anticipates completing the special distribution in the first half of 2020."

06:48 EST Google News Initiative partners with Lee Enterprises, TownNews on paywall - Lee Enterprises (LEE) announced that the Google News Initiative (GOOG, GOOGL) is partnering with Lee Enterprises and its digital technology subsidiary, TownNews, to expedite the development of a machine learning-based paywall technology. The company plans to begin testing the program in December.

06:42 EST Amarin provides updated results from REDUCE-IT trial - Amarin announced the results from the subgroup of 3,146 patients randomized in the United States within the global Vascepa cardiovascular outcomes trial, REDUCE-IT. This prespecified REDUCE-IT subgroup analysis showed robust risk reductions in the USA patients treated with icosapent ethyl 4 g/day versus placebo across all prespecified composite and individual primary and secondary endpoints, including 31% relative risk reduction and 6.5% absolute risk reduction in first occurrence of 5-point major adverse cardiovascular events, corresponding to a number needed to treat of 15, and a significant 30% relative and 2.6% absolute risk reduction in all-cause mortality in the USA subgroup. Additional prespecified cardiovascular endpoints in which the REDUCE-IT USA subgroup showed significant relative risk reduction included myocardial infarction, cardiovascular death, and stroke, similar to the full cohort in the overall REDUCE-IT global results. These results were incremental to the cardiovascular risk reduction achieved by conventional therapy administered to the high-risk patients studied, including incremental to statin therapy.

06:38 EST Regis names Kersten Zupfer as CFO, succeeding Andrew Lacko - Regis, announced the appointment of Kersten Zupfer as Executive Vice President and CFO, effective November 11. Zupfer previously served as the company's Senior Vice President and Chief Accounting Officer. Zupfer will replace Andrew Lacko, who is leaving the company for another opportunity. Lacko will remain employed through the end of November to facilitate a smooth transition of responsibilities and key initiatives. Zupfer has served in accounting and finance roles of increasing leadership at Regis for more than 12 years. Most recently, she served as Senior Vice President and Chief Accounting Officer since November 2017, prior to which she served as Vice President, Corporate Controller, Chief Accounting Officer since December 2014.

06:36 EST Mereo BioPharma: Phase 2b ASTEROID study did not meet primary endpoints - Mereo BioPharma announces 12-month topline data from the company's Phase 2b dose-ranging "ASTEROID" clinical study of setrusumab, an anti-sclerostin antibody, in adults with Type I, III or IV osteogenesis imperfecta, a rare bone disease with no approved treatments. ASTEROID was the largest, prospectively-designed, interventional clinical study to be performed in this patient group. The primary endpoint of the ASTEROID study was change in Trabecular Volumetric Bone Mineral Density of the radius (wrist) over baseline after 12 months of treatment as measured by High Resolution peripheral Quantitative Computed Tomography. As a result of the unexpected high heterogeneity of the study patients' trabecular bone baseline values at the wrist, the primary endpoint was not met at any of the three setrusumab dose levels. HR-pQCT is a relatively new imaging technique that has not been used widely in clinical studies and was chosen in order to improve the understanding of the effect of setrusumab on the bone biology in OI patients, given it can measure both trabecular and cortical vBMD separately. Importantly, an increase in total vBMD at the wrist as measured by HR-pQCT, a secondary endpoint of the study, was observed and reached statistical significance in the medium and high dose cohorts. Mean increases in total vBMD were 4.11%, 4.5%, and 0.58% in the high, medium, and low dose cohorts, respectively. This suggests total vBMD increases were driven by the ability of setrusumab to increase cortical vBMD. The study achieved its important secondary endpoint of increase in areal Bone Mineral Density at the lumbar spine at 6 and 12 months over baseline using two-dimensional dual-energy X-ray absorptiometry, a well-established measurement tool of BMD, reaching statistical significance in the high and medium doses cohorts at both 6 and 12 months with a clear dose-dependent response. Mean increases in areal BMD at the lumbar spine were 8.8%, 6.8 %, and 2.6% in the high, medium, and low dose cohorts at 12 months, respectively. Moreover, increases in areal BMD were consistent across all OI subtypes represented in the study and improved with duration of treatment. Statistically significant changes in areal BMD were also observed by DXA at the femoral neck and total hip with mean increases of 3.1% and 2.2%, respectively, at 12 months in the high dose cohort. Although the ASTEROID study was not powered to show a difference in fracture rates, a trend of reduction in fractures was observed in the high dose cohort. Setrusumab was safe and well-tolerated in the study. There were no cardiac-related safety concerns observed in the study.

06:05 EST Neptune Wellness, International Flavors to co-develop CBD products - Neptune Wellness (NEPT) announced that it has entered into a collaboration agreement with International Flavors (IFF) to co-develop hemp-derived CBD products for the mass retail and health & wellness markets. App Connect is also a party to the agreement to provide related branding strategies and promotional activities. In conjunction with the co-development partnership, Neptune will issue to IFF 2,000,000 warrants, each warrant allowing the holder to purchase one common share of Neptune at an exercise price of $12.00 per share with a 5-year expiration date. The issuance of warrants discussed in this press release is subject to Toronto Stock Exchange approval. App Connect is a company indirectly controlled by Michael Cammarata, CEO and director of Neptune. As a result, the payment of royalties to App Connect under the agreement as contemplated above is also subject to TSX approval. Under this strategic product development partnership, IFF will leverage its intellectual property for taste, scent and nutrition to provide essential oils and product development resources. Neptune will leverage its proprietary cold ethanol extraction processes and formulation IP to deliver extracts for the development, manufacture and commercialization of hemp-derived products, infused with essential oils, for the cosmetics, personal care and home care markets. The first products are expected to launch under Neptune's Forest Remedies brand at U.S. retailers in the first half of calendar 2020. The Initial launch will include a variety of topical products across the aromatherapy category, a market estimated at approximately $3B annually. Additional category launches should follow and the total SKU count could ultimately exceed 50 SKUs. Neptune will be responsible for the marketing and sale of the products. Neptune will record revenues from product sales and in turn will pay a royalty to each of IFF and App Connect associated with the sales of co-developed products.

06:04 EST Credit Suisse names David Miller as CEO of Investment Banking & Capital Markets - The Board of Directors has approved a change to the Executive Board of Credit Suisse. This change, along with a number of additional appointments, are effective immediately. James L. Amine has decided to step down from his role of CEO of IBCM and from the Group Executive Board, after leading that activity successfully for more than ten years in order to take on a newly created role as head of Private Credit Opportunities, based in New York. David Miller is appointed CEO of Investment Banking & Capital Markets and will join the Group Executive Board. Miller was previously Global Head of Credit, Head of Global Credit Products and a member of the Global Markets Management Committee. Eric Varvel is appointed Chairman of IBCM, in addition to his existing responsibilities as CEO Asset Management and President and CEO Credit Suisse Holdings (USA). Harold Bogle, who was until now Chairman of IBCM will become Vice-Chairman, Group Executive Office.

06:01 EST Foamix, MenloTherapeutics to merge in stock-for-stock exchange

05:32 EST Rocky Mountain Chocolate: update on strategic alternatives, board composition - Rocky Mountain Chocolate Factory is providing an update to shareholders on its previously announced strategic alternatives process as well as its board composition. "On May 29, the company announced that its board was conducting a process to explore and evaluate strategic alternatives to maximize shareholder value and position the company for long-term success. As part of this process, the company and its financial advisor, North Point Advisors, held discussions with numerous potential acquirors and strategic partners. However, given some of the recent headwinds faced by the company, none of those discussions has resulted in alternatives that the board believes would be in the best interest of shareholders. By way of background, in early March the company received an unsolicited offer to acquire the company for a premium to the then current market price. Based upon discussions with the potential acquiror and after consultation with our financial and legal advisors, the board considered the offer to be credible and worth exploring to maximize value to shareholders. However, after a thorough due diligence process, the potential acquiror advised the board that it was no longer interested in pursuing an acquisition of the company. Based on the board's prior analysis of the headwinds facing the company, the board determined that North Point Advisors should continue to evaluate the company's strategic alternatives and engage in a broad process to identify an acquiror or strategic partner that would benefit all shareholders. As noted above, that process has not yet yielded an alternative that the board believes would be in the best interest of shareholders. The board has been actively engaged throughout this rigorous process and is continuing to evaluate an additional range of business changes and alternatives to improve company results and maximize shareholder value. The Board recognizes that new directors with fresh, different and diverse perspectives would benefit the company and its shareholders. As such, the board invited the two potential directors proposed by AB Value Partners, Andrew Berger and Mary Kennedy Thompson, for interviews with the entire board. Following those interviews, the Board extended an offer to Ms. Thompson to join the board due to her background and extensive franchising expertise. This offer was not made as a means to settle a potential proxy contest with AB Value, but rather was made without any conditions attached. The board did not believe that Mr. Berger would add expertise or perspective that would benefit the company's shareholders and accordingly did not make him an offer to join the board, although the board remains open to a continued dialogue with Mr. berger and his view of our company. The board intends to hire a search firm to identify other potential new and diverse director candidates who can add value and bring additional perspective to the board. There is no specific timetable for this evaluation to be completed."

05:12 EST Intercontinental Exchange to launch new exchange in Abu Dhabi Global Market - Intercontinental Exchange announced that it will launch a new exchange, ICE Futures Abu Dhabi, or IFAD, "to host the world's first futures contracts based on Abu Dhabi National Oil Company's, or ADNOC, Murban crude oil." On November 4, Abu Dhabi's Supreme Petroleum Council, or SPC, announced that it would implement a new pricing mechanism for ADNOC's Murban crude. As a result, Murban pricing will move from a retroactive official selling price to market-driven, forward pricing using a Murban futures contract as its price marker. The SPC also authorized ADNOC to remove destination restrictions on Murban crude sales. With the support of ADNOC, the Murban futures contract referenced by the SPC will be hosted on ICE Futures Abu Dhabi.

05:08 EST Genentech pivotal Part 2 of SUNFISH study met primary endpoint - Genentech, a member of the Roche Group, announced positive data from the pivotal Part 2 of the SUNFISH study evaluating risdiplam in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy, or SMA. The study met its primary endpoint of change from baseline in the Motor Function Measure 32, or MFM-32, scale after one year of treatment with risdiplam, compared to placebo. No treatment-related safety findings leading to study withdrawal have been seen in any risdiplam trial to date. Safety for risdiplam was consistent with its known safety profile and no new safety signals were identified.