Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb (NYSE:BMY) announced positive results from the POETYK PSO-1 Phase 3 trial for deucravacitinib, an oral selective TYK2 inhibitor, in moderate to severe plaque psoriasis. The trial met both co-primary endpoints, with more patients achieving a 75% improvement in PASI and a clear sPGA score after 16 weeks. Additionally, deucravacitinib showed superiority over Otezla. The trial's safety profile aligns with earlier results, supporting its potential as a new treatment option. Further evaluation of the data will be presented at future medical meetings.

The Bristol Myers Squibb–Pfizer Alliance has launched the No Time to Wait campaign aimed at raising awareness of atrial fibrillation (AFib), deep vein thrombosis (DVT), and pulmonary embolism (PE) symptoms. AFib increases stroke risk fivefold, affecting approximately 8.4 million people in the U.S. in 2020. The campaign addresses a concerning 20% decrease in primary care visits during the pandemic, emphasizing the importance of seeking timely medical attention. The initiative is supported by various advocacy organizations and medical societies to educate the public on these serious health conditions.

Bristol Myers Squibb and Exelixis announced that the FDA has accepted supplemental applications for OPDIVO® and CABOMETYX® in treating advanced renal cell carcinoma (RCC). The FDA granted Priority Review, with a target action date of February 20, 2021. This decision is based on the Phase 3 CheckMate -9ER trial, which showed significant improvements in overall survival, progression-free survival, and objective response rate when combining OPDIVO and CABOMETYX compared to sunitinib. Patient-reported outcomes indicated enhanced quality of life for patients using the combination therapy.

Bristol Myers Squibb (NYSE:BMY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Opdivo (nivolumab) for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) post chemotherapy. This opinion is based on the Phase 3 ATTRACTION-3 trial, showing significant overall survival improvement and favorable safety. If approved by the European Commission, it will be a landmark as the first immunotherapy for upper gastrointestinal cancers in the EU.

Bristol Myers Squibb (NYSE:BMY) announced results from the Phase 3 True North trial for Zeposia (ozanimod) in patients with moderate to severe ulcerative colitis. The trial met primary endpoints, showing significant clinical remission rates at Week 10 (18.4% vs 6.0%) and Week 52 (37.0% vs 18.5%), both with p-values < 0.0001. Key secondary endpoints, including clinical response and mucosal healing, also showed significant improvements. The safety profile aligns with previous data. A virtual Investor Event is scheduled for October 12, 2020, to discuss these results.

Bristol Myers Squibb (NYSE: BMY) has announced a definitive merger agreement to acquire MyoKardia (Nasdaq: MYOK) for $13.1 billion, or $225.00 per share in cash. This acquisition, expected to close in Q4 2020, will enhance Bristol Myers Squibb's portfolio with mavacamten, a potential first-in-class treatment for obstructive hypertrophic cardiomyopathy (HCM). The New Drug Application for mavacamten is anticipated for submission to the FDA in Q1 2021. The acquisition is expected to add significant growth drivers and is projected to be minimally dilutive to non-GAAP EPS in 2021 and 2022, and accretive by 2023.

Bristol Myers Squibb (NYSE: BMY) announced results from the CheckMate -915 Phase 3 study, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo alone for patients with completely resected stage IIIb/c/d or stage IV melanoma. The combination did not show a statistically significant improvement in recurrence-free survival (RFS) compared to Opdivo monotherapy. Despite this, Opdivo remains a standard treatment in the adjuvant setting. The safety profiles for both regimens were consistent with prior studies, and no new safety signals were reported.

Bristol Myers Squibb (NYSE: BMY) has received FDA approval for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for adults with unresectable malignant pleural mesothelioma (MPM). This decision stems from the Phase 3 CheckMate -743 trial, demonstrating a significant improvement in overall survival. Patients treated with Opdivo + Yervoy had a median overall survival of 18.1 months compared to 14.1 months for chemotherapy. This marks the first systemic therapy for MPM in over 15 years, providing new hope for patients facing this aggressive cancer.

Bristol Myers Squibb (NYSE:BMY) will host a virtual Investor Event on October 12, 2020, at 8:00 a.m. EDT. The event will focus on the results from the Phase 3 True North trial of Zeposia® (ozanimod) for treating moderate to severe ulcerative colitis, to be presented at UEG Week 2020. Executives will provide insights and answer questions from investors and analysts. The public can access the live webcast on the company's investor site, with an archived version available later the same day.