MediWound Announces Submission of Biologics License Application to the U.S. FDA for NexoBrid for the Treatment of Severe Thermal Burns
MediWound Ltd. - Ordinary Shares (MDWD)
Last mediwound ltd. - ordinary shares earnings: 2/25 07:00 am
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ir.mediwound.com/press-releases
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Source: GlobeNewswire
YAVNE, Israel, June 30, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet medical needs in severe burn and wound management, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and full-thickness thermal burns up to 30% of total body surface area. The DETECT study successfully met its primary endpoint and all secondary endpoints, with a comparable safety profile. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan
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News
- MediWound Ltd. (NASDAQ: MDWD) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- What Makes MediWound (MDWD) a Good Fit for 'Trend Investing' [Yahoo! Finance]Yahoo! Finance
- MediWound Ltd. (NASDAQ:MDWD) Just Reported Full-Year Earnings: Have Analysts Changed Their Mind On The Stock? [Yahoo! Finance]Yahoo! Finance
- MediWound Ltd. (NASDAQ: MDWD) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- MediWound Ltd. (NASDAQ: MDWD) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $28.00 price target on the stock.MarketBeat
MDWD
Earnings
- 3/21/24 - Beat
MDWD
Analyst Actions
- 3/22/24 - HC Wainwright
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Sec Filings
- 3/21/24 - Form 20-F
- 3/21/24 - Form 6-K
- 2/14/24 - Form SC
- MDWD's page on the SEC website