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PolyPid Unveils Expanded Pipeline Strategy, Introducing PD01B, a New Kynatrix™ Based Product Candidate for the Treatment of Diabetic Foot Infections

PYPD
  • PolyPid will host a virtual Investor Day today at 11:30 AM ET to discuss its expanded pipeline & long-term strategy.
  • The event will feature Warren S. Joseph, DPM, FIDSA, as a key opinion leader to address diabetic foot infection treatment.
  • All FDA interactions for D-PLEX₁₀₀ remain on track for the PDUFA goal date of November 28, 2026.
  • PolyPid introduced PD01B, a new product candidate using Kynatrix technology for hyper-localized, controlled-release doxycycline treatment of diabetic foot infections.
  • PD01B is planned as a new NDA with a pre-IND meeting & first-in-human study expected in the second half of 2027.
  • PD01B aims to sustain high local antibiotic concentrations for weeks, addressing limitations of current systemic treatments in infected tissue with poor blood supply.
  • D-PLEX₁₀₀ is under FDA Priority Review with a U.S. launch expected in early 2027, subject to approval.
  • FDA communications on D-PLEX₁₀₀ label expansion into additional abdominal surgeries are expected in Q4 2026.
  • A CMS decision on New Technology Add-on Payment for D-PLEX₁₀₀ is expected in August 2027.
  • Canadian New Drug Submission for D-PLEX₁₀₀ is planned for 2027.
  • The EMA decision on the D-PLEX₁₀₀ Marketing Authorization Application is expected in the second half of 2027.
  • PolyPid has regained U.S. & European rights for D-PLEX₁₀₀ to advance other assets in its pipeline.