Stockwinners Market Radar for June 07, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:57 EDT Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. AstraZeneca (AZN) has made a preliminary approach to rival drugmaker Gilead Sciences (GILD) about a potential merger, in what would be the biggest health-care deal on record, Bloomberg's Ed Hammond, Aaron Kirchfeld, and Dinesh Nair reported, citing people familiar with the matter. The U.K.-based company informally contacted Gilead last month to gauge its interest in a possible tie-up, the people said. While Gilead has discussed the idea with advisers, no decisions have been made on how to proceed and the companies aren't in formal talks, sources added. 2. Facebook (FB) CEO Mark Zuckerberg said that the company will review existing policies on how it handles content related to civil unrest or violence, as the company faces criticism over its decision to not moderate or take down some posts, The Wall Street Journal's Kimberly Chin reported. Facebook said it will review its policies on content concerning threats of state use of force as well as content in countries with civil unrest or violent conflicts, the author noted. While the company has some policies in place that call for greater restrictions during emergencies and countries undergoing conflict, "there may be additional policies or integrity measures to consider around discussion or threats of state use of force when a country is in this state," Zuckerberg said. 3. Chasing COVID-19 vaccine news has sent investors on a wild ride this spring, as shares of biotechs like Moderna (MRNA) and Novavax (NVAX) have spiked one day and crashed the next, Josh Nathan-Kazis wrote in this week's edition of Barron's. Over the next few months, a handful of pharmaceutical companies plan to begin testing a new category of drugs designed to treat, or even prevent, a COVID-19 infection. Called monoclonal antibodies, the drugs mimic the proteins a human body would make to fight the virus that causes COVID-19, and while they don't hold out the promise of eliminating the threat of COVID-19 in the way that an effective vaccine could, the new antibodies could help curb the pandemic, he noted. This summer, at least three programs aim to begin testing their antibodies in humans, namely Eli Lilly (LLY), Regeneron Pharmaceuticals (REGN), and a collaboration between Vir Biotechnology (VIR) and GlaxoSmithKline (GSK). 4. The New York Times (NYT) said that its editorial page editor James Bennet has resigned following public furor over the paper's decision to publish an op-ed by Republican Senator Tom Cotton under the headline "Send in the Troops," Bloomberg's Yuegi Yang reported. Bennet's deputy, James Dao, will resign from the paper's masthead and be reassigned to the newsroom, the author noted. 5. Twitter (TWTR), FMC (FMC), Sysco (SYY), US Foods (USFD), Performance Food Group (PFGC), MGM Growth Properties (MGP), and GlaxoSmithKline saw positive mentions in this week's edition of Barron's.

16:13 EDT Blueprint Medicines presents updated Part 1 data from PIONEER trial - Blueprint Medicines announced updated clinical data from part 1 of the PIONEER trial showing robust and consistent clinical activity for avapritinib across multiple qualitative and quantitative measures of cutaneous disease in patients with indolent systemic mastocytosis. Additional data showed avapritinib treatment resulted in deepening improvements in overall disease symptoms, as measured by the Indolent SM Symptom Assessment Form total symptom score , and was well-tolerated through 24 weeks of follow-up. These data were presented during the European Academy of Allergy and Clinical Immunology Digital Congress 2020. SM is a rare disease driven by the KIT D816V mutation in nearly all patients and characterized by uncontrolled mast cell proliferation and activation. The disorder can lead to debilitating systemic, gastrointestinal and neurocognitive symptoms, including life-threatening anaphylaxis. Additional skin manifestations such as itching, flushing and pigmented skin lesions are common and can significantly impact quality of life. Avapritinib is a potent and highly selective inhibitor of D816V mutant KIT. Previously reported data from part 1 of the PIONEER trial showed that treatment with avapritinib was well-tolerated and resulted in robust and clinically meaningful improvements on measures of mast cell burden, disease symptoms and patient-reported quality of life through 16 weeks. Based on these data, avapritinib 25 mg once daily was selected as the recommended part 2 dose. As of a data cutoff date of March 31, 2020, updated data from part 1 of the PIONEER trial showed a deepening of symptom reductions in patients treated with avapritinib through 24 weeks of follow-up. The mean percent change from baseline in ISM-SAF TSS was -35% in patients treated with avapritinib 25 mg QD compared to -4% in patients treated with placebo. In addition, the mean percent change from baseline in ISM-SAF skin domain score was -38% for avapritinib 25 mg QD versus +11% for placebo. The updated data also showed a 60% response rate in patients treated with avapritinib 25 mg QD compared to a 0% response rate in patients treated with placebo at 24 weeks, with response defined as a 30% or greater reduction in ISM-SAF TSS. Based on these data and feedback from the U.S. Food and Drug Administration, Blueprint Medicines has selected response rate at 24 weeks as the primary endpoint for the registration-enabling part 2 of the PIONEER trial and plans to enroll approximately 200 patients. Blueprint Medicines continues to plan to initiate patient screening in part 2 of the PIONEER trial in June 2020. As of a data cutoff date of March 31, 2020, avapritinib 25 mg QD was well-tolerated and safety results were consistent with previously reported data, with no Grade greater than or equal to 3 adverse events or discontinuations due to adverse events.

16:04 EDT Takeda announces findings from data analyses of Phase 3 HELP Study OLE - Takeda Pharmaceutical announced findings from two new interim analyses of data from the Phase 3 HELP Study Open-label Extension. The analyses suggest that TAKHZYRO is well-tolerated and can prevent hereditary angioedema attacks over an extended treatment period, with sustained and consistent reduction in monthly attack rate across a range of different patient subgroups. The data was presented at the 2020 European Academy of Allergy and Clinical Immunology Digital Congress. The original Phase 3 HELP Study was conducted in 125 patients aged 12 years and older over 26 weeks, making it the largest randomised, controlled prevention study in HAE, with the longest active treatment duration, to date. The HELP Study OLE was designed to evaluate the long-term safety and efficacy of TAKHZYRO for up to 2.5 years and was completed in November 2019. These interim analyses were based on data collected between May 2016 and August 2018 and included 109 rollover patients, who were originally evaluated in the HELP Study, and 103 eligible non-rollover patients who did not participate in the initial study but had experienced at least one HAE attack in 12 weeks. At the time of the interim analyses, patients received treatment for a mean duration of 19.7 months. Results from the HELP Study OLE showed that the safety profile of TAKHZYRO was consistent with the original findings from the HELP Study, with treatment-related treatment emergent adverse events occurring in 50% of patients. In addition, data from the HELP Study OLE showed that the efficacy of TAKHZYRO 300 mg administered subcutaneously every two weeks in rollover patients was consistent with the original findings from the HELP Study. A sustained reduction in attack rate was observed in this group, with numerically lower mean monthly attack rates of 0.18 during the extended treatment period of the HELP Study OLE and 0.26 at the end of the HELP Study. The efficacy profile of non-rollover patients was similar to efficacy in rollover patients with two years of cumulative study experience in the HELP Study and HELP Study OLE. The median attack rate reduction was consistent across all subgroups, including patient sex, race, HAE type, age, BMI, history of prophylaxis use, history of laryngeal attacks, and baseline attack rate. In the study TEAEs occurred in about 95% of patients and were mostly mild or moderate in severity. The safety profile of TAKHZYRO was comparable across all subgroups, with treatment-related treatment emergent adverse events occurring in 50% of patients and the most common being mild injection site pain. At the end of the HELP Study and at the start of the HELP Study OLE, the mean attack rates per month in the patients receiving TAKHZYRO 300 mg every two weeks ranged from 0.26 for the treatment group and 2.39 for the control group. For patients treated with TAKHZYRO 300 mg every two weeks in the original HELP Study, sustained reductions in HAE attacks were observed in the HELP Study OLE, with a mean monthly attack rate of 0.18. Similarly, further numerical reductions were also shown for the number of attacks requiring acute treatment and for the rate of moderate or severe attacks for this group as well as for patients receiving TAKHZYRO 300 mg every four weeks in the HELP Study. The efficacy profile of non-rollover patients was similar to efficacy in rollover patients with two years of cumulative study experience in the HELP Study and HELP Study OLE.

15:48 EDT Celldex announces results from Phase 1 dose escalation study of CDX-0159 - Celldex Therapeutics announced results from the company's Phase 1 randomized, double-blind, placebo-controlled, dose escalation study of KIT inhibitor CDX-0159 in healthy subjects. Data were featured in a late breaking presentation at the European Academy of Allergy and Clinical Immunology Annual Congress 2020. "CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, consistent with systemic mast cell suppression," the company said. A single dose of CDX-0159 induced dose-dependent tryptase reduction below the level of assay detection within days at doses as low as 1.0 mg/kg and maintained suppression for over two months at 3.0 mg/kg and above. Tryptase is an enzyme synthesized and secreted almost exclusively by mast cells and decreases in plasma tryptase levels are believed to reflect a systemic reduction in mast cell burden in both healthy volunteers and in disease, providing important proof of concept for the program. The data also support expansion of the program into mast cell driven diseases, including initially studies in forms of chronic urticaria given the central role mast cells are known to play in the etiology of CU.

15:14 EDT Opiant Pharmaceuticals 'disappointed' with court decision in patent case - The U.S. District Court for the District of New Jersey has entered a decision in the patent litigation regarding NARCAN Nasal Spray 4mg/spray product. The Court ruled in favor of the Defendants, Teva Pharmaceuticals (TEVA). Opiant's (OPNT) commercial partner Emergent BioSolutions, intends to appeal the decision to the Court of Appeals for the Federal Circuit. "While we are disappointed by the decision today, we are mindful of the important role NARCAN Nasal Spray plays across the United States in helping our communities save lives from opioid overdose," said Roger Crystal, President and Chief Executive Officer of Opiant. "With our pipeline and strong financial position, we remain committed to develop best-in-class medicines for addiction and overdose."