For the quarter ended December 2019, the Yavne, Israel-based company posted a loss of $0.06 per share on revenue of $1 million. The consensus estimate was a loss of $0.15 per share on revenue of $0.8 million. Revenue grew 87.2% on a year-over-year basis.
Shares in MediaWound climbed 7.5% to $5.58 before the opening bell.
In January, the company announced positive top-line results from the Phase 3 DETECT study in NexoBrid which removes dead tissue resulting from a severe burn.
MediWound plans to file a biologics license application for NexoBrid in the second half of 2019. A biologics license application is a request to distribute a biologic across states.
“We plan to file the biologics license application in the second half of 2019, subject to Food and Drug Administration concurrence in a meeting planned for the second quarter,” MediWound CEO Gal Cohen said in a statement.
Cohen announced earlier in March that he will step down as CEO by the end of May and that
The niche company specializes in developing therapeutics to treat conditions related to severe burns and chronic or slow-to-heal wounds.
Contact Uttara Choudhury at [email protected]