Stockwinners Market Radar for November 15, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:13 EST Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Johnson & Johnson (JNJ) announced the expansion to the partnership between its Janssen Pharmaceutical and the Biomedical Advanced Research and Development Authority, which is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services for the ongoing development of Janssen's investigational COVID-19 vaccine candidate. Under the amendment, Janssen will commit approximately $604M and BARDA will commit approximately $454M to support the ongoing Phase 3 ENSEMBLE trial evaluating Janssen's investigational COVID-19 vaccine candidate as a single-dose in up to 60,000 volunteers worldwide. 2. PNC Financial (PNC) is in talks to buy the U.S. arm of Spanish lender BBVA (BBVA), The Wall Street Journal's Cara Lombardo and Liz Hoffman reported, citing people familiar with the matter. A deal, which would likely be valued at more than $10B, would create the nation's fifth largest retail bank, with more than $550B of assets and branches up and down the eastern half of the country, the authors noted. 3. Investors have long viewed memory as a commodity and one can the consequences in the low multiple they have paid for Micron (MU), the biggest pure play bet, Eric Savitz wrote in this week's edition of Barron's. But the outlook for Micron is brightening - and the stock could double from here, the author contended. 4. Walmart (WMT), KKR (KKR) and Rakuten announced the signing of definitive agreements under which KKR will purchase a majority stake and a new Rakuten subsidiary will purchase a minority stake in Seiyu GK in a deal valuing the business at approximately $1.6B. Under the terms of the agreements, KKR will acquire a 65% stake in Seiyu, and Rakuten will acquire a 20% stake, through a newly created subsidiary focused on retailer digital transformation. Walmart will retain a 15% stake in Seiyu. 5. Target (TGT), SPPlus (SP), Wintrust Financial (WTFC), ACME United (ACU), Century Communities (CCS), AtlasAir Worldwide (AAWW) and Logitech (LOGI) saw positive mentions in this week's edition of Barron's.

20:01 EST Foundation Building Materials to be acquired by American Securities - Foundation Building Materials announced that it has entered into a definitive agreement under which an affiliate of American Securities will acquire all outstanding shares of FBM for $19.25 per share in an all-cash transaction valued at approximately $1.37B, including outstanding debt. An affiliate of Lone Star Funds acquired FBM in 2015 and has maintained a majority ownership since the company's initial public offering in 2017. Upon completion of the transaction, FBM will become a privately held company. The transaction, which was unanimously approved by the FBM Board of Directors, represents a premium of approximately 27% to the closing price of FBM common stock on November 13, 2020, the last trading day prior to the transaction announcement. The transaction is expected to close in the first quarter of 2021, subject to customary closing conditions, including receipt of clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the Competition Act.

18:32 EST Mirum Pharmaceuticals announces data from ITCH, IMAGINE II studies - Mirum Pharmaceuticals announced data presented at the Annual Meeting of the American Association for the Study of Liver Diseases - The Liver Meeting Digital Experience. The data were presented in a late-breaking oral presentation titled "Preliminary Analysis of ITCH and IMAGINE II - Outcome of Long-term Administration of Maralixibat in Children with Alagille Syndrome." The objective of the studies was to assess pruritus and other markers of cholestasis in patients with Alagille syndrome with up to 220 weeks of treatment with maralixibat. Maralixibat, an apical sodium bile acid transporter inhibitor, has previously been shown to interrupt the enterohepatic circulation of bile acids, reducing pruritus. Of the children enrolled in the ITCH and IMAGINE II studies, 28 of the 37 patients were on study at 48 weeks with 80% of those experiencing clinically meaningful reductions in pruritus which were durable beyond four years, with 90% of patients who continued on study experiencing a pruritus response at the end of treatment. The mean reduction in ItchRO at week 48 was -1.9 points and deepened to -2.3 points at the end of treatment. Maralixibat treatment improved quality of life and led to improved growth parameters. The long-term data suggest that maralixibat has the potential to be an effective treatment and could serve as an alternative to surgery for ALGS patients, if approved.

17:36 EST Gilead, Novo Nordisk present new data from Proof-of-Concept trial in NASH - Gilead Sciences (GILD) and Novo Nordisk (NVO) announced results from a Phase 2 proof-of-concept trial. The five-arm trial evaluated combinations of Novo Nordisk's semaglutide, a GLP-1 receptor agonist, with Gilead's investigational FXR agonist cilofexor and/or Gilead's investigational ACC inhibitor firsocostat over 24 weeks in 108 people with non-alcoholic steatohepatitis. The trial met its primary endpoint by demonstrating that in people with NASH and mild to moderate fibrosis all regimens were well tolerated. The most common adverse events were gastrointestinal. Minimal pruritus was observed in people treated with cilofexor. Across all groups, 5%-14% of people discontinued any trial treatment due to AEs. Exploratory efficacy endpoints assessing biomarkers of liver health at 24 weeks in post-hoc analyses showed statistically significant improvements in hepatic steatosis and liver injury in the combination arms versus semaglutide alone. Although liver stiffness measured by vibration-controlled transient elastography and enhanced liver fibrosis score declined in all groups, statistically significant differences between groups were not observed. The companies also presented preclinical data supporting the development of combination approaches in NASH. In the preclinical trial, semaglutide alone and in combination with cilofexor and/or GS-834356 were administered daily for 12 weeks in a murine model of diet-induced NASH. The results demonstrated that while semaglutide significantly improved NASH and fibrosis-related endpoints, the addition of either cilofexor or the firsocostat analog further improved liver fat reduction. The combination of all three agents had the greatest impact on changes in the NAFLD Activity Score. The safety and efficacy of firsocostat, GS-834356 and cilofexor have not been established. Firsocostat, GS-834356 and cilofexor are investigational compounds and are not approved by the FDA or any other regulatory authority. Semaglutide has not been approved by the FDA or any other regulatory authority for the treatment of people living with NASH, but has been approved for the treatment of type 2 diabetes.

16:18 EST Atara to present new open-label extension data in Phase 1a study of ATA188 - Atara Biotherapeutics announced the Company will present for the first time 15-month safety and efficacy data from all patients in the two highest dose cohorts of the Phase 1a open-label extension study of ATA188 for the treatment of progressive forms of multiple sclerosis. The results are featured in a poster presentation at the European Charcot Foundation 28th Annual Meeting, held November 15-19, 2020. Findings presented include data on 24 patients from the 12-month dose escalation portion of the trial, 16 of whom entered the OLE and have greater than or equal to 15-month data available as of October 2020. Throughout the entire Phase 1a and OLE study, nine of the 16 patients who entered the OLE demonstrated sustained disability improvement with ATA188 treatment. In seven out of the nine patients, SDI was driven by sustained improvement in Expanded Disability Status Score. A dose-related increase in the number of patients meeting SDI criteria was observed. Similar safety profile with no dose-limiting toxicities was shown in the highest dose cohorts. In the two highest dose cohorts, five out of 12 total patients and six out of 12 total patients demonstrated SDI at 12 and 15 months, respectively. SDI was driven by EDSS in all but one of the patients in Cohorts 3 and 4; all SDI observed in Cohort 4 was based on EDSS improvement. The Cohort 3 and 4 doses demonstrated similar efficacy profile based on SDI, with the Cohort 4 dose trending toward greater effect on EDSS. Given clinical results to date in ATA188 studies and the significant unmet medical need in progressive forms of MS, the company is increasing its investment in the ATA188 program. Atara is expanding the size of the RCT to at least 64 patients, changing the primary endpoint of the study to disability improvement, and maintaining biological and functional endpoints. The company recently submitted material to the U.S. Food and Drug Administration, that includes the Phase 1a data, planned updated design of the RCT and discussion of potential opportunities for expedited development of ATA188 for patients living with progressive forms of MS. Feedback from the agency is expected at the end of 2020.

16:05 EST Adverum announces interim data from Cohorts 1-4 from OPTIC Phase 1 trial - Adverum Biotechnologies announced new interim data from Cohorts 1-4 of the OPTIC Phase 1 clinical trial of ADVM-022 intravitreal injection gene therapy in patients requiring frequent anti-VEGF injections for their wet age-related macular degeneration. "With these impressive OPTIC data and the removal of the partial clinical hold on ADVM-022 by the FDA, our goal is to continue to advance into pivotal trials to demonstrate the transformative potential of our gene therapy," said Laurent Fischer, chief executive officer of Adverum. "We are excited that ADVM-022 has the potential to be a "one and done" IVT injection that may dramatically reduce the treatment burden for the millions of patients with wet AMD and DME worldwide. Particularly during COVID-19, we are reminded of the benefits that ADVM-022, a novel gene therapy that has demonstrated long-term treatment benefit after one in-office IVT injection, could deliver to patients. Our Adverum team is laser-focused on accelerating the development and future commercial launch plans for ADVM-022. I am humbled by the dedication of the retina specialists and their staff, and our employees, to help progress our clinical trials which generate the data necessary to drive our mission of helping patients with severe ocular diseases."

15:58 EST VIVUS seeks bankruptcy court approval of second amended joint Chapter 11 - On November 10, 2020, VIVUS filed the Second Amended Joint Prepackaged Chapter 11 Plan of Reorganization of VIVUS and Its Affiliated Debtors with the United States Bankruptcy Court for the District of Delaware. As set forth in a letter filed with the Bankruptcy Court, the Plan has the full support of the official committee of equity security holders appointed in the company's chapter 11 case and incorporates the terms and conditions of the plan support agreement filed with the Bankruptcy Court on November 5, 2020. Upon confirmation of the Plan by the Bankruptcy Court, only holders of issued and outstanding common stock of the Company as of the "Existing Stock Record Date" will be eligible to participate in the "Existing Stock Settlement" set forth in Section 5.3 of the Plan and subject to the conditions thereof. The company has announced that, subject to confirmation of the Plan, the "Existing Stock Record Date" shall be Friday, November 13, 2020. The Existing Stock Settlement, as described in the Plan, may entitle eligible holders of Existing Stock to receive interests in a liquidating trust that will be established on the Effective Date solely for the purpose of distributing certain Royalty Payments in connection with Net Sales of VI-0106, if any, pursuant to the Royalty Agreement to eligible holders of Existing Stock. The initial seed funding amount for the Liquidating Trust will be determined by the Equity Committee and will be funded by the company from the $6M Existing Stock Cash amount pursuant to the Plan. Upon confirmation of the Plan by the Bankruptcy Court, any person who acquires Interests in the Company, including, without limitation, common stock, directly or indirectly, after the Existing Stock Record Date will not be eligible to participate in the Existing Stock Settlement and will receive no recovery on account thereof. A combined hearing to consider, among other things, approval of the disclosure statement and confirmation of the Plan and any objections thereto will be held before the Bankruptcy Court on December 3, 2020 at 10:00 a.m.