PYPD News & Events

PolyPid announced that the FDA has granted a small business waiver of the Prescription Drug User Fee Act, or PDUFA, fee of approximately $4.3M for the New Drug Application, or NDA, for D-PLEX, the company's lead product candidate for the prevention of surgical site infections in abdominal colorectal surgeries. This waiver advances PolyPid toward its upcoming NDA submission initiation and enables the company to focus its resources on commercialization preparations. The company remains on track to submit the first sections of its rolling NDA by the end of this month, following positive feedback from the FDA during the pre-NDA meeting communication completed in December 2025.

"2025 was a pivotal year for PolyPid as we successfully completed the SHIELD II Phase 3 trial and advanced D-PLEX into the final stages of regulatory approval," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "Following our positive Phase 3 results and progress made in the past quarter, we have moved into advanced stage discussions for potential commercial partnership in the U.S., reflecting the growing recognition of D-PLEX's clinical and commercial value. At the same time, positive engagement with the FDA, including agreement on a rolling NDA review, further advanced our regulatory path as we work toward an NDA submission beginning by end of the first quarter of 2026. We believe 2026 has the potential to be a transformative year for PolyPid, marking our transition from late-stage development into full commercial execution, and we look forward to providing updates as these developments occur."

PolyPid announced the appointment of Brooke Story as Chairman of the Board of Directors, effective as of December 11, 2025. Story brings over 25 years of leadership experience in the MedTech industry.