PolyPid Nears Completion of Rolling FDA Filing for D‑PLEX100
Fast‑track status could shorten review to speed the infection‑prevention drug toward hospitals.
Overview
- PolyPid said it has filed all parts of its rolling new drug application except the clinical section, with the final piece expected soon.
- D‑PLEX100 holds Fast Track and Breakthrough Therapy designations that make priority review possible, and the company received a waiver of the roughly $4.3 million FDA user fee.
- Executives said U.S. partnership talks are in late stages as they seek a hospital‑focused seller, with a launch goal targeted for early 2027.
- PolyPid is preparing its manufacturing sites for FDA inspection and building launch plans, while warning that inspection timing could slip due to outside factors.
- First‑quarter results showed a narrower $7.7 million loss, $10.9 million in cash and a repaid loan, with funds expected to last into the second half of 2026.