Relutrigine (PRAX-562) is a Praxis Precision Medicines Inc. program in developmental epileptic encephalopathies (DEEs). Its PDUFA date is Dec 27, 2026, the FDA's goal date to complete review of the application. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Developmental epileptic encephalopathies (DEEs). Sponsor: Praxis Precision Medicines Inc. (PRAX). Review status: NDA for SCN2A and SCN8A developmental and epileptic encephalopathies. Review extended by three months (major amendment) to December 27, 2026; mid-cycle meeting complete with no major safety or efficacy concerns identified to date and no advisory committee planned (Praxis, August 6, 2026). Market-cap tier at the time we tracked it: Mid. 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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Perceptive Advisors | 2,035,986 | $681.6 million | filed August 14, 2026 |
| Baker Bros. Advisors | 1,753,198 | $587.0 million | filed August 14, 2026 |
| Cormorant Asset Management | 640,000 | $214.3 million | filed August 14, 2026 |
| OrbiMed Advisors | 230,100 | $77.0 million | filed 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.
Relutrigine (PRAX-562)'s PDUFA date is Dec 27, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
No FDA decision for Relutrigine (PRAX-562) is in our archive yet.
In our records Relutrigine (PRAX-562) is under review or in development for Developmental epileptic encephalopathies (DEEs).
Praxis Precision Medicines Inc. (PRAX).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.