Shares of MediWound MDWD and its development partner, Vericel Corporation VCEL, are trading lower after MediWound received a Complete Response Letter from the FDA for its NexoBrid Biologics License Application.
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. Vericel Corporation holds an exclusive license for North American commercial rights to NexoBrid.
MediWound Ltd., a biopharmaceutical company, develops, manufactures and commercializes novel and bio-therapeutic solutions for tissue repair and regeneration.
At the time of publication, shares of MediWound were trading 27.12% lower at $4.11. The stock has a 52-week low of $2.72 and a 52-week high of $6.22.
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