GlobeNewswire·Nov 11, 2026, 7:30 AM ET

PolyPid Provides Corporate Update and Reports Third Quarter 2026 Financial Results

PYPD

The FDA is conducting Priority Review of PolyPid's NDA for D-PLEX₁₀₀ to prevent surgical site infections, with a PDUFA goal date of November 28, 2026.
PolyPid and partner Azurity are preparing for a potential U.S. commercial launch of D-PLEX₁₀₀ in early 2027.
An application for a New Technology Add-on Payment (NTAP) was submitted to CMS, with a decision expected in August 2027 to potentially increase hospital reimbursement.
PolyPid submitted a Marketing Authorization Application (MAA) for D-PLEX₁₀₀ to the EMA on September 14, 2026, which was validated, initiating formal review with a decision expected in the second half of 2027.
PolyPid regained exclusive European commercialization rights for D-PLEX₁₀₀ after terminating its agreement with ADVANZ PHARMA.
PolyPid unveiled its "PolyPid 2030" growth strategy, introducing PD01B, a new Kynatrix-based candidate for diabetic foot infections, while continuing preclinical development for the obesity program PD03A.
The Company received a total of $30 million from Azurity, including $15 million upfront and $15 million upon FDA NDA acceptance.
PolyPid reported a net loss of $5.8 million ($0.24 per share) for the three months ended September 30, 2026, and $21.3 million ($0.94 per share) for the nine months ended September 30, 2026.
Cash, cash equivalents, and short-term deposits totaled $15.5 million as of September 30, 2026, with funding expected to support operations through 2028.
PolyPid plans to initiate FDA communications regarding label expansion for D-PLEX₁₀₀ into broader abdominal surgery in the fourth quarter of 2026.

Company: PolyPid Ltd.
Keywords: Nasdaq:PYPD, PolyPid Ltd., PolyPid, PYPD, NASDAQ:PYPD