The U.S. Food and Drug Administration accepted Bristol‑Myers Squibb’s New Drug Application for Iberdomide on February 17, 2026, setting a target action date of August 17, 2026. The acceptance is part of the FDA’s Project Orbis program, which allows concurrent review by international regulators.
Iberdomide is a cereblon‑modulating agent that enhances the degradation of proteins that drive multiple myeloma cell growth. It is the first drug in the CELMoD class to reach regulatory acceptance, and the application is based on MRD‑negative rates from the Phase 3 EXCALIBER‑RRMM study.
The acceptance follows Bristol‑Myers Squibb’s Q4 2025 earnings, in which the company reported revenue of $12.5 billion, a 1 % year‑over‑year increase, and a non‑GAAP EPS of $1.26. The growth portfolio grew 16 % to $7.4 billion, driven by its immuno‑oncology products, while the legacy portfolio declined. The company also highlighted headwinds from upcoming patent expirations for Eliquis and Opdivo.
Executive Vice President and Chief Medical Officer Cristian Massacesi said, “The FDA’s acceptance of this application is a testament to the potential of iberdomide, in combination with anti‑CD38 monoclonal antibodies, as a novel, potent, oral treatment option, with a manageable safety profile, for patients with multiple myeloma.” Chief Executive Officer Christopher Boerner added, “2026 is data‑rich, and we are advancing a truly differentiated pipeline with multiple pivotal readouts expected in the back half of the year. Our core business is strong and growing, and we have the potential to achieve industry‑leading, sustainable growth into the 2030s and beyond.”
No immediate market reaction to the FDA acceptance was reported.
The acceptance marks a critical step toward potential approval and positions Iberdomide as a first‑in‑class oral therapy for relapsed or refractory multiple myeloma. The milestone also reinforces Bristol‑Myers Squibb’s strategy to expand its oncology portfolio and could enhance its competitive standing against other immunomodulatory and proteasome‑inhibitor therapies.
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