pdufa.bio

Mezigdomide

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

Mezigdomide is a Bristol-Myers Squibb Company program in relapsed or refractory multiple myeloma. Its PDUFA date is May 13, 2027, the FDA's goal date to complete review of the application. Every date links its source.

BMY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Relapsed or refractory multiple myeloma. Sponsor: Bristol-Myers Squibb Company (BMY). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · May 13, 2027BMY

Specialist biotech funds holding BMY, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
OrbiMed Advisors925,000$53.3 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is Mezigdomide's next FDA decision or readout?

Mezigdomide's PDUFA date is May 13, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at Mezigdomide's most recent FDA decision?

No FDA decision for Mezigdomide is in our archive yet.

What is Mezigdomide used for?

In our records Mezigdomide is under review or in development for Relapsed or refractory multiple myeloma.

Who makes Mezigdomide?

Bristol-Myers Squibb Company (BMY).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.