Wed, Feb. 3, 12:59 PM
- Ultra-thinly traded micro cap MediWound (MDWD +13.1%) is up on average volume, albeit on turnover of only 15K shares, on the news of successful results in a Phase 2 clinical trial assessing EscharEx for debridement (removal) of dead or damaged tissue in chronic or other hard-to-heal wounds.
- EscharEx is biopharmaceutical based on the same proteolytic enzyme technology used in the company's NexoBrid product which is commercially available in Europe and Israel for the removal of eschar (dead skin) in adults with serious thermal burns.
- The study, the second mid-stage trial of EscharEx, was conducted across 15 sites in Europe and Israel with 73 patients. Its efficacy was compared to hydrogel vehicle (placebo) in a variety of difficult-to-heal wounds. The trial met its primary endpoint of a statistically valid higher incidence of complete debridement in patients treated with EscharEx compared to hydrogel vehicle (55% vs 29%; p=0.047). A secondary endpoint of time to complete debridement fell short of statistical significance (p=0.075).
- The company intends to submit the data to the FDA in H2 and request an end-of-Phase 2 meeting to discuss the results and clarity the trial design and objectives for a Phase 3 study.
- Previously: MediWound completes enrollment in second mid-stage study of EscharEx (Sept. 1, 2015)
Oct. 21, 2015, 12:49 PM
Sep. 30, 2015, 12:43 PM
Sep. 30, 2015, 8:47 AM
- Thinly traded micro cap MediWound (NASDAQ:MDWD) is up 25% premarket on light volume in response to its announcement that it has been awarded a contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to fund the development, manufacturing and procurement of NexoBrid, the company's proprietary pharmaceutical product for the enzymatic removal of eschar (dead skin) in adults with deep-partial and full-thickness thermal burns.
- The five-year contract, valued as much as $112M, is part of BARDA's preparedness for mass casualty events. It includes $24M to support the activities to complete a U.S. regulatory filing seeking clearance for the use of NexoBrid for thermal burn injuries, $16M to procure NexoBrid and options to fund expanded indications for NexoBrid ($22M) as well as additional procurement ($50M).
Jun. 2, 2015, 5:38 PM
Feb. 12, 2015, 12:45 PM
Jul. 14, 2014, 5:37 PM
Mar. 20, 2014, 4:04 PM
- IPO MediWound (MDWD) closes at $17.27 up 23% today on 4.2M shares giving it a market cap of $364M.
- The Israel-based biopharmaceutical company focuses on severe burns, chronic and hard-to-heal wounds and connective tissue disorders.
- Its lead product, NexoBrid, is a topical gel for the removal of eschar (debridement).
- The firm launched NexoBrid in Europe in December 2013.
- A phase 3 clinical trial will commence in the U.S. by June.
- No sales as of year end.
- Operations burned $8M in 2013.
MediWound Ltd. is a biopharmaceutical company that engages in the development, manufacture, and commercialize novel products to address unmet needs in the fields of severe burn; chronic and other hard-to-heal wounds; and connective tissue disorders. Its medicinal product, NexoBrid, is used to... More