PolyPid has entered an exclusive commercial partnership with Azurity Pharmaceuticals for D-PLEX100 in the United States and Canada. PolyPid will receive a $15 million upfront payment and a $15 million near-term milestone payment upon FDA acceptance of the NDA, expected in August 2026, with up to approximately $300 million in additional regulatory, development, and sales-based milestones, plus tiered royalties from mid-teen to mid-twenties percentages. Azurity will commercialize D-PLEX100 upon approval, leveraging its first-in-class commercial model, while PolyPid will manufacture and supply the product. Azurity will also fund clinical development for potential label expansion beyond abdominal surgical site infections. The partnership follows positive Phase 3 SHIELD II results showing a 60% relative risk reduction in SSI incidence, and a U.S. launch is targeted for the first quarter of 2027.
PolyPidPolyPid receives $15M upfront, $15M milestone, and up to $300M in milestones plus royalties from Azurity partnership.
Azurity gains exclusive rights to commercialize D-PLEX100, a product with positive Phase 3 results and significant market potential.