RegulatoryCompany release

PolyPid's D-PLEX100 under FDA priority review with 28 November goal date; EMA validates MAA

PolyPid Ltd. (PYPD) · Thu 12 Nov 2026

PolyPid says the FDA is reviewing D-PLEX100 for preventing surgical site infections in colorectal surgery, while the EMA has validated its marketing authorisation application and European rights have reverted to the company.

PolyPid reported its third-quarter 2026 results on 11 November, setting out regulatory progress for D-PLEX100 on both sides of the Atlantic. The product is intended to prevent surgical site infections in colorectal surgery.

In the US, the FDA is reviewing the company's new drug application under Priority Review, with a PDUFA goal date of 28 November 2026. Following the FDA's acceptance of the NDA, PolyPid received $15 million from Azurity.

In Europe, the EMA has validated the marketing authorisation application. PolyPid expects a decision in the second half of 2027. The licence agreement with ADVANZ for Europe has been terminated, so European rights have returned to PolyPid.

The company also has a pending application with the US Centers for Medicare & Medicaid Services for New Technology Add-on Payment (NTAP) status, with a decision expected in August 2027. As general context, NTAP is a Medicare mechanism that can provide additional payment for certain new technologies used in inpatient care.

What it means for your team

  • The FDA decision on D-PLEX100 is due by the 28 November 2026 PDUFA goal date, which is imminent for US regulatory and market-access planning.
  • With EMA validation complete, the review clock is running, and the company expects a decision in the second half of 2027.
  • European commercialisation rights are back with PolyPid after the ADVANZ termination, so partnering or launch arrangements in Europe remain open.
  • A CMS NTAP decision expected in August 2027 will be relevant to US hospital reimbursement planning.

Company's press release (SEC filing): PolyPid Ltd. ↗

Article written by VigiEye from the official source (PolyPid Ltd.). Claims are the company's own. AI-assisted; check the source before acting.

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