PolyPid Secures $4.3M FDA Fee Waiver, Initiates Rolling NDA for D-PLEX100
PolyPid initiated a rolling NDA submission to the FDA for D-PLEX100 with CMC and nonclinical data, securing a $4.3 million PDUFA fee waiver and with clinical sections expected imminently. The company is in late-stage U.S. partnership talks for D-PLEX100 and plans EMA meetings in Q2 ahead of a Q3 MAA.
1. NDA Submission Initiation
On March 30, PolyPid submitted the first modules of its rolling NDA to the FDA for D-PLEX100, including Chemistry, Manufacturing and Controls and nonclinical data. The company secured a $4.3 million PDUFA fee waiver, enabling focus on clinical modules, which are expected to be filed imminently.
2. Regulatory and Commercial Progress
PolyPid has scheduled Q2 meetings with EMA rapporteurs to align on its centralized MAA submission planned for Q3 2026. Concurrently, the company’s U.S. commercial partnership discussions have reached late stages, positioning D-PLEX100 for potential collaborative launch.
3. First Quarter Financial Results
In Q1 2026, R&D expenses fell to $5.8 million from $6.1 million year-over-year, reflecting trial completion and regulatory focus, while net loss narrowed to $7.7 million from $8.3 million. Cash and equivalents stood at $10.9 million as of March 31, and the company eliminated its $0.8 million loan facility in early May.