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BMY Reports Positive Data on Sotyktu From Arthritis Study

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Key Takeaways

  • BMY's Sotyktu met primary and multiple secondary endpoints in a phase III PsA study.
  • Sotyktu showed superior efficacy over placebo at Week 16 and sustained responses through Week 52.
  • RayzeBio inked a $1.35B licensing deal for Philochem's prostate cancer therapy, OncoACP3.

Bristol Myers (BMY - Free Report) announced that the late-stage study on Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA) met its primary endpoint.

Sotyktu is an oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action, representing a new class of small molecules. It is the first selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases.

The drug is already approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.

Shares of Bristol Myers have lost 15.9% in the past three months compared with the industry’s decline of 5.3%.

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More on BMY’s Sotyktu

Th phase III POETYK PsA-1 study (n=670) is evaluating the efficacy and safety of Sotyktu in adults with PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD).

The trial met its primary endpoint, with a significantly greater proportion of patients treated with Sotyktu achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) compared with placebo at week 16.

In addition, several key secondary endpoints were met, including Psoriasis Area and Severity Index (PASI) 75 response, Health Assessment Questionnaire-Disability Index (HAQ-DI) score, 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) score and Minimal Disease Activity (MDA) response.

The late-stage PsA program on Sotyktu includes two phase III, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety in adults 18 years of age and older with active PsA: POETYK PsA-1 and POETYK PsA-2.

POETYK PsA-2 enrolled approximately 730 patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment.

BMY also presented new data from POETYK PsA-2 study.  Results showed superior efficacy of Sotyktu compared with placebo at Week 16. Additionally, through Week 52, clinical responses continued to improve for those who remained on or switched to Sotyktu treatment, and outcomes were maintained for those receiving continuous Sotyktu treatment.

Data from the POETYK PsA-1 and PsA-2 studies will be discussed with global regulatory authorities.

BMY is also evaluating Sotyktu in late-stage studies for the treatment of Sjögren's syndrome and systemic lupus erythematosus.

BMY’s Subsidiary Announces Deal

RayzeBio, Inc., a wholly owned subsidiary of BMY entered into an exclusive worldwide licensing agreement with Philochem AG a wholly-owned subsidiary of the Philogen Group.

Philochem will license the exclusive worldwide rights to develop, manufacture, and commercialise OncoACP3, a clinical stage therapeutic and diagnostic agent targeting prostate cancer, to RayzeBio.

Under the terms of the agreement, Philochem will receive an upfront payment of $350 million upfront along with $1 billion in potential development, regulatory, and commercial milestones. Philochem will also receive mid-single to low double-digit royalties on global net sales of both therapeutic and diagnostic forms of OncoACP3.

The deal is expected to be closed in the third quarter of 2025.

BMY Looks to Expand Portfolio/Pipeline

BMY’s legacy drugs face generic competition, and hence, the company depends on newer drugs to stabilize its revenue base. 
A potential label expansion of Sotyktu will expand its target patient population.

Simultaneously, the company is also looking to strengthen its pipeline through strategic acquisitions and pipeline.  

Last week, BMY announced a strategic collaboration agreement with BioNTech (BNTX - Free Report) for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types.

Per the terms, BMY and BNTX will jointly develop and commercialize BNT327, including the development of BNT327 as monotherapy and in combination with other products.

Both the companies own the right to develop BNT327 independently in further indications and combinations, including combinations of BNT327 with proprietary pipeline assets.

BMY has experienced a few pipeline setbacks in recent months, which negatively impacted its share price.

BMY’s Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma/biotech sector are Novartis (NVS - Free Report) and Bayer (BAYRY - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate Novartis’ 2025 earnings per share (EPS) has risen from $8.46 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 35 cents to $9.02 during this timeframe. The stock has risen 24.2% so far this year.

BAYRY’s 2025 EPS estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 63.5%.

 

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