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- What is PolyPid's primary focus as a biopharmaceutical company?
- PolyPid is a late-stage biopharmaceutical company focused on improving surgical outcomes through locally administered, controlled, prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology.
- What is the status of PolyPid's lead product candidate, D-PLEX100?
- PolyPid's lead product candidate, D-PLEX100, is in a phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections.
- When did PolyPid become a public company and on which exchange?
- PolyPid became public on NASDAQ in June 2020.
- What was a significant regulatory milestone for PolyPid in March 2017?
- In March 2017, the FDA fast-tracked PolyPid.
- What was the outcome of PolyPid's Phase 3 SHIELD II trial for D-PLEX₁₀₀ in June 2025?
- In June 2025, PolyPid announced positive topline results from its Phase 3 SHIELD II trial, where D-PLEX₁₀₀ demonstrated a significant reduction in surgical site infections and met its primary and all key secondary endpoints.
- What new delivery platform did PolyPid unveil in July 2025?
- In July 2025, PolyPid unveiled a long-acting GLP-1 Receptor Agonists delivery platform, targeting the diabetes and weight loss market.
- What was a key operational development for PolyPid in September 2025 regarding manufacturing readiness?
- In September 2025, PolyPid successfully completed an Israeli Ministry of Health GMP Inspection, advancing towards commercial manufacturing readiness for D-PLEX₁₀₀.
- What was the outcome of the FDA Pre-NDA meeting for D-PLEX₁₀₀ in December 2025?
- In December 2025, PolyPid announced positive FDA Pre-NDA Meeting Minutes for D-PLEX₁₀₀, supporting its New Drug Application submission.
- What was a significant financial event for PolyPid in January 2024?
- In January 2024, PolyPid announced a private placement for $16 million in gross proceeds.
- What was the status of D-PLEX₁₀₀'s NDA submission to the FDA in March 2026?
- In March 2026, PolyPid initiated the D-PLEX₁₀₀ NDA Submission to the FDA and received a PDUFA Fee Waiver for it.