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.
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 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.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.