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PDUFAApproval decision

Mezigdomide (CELMoD Modulator)

Relapsed Or Refractory Multiple Myeloma

BMYBristol-Myers Squibb
Expected catalystMay 13, 2027

Catalyst overview

Event details

Drug or asset
Mezigdomide (CELMoD Modulator)
Development stage
PDUFA
Event type
Approval decision
Indication
Relapsed Or Refractory Multiple Myeloma

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Mezigdomide (CELMoD Modulator) in Relapsed Or Refractory Multiple Myeloma. The expected timing is based on the latest available company guidance and may change.

Development notes

05/21/26:- Phase 3 SUCCESSOR-2 MeziKd results in R/R MM to be presented May 29, 2026. 05/28/26:- SUCCESSOR-2 Ph3 showed PFS benefit for MeziKd; ASCO 2026 late-breaking oral. Regulatory discussions planned. 07/13/26:- FDA accepted NDA for MeziKd in R/R MM; PDUFA May 13, 2027.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

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Company

Bristol-Myers Squibb

BMY · NYSE
Industry
Biotechnology
Pipeline assets
62
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
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