Dyne Therapeutics receives FDA Fast Track designation for DYNE-101
FDA Fast Track Designation: Dyne Therapeutics has received Fast Track designation from the FDA for DYNE-101, aimed at treating myotonic dystrophy type 1.
Clinical Trial Progress: The drug is currently being assessed in the Phase 1/2 ACHIEVE global clinical trial, which has shown significant functional benefits and effects on disease biomarkers.
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Dyne Therapeutics Receives Orphan Drug Designation for z-basivarsen, ACHIEVE Trial Shows Sustained Improvement
- Clinical Trial Progress: Z-basivarsen demonstrates sustained functional improvement in the ACHIEVE trial, particularly in muscle strength and function, with enrollment for the registrational expansion cohort expected to complete in early Q2 2026, further advancing treatment options.
- Orphan Drug Designation: The MHLW in Japan has granted z-basivarsen orphan drug status for myotonic dystrophy type 1 (DM1), highlighting the urgent need for new therapies and potentially providing up to 10 years of market exclusivity if approved.
- Multiple Designations: Z-basivarsen has received Breakthrough Therapy, Fast Track, and Orphan Drug designations from the FDA, along with Orphan Drug designation from the EMA, indicating its development potential and market recognition on a global scale.
- Treatment Need: DM1 affects approximately 40,000 people in the U.S. and 55,000 in the EU, and the development of z-basivarsen aims to address the significant unmet medical need, carrying important social and economic implications.
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