Praxis Precision Medicines, Inc. PRAX
Praxis Precision Medicines, Inc. (Nasdaq: PRAX) is a CNS/neurology/psychiatry drug developer. Its lead program, relutrigine, is in Phase 3 for SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs). Its next catalyst on record is relutrigine: PDUFA action date (NDA, priority review, extended three months) (December 27, 2026).
Upcoming catalysts
- December 27, 2026relutrigine — PDUFA action date (NDA, priority review, extended three months)
In June 2026, the FDA notified us that it had extended by three months the review period for our NDA for relutrigine, setting an updated PDUFA action date of December 27, 2026.
- January 29, 2027ulixacaltamide — PDUFA action date (NDA)
it was accepted for review with a target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027.
Next further out: relutrigine EMERALD — Topline results (Q4 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| relutrigine (NDA under priority review) | SCN2A and SCN8A DEEs | small molecule | Phase 3 |
| ulixacaltamide (NDA under review) | essential tremor | small molecule | Phase 3 |
| elsunersen (EMBRAVE3 Phase 3 registrational) | early-seizure-onset SCN2A DEE (gain-of-function) | RNA (siRNA/ASO/mRNA) | Phase 3 |
| relutrigine EMERALD | broad developmental and epileptic encephalopathies | small molecule | Phase 2 |
| vormatrigine (ENERGY program: POWER1 missed primary endpoint; POWER2 paused) | focal onset seizures / generalized epilepsy | small molecule | Phase 2 |
| PRAX-080 | PCDH19 mosaic expression disorders | RNA (siRNA/ASO/mRNA) | Pre-clinical |
| PRAX-090 | SYNGAP1 loss-of-function | RNA (siRNA/ASO/mRNA) | Pre-clinical |
| PRAX-100 | SCN2A loss-of-function (autism spectrum disorder) | RNA (siRNA/ASO/mRNA) | Pre-clinical |
Recent results and decisions
- Dec 6, 2025positive RADIANT: vormatrigine produced 54% median seizure reduction at 8 weeks in focal onset seizures (n=62); about one third seizure-free for 28 consecutive days.
Patients taking vormatrigine for 8 weeks on background anti-seizure medications saw a 54% median reduction in seizures.
Filing - Dec 4, 2025met EMBOLD registrational cohort stopped early for efficacy: relutrigine gave 53% placebo-adjusted seizure reduction over 16 weeks (n=51, p<0.0002).
Patients receiving relutrigine (n=51) experienced a 53% placebo-adjusted reduction in seizures over 16-weeks (p<0.0002).
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.