PolyPid Ltd. PYPD
PolyPid Ltd. (Nasdaq: PYPD) is an infectious disease drug developer. Its lead program, D-PLEX100, is in Phase 3 for Prevention of surgical site infections (colorectal and abdominal surgery). Its next catalyst on record is D-PLEX100: D-PLEX100 NDA under FDA Priority Review with November 28, 2026 PDUFA goal date. (November 2026).
Upcoming catalysts
- November 2026D-PLEX100 — D-PLEX100 NDA under FDA Priority Review with November 28, 2026 PDUFA goal date.
The U.S. Food and Drug Administration has accepted PolyPid's NDA for D-PLEX₁₀₀ and granted Priority Review, with a PDUFA goal date of November 28, 2026.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| D-PLEX100 (doxycycline in PLEX controlled-release polymer) | Prevention of surgical site infections in abdominal colorectal surgery | small molecule | Phase 3 |
Recent results and decisions
- Oct 1, 2026accepted EMA validated PolyPid MAA for D-PLEX100 (submitted Sept 14, 2026); CHMP formal review begins (ex-US regulator action).
the European Medicines Agency (“EMA”) has validated the Company’s recently submitted Marketing Authorization Application (“MAA”) for D-PLEX100
Filing - Oct 1, 2026accepted European Medicines Agency validates PolyPid's Marketing Authorization Application for D-PLEX100.
The European Medicines Agency has validated the Company's recently submitted Marketing Authorization Application for D-PLEX₁₀₀.
Filing - Sep 14, 2026submitted PolyPid submitted Marketing Authorization Application to EMA for D-PLEX100 on September 14, 2026.
The MAA was submitted to the EMA on September 14, 2026 under the Centralized Procedure on the basis of therapeutic innovation.
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 infectious disease companies
- Gilead Sciences, Inc. GILD
- GSK plc GSK
- Moderna, Inc. MRNA
- Vaxcyte, Inc. PCVX
- Vir Biotechnology, Inc. VIR
- Novavax Inc NVAX
- Sinovac Biotech Ltd SVA
- CorMedix Inc. CRMD
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.