FDA Accepts Praxis' Ulixacaltamide NDA for Essential Tremor, Sets January 2027 PDUFA Date
PRAX has more than doubled off its 52-week low of $28.08.
Summary
Praxis Precision Medicines announced that the FDA has accepted its New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor, assigning a PDUFA target action date of January 29, 2027. This is a critical regulatory milestone, confirming the FDA will proceed with a full review of the drug, which previously received Breakthrough Therapy Designation and showed positive Phase 3 results. The absence of a planned advisory committee meeting is generally viewed as a positive indicator, suggesting a potentially smoother path to approval. This acceptance significantly de-risks a key pipeline asset for Praxis, providing a clear timeline for potential commercialization. Investors will now closely monitor the PDUFA date for the final regulatory decision.
At the time of this announcement, PRAX was trading at $350.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $8.8B. The 52-week trading range was $28.08 to $356.00. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.