Dyne Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2018-01-01
- Employees
- 141
- Market Cap
- $4.4B
- Website
- http://www.dyne-tx.com
- Introduction
Dyne Therapeutics Inc is a biotechnology company focused on providing therapeutics for patients with genetically driven diseases. The company overcomes the limitations of muscle tissue delivery and modern oligonucleotide therapeutics for muscle diseases. The company is developing therapies for muscle disorders like Myotonic dystrophy, Duchenne muscular dystrophy, and Facioscapulohumeral muscular dystrophy. The company's product candidates are DYNE-101 and DYNE-251, both are in the ongoing phase 1/2 clinical trial.
Dyne Therapeutics Reports New Clinical Data Showing DYNE-101's Potential in Treating DM1
The ACHIEVE trial highlights DYNE-101's potential in treating DM1, showing significant splicing correction and functional improvements at 6.8 mg/kg Q8W dose. DYNE-101 demonstrated a favorable safety profile, with most adverse events being mild or moderate. Dyne plans for U.S. Accelerated Approval based on splicing as a surrogate endpoint, with a Registrational Expansion Cohort expected to complete enrollment by mid-2025.
Dyne Plans to Initiate Registrational Expansion Cohort for DYNE-101 and Reports Positive Data for DYNE-251
The ACHIEVE trial highlights DYNE-101's potential in treating DM1, showing significant splicing correction and functional improvements at 6.8 mg/kg Q8W dose. DYNE-101 demonstrated a favorable safety profile, with plans for U.S. Accelerated Approval based on splicing as a surrogate endpoint. Dyne also reported positive safety and efficacy data for DYNE-251 in DMD, aiming for global expedited approval.
Dyne Therapeutics' DM1 Treatment Shows Breakthrough Results, Plans Accelerated FDA Filing
Dyne Therapeutics announced new clinical data for DYNE-101 showing significant improvements in myotonic dystrophy type 1 (DM1) patients, including splicing correction and functional benefits. Plans for a global Registrational Expansion Cohort aim to support U.S. Accelerated Approval submission by H1 2026. DYNE-251 for DMD also progresses towards accelerated approval.
Dyne Therapeutics Reports Promising Clinical Data for DYNE-101 in Myotonic Dystrophy Type 1 and Unprecedented Dystrophin Expression with DYNE-251 in Duchenne Muscular Dystrophy
Dyne Therapeutics reports promising clinical data for DYNE-101 in Myotonic Dystrophy Type 1, planning a registrational expansion cohort for potential U.S. accelerated approval by H1 2026. Also, DYNE-251 shows unprecedented dystrophin expression in Duchenne Muscular Dystrophy, with registrational cohorts expected by end of 2024.
Dyne Therapeutics Reports New Clinical Data Showing Positive Outcomes from Phase 1/2 ACHIEVE Trial for DYNE-101 in DM1
Dyne Therapeutics announced positive clinical data from its Phase 1/2 ACHIEVE trial for DYNE-101 in DM1, showing splicing correction and functional improvements. Plans for a global Registrational Expansion Cohort aim for U.S. Accelerated Approval by H1 2026. DYNE-251 for DMD is also progressing, with data expected late 2025 for potential early 2026 submission.
Dyne Therapeutics to Host Investor Conference Call and Webcast on Phase 1/2 ACHIEVE Clinical Trial Data
Dyne Therapeutics, Inc. will report new Phase 1/2 ACHIEVE clinical trial data on January 10, 2025, and host a webcast at 8:00 a.m. ET. The webcast, available on Dyne’s website, will include a slide presentation and be accessible for 90 days. Dyne focuses on innovative treatments for genetically driven neuromuscular diseases.
Dyne Therapeutics (NASDAQ:DYN) Shares Down 3.7% - What's Next?
Dyne Therapeutics' stock fell 3.7% to $24.52, with trading volume down 43%. Analysts' ratings vary, with an average 'Moderate Buy' and a $49.91 target. The company reported a quarterly loss of $0.96 per share, missing estimates. Insiders sold shares, decreasing ownership. Institutional investors adjusted their stakes, with 96.68% of stock owned by them. Dyne focuses on muscle disease therapeutics.
Top 10 MD News Stories of 2024
In 2024, Muscular Dystrophy News Today highlighted key developments in MD research, including gene therapy trials, new treatments like SAT-3247 and Elevidys, and clinical advancements for DMD and FSHD, emphasizing progress in muscle function and dystrophin production.
Dyne Therapeutics (NASDAQ:DYN) Coverage Initiated by Analysts at Robert W. Baird
Robert W. Baird initiated coverage on Dyne Therapeutics with an 'outperform' rating and a $46.00 price target, suggesting a 78.78% upside. Other firms also rated DYN positively, with a consensus 'Moderate Buy' and an average target price of $50.42. DYN reported a Q3 loss of ($0.96) per share, missing estimates. Insiders sold shares, and institutional investors increased stakes, with 96.68% of stock owned by institutions. Dyne Therapeutics focuses on therapeutics for genetically driven muscle diseases.
Myotonic Dystrophy Clinical Trial Pipeline Boom as Over 20 Companies Leading
Increased R&D in myotonic dystrophy drives market growth, attracting funding and partnerships. DelveInsight's 'Myotonic Dystrophy Pipeline Insight 2024' reports on 20+ companies developing 22+ therapies, including AOC 1001, Tideglusib, and PGN EDODM1. Key events include FDA designations for ATX-01 and DYNE-101, and Fast Track designation for PGN-EDODM1.
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