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Praxis Precision Medicines (PRAX) FDA Events

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FDA Events for Praxis Precision Medicines (PRAX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Praxis Precision Medicines (PRAX). Over the past two years, Praxis Precision Medicines has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as PRAX-562, PRAX-562, and Ulixacaltamide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Praxis Precision Medicines' Drugs in FDA Review

PRAX-562 (SCN2A) - FDA Regulatory Timeline and Events

PRAX-562 (SCN2A) is a drug developed by Praxis Precision Medicines for the following indication: CN2A development and epileptic encephalopathy (SCN2A-DE. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

PRAX-562 (SCN8A) - FDA Regulatory Timeline and Events

PRAX-562 (SCN8A) is a drug developed by Praxis Precision Medicines for the following indication: SCN8A development and epileptic encephalopathy (SCN8A-DEE). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Ulixacaltamide Essential1 - FDA Regulatory Timeline and Events

Ulixacaltamide Essential1 is a drug developed by Praxis Precision Medicines for the following indication: Designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity and being developed for Essential Tremor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Praxis Precision Medicines FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Praxis Precision Medicines (PRAX) has reported FDA regulatory activity for the following drugs: Ulixacaltamide Essential1, PRAX-562 (SCN8A) and PRAX-562 (SCN2A).

The most recent FDA-related event for Praxis Precision Medicines occurred on September 26, 2024, involving Ulixacaltamide Essential1. The update was categorized as "Presentation," with the company reporting: "Praxis Precision Medicines, Inc. announced the presentation of a poster and platform talk showcasing its Phase 3 clinical program evaluating ulixacaltamide for adults with essential tremor (ET) at the Movement Disorders Society (MDS) 2024 International Congress taking place in Philadelphia, Pennsylvania, September 27 – October 1, 2024."

Current therapies from Praxis Precision Medicines in review with the FDA target conditions such as:

  • Designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical (CTC) circuit correlated with tremor activity and being developed for Essential Tremor. - Ulixacaltamide Essential1
  • SCN8A development and epileptic encephalopathy (SCN8A-DEE) - PRAX-562 (SCN8A)
  • CN2A development and epileptic encephalopathy (SCN2A-DE - PRAX-562 (SCN2A)

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:PRAX) was last updated on 7/10/2025 by MarketBeat.com Staff
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