Stockwinners Market Radar for May 31, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:22 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. Amazon (AMZN) scaled back deliveries and adjusted routes in cities including Chicago and Los Angeles, Apple (APPL) kept some outlets shut, while Target (TGT) extended store closures nationwide after the death of George Floyd sparked demonstrations across the country, Bloomberg's Spencer Soper and James Ludden reported. "We are monitoring the situation closely and in a handful of cities we adjusted routes or scaled back typical operations to ensure the safety of our teams," an Amazon spokeswoman told Bloomberg News. 2. According to a company's filing, "On May 28, 2020, Alexion Pharmaceuticals [ALXN] and Amgen [AMGN] entered into a Confidential Settlement and License Agreement to settle three inter partes review proceedings at the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office initiated by Amgen that the Company previously disclosed. Pursuant to the Settlement Agreement, the company and Amgen have agreed to file a motion with the PTAB to terminate each of the pending IPRs. In addition, effective March 1, 2025 (or an earlier date in certain circumstances), the company grants to Amgen (and its affiliates and certain partners) a non-exclusive, royalty-free, license under U.S. patents and patent applications related to eculizumab and various aspects of the eculizumab product that the company currently markets and sells under the tradename SOLIRIS. This license will allow Amgen (and its affiliates and certain partners), effective March 1, 2025, the right to make, have made, use, import, have imported, sell, have sold, offer for sale, have offered for sale, distribute, and have distributed in or for the U.S., an eculizumab product." 3. President Trump declared war on Twitter (TWTR), and Wall Street trembled, with the stock shedding 9% of its value from Wednesday to Friday as investors digested the financial implications of the company having the world's most powerful person-and its most loyal user-as a mortal enemy, Eric Savitz wrote in this week's edition of Barron's. While tech stocks have outperformed during the pandemic, the Twitter-White House spat brings back a bad memory from 2019 and could mean a return of the "tech lash," another challenge for stocks this summer, the author added. Twitter's 9% decline equated to $2.4B in lost market value, the publication notes, pointing out that a similar move applied to the tech giants, would be far more substantial. Microsoft (MSFT), Apple, Amazon, Alphabet (GOOGL), and Facebook (FB) have a combined market value of $5.6T. A 9% haircut comes to $500B, Savitz contended. 4. Coty (COTY) is set to appoint its fourth new chief executive in less than four years, as the cosmetics and fragrance maker strives to revive slumping sales and reduce its burdensome debt load, The Wall Street Journal's Ben Dummett and Sharon Terlep reported. Peter Harf, Coty's current chairman, will also assume the CEO role as soon as Monday, the authors noted, citing people familiar with the matter. 5. Spirit Airlines (SAVE), Southwest Airlines (LUV), Delta Air Lines (DAL), Extended Stay America (STAY), Lindblad Expeditions (LIND), Marathon Petroleum (MPC), Las Vegas Sands (LVS), CareTrust (CTRE), Valero Energy (VLO) and Phillips 66 (PSX), Cheniere Energy Partners (CQP), BAE Systems (BAESY) saw positive mentions in this week's edition of Barron's.

20:08 EDT Immutep announces data from Phase II TACTI-002 study - Immutep (IMMP) announced new interim data from its ongoing Phase II TACTI-002 study. This data relates to the cut-off date of 4 May 2020 and shows "improving efficacy results," the company said. The results were presented as a poster short talk at the 2020 American Society of Clinical Oncology Virtual Annual Meeting. TACTI-002 is being conducted in collaboration with Merck (MRK). The study is evaluating the combination of the company's lead product candidate eftilagimod alpha with Merck's KEYTRUDA in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma or Non-Small Cell Lung Cancer in first and second line. Immutep CSO and CMO, Frederic Triebel said: "TACTI-002 is generating increasingly promising data from both the NSCLC and HNSCC arms of study, as patients continue to receive efti in combination with KEYTRUDA. Remarkably, one HNSCC patient has even achieved a complete response, bringing the total response rate to an improved 39% in this arm. This is an early indication that the efti in combination with pembrolizumab may more than double the proportion of HNSCC patients that respond to pembrolizumab monotherapy, which is usually 18% or less1."

20:01 EDT Innovent Biologics, Eli Lilly announce results of TYVYT ORIENT-2 study - Innovent Biologics jointly announced with Eli Lilly the results of TYVYT ORIENT-2 study, a pivotal clinical study of second-line treatment for locally advanced or metastatic esophageal squamous cell carcinoma at the 56th Annual Meeting of the American Society of Clinical Oncology. The ORIENT-2 study was a randomized, open-label, multicenter, Phase 2 clinical study comparing the efficacy and safety of sintilimab with chemotherapy in patients with advanced or metastatic ESCC whose disease progressed on first-line therapy. A total of 190 subjects were enrolled in the study and randomly assigned in a 1:1 ratio to receive either sintilimab injection or chemotherapy. The study's primary endpoint was overall survival. As of August 2, 2019, compared with paclitaxel/irinotecan, sintilimab demonstrated a statistically significant improvement in OS in the intent-to-treat population. The median OS in the sintilimab-treated group and the chemotherapy-treated group were 7.2 months and 6.2 months and the 12-month OS rates were 37.4% and 21.4%, respectively, showing "encouraging" antitumor efficacy in the sintilimab-treated group, the companies said. The safety profile of sintilimab in this study of ESCC patients was similar to that seen in studies of sintilimab in other tumors.

16:18 EDT BioMarin provides update from Phase 1/2 study of Valoctocogene Roxaparvovec - BioMarin Pharmaceutical announced an update to its previously reported results of an open-label Phase 1/2 study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with severe hemophilia A. The data have been submitted as a late-breaking abstract to the World Federation of Hemophilia Virtual Summit to be held June 14-19, 2020. The four-year update for the 6e13 vg/kg and three-year update for the 4e13 vg/kg cohorts demonstrated that all subjects in both cohorts remain off prophylactic Factor VIII treatment since receiving their single dose of valoctocogene roxaparvovec. Cumulative mean annualized bleed rates remain less than one in both cohorts and below pre-treatment baseline levels. The mean ABR in year four for the 6e13 vg/kg cohort was 1.3, and the mean ABR in year three for the 4e13 vg/kg cohort was 0.5. Over the past year, six of the seven participants in the 6e13 vg/kg cohort and five of the six participants in the 4e13 vg/kg cohort remain free of spontaneous bleeds. Factor VIII activity levels declined commensurate with the most recent years' observations and remain in a range to provide hemostatic efficacy. Overall, the safety profile of valoctocogene roxaparvovec remains consistent with previously reported data with no delayed-onset treatment related events. No participants developed inhibitors to Factor VIII, and no participants withdrew from the study. No participants have developed thrombotic events. The most common adverse events associated with valoctocogene roxaparvovec occurred early and included transient infusion-associated reactions and transient, asymptomatic, and mild to moderate rise in the levels of certain proteins and enzymes measured in liver function tests with no long-lasting clinical sequelae. The Food and Drug Administration is reviewing the biologics license application, under Priority Review, for valoctocogene roxaparvovec with a PDUFA action date of August 21, 2020. The FDA also granted valoctocogene roxaparvovec Breakthrough Therapy designation. The European Medicines Agency validated the company's Marketing Authorization Application for valoctocogene roxaparvovec which has been in review under accelerated assessment since January. Recognizing valoctocogene roxaparvovec for its potential to benefit patients with unmet medical needs, EMA granted access to its Priority Medicines regulatory initiative. Although the MAA remains under accelerated assessment at this time, the company expects the review procedure to be extended by at least three months due to COVID-19 delays. Further, the company believes there is a high possibility that the MAA will revert to the standard review procedure, as is the case with most filings that initially receive accelerated assessment. Because of the combination of these events, the company expects an opinion from the Committee for Medicinal Products for Human Use in late 2020/early 2021. BioMarin's valoctocogene roxaparvovec has also received orphan drug designation from the FDA and EMA for the treatment of severe hemophilia A. The Orphan Drug Designation program is intended to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

11:55 EDT Taiwan Liposome announces topline results for TLC590 Phase II trial - TLC announced topline results from the TLC590 Phase II clinical trial, a randomized, double-blind, placebo- and comparator- controlled study of TLC590 in patients following bunionectomy. Results show that TLC590 demonstrated greater reductions in pain than both placebo and bupivacaine through 168 hours. TLC590 is a non-opioid, proprietary BioSeizer sustained release formulation of ropivacaine. The trial compared TLC590 with normal saline placebo and the current standard of care for postsurgical pain relief, bupivacaine, in 150 patients randomized at the ratio of 1:1:1. The primary outcome measure was comparison of pain relief between TLC590, placebo, and bupivacaine in area under the curve on the numerical pain rating scale. The overall reduction in pain intensity provided by TLC590 was greater than that of placebo as well as bupivacaine at every time interval from 0 hours through the end of the study at 168 hours. TLC590 achieved statistically significant pain relief over both placebo from 0 to 24 hours. The differences in AUC0-72 did not reach statistical significance. TLC590 delayed the median time to first post-operative opioid use, and the total post-operative opioid consumption of TLC590 was less than both placebo and bupivacaine at every time point through 168 hours. TLC590 was well-tolerated, with a safety profile comparable to bupivacaine and placebo. Most adverse events were mild and unrelated to the treatment. There were no serious adverse events in the TLC590 group.