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PRINCETON, N.J. - Bristol Myers Squibb (NYSE:BMY), a prominent pharmaceutical company with annual revenue of $47.7 billion and currently trading near its 52-week low, announced new 52-week data from its Phase 3 POETYK PsA-1 trial showing sustained efficacy and consistent safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis who had not previously received biologic treatments. According to InvestingPro analysis, BMY appears undervalued based on its Fair Value estimates.
The data, presented at the American College of Rheumatology Convergence in Chicago, demonstrated that ACR20 responses (at least 20% improvement in disease symptoms) achieved at Week 16 continued to improve and were maintained through Week 52 for patients receiving continuous Sotyktu treatment (63.1%). This development comes as BMY maintains strong financial health with an EBITDA of $19.1 billion and an attractive dividend yield of 5.68%.
Patients who switched from placebo to Sotyktu at Week 16 showed similar response rates (60.8%) by Week 52. The trial also showed inhibition of structural joint damage progression was maintained through Week 52.
"These compelling results build on the previously disclosed data, showing that Sotyktu delivered meaningful improvements across key domains of psoriatic arthritis disease activity with a consistent safety profile," said Philip Mease, MD, director of rheumatology research at Providence Swedish Medical Center.
The company also presented data from Phase 2 PAISLEY studies showing sustained efficacy and consistent safety with up to four years of Sotyktu treatment for moderate-to-severe systemic lupus erythematosus.
The safety profile through Week 52 in the POETYK PsA-1 trial was consistent with previous findings, with upper respiratory infection being the most frequent adverse event. No new safety signals were identified.
Regulatory applications for Sotyktu for psoriatic arthritis are currently under review in the U.S., Europe, Japan and China, with an FDA decision expected by March 6, 2026.
The data was presented at the American College of Rheumatology Convergence taking place from October 24-29, 2025, according to the company's press release statement.
In other recent news, Bristol Myers Squibb has reported positive early results from its Phase 1 Breakfree-1 study of a CD19-targeted CAR T cell therapy for autoimmune diseases. The study, which included 71 patients, showed that 94% of evaluable participants remained off chronic immunosuppressive therapy. Additionally, Bristol Myers Squibb, in collaboration with SystImmune Inc., presented promising results for iza-bren, an EGFR x HER3 bispecific antibody-drug conjugate, in a global phase I trial. This study demonstrated a 55% confirmed response rate among patients with advanced non-small cell lung cancer and other solid tumors.
In another development, SystImmune received a $250 million milestone payment from Bristol Myers Squibb for the IZABRIGHT-Breast01 study under their 2023 collaboration. Furthermore, Bristol Myers Squibb and insitro have extended their collaboration to develop treatments for amyotrophic lateral sclerosis (ALS) with a focus on AI technology. This extension could bring up to $20 million in new funding. Meanwhile, President Donald Trump is reportedly planning a new investigation into drug prices to ensure foreign countries pay comparable prices to Americans, according to Bloomberg.
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