PolyPid Nears Completion of DPLEx100 NDA, Targets FDA Priority Review

Overview

• PolyPid said it is about to finish a rolling New Drug Application for its drug candidate DPLEx100 and will request priority review.
• Executives said they have not received formal FDA questions because the submission is not yet complete.
• The company reported late-stage talks with prospective U.S. partners to lead hospital-based commercialization of DPLEx100.
• PolyPid posted a Q1 net loss of $7.7 million, an improvement from last year, and said cash should fund operations into the second half of 2026 after repaying a loan facility.
• Management said manufacturing sites are preparing for potential FDA inspection, with plans to engage European regulators later in 2026.