Benzinga | Jun 29, 2021 09:23AM EDT

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

* Vericel Corporation's (NASDAQ:VCEL) development partner, MediWound Ltd (NASDAQ: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.