USFDAAug 12, 2026, 07:41 AM
PolyPid D-PLEX₁₀₀ NDA Accepted with Priority Review; PDUFA Nov 28
AI Summary
PolyPid announced that the FDA accepted its D-PLEX₁₀₀ New Drug Application (NDA) for preventing surgical site infections with Priority Review, setting a PDUFA goal date of November 28, 2026. This acceptance triggered $30 million in upfront and near-term milestone payments from its exclusive U.S. and Canada commercialization partnership with Azurity Pharmaceuticals, with potential for over $290 million in additional milestones and tiered royalties. The company reported a Q2 2026 net loss of $7.8 million and expects its current cash, combined with partnership proceeds, to fund operations into 2028.
Key Highlights
- FDA accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA goal date November 28, 2026.
- Secured $30 million upfront and near-term milestones from Azurity Pharmaceuticals partnership.
- Eligible for up to $290 million additional milestones plus tiered royalties up to mid-twenties percentages.
- Q2 2026 net loss of $7.8 million, or $(0.35) per share.
- Q2 2026 R&D expenses were $6.1 million, compared to $6.2 million in Q2 2025.
- Cash and cash equivalents of $6.6 million as of June 30, 2026.
- Expects current cash and partnership proceeds to fund operations into 2028.
Price Impact
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