Edgewise Receives Orphan Drug And Rare Pediatric Disease Designations For Its Muscular Dystrophy Program From FDA
Portfolio Pulse from Benzinga Newsdesk
Edgewise Therapeutics, Inc. (NASDAQ:EWTX) has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA for EDG-5506, a treatment for Duchenne and Becker muscular dystrophy. EDG-5506 is an investigational drug currently in Phase 2 trials. ODD and RPDD provide benefits such as market exclusivity, tax credits, and fee waivers, which support the development of rare disease treatments.
November 30, 2023 | 1:11 pm
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Edgewise Therapeutics received FDA Orphan Drug and Rare Pediatric Disease Designations for EDG-5506, potentially benefiting from market exclusivity, tax credits, and fee waivers upon approval.
The FDA's designations for Edgewise's EDG-5506 are significant positive developments, likely to enhance investor confidence in the company's pipeline. These designations can lead to financial incentives and a potentially expedited pathway to market, which are critical for a biopharmaceutical company focusing on rare diseases. The news is expected to have a positive short-term impact on EWTX's stock price as it validates the company's research and development efforts and could improve its competitive position.
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