USFDAJun 29, 2026, 04:31 PM
Praxis: FDA Extends Relutrigine PDUFA Date to Dec 27, 2026
AI Summary
Praxis Precision Medicines announced that the FDA has extended the review period for its New Drug Application (NDA) for relutrigine by three months. The new PDUFA target action date is December 27, 2026, moved from September 27, 2026. This extension follows Praxis's submission of additional sensitivity analyses, which the FDA classified as a "major amendment," requiring more review time. The FDA did not request new clinical studies or cite any safety or manufacturing concerns, and Praxis remains confident in the application.
Key Highlights
- FDA extended the PDUFA date for relutrigine by three months.
- New PDUFA target action date is December 27, 2026.
- Original PDUFA date was September 27, 2026.
- Extension due to Praxis's submission of additional sensitivity analyses.
- FDA deemed the submission a "major amendment."
- No new clinical studies were requested by the FDA.
- FDA did not cite any safety or manufacturing concerns.
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