Praxis Precision Medicines PDUFA Date September 27, 2026: What the FDA Action Day Covers

Praxis Precision Medicines (PRAX) is approaching a Prescription Drug User Fee Act (PDUFA) target action date of September 27, 2026 — the first of three PDUFA dates now on the company's catalyst calendar within roughly four months. BioSnipper began tracking this event on September 10, 2026, when the target action date entered our regulatory dataset. This preview lays out what our data verifies, what remains unknown, and how the date fits into the broader catalyst calendar for this neuroscience-focused company, which carries a market capitalization of approximately $9.34 billion in our most recent snapshot.

The event

A PDUFA target action date is the deadline the FDA commits to for completing its review of a submitted marketing application. For Praxis Precision Medicines, our tracked record states it plainly: "The FDA has set a target action date under the Prescription Drug User Fee Act of September 27, 2026."

The date is recorded with "exact" confidence in our system, meaning it comes from a primary disclosure rather than an estimate. By September 27, 2026, the FDA is expected to have completed its review action on the application in question — which, depending on the outcome, could be an approval, a complete response letter, or another regulatory action. Our data does not yet contain the outcome, and this article makes no prediction about it.

What's verified

The following facts are verifiable directly from our tracked catalyst data:

• Company: Praxis Precision Medicines, Inc., listed with ticker PRAX and active listing status.
• Event type: PDUFA target action date.
• Date: September 27, 2026, with "exact" date confidence.
• First tracked: The event entered our dataset on September 10, 2026 (the known_at date) — meaning the market has had this date in public view for only days.
• Company scale: Market capitalization of $9,341,469,696 in our snapshot — a mid-cap biotech by market value, and one of the larger pure neuroscience names in our coverage universe.
• Source quote: "The FDA has set a target action date under the Prescription Drug User Fee Act of September 27, 2026."

What remains unknown

Discipline about unknowns matters as much as the verified record. As of this article:

• Which product is under review is UNKNOWN in our data. The tracked record's title is a filing accession identifier ("0001689548-26-000031") rather than a drug name, and the drug name field in our dataset is empty for this event. We will not speculate on which Praxis candidate the application covers.
• The outcome is UNKNOWN. No approval, complete response letter, or other action has been recorded.
• The indication under review is UNKNOWN in this event record.

A dense PDUFA stretch for Praxis

What makes this particular date notable is context: our calendar shows two further PDUFA target action dates for Praxis in quick succession — December 27, 2026 (a record explicitly titled "PDUFA: relutrigine") and January 29, 2027. Three PDUFA dates inside a four-month window is an unusually concentrated regulatory cadence for a company of this size, and it frames the September 27 action as the opening event rather than an isolated one.

Platform context: the trial engine behind the regulatory calendar

The PDUFA dates sit on top of a Phase 3 clinical engine that our data shows running across four named candidates:

• Relutrigine — a Phase 3 randomized, multi-center, double-blind, placebo-controlled trial in developmental and epileptic encephalopathy (DEE) followed by an open-label extension, with a start date recorded as July 9, 2025. The December 27, 2026 PDUFA record carries this drug's name explicitly.
• Vormatrigine — two Phase 3 records: a double-blind, randomized trial in adults with focal seizures (recorded start January 29, 2026) and an open-label extension trial in adult patients with epilepsy (recorded start October 27, 2025).
• Elsunersen — a multi-center, single-arm Phase 3 trial in pediatric participants with early-onset SCN2A developmental and epileptic encephalopathy (recorded start August 13, 2025).
• PRAX-628 — a Phase 3 double-blind, randomized, multicenter trial in adults with focal seizures (the POWER1 study, recorded start December 11, 2024), plus an earlier Phase 2 open-label trial in focal onset or primary generalized tonic-clonic seizures (recorded start January 10, 2025) and a Phase 1 formulation bioavailability study (recorded start April 28, 2025).

In total, our tracker holds nine prior or parallel catalyst records for Praxis spanning Phase 1 through PDUFA-stage events. Whether the September 27 action date connects to any of the four candidates above is not something our event record currently resolves — and we flag that openly rather than fill the gap.

How to track it

We will update the event record as the action date approaches and when the outcome becomes known:

• Praxis Precision Medicines company page: tracked catalysts, pipeline events, and filings — https://biosniper.co/company/PRAX
• This specific PDUFA event page: https://biosniper.co/calendar/event/972701

Bottom line

September 27, 2026 is a verified, exact-confidence PDUFA target action date for Praxis Precision Medicines — the first of three such dates within four months on our calendar. The product under review and the outcome are both unknown in our data as of publication. For a company running Phase 3 programs across relutrigine, vormatrigine, elsunersen, and PRAX-628, the regulatory calendar is unusually dense, and this date is where it starts. We report what the data shows, mark what it does not, and update when it changes.