Bristol-Myers Squibb has achieved a significant milestone in its strategic effort to revitalize its oncology pipeline. The U.S. Food and Drug Administration (FDA) has accepted for priority review the company’s application for Iberdomide in the treatment of multiple myeloma. This regulatory advancement is viewed as critical for the pharmaceutical giant as it prepares for the loss of patent exclusivity on several of its established blockbuster drugs.
A Potential Successor to Legacy Therapies
On February 17, 2026, the regulatory agency granted Iberdomide a “Priority Review” designation, a status reserved for therapies that demonstrate the potential for significant improvements in treating serious conditions. This classification sets a target action date of August 17, 2026, for the FDA to deliver its final verdict on market approval.
Approval would position Iberdomide as the first-in-class CELMoD therapeutic agent. This novel class of drugs is designed to succeed previous standard-of-care treatments, namely Revlimid and Pomalyst, which are facing increasing generic competition. Market analysts consider this regulatory progress a pivotal factor for the company’s valuation trajectory through the latter half of the decade.
The submission is supported by data from the Phase 3 EXCALIBER-RRMM clinical trial. The study showed that Iberdomide, used in combination with other agents, provided statistically significant benefits for patients with relapsed or refractory multiple myeloma.
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Financial Performance and Forward Guidance
Investor confidence in the company’s strategy is evident in its stock performance. Since the start of the year, Bristol-Myers Squibb shares have appreciated by approximately 11.7%. Although the stock currently trades at €50.99, slightly below the previous day’s close, it remains firmly above its 50-day moving average of €47.29.
While newer oncology assets like Iberdomide are slated to drive future growth, the anticoagulant Eliquis continues to provide stable revenue. Management forecasts Eliquis sales to grow between 10% and 15% for the current year.
For the full 2026 fiscal year, the company has provided explicit guidance. It projects total revenue in the range of $46.0 billion to $47.5 billion. This is expected to translate to an adjusted earnings per share (EPS) of $6.05 to $6.35.
All attention now turns to the upcoming FDA decision date of August 17, 2026, which will determine the commercial future of Iberdomide and mark a key moment in Bristol-Myers Squibb’s ongoing portfolio transition.
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