Stock Taper 
| DATE | TYPE | RATIO |
|---|---|---|
| 2023-09-21 | Reverse | 1:30 |
PolyPid Ltd., an Israeli late-stage biopharma company, develops PLEX platform-based products like D-PLEX100, currently in Phase III trials to prevent surgical site infections.
D-PLEX100 by PolyPid is a drug-eluting paste delivering doxycycline over 30 days to prevent surgical site infections, currently in late-stage regulatory review and nearing commercialization.
PolyPid announced positive topline results from its SHIELD II Phase 3 trial, showing that its lead product candidate, D-PLEX₁₀₀, demonstrated a statistically significant reduction in surgical site infections in patients undergoing abdominal colorectal surgery. The successful outcome of this pivotal trial was a transformational event for the company, paving the way for a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).
In a pivotal move, PolyPid appointed Brooke Story, a seasoned MedTech executive with extensive experience in the surgical market and infection prevention, as Chairman of the Board. [15] This leadership change is strategically timed to guide the company's transition from a clinical-stage to a commercial-stage entity as it prepares for the New Drug Application (NDA) submission for its lead product, D-PLEX₁₀₀. [15, 33]
PolyPid (NASDAQ: PYPD) is approaching a November 28 PDUFA date for D-PLEX100, its lead product candidate for preventing surgical site infections in patients undergoing colorectal surgery, Chief Executive Officer Dikla Czaczkes Akselbrad said during the Lytham Partners Fall 2026 Investor Conference. The company submitted its New Drug Application earlier this year, and the FDA accepted the
PolyPid Submitted Marketing Authorization Application to European Medicines Agency for D-PLEX₁₀₀ Last month
PETACH TIKVA, Israel, Oct. 01, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced that PolyPid and ADVANZ PHARMA have mutually agreed to terminate their 2022 exclusive License, Distribution and Supply Agreement for D-PLEX₁₀₀ in Europe.
Overall rating: C-
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