PolyPid Completes FDA New Drug Application for D-PLEX 100
PYPD sits 99% above its 52-week low of $2.44.
Summary
PolyPid has completed its New Drug Application (NDA) submission to the FDA for D-PLEX 100, a significant step towards potential market approval for its lead product.
Key Events · Product Development and Regulatory · PYPD
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NDA Submission Completed
PolyPid announced the successful completion of its New Drug Application (NDA) submission to the FDA for D-PLEX 100, its lead product candidate for the prevention of surgical site infections.
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PDUFA Target Date Set
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for the first quarter of 2027 for D-PLEX 100, indicating a timeline for a potential approval decision.
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Supported by Positive Phase 3 Data
The NDA is backed by positive results from the pivotal Phase 3 SHIELD II trial, which demonstrated a 60% relative risk reduction in surgical site infections compared to standard of care.
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Expedited Review Designations
D-PLEX 100 holds Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations from the FDA, supporting eligibility for Priority Review.
Analysis · PYPD · Industrial Applications And Services
PolyPid has successfully completed its New Drug Application (NDA) submission to the FDA for D-PLEX 100, its lead product candidate for preventing surgical site infections. This marks a critical regulatory milestone, moving the company closer to potential commercialization. The FDA has set a PDUFA target action date for the first quarter of 2027, providing a clear timeline for a potential approval decision.
At the time of this filing, PYPD was trading at $4.85 on NASDAQ in the Industrial Applications And Services sector, with a market capitalization of approximately $90.1M. The 52-week trading range was $2.44 to $5.20. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.