Stockwinners Market Radar for April 30, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:32 EDT Astellas to acquire Iveric Bio for $40 per share in cash - Astellas Pharma and Iveric Bio announced that on April 29, the companies have entered into a definitive agreement under which Astellas through Berry Merger Sub, a wholly-owned subsidiary of Astellas US Holding, has agreed to acquire 100% of the outstanding shares of Iveric Bio for $40 per share in cash for a total equity value of approximately $5.9B. In the acquisition, Iveric Bio will become an indirectly wholly-owned subsidiary of Astellas. The total equity value of Iveric Bio in the acquisition assumes that there are approximately 148.2M outstanding shares of Iveric Bio common stock on a fully diluted basis. The purchase price represents a premium of 64% to Iveric Bio's unaffected closing share price of $24.33 on March 31, 2023, and a premium of 75% to Iveric Bio's 30 trading day volume weighted average price as of March 31, 2023. The Boards of Directors of both companies have unanimously approved the transaction. Astellas expects that the acquisition of Iveric Bio will not only contribute to Astellas' fiscal 2025 revenue targets set in its Corporate Strategic Plan 2021, but also, that ACP in conjunction with fezolinetant and PADCEV, is anticipated to be a revenue-generating pillar to help compensate for the decline in sales of XTANDI due to anticipated patent expiration later this decade. The completion of the acquisition is not subject to a financing condition. Astellas does not anticipate making any change in its dividend policy following the acquisition. The closing of the proposed acquisition is subject to approval by Iveric Bio's stockholders and other customary closing conditions, including receipt of required regulatory approvals. The companies expect to complete the acquisition in the second quarter of Astellas' fiscal year 2023.

16:26 EDT Pliant Therapeutics announces long-term data from INTEGRIS-IPF Phase 2a trial - Pliant Therapeutics announced 24-week data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, dose-ranging, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with idiopathic pulmonary fibrosis. The 320 mg dose group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated up to 40 weeks and displayed a favorable pharmacokinetic profile. The trial's exploratory efficacy endpoints assessed changes in forced vital capacity, Quantitative Lung Fibrosis imaging, patient reported cough severity and biomarkers. At Week 24, bexotegrast-treated patients demonstrated improvements across all of these exploratory efficacy endpoints versus placebo. The INTEGRIS-IPF Phase 2a trial was designed to evaluate bexotegrast at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks and 320 mg or placebo for up to 48 weeks in 119 patients with IPF. The 320 mg group enrolled 21 patients in the active arm and 8 patients in the placebo arm. Comparable to the lower dose groups, approximately 80% of enrolled patients were on standard of care and were equally distributed between nintedanib and pirfenidone. The primary endpoint of the INTEGRIS-IPF trial was the evaluation of the safety and tolerability of bexotegrast. Bexotegrast was well tolerated at 320 mg up to 40 weeks of treatment with no drug-related serious adverse events reported. Most frequently reported treatment-emergent adverse events were mild or moderate in severity and not related to study drug. No TEAE-related discontinuations occurred after Week 12. The trial's secondary endpoint was an assessment of its pharmacokinetics. Bexotegrast exhibited dose-proportional increases in plasma concentrations, consistent with prior dose groups. The exploratory efficacy endpoints of the INTEGRIS-IPF trial measured changes in FVC, high-resolution CT-based QLF, patient reported cough severity and profibrotic biomarkers to Week 24. At Week 24, 50% of bexotegrast-treated patients experienced an increase in FVC from baseline versus 0% in the placebo group. Moreover, of the bexotegrast-treated patients who experienced an increase in FVC from baseline at Week 12, 89% maintained an increase in FVC from baseline at Week 24.

06:45 EDT Teva announces FDA approval of UZEDY extended-release injectable suspension - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and MedinCell announced that the U.S. Food and Drug Administration has approved UZEDY, or risperidone, extended-release injectable suspension for the treatment of schizophrenia in adults. UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose. UZEDY will be available in the U.S. in the coming weeks.