Bristol‑Myers Squibb Secures FDA Approval for Sotyktu in Psoriatic Arthritis

BMY
March 07, 2026

Bristol‑Myers Squibb announced that the U.S. Food and Drug Administration approved its drug Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis on March 7, 2026. The approval adds a new indication to the company’s immunology portfolio and marks the first selective tyrosine kinase 2 (TYK2) inhibitor to receive U.S. approval for psoriatic arthritis.

Sotyktu’s approval expands BMS’s therapeutic reach in a market that was valued at roughly $12.18 billion in 2024 and is projected to reach $25.89 billion by 2034, growing at a compound annual growth rate of 7.83%. North America accounted for 42% of the market in 2024, positioning the drug to capture a significant share of the U.S. patient base.

The drug’s mechanism—selective inhibition of TYK2, which mediates IL‑23, IL‑12, and type 1 interferon signaling—provides a novel oral treatment option. Analysts expect Sotyktu to compete primarily with other oral therapies such as JAK inhibitors and apremilast, rather than established biologic biologics, potentially displacing these agents in the treatment algorithm.

BMS’s recent financial performance underscores the strategic importance of the approval. In Q1 2025, the company reported $11.2 billion in revenue, a 6% decline YoY, while its Growth Portfolio grew 18% (ex‑FX) driven by Opdivo and Breyanzi. The company raised its full‑year 2025 revenue guidance to $45.8 billion–$46.8 billion and its 2026 guidance to $46.0 billion–$47.5 billion, reflecting confidence in its growth pipeline and the expanding immunology segment.

CEO Christopher Boerner has emphasized the company’s multi‑year plan to become more agile and efficient, while strengthening the foundation for long‑term growth. In Q4 2025, he noted that 2026 would be a data‑rich year with multiple pivotal pipeline readouts, positioning the firm to capitalize on new approvals such as Sotyktu.

BMS has also announced a direct‑to‑patient platform, BMS Patient Connect, launched in January 2026, which offers Sotyktu at a discount of over 80% of list price for eligible cash‑paying patients, improving access and potentially accelerating uptake.

The FDA approval of Sotyktu represents a significant milestone for BMS, adding a new revenue stream, expanding its immunology portfolio, and reinforcing its strategy to grow the Growth Portfolio while navigating legacy portfolio challenges.

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