PolyPid stock faces FDA and EMA decisions for D-PLEX100

Published on 10/08/2026 at 02:35 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

PolyPid stock traded at USD 4.95 on Nasdaq on October 7, 2026, down 3.51 percent. D-PLEX100 now faces an FDA date of November 28 and an active EMA review.

PYPD, IL0011326795, Illustration mit AI erstellt.

PolyPid stock (ISIN IL0011326795) carried a market capitalization of USD 94.5 million as of October 7, 2026. The company is approaching two regulatory checkpoints for D-PLEX100, its lead candidate for preventing surgical-site infections after abdominal surgery.

EMA review starts for D-PLEX100

According to PolyPid on October 1, 2026, the European Medicines Agency validated the marketing authorization application for D-PLEX100. The validation confirms that the submission is complete and moves it into formal review by the EMA's Committee for Medicinal Products for Human Use.

The application was submitted on September 14, 2026, under the centralized procedure for therapeutic innovation. PolyPid said approval would create a single marketing authorization covering European Union member states, giving the company a broader commercial route for the product.

FDA date sets the next checkpoint

The same PolyPid release says the U.S. Food and Drug Administration granted Priority Review to the D-PLEX100 application with a November 28, 2026, PDUFA goal date. The U.S. review therefore supplies the nearer fixed decision point while the European process has only entered formal assessment.

In the Phase 3 SHIELD II trial, D-PLEX100 reduced surgical-site infections by 60 percent versus standard care, with a p-value of 0.0013, according to PolyPid. That result supports the regulatory case, but approval and commercialization remain separate milestones.

Losses keep valuation focused

Yahoo Finance reported Q2 2026 net loss of USD 7.85 million and diluted EPS of negative USD 0.35 for the half year ended June 30, 2026. The EPS result was better than the USD 0.38 consensus loss shown for the quarter, but the company remains in a cash-funded clinical development phase.

For market expectations, Rallies lists three analysts with a Strong Buy consensus and an average price target of USD 11.00. That target lies 122.2 percent above the USD 4.95 price, making regulatory execution the central variable behind the valuation spread.

PYPD stock stays below its yearly high

PYPD was last at USD 4.95 on Nasdaq at 4:00 p.m. ET on October 7, 2026, down 3.51 percent from the prior close of USD 5.13. The October 7 range was USD 4.90 to USD 5.13, while the 52-week range was USD 3.06 to USD 5.73.