Welcome to our dedicated page for Dyne Therapeutics news (Ticker: DYN), a resource for investors and traders seeking the latest updates and insights on Dyne Therapeutics stock.
Dyne Therapeutics, Inc. (Nasdaq: DYN) is a pioneering biotechnology company based in Waltham, Massachusetts, that is dedicated to developing therapeutic solutions for genetically driven muscle diseases. Founded in 2017, Dyne Therapeutics leverages its proprietary FORCE™ platform to overcome the delivery challenges associated with modern oligonucleotide therapeutics, aiming to provide life-transforming treatments for patients.
Dyne's primary focus is on advancing therapeutics for muscle disorders such as Myotonic Dystrophy Type 1 (DM1), Duchenne Muscular Dystrophy (DMD), and Facioscapulohumeral Muscular Dystrophy (FSHD). The company’s lead programs include DYNE-101 for DM1 and DYNE-251 for DMD, both of which have shown promising clinical results. Recent clinical trials have demonstrated dose-dependent splicing correction, improvement in muscle strength, and favorable safety profiles.
In January 2024, Dyne announced the successful completion of a $345 million public offering, extending its cash runway through 2025. This funding enables the company to advance its clinical programs and pursue expedited regulatory pathways to bring its therapies to market more swiftly.
Dyne’s recent milestones include:
- Positive clinical data from the Phase 1/2 ACHIEVE trial of DYNE-101 in DM1 patients, showing dose-dependent muscle delivery and splicing correction.
- Meaningful improvement in functional endpoints and dystrophin expression in the Phase 1/2 DELIVER trial of DYNE-251 in DMD patients.
- Ongoing efforts to enhance dosing regimens and seek accelerated approval pathways with global regulatory authorities.
With a robust pipeline and a dedicated team, Dyne is committed to addressing the unmet needs of patients with rare muscle diseases, aiming to transform their treatment landscape and improve their quality of life.
Dyne Therapeutics (DYN) reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical programs. The company received FDA Fast Track Designation for DYNE-101 in DM1 treatment, with plans to complete enrollment of the Registrational Expansion Cohort by mid-2025.
Financial highlights include:
- Cash position of $642.3 million as of December 31, 2024
- Additional $140.6 million raised in Q1 2025 through ATM offering
- Q4 2024 net loss of $89.5 million ($0.88 per share)
- Full year 2024 net loss of $317.4 million ($3.37 per share)
The company expects its current cash position to fund operations into H2 2026. Both DYNE-101 and DYNE-251 programs are advancing toward potential U.S. Accelerated Approval submissions in H1 2026 and early 2026, respectively.
Dyne Therapeutics (Nasdaq: DYN) has announced multiple presentations scheduled for the 2025 MDA Clinical & Scientific Conference in Dallas, TX, from March 16-19, 2025. The company will present two oral and five poster presentations, highlighting data from their ongoing clinical trials.
Key presentations include results from the DELIVER trial for Duchenne muscular dystrophy (DMD) and the ACHIEVE trial for myotonic dystrophy type 1 (DM1). Dr. Kevin Flanigan will present DELIVER trial data on March 19 at 8:30 AM CT, while Dr. James Lilleker will present ACHIEVE trial results at 12:30 PM CT.
The company will also host a symposium titled 'Harnessing the FORCE™ Platform to Advance Targeted Therapies for Neuromuscular Diseases' on March 18 at 12:00 PM CT, featuring data on splicing correction as a prognostic biomarker for DM1 outcomes. Poster sessions will run from March 16-18, showcasing additional research on the FORCE™ Platform's capabilities in treating various muscular dystrophies.
Dyne Therapeutics (Nasdaq: DYN), a clinical-stage neuromuscular disease company, has announced its upcoming participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's management will engage in a virtual fireside chat scheduled for Tuesday, February 11, 2025, at 4:00 p.m. ET.
Interested parties can access a live webcast of the presentation through the Investors & Media section of Dyne's website. The presentation recording will remain available for 90 days following the event on the company's investor relations platform at https://investors.dyne-tx.com/news-and-events/events-and-presentations.
Dyne Therapeutics (Nasdaq: DYN) has received FDA Fast Track designation for DYNE-101, their treatment candidate for myotonic dystrophy type 1 (DM1). The designation follows positive clinical data from their ongoing Phase 1/2 ACHIEVE global trial, which showed substantial functional benefits and splicing correction in patients.
The company plans to submit for U.S. Accelerated Approval in H1 2026. The Fast Track status enables more frequent FDA communications, rolling review of marketing applications, and potential eligibility for Accelerated Approval and Priority Review. This development pathway aims to expedite the delivery of DYNE-101 to DM1 patients, for whom there are currently no approved therapies.
Dyne Therapeutics (DYN) has announced significant progress in its Phase 1/2 ACHIEVE trial of DYNE-101 for myotonic dystrophy type 1 (DM1). The company plans to initiate a global Registrational Expansion Cohort with a 6.8 mg/kg Q8W dose, targeting a potential U.S. Accelerated Approval submission in H1 2026.
The clinical data showed substantial functional benefits across multiple measures, including DMPK knockdown, splicing correction, and improvements in myotonia, strength, and mobility. The trial demonstrated a favorable safety profile across 56 patients, with most adverse events being mild or moderate.
The company will proceed with a placebo-controlled Registrational Expansion Cohort including approximately 32 patients. Additionally, Dyne reported progress on DYNE-251 for Duchenne muscular dystrophy, pursuing U.S. Accelerated Approval with dystrophin as surrogate endpoint, with data expected in late 2025.
Dyne Therapeutics (Nasdaq: DYN), a clinical-stage neuromuscular disease company, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. John Cox, the company's president and chief executive officer, will deliver a presentation on Wednesday, January 15, 2025, at 10:30 a.m. PT (1:30 p.m. ET).
The presentation will be accessible through a live webcast on the Investors & Media section of Dyne's website. Interested parties can view the replay for 30 days after the presentation through the company's investor relations portal at investors.dyne-tx.com.
Dyne Therapeutics focuses on developing innovative life-transforming therapeutics for individuals affected by genetically driven diseases.
Dyne Therapeutics (Nasdaq: DYN) has announced plans to release new clinical data from its Phase 1/2 ACHIEVE clinical trial on January 10, 2025. The company will host a webcast and investor conference call at 8:00 a.m. ET on the same day, with a press release to be issued before the event. The presentation will be accessible through the Events & Presentations page on Dyne's website, with a replay available for 90 days afterward. An accompanying slide presentation will also be provided for investors.
Dyne Therapeutics (DYN) reported Q3 2024 financial results and clinical progress. The FDA cleared the IND application for DYNE-101, currently in Phase 1/2 ACHIEVE trial for DM1 with 56 participants. New trial data is expected in January 2025. The company is enrolling a registrational cohort for DYNE-251 at 20 mg/kg following positive efficacy data in DMD patients. Financial highlights include cash position of $723.7 million, R&D expenses of $92.8 million, and net loss of $97.1 million ($0.96 per share) for Q3 2024.
Dyne Therapeutics (Nasdaq: DYN), a clinical-stage muscle disease company, has announced its participation in three major upcoming investor conferences. The company will participate in fireside chats at the Guggenheim Inaugural Healthcare Innovation Conference on November 13 in Boston, the Stifel 2024 Healthcare Conference on November 19 in New York, and the Piper Sandler 36th Annual Healthcare Conference on December 3 in New York. Live webcasts of all presentations will be available on Dyne's website, with replays accessible for 90 days.
Dyne Therapeutics (Nasdaq: DYN) is presenting data at the 29th Annual Congress of the World Muscle Society, showcasing the potential of its FORCE™ platform for neuromuscular diseases. Key highlights include:
1. DYNE-251 for DMD: Demonstrated dose-dependent exon skipping, dystrophin expression, and functional improvements. The 20 mg/kg cohort showed 3.7% mean absolute dystrophin expression (8.7% adjusted for muscle content).
2. DYNE-101 for DM1: Exhibited robust muscle delivery, dose-dependent splicing correction, and improvements in myotonia, muscle strength, and patient-reported outcomes.
3. DYNE-302 for FSHD: Preclinical data showed durable DUX4 suppression and functional benefits in a mouse model.
4. Pompe disease: Preclinical data demonstrated potential for enzyme replacement therapy delivery to muscle and CNS.
Both DYNE-251 and DYNE-101 have shown favorable safety profiles in clinical trials.
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