- The shares of Vericel Corporation ( NASDAQ: VCEL ) and MediWound Ltd. ( NASDAQ: MDWD ) rose on Thursday on the FDA approval of NexoBrid, a botanical drug product the companies collaborated to develop as a treatment for thermal burns.
- Specifically, the FDA has greenlighted NexoBrid, also known as anacaulase-bcdb, for the removal of eschar in adults with thermal burns after a review of data from eight clinical studies, including a pivotal Phase 3 U.S. clinical study.
- With the FDA approval, MediWound ( MDWD ) is entitled to receive $7.5M from Vericel ( VCEL ), which has partnered with the company to commercialize NexoBrid in North America.
- NexoBrid development was backed by funding from U.S. Biomedical Advanced Research and Development Authority (BARDA) Administration for Strategic Preparedness and Response (ASPR) which comes under the U.S. Department of Health and Human Services (HHS).
- Vericel’s ( VCEL ) valuation is unlikely to change even if FDA clears NexoBrid and its revenue matches that of the cell therapy product Epicel, Seeking Alpha contributor Eric Egana argued in October.
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MediWound, Vericel gain on FDA approval of burn therapy