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Bitopertin

Updated ยทnext FDA decision on the calendar

Bitopertin 1 FDA decision on record below. Every date links its source.

IRON catalyst hub

About this program

We track 1 catalyst event for this program: 0 upcoming and 1 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 · Feb 13, 2026 CRLIRON

Questions

When is Bitopertin's next FDA decision or readout?

No upcoming catalyst is on our calendar for Bitopertin; 1 FDA decision is on record below.

What happened at Bitopertin's most recent FDA decision?

On Feb 13, 2026 the FDA issued a Complete Response Letter. The decision page carries the source document and the measured share-price reaction.