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PRINCETON, N.J. - Bristol Myers Squibb (NYSE:BMY), a pharmaceutical giant with a market capitalization of $96.38 billion and impressive gross profit margins of nearly 75%, announced Monday that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. The FDA has set a target action date of March 6, 2026. According to InvestingPro analysis, BMY currently trades below its Fair Value, suggesting potential upside for investors.
The application is supported by results from the Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials, which showed that significantly more patients treated with Sotyktu achieved ACR20 response (at least 20% improvement in disease symptoms) compared to placebo at Week 16. With annual revenue of $47.64 billion and a strong financial health rating from InvestingPro, Bristol Myers Squibb demonstrates robust capacity for continued drug development and commercialization. Discover 10+ additional exclusive insights about BMY with an InvestingPro subscription.
Sotyktu, an oral selective tyrosine kinase 2 (TYK2) inhibitor, received FDA approval in 2022 for treating adults with moderate-to-severe plaque psoriasis. If approved for psoriatic arthritis, it would become the first TYK2 inhibitor for this condition.
"There is a significant need for additional oral treatments for individuals living with psoriatic arthritis," said Roland Chen, Senior Vice President of Drug Development, Immunology and Cardiovascular at Bristol Myers Squibb, in a press release statement.
The safety profile of Sotyktu through 16 weeks in the POETYK PsA trials was consistent with previous studies, with no new safety signals observed. The trials included approximately 1,400 patients across both studies, with POETYK PsA-2 also evaluating outcomes through 52 weeks of treatment.
Regulatory applications for Sotyktu in psoriatic arthritis have also been accepted for review by health authorities in China, Japan, and the European Union.
Psoriatic arthritis is a chronic immune-mediated disease affecting up to 30% of psoriasis patients, causing inflammatory arthritis, skin lesions, and other symptoms that can significantly impact physical function and quality of life. For detailed analysis of BMY’s financial health and growth prospects, including expert insights and comprehensive valuation metrics, access the full Pro Research Report available exclusively on InvestingPro.
In other recent news, Bristol Myers Squibb announced that its Phase 3 INDEPENDENCE trial for Reblozyl did not meet its primary endpoint of achieving red blood cell transfusion independence in myelofibrosis-associated anemia. Despite this, the company reported clinically meaningful improvements in other areas, such as a reduction in transfusion burden and increases in hemoglobin levels. Raymond James maintained its Market Perform rating for the company following these results. Additionally, Bristol Myers Squibb and Pfizer have introduced a program offering their anticoagulant medication Eliquis at a 40% discount for eligible patients, which aims to make the drug more accessible amid ongoing discussions about prescription drug pricing. UBS reiterated its Neutral rating for Bristol Myers Squibb, with projected second-quarter sales of $3.5 billion for Eliquis and an earnings per share estimate of $1.72, excluding certain expenses. The company also declared a quarterly dividend of $0.62 per share on its common stock, maintaining its consistent dividend payment schedule.
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