FDA Strikes Off MediWound - Vericel's NexoBrid Biologics License Application; Stocks Drop - MediWound (NASDAQ:MDWD), Vericel (NASDAQ:VCEL)

Vericel Corporation's VCEL development partner, MediWound Ltd MDWD, received a complete response letter from FDA regarding the NexoBrid application seeking approval for eschar removal in adults with deep partial-thickness or full-thickness burns.
The FDA identified issues related to the Chemistry, Manufacturing, and Controls (CMC) section of the application and requested that MediWound provide additional CMC information. It also requested that MediWound provide a safety update as part of its application resubmission.
The agency stated that it had not reviewed several amendments submitted by MediWound in response to the CMC information requests for this action.
The FDA also stated that inspections of manufacturing facilities in Israel and Taiwan are required before the application can be approved, but it could not conduct the necessary checks.
Price Action: VCEL shares are down 14.5% at $58, and MDWD shares are down 35.3% at $3.65 in the premarket session on the last check Tuesday.

FDA Strikes Off MediWound - Vericel's NexoBrid Biologics License Application; Stocks Drop