FDA Accepts D-PLEX100 NDA with Priority Review, PDUFA Date Set for Nov 28
PYPD sits 35% above its 52-week low of $3.06.
Summary
The FDA accepted PolyPid's NDA for D-PLEX100 and granted Priority Review, setting a PDUFA date of November 28, 2026. This is the critical regulatory step following the June NDA submission and the recent $320M+ licensing deal with Azurity. Acceptance triggers a $15M milestone payment, bringing total upfront payments to $30M — a meaningful cash infusion for a company with a ~$72M market cap. Priority Review signals the FDA sees D-PLEX100 as a potential significant improvement over existing surgical site infection prevention. The November 28 decision is now the binary event that will define the stock's trajectory.
At the time of this announcement, PYPD was trading at $4.14 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $71.6M. The 52-week trading range was $3.06 to $5.73. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: Reuters.