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May 21, 2014
07:05 EDTMDWDMediWound initiates second Phase 2 clinical trial of EscharEx
MediWound announces initiation of its second Phase 2 clinical trial of EscharEx to treat chronic and other hard-to-heal wounds. EscharEx is based on MediWound's patented proteolytic enzyme technology. This prospective, randomized, controlled, multicenter Phase 2 study of approximately 72 subjects is planned to be conducted at approximately 10 clinical sites and intends to evaluate safety and efficacy of EscharEx compared with gel vehicle for the treatment of a variety of chronic and other hard-to-heal wounds, including diabetic foot ulcers, or DFUs, venous ulcers and post-surgical or traumatic hard-to-heal wounds. The blinded study intends to assess non-viable tissue removal, wound bed preparation and wound healing as well as other additional endpoints. The Company has concluded a Phase 2 feasibility study of EscharEx to treat chronic and other hard-to-heal wounds in 24 patients at two clinical sites in Israel. The results from that trial demonstrated efficacy in debriding various wound etiologies such as DFUs, venous ulcers, pressure sores and other post-surgical or post-trauma hard-to-heal wounds.
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September 30, 2015
09:13 EDTMDWDOn The Fly: Pre-market Movers
HIGHER: Mediwound (MDWD), up 25.5% after being awarded a BARDA contract valued up to $112M... Novavax (NVAX), up 8.4% after RSV F vaccine meets safety endpoints in its Phase 1 clinical trial... Western Digital (WDC), up 11.7% after receiving a $3.78B equity investment by Unisplendour Corporation... Esperion Therapeutics (ESPR), up 9.9% after being upgraded to Neutral from Sell at Chardan and after JPMorgan said they still see longer-term upside in the shares... Pericom Semiconductor (PSEM), up 6.5% after Montage Technology proposes to acquire the company for $18.50 per share... Fiat Chrysler (FCAU), up 5.2% after CNBC reported that the company could launch Ferrari's IPO as soon as Friday. NOTABLE: Ralph Lauren (RL), up 6.4% after appointing Gap's (GPS) global president of Old Navy, Stefan Larsson as CEO... Gap is down 7.4%. DOWN AFTER EARNINGS: Barracuda Networks (CUDA), down 28.5%... Costco (COST), down a half a percent.
07:03 EDTMDWDMediWound awarded BARDA contract valued up to $112M
MediWound announces that the U.S. Biomedical Advanced Research and Development Authority, or BARDA, has awarded the Company a contract valued at up to $112M. The contract is for the advancement of the development and manufacturing, as well as the procurement of NexoBrid, the company's proprietary pharmaceutical product for enzymatic removal of eschar in adults with deep-partial and full-thickness thermal burns, as a medical countermeasure as part of BARDA preparedness for mass casualty events. The five-year base contract includes $24M of funding to support development activities to complete the FDA approval process for NexoBrid for use in thermal burn injuries, as well as $16M for procurement of NexoBrid, which is contingent upon FDA Emergency Use Authorization and/or FDA marketing authorization for NexoBrid. In addition, the contract includes options for further funding of up to $22M for expanding NexoBrid's indications and of up to $50M for additional procurement of NexoBrid.

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