Bristol-Myers Squibb Co. - BMY STOCK NEWS

Bristol Myers Squibb (BMY) received a positive CHMP opinion recommending approval of Opdivo plus Yervoy for first-line treatment of adult patients with MSI-H or dMMR metastatic colorectal cancer. The recommendation is based on the Phase 3 CheckMate -8HW trial results, which showed a 79% reduction in risk of disease progression or death compared to chemotherapy (HR: 0.21; p<0.0001). This dual immunotherapy combination would be the first of its kind for first-line metastatic colorectal cancer treatment in the EU. The treatment targets approximately 5-7% of metastatic colorectal cancer patients with dMMR or MSI-H tumors.

Bristol Myers Squibb (BMY) has received a positive recommendation from the European Medicines Agency's CHMP for repotrectinib, a next-generation tyrosine kinase inhibitor. The drug is intended for treating adult patients with ROS1-positive advanced non-small cell lung cancer and patients 12 years and older with advanced NTRK-positive solid tumors. The recommendation is based on the TRIDENT-1 and CARE trials, which showed significant response rates and durable activity. The European Commission's final decision is expected in January 2025.

Bristol Myers Squibb (NYSE: BMY) has announced its participation in two major investor conferences in November 2024. At Guggenheim's Inaugural Healthcare Innovation Conference on November 11, Dr. Samit Hirawat (EVP, Chief Medical Officer) and Dr. Robert Plenge (EVP, Chief Research Officer) will participate in a fireside chat at 10:00 a.m. ET. Later, at the 2024 Jefferies London Healthcare Conference on November 19, David Elkins (EVP, CFO) will join a fireside chat at 9:30 a.m. GMT. Both sessions will be accessible to investors and the public through the company's investor website, with archived recordings available afterward.

Bristol Myers Squibb (NYSE: BMY) presented new long-term data from the Phase 3 EMERGENT-4 and EMERGENT-5 trials evaluating COBENFY in adults with schizophrenia over 52 weeks. The trials demonstrated continued improvement in schizophrenia symptoms and maintenance of effect. EMERGENT-4 showed 69% of participants achieved ≥30% symptom improvement, while EMERGENT-5 showed 30% of participants had ≥30% reduction in PANSS total score. COBENFY was generally well-tolerated with no new safety issues, showing weight loss of approximately 2kg across both trials. Qualitative interviews revealed that 86% of participants reported Quality of Life improvements within six weeks of treatment.

Bristol Myers Squibb (BMY) reported strong Q3 2024 results with revenues of $11.9 billion, up 8% year-over-year. The Growth Portfolio revenues reached $5.8 billion, increasing 18%. GAAP EPS was $0.60 and Non-GAAP EPS was $1.80, including a net impact of $(0.09) due to Acquired IPRD charges. U.S. revenues increased 9% to $8.2 billion, while International revenues grew 7% to $3.7 billion. The company achieved U.S. approval for Cobenfy for schizophrenia treatment and raised its 2024 revenue guidance to approximately +5% (+6% excluding foreign exchange), with updated Non-GAAP EPS range of $0.75 to $0.95.

Bristol Myers Squibb (BMY) will present new clinical and health economics data for COBENFY™ (xanomeline and trospium chloride) at Psych Congress 2024 in Boston, October 29 - November 2. The presentations will showcase results from the 52-week EMERGENT-4 and EMERGENT-5 trials, focusing on safety, efficacy, and patient satisfaction in treating adult schizophrenia.

Key presentations include long-term safety data, patient satisfaction studies, quality of life changes, and comparative efficacy analyses versus other antipsychotics. The research demonstrates COBENFY as a differentiated treatment option, following its recent FDA approval. Presentations will take place in the Exhibit Hall on October 31 and November 1.

Bristol Myers Squibb announced FDA approval of Opdivo® (nivolumab) for the perioperative treatment of adult patients with resectable non-small cell lung cancer (NSCLC). The approval is based on the CheckMate-77T trial, where Opdivo with chemotherapy showed significantly longer event-free survival compared to chemotherapy alone. Key findings include:

- 42% reduction in risk of disease recurrence, progression, or death
- 70% 18-month event-free survival rate vs 50% in control arm
- 25% pathologic complete response rate vs 4.7% in control arm

Opdivo is now the only PD-1 inhibitor approved for resectable NSCLC in both neoadjuvant-only and perioperative regimens. This expands Bristol Myers Squibb's thoracic portfolio and reinforces their commitment to early-stage disease treatment.

Bristol Myers Squibb (NYSE:BMY) announced positive results from two trials demonstrating Sotyktu (deucravacitinib) efficacy in moderate-to-severe scalp psoriasis and real-world settings. The Phase 3b/4 PSORIATYK SCALP trial showed Sotyktu's superiority over placebo across all primary and secondary endpoints at Week 16. Notably, 48.5% of Sotyktu-treated patients achieved clear/almost clear scalp psoriasis compared to 13.7% on placebo.

The real-world RePhlect registry analysis revealed that six months of Sotyktu treatment was consistent with efficacy outcomes observed in previous clinical studies. Patients achieved significant decreases in disease severity measures, with 67.9% reaching PASI scores ≤3 and 64.1% achieving BSA ≤3%.

Sotyktu's safety profile in PSORIATYK SCALP was consistent with previous trials. These results reinforce Sotyktu as a potential oral standard of care for moderate-to-severe psoriasis, especially with scalp involvement.

PureTech Health announced that KarXT, now marketed as Cobenfy, has received FDA approval for treating schizophrenia in adults. This milestone triggers $29 million in payments to PureTech and unlocks potential future payments and royalties. Cobenfy, invented by PureTech, is the first new drug mechanism approved in over 50 years for schizophrenia treatment.

The approval validates PureTech's unique R&D model, which has now produced three FDA-approved therapeutics. PureTech has generated approximately $1.1 billion from its involvement with Karuna Therapeutics, which was recently acquired by Bristol Myers Squibb. This success enables PureTech to self-fund the advancement of several programs, including LYT-100 for idiopathic pulmonary fibrosis, with topline data expected by year-end.