FDA Approves MediWound's NexoBrid For Burn Treatment

The FDA has approved MediWound Ltd's MDWD NexoBrid (anacaulase-bcdb) to remove eschar in adults with deep partial-thickness and/or full-thickness thermal burns.
NexoBrid, a botanical drug product containing proteolytic enzymes, is already approved in 43 countries.
Recently, MediWound signed an agreement with Triskel Integrated Services to market and distribute NexoBrid in Switzerland, with a launch planned for Q1 of 2023. Triskel also holds the distribution rights of NexoBrid in France, where NexoBrid is expected to launch in Q3 2023.
Vericel Corporation VCEL holds an exclusive license to commercialize NexoBrid in North America.
MediWound will receive a $7.5 million milestone payment from Vericel, triggered by the FDA approval of NexoBrid.
NexoBrid can be applied in up to two applications of four hours each. The first application of NexoBrid may be applied to an area of up to 15% body surface area. The second application of NexoBrid may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA.
In addition, BARDA has supported the evaluation of NexoBrid in the pediatric population, and the marketing application is expected to be submitted for FDA approval in 2023.
Price Action: MDWD shares closed higher by 3.96% at $13.38 on Thursday.