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 28, 2026).
Upcoming catalysts
- November 28, 2026D-PLEX100 — D-PLEX100 NDA under FDA Priority Review with November 28, 2026 PDUFA goal date.
D-PLEX₁₀₀ NDA concurrently under FDA Priority Review with November 28, 2026 PDUFA goal date
- 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 Prescription Drug User Fee Act goal date of November 28, 2026.
Next further out: D-PLEX100 — PolyPid expects U.S. launch of D-PLEX100 in early 2027, subject to FDA approval. (H1 2027). 6 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
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 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 - Jul 29, 2026accepted FDA accepted the D-PLEX100 NDA with Priority Review, no filing review issues, PDUFA target action date November 28, 2026.
The FDA did not identify any filing review issues and set a Prescription Drug User Fee Act (“PDUFA”) target action date of November 28, 2026
Filing
2 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
- GSK plc GSK
- Vaxcyte, Inc. PCVX
- Sinovac Biotech Ltd SVA
- Valneva SE VALN
- Kamada Ltd KMDA
- CorMedix Inc. CRMD
- Atea Pharmaceuticals, Inc. AVIR
- SIGA Technologies, Inc. SIGA
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.