FDA Accepts Pharvaris' NDA for HAE Drug Deucrictibant IR, Sets April 2027 PDUFA Date
PHVS has more than doubled off its 52-week low of $17.05.
Summary
The FDA has accepted Pharvaris' New Drug Application (NDA) for deucrictibant IR, an on-demand treatment for Hereditary Angioedema (HAE) attacks, setting a PDUFA target action date of April 23, 2027. This significant regulatory milestone follows the company's successful $132.3 million public offering in May, which was intended to extend its operational runway. The NDA acceptance is a critical de-risking event for Pharvaris, moving its lead drug candidate substantially closer to potential market approval and commercialization. Deucrictibant IR demonstrated strong efficacy and a well-tolerated safety profile in its pivotal Phase 3 study, meeting all primary and secondary endpoints. The market will now closely watch for the final FDA approval decision on the specified PDUFA date.
At the time of this announcement, PHVS was trading at $34.42 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.4B. The 52-week trading range was $17.05 to $35.91. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.