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The European Medicines Agency's validation starts formal review of PolyPid's surgical infection prevention drug, which is also under FDA Priority Review with a November 28, 2026 PDUFA date.
SEC filing
FDA accepted PolyPid's NDA with priority review, moving the PDUFA date to November 28, 2026, and the company banked $30 million from a new Azurity partnership.
SEC filing
FDA acceptance triggers a $15 million milestone payment from partner Azurity, and PolyPid says review is now on track to finish about three months sooner than expected.
SEC filing
PolyPid could receive over $320 million in payments as Azurity takes on U.S. and Canadian commercial rights for the surgical infection candidate, with launch targeted for early 2027.
SEC filing