PolyPid announced two transformative milestones: the FDA's acceptance for filing of its new drug application, or NDA, for D-PLEX100 with Priority Review, and the signing of an exclusive commercialization partnership with Azurity Pharmaceuticals for the United States and Canada. The FDA granted Priority Review with a PDUFA goal date of November 28, 2026, and identified no filing review issues. Under the Azurity agreement, PolyPid has secured $30 million in upfront and near-term milestone payments and is eligible for over $290 million in additional regulatory, launch, and sales milestones, plus tiered royalties ranging from mid-teens to mid-20s percentages and a transfer price on every unit supplied. PolyPid expects to submit a Marketing Authorization Application to the European Medicines Agency in the third quarter of 2026 and anticipates a commercial launch of D-PLEX100 by Azurity in early 2027. The company reported a net loss of $7.8 million for the second quarter of 2026, with cash and cash equivalents of $6.6 million as of June 30, 2026, and expects existing cash resources to fund operations into 2028.
PolyPidFDA acceptance of NDA with Priority Review for D-PLEX100
Commercial Metals CompanyExclusive commercialization partnership for D-PLEX100 in US and Canada
