EMA Accepts MediWound’s Application for Extended Indication for NexoBrid to Treat Pediatric Patients with Severe Thermal Burns
MediWound Ltd. - Ordinary Shares (MDWD)
Last mediwound ltd. - ordinary shares earnings: 2/25 07:00 am
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Source: GlobeNewswire
YAVNE, Israel, Sept. 20, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD) (the “Company”), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the European Medicines Agency (EMA) has validated for review the Type II Variation submitted by MediWound in order to expand the current approved indication for NexoBrid (removal of eschar in adults with deep partial-and full-thickness thermal burn wounds) into the pediatric population. MediWound expects a decision from the European Commission in the first quarter of 2023. EMA has initiated evaluation of the application to extend the use of NexoBrid to children aged newborn through eighteen. The submission is supported by the interim results of a global, Phase 3 trial (CIDS - Children Innovative Debridement Study), evaluating the safety and efficacy of NexoBrid in hospitalized pediatric patients, and by additional data available from
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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
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- 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
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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