PYPD - PolyPid's surgical site infections treatment eligible for marketing nod submission in EU

• PolyPid ( NASDAQ: PYPD ) on Wednesday said it had got confirmation from Europe's drug regulator that its D-PLEX ₁₀₀ product candidate for the treatment of surgical site infections was eligible to be submitted for a marketing authorization.
• The company said the product candidate was eligible for the European Medicines Agency's (EMA) centralized procedure under the therapeutic innovation criteria.
• "The centralized procedure allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states as well as in Iceland, Liechtenstein and Norway," PYPD said in a statement .
• The company is currently evaluating its recently concluded phase 3 trial which evaluated D-PLEX ₁₀₀ for the prevention of surgical site infections in abdominal surgery.
• PYPD said it intends to discuss the data from the late-stage trial and potential next steps with U.S. and EU regulators in Q1 2023.
• PolyPid ( PYPD ) stock +1.2% to $1.10 in morning trading.

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