PolyPid reports Q2 2026 financial results and corporate update
FDA accepted D-PLEX100 NDA with Priority Review; Azurity partnership brings $30M upfront, with PDUFA date November 28, 2026.
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Developer of long-acting controlled-release medicines
polypid.comLast updated
In short: PolyPid received FDA Priority Review for its D-PLEX100 NDA and secured a $320 million commercialization deal with Azurity Pharmaceuticals.
FDA accepted D-PLEX100 NDA with Priority Review; Azurity partnership brings $30M upfront, with PDUFA date November 28, 2026.
The FDA set a PDUFA date of November 28, 2026, nearly a quarter ahead of guidance, and triggered a $15 million milestone payment.
PolyPid will receive over $320 million in milestone payments and tiered royalties for D-PLEX100 commercialization in US and Canada.
The submission aims to prevent surgical site infections; PDUFA target in Q1 2027.
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PolyPid (PYPD) received FDA Priority Review for D-PLEX100, with a PDUFA goal date of November 28, 2026. The company also secured a U.S. and Canada...
PolyPid Ltd (NASDAQ: PYPD) reported Q2 2026 EPS of $(0.35), beating estimates by 7.89% as net losses narrowed 55% YoY to $7.8 million. Key drivers...
FDA accepted NDA for D-PLEX 100 with Priority Review, setting a PDUFA goal date ahead of schedule. Secured $30 million in milestone payments through a...
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