Edgewise Receives U.S. FDA Fast Track Designation for EDG-5506 for the Treatment of Duchenne Muscular Dystrophy (Duchenne) [Yahoo! Finance]
Edgewise Therapeutics, Inc. (EWTX)
Company Research
Source: Yahoo! Finance
Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne. EDG-5506 is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies, including Duchenne and Becker muscular dystrophy (Becker). The FDA previously granted EDG-5506 Orphan Drug Designation (ODD) for the treatment of Duchenne and Becker, Rare Pediatric Disease Designation (RPDD) for the treatment of Duchenne, and Fast Track designation for the treatment of Becker. "Every day is important for individuals living with Duchenne and their families, and we are pleased that the FDA granted Fast Track designation," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "Our roster of regulatory designations granted to EDG-5506 highlights the urgent and critical need for new and better therapeutic options for people living with these rare and life-threatening muscle disorders." The FDA F
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News
- Edgewise Receives European Medicines Agency (EMA) Orphan Drug Designations for Sevasemten (EDG-5506) for the Treatment of Becker and Duchenne Muscular Dystrophies [Yahoo! Finance]Yahoo! Finance
- Edgewise Receives European Medicines Agency (EMA) Orphan Drug Designations for Sevasemten (EDG-5506) for the Treatment of Becker and Duchenne Muscular DystrophiesBusiness Wire
- Edgewise Therapeutics, Inc. (NASDAQ: EWTX) had its price target raised by analysts at Royal Bank of Canada from $28.00 to $32.00. They now have an "outperform" rating on the stock.MarketBeat
- Edgewise Therapeutics, Inc. (NASDAQ: EWTX) had its "outperform" rating re-affirmed by analysts at Wedbush. They now have a $26.00 price target on the stock.MarketBeat
- Edgewise Therapeutics Announces Positive Two-Year Topline Results from the ARCH Open Label Trial of Sevasemten (EDG-5506) in Adults with Becker Muscular Dystrophy (Becker) [Yahoo! Finance]Yahoo! Finance
EWTX
Earnings
- 2/22/24 - Miss
EWTX
Sec Filings
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- 4/15/24 - Form PRE
- EWTX's page on the SEC website