FDA Delays Relutrigine NDA Decision by 3 Months to December 27
PRAX has more than doubled off its 52-week low of $37.19.
Summary
The FDA has extended the review period for Praxis's relutrigine New Drug Application by three months, pushing the PDUFA date to December 27, 2026. This delay stems from the company's submission of additional sensitivity analyses, which the FDA classified as a major amendment. While no new clinical studies were requested and no safety concerns were cited, this pushes back the potential approval and commercialization timeline for a key drug candidate targeting SCN2A and SCN8A DEEs. The new PDUFA date of December 27, 2026, is the next key milestone.
At the time of this announcement, PRAX was trading at $340.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $9.8B. The 52-week trading range was $37.19 to $366.52. This news item was assessed with negative market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.