Bristol-Myers Squibb Co Stock Price, News & Analysis

Bristol Myers Squibb (NYSE:BMY) reported Week 52 data from the pivotal Phase 3 POETYK PsA-1 trial showing sustained efficacy and a consistent safety profile for Sotyktu (deucravacitinib) in adults with active psoriatic arthritis.

Key results: ACR20 at Week 16 was 54.2% (placebo 34.1%, p<0.0001) and was maintained at Week 52 at 63.1%; patients switched from placebo reached 60.8% at Week 52. Radiographic no-progression rates: 82.0% (Sotyktu) vs 71.5% (placebo) at Week 16; sustained through Week 52. Integrated Phase 2 PAISLEY-SLE/LTE data showed durable efficacy and consistent safety with up to 4 years exposure. Regulatory reviews are ongoing; FDA PDUFA goal date: March 6, 2026.

Bristol Myers Squibb (NYSE: BMY) presented updated Phase 1 Breakfree-1 data (Oct 25, 2025) for autologous CD19 NEX-T CAR T therapy BMS-986353 in systemic sclerosis (SSc), systemic lupus erythematosus (SLE) and idiopathic inflammatory myopathies (IIM).

Across 71 treated patients, results show robust CAR T expansion, complete B cell depletion and a potential immune reset; 94% of evaluable patients remained off chronic immunosuppressive therapy at analysis. Key cohort results: SSc pFVC median +10% at six months (ILD subgroup); SLE: 92% off SLE-specific ISTs and DL1 selected as RP2D; IIM: 91% achieved moderate-major responses. Safety: mostly transient, early TEAEs with some grade 3 ICANS/CRS events that resolved.

SystImmune and Bristol Myers Squibb (NYSE: BMY) presented first global Phase I results for iza-bren (EGFR x HER3 bispecific ADC) at ESMO 2025 on Oct 17, 2025.

At data cut-off July 23, 2025, 107 heavily pre-treated patients were treated. At 2.5 mg/kg (Days 1 & 8 q3w), confirmed response rate was 55% (11/20) with median progression-free survival 5.4 months. Confirmed responses occurred in EGFR-mutated (3/10) and EGFR wild-type (3/4) NSCLC subgroups. No interstitial lung disease observed; hematologic AEs (neutropenia) were manageable and prompted mandatory preventative measures in ongoing studies. Breakthrough Therapy designation granted Aug 2025.

insitro and Bristol Myers Squibb (NYSE: BMY) extended their collaboration on October 14, 2025 to apply insitro’s ChemML™ platform toward discovery of small-molecule therapies for a novel preclinical ALS target identified in the prior biological evaluation phase.

The one-year extension may provide up to $20 million in new funding and the partnership could deliver a program with aggregate milestone and royalty value exceeding $2 billion. ChemML™ capabilities cited include large-scale QAL data generation, ADMET modeling, an AI-driven design loop, and a 192 H100 GPU compute cluster.

Bristol Myers Squibb (NYSE: BMY) will present oncology data at ESMO Congress 2025 in Berlin, Oct 17–21, showcasing results from >50 company‑sponsored, investigator‑sponsored and collaborative studies across >10 cancer types.

Key highlights include first disclosure of a global Phase 1 study of iza‑bren (BL‑B01D1) (EGFR×HER3 ADC) and data that supported an FDA Breakthrough Therapy designation; late‑breaking PFS and first OS from CheckMate‑8HW in MSI‑H/dMMR mCRC; five‑year DFS/OS/ctDNA follow‑up from CheckMate‑274 in high‑risk MIUC; and the nine‑year final analysis of CheckMate‑238 in resected advanced melanoma.

SystImmune (collaborating with BMY) announced the first patient treated in the IZABRIGHT-Breast01 Phase 2/3 registrational study of izalontamab brengitecan (iza-bren) in previously untreated triple negative breast cancer ineligible for anti-PD(L)1 drugs.

That event triggered a $250 million one-time milestone payment from Bristol Myers Squibb (BMY) under the 2023 collaboration and exclusive license agreement. SystImmune is eligible for up to an additional $250 million near-term and up to $7.1 billion in further contingent development, regulatory and sales milestones. Iza-bren has received Breakthrough Therapy Designation from the FDA for previously treated advanced EGFR-mutated NSCLC and is being evaluated in multiple ongoing global trials.

Bristol Myers Squibb (NYSE: BMY) will acquire Orbital Therapeutics for $1.5 billion cash at closing, adding Orbital’s lead preclinical program OTX-201 and a proprietary RNA platform that combines circular and linear RNA, targeted LNP delivery, and AI-driven design.

The deal aims to expand BMS’s cell therapy portfolio by enabling in vivo CAR T approaches intended to reduce treatment burden and broaden patient access for autoimmune diseases. Closing is subject to customary conditions, including the Hart-Scott-Rodino waiting period, and accounting treatment will be determined at close.

Bristol Myers Squibb (NYSE: BMY) launched COBENFY Connections on October 10, 2025 to reduce stigma around schizophrenia by sharing real stories from adults taking COBENFY™ (xanomeline and trospium chloride), their care partners, and clinicians.

The program, introduced on World Mental Health Day, features TV host Gail Simmons discussing her brother’s lived experience and a hosted gathering that highlighted peer support, treatment exploration, and community connection. The initiative directs audiences to connections.bms.com and includes Important Safety Information for COBENFY.

Bristol Myers Squibb (NYSE: BMY) announced that its anti-MTBR-tau antibody, BMS-986446, has received Fast Track Designation from the FDA for early Alzheimer's disease treatment. The drug, currently in Phase 2 development, targets pathological tau protein fragments and aims to modify the disease's progression by neutralizing tau spread and promoting its clearance.

The investigational therapy has shown promising results in preclinical models, demonstrating significant reductions in tau uptake and spread, and protection against behavioral deficits. A Phase 1 study confirmed safety and tolerability across three dose cohorts. The ongoing Phase 2 study is fully enrolled and will evaluate the drug's impact on disease progression through various biomarkers and clinical outcome measures.