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Bitopertin

Updated ยทnext FDA decision on the calendar

Bitopertin The FDA issued a Complete Response Letter on Feb 15, 2026. 3 FDA decisions on record below. Every date links its source.

IRON catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

We track 3 catalyst events for this program: 0 upcoming and 3 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 · Jan 21, 2025 ✓ ApprovedIRONPDUFA · Feb 13, 2026 CRLIRONPDUFA · Feb 15, 2026 CRLIRON

Questions

When is Bitopertin's next FDA decision or readout?

No upcoming catalyst is on our calendar for Bitopertin; 3 FDA decisions are on record below.

What happened at Bitopertin's most recent FDA decision?

On Feb 15, 2026 the FDA issued a Complete Response Letter. The decision page carries the source document and the measured share-price reaction.

Has Bitopertin been approved by the FDA?

Yes. The FDA approved an application for Bitopertin on Jan 21, 2025; the decision page linked above carries the source.

Where does this data come from?

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