Dyne Therapeutics, Inc.
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- Dyne Therapeutics, Inc. Dyne Therapeutics, Inc. (NASDAQ: DYN) is a clinical-stage biotechnology company focused on developing nucleic acid therapeutics for genetically driven neuromuscular diseases using its proprietary FORCE platform, which enables targeted delivery of oligonucleotides to muscle and the central nervous system. Founded in 2017 and headquartered in Waltham, Massachusetts, the company advances a broad pipeline including lead clinical candidates z-basivarsen, an antisense oligonucleotide (ASO) conjugated to a transferrin receptor 1-binding Fab for myotonic dystrophy type 1 (DM1) via the Phase 1/2 ACHIEVE trial targeting toxic DMPK RNA reduction; z-rostudirsen, a phosphorodiamidate morpholino oligomer (PMO) conjugated to a TfR1-binding Fab for Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping via the Phase 1/2 DELIVER trial aiming to restore dystrophin production; preclinical programs such as DYNE-302, an siRNA conjugate for facioscapulohumeral muscular dystrophy (FSHD) suppressing DUX4 expression; additional DMD candidates targeting exons 53, 45, and 44; and efforts in Pompe disease, with global operations pursuing regulatory designations across the U.S., EU, and Japan. Core offerings emphasize muscle-targeted therapies addressing root causes like spliceopathy in DM1 affecting approximately 40,000 U.S. patients, dystrophin loss in DMD impacting 12,000 U.S. individuals, and DUX4 toxicity in FSHD; z-basivarsen and z-rostudirsen have secured FDA Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric designations, alongside EMA and Japanese approvals. Recent developments include FDA Breakthrough Therapy Designation for DYNE-101 (z-basivarsen) in DM1 in June 2025 and for DYNE-251 (z-rostudirsen) in DMD in August 2025; full enrollment of registrational expansion cohorts in ACHIEVE and DELIVER trials with data expected mid-2026 and late 2025 to support potential U.S. accelerated approval submissions in 2026; closure of a $230 million public stock offering in July 2025 extending cash runway into Q3 2027; plans for confirmatory Phase 3 DM1 trial initiation in Q1 2026; leadership team enhancements in early 2025 ahead of anticipated 2027 commercial launches; and ongoing preclinical expansion in DMD exons and Pompe disease.
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Dyne Therapeutics Appoints Barry Greene to Board of Directors
Dyne Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Dyne Therapeutics Announces Expanded Debt Facility of Up To $400 Million with Hercules Capital, Inc.
Dyne Therapeutics Announces Completion of Enrollment in Registrational Expansion Cohort of ACHIEVE Trial of Z-Basivarsen for Myotonic Dystrophy Type 1 (DM1)
Dyne Therapeutics Stock Gains 4.5% After BLA Filing for DMD Therapy
Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)
Dyne Therapeutics: 'Strong Buy' Due To Upcoming Z-Rostudirsen BLA Submission
Dyne Stock Gains 10% on Initiation of Late-Stage Study in DMD Patients
Dyne Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Dyne Therapeutics Announces Initiation of Phase 3 FORZETTO Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD) Ahead of Planned BLA Submission for U.S. Accelerated Approval
Dyne Therapeutics Is Up 40%, but One Biotech Fund Just Disclosed Selling $14 Million Worth of Shares
Dyne Therapeutics to Participate in Upcoming Investor Conferences
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