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pdufa.bio

BIIB122

Updated ยทnext FDA decision on the calendar

BIIB122 is a Denali Therapeutics Inc. program. Its next catalyst is a Readout in Mar 2027. Every date links its source.

DNLI catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Denali Therapeutics Inc. (DNLI). 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

Readout · Mar 2027DNLI

Questions

When is BIIB122's next FDA decision or readout?

The next tracked catalyst for BIIB122 is a Readout in Mar 2027.

What happened at BIIB122's most recent FDA decision?

No FDA decision for BIIB122 is in our archive yet.

Who makes BIIB122?

Denali Therapeutics Inc. (DNLI).

Where does this data come from?

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