PRINCETON, N.J. - Bristol Myers Squibb (NYSE:BMY) announced today that the U.S. Food and Drug Administration has approved Sotyktu (deucravacitinib) for treating adults with active psoriatic arthritis. The oral medication is the first tyrosine kinase 2 inhibitor approved for this indication, according to a company press release.The approval comes as Bristol Myers Squibb, with a market capitalization of $122.8 billion, trades at $60.29 per share. The stock has surged over 31% in the past six months, though InvestingPro analysis suggests the company remains undervalued with a Fair Value of $65.01. For investors seeking undervalued opportunities, Bristol Myers appears on InvestingPro's Most Undervalued stocks list.
The approval is based on results from two Phase 3 clinical trials, POETYK PsA-1 and POETYK PsA-2. In POETYK PsA-1, 54% of patients treated with Sotyktu 6 mg once daily achieved an ACR20 response at Week 16, compared with 34% receiving placebo. In POETYK PsA-2, 54% of Sotyktu-treated patients achieved ACR20 response versus 39% on placebo.
POETYK PsA-1 enrolled 670 patients with active psoriatic arthritis who had not previously received biologic disease-modifying antirheumatic drugs. POETYK PsA-2 included 624 patients who were either biologic-naive or had previously received TNF-alpha inhibitor treatment.
The most common adverse reactions occurring in at least 1% of patients taking Sotyktu and more frequently than placebo included upper respiratory infections, increased blood creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne. The drug carries warnings for hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis, and laboratory abnormalities.
Sotyktu was first approved in 2022 for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The medication is not recommended for use with other potent immunosuppressants in that patient population.
Psoriatic arthritis is a chronic autoimmune condition affecting joints and skin. Up to 30% of patients with psoriasis develop psoriatic arthritis.Bristol Myers Squibb has maintained dividend payments for 56 consecutive years, currently offering a 4.18% yield.
In other recent news, Bristol-Myers Squibb has announced a quarterly dividend of $0.63 per share, payable on May 1, 2026, to stockholders of record as of April 2, 2026. UBS has raised its price target for the company to $70 from $65, maintaining a Buy rating, citing upcoming Phase III data for Milvexian as a significant catalyst expected in the latter half of 2026. Additionally, RBC Capital has initiated coverage on Bristol-Myers Squibb with a Sector Perform rating and a $60 price target, highlighting the company's robust Phase 3 pipeline. In collaboration news, Bristol-Myers Squibb is working with Revolution Medicines on a clinical trial combining their PRMT5 inhibitor with daraxonrasib for pancreatic ductal adenocarcinoma. Furthermore, Izalontamab brengitecan has met both primary endpoints in a Phase 3 trial for triple-negative breast cancer in China, showing significant improvements in progression-free and overall survival. These developments reflect the company's active engagement in advancing its pharmaceutical pipeline and strategic collaborations.