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 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.
Dyne Therapeutics (Nasdaq: DYN), a clinical-stage muscle disease company, has announced its participation in Chardan's 8th Annual Genetic Medicines Conference. The event is scheduled to take place in New York on Monday, September 30, 2024. Dyne's management team will engage in a fireside chat at 2:00 p.m. ET.
The company, which focuses on developing innovative life-transforming therapeutics for people with genetically driven diseases, will provide a live webcast of the presentation. Interested parties can access the webcast through the Investors & Media section of Dyne's official website. For those unable to attend the live event, a replay will be available for 90 days following the presentation.
The Schall Law Firm, a national shareholder rights litigation firm, is investigating potential securities law violations by Dyne Therapeutics, Inc. (NASDAQ:DYN). The investigation stems from Dyne's September 3, 2024 press releases, which announced positive clinical data from its DELIVER trial for DYNE-251 in Duchenne muscular dystrophy patients. However, on the same day, the company revealed that its CMO, COO, and CBO were stepping down. This news caused Dyne's stock to plummet by 30.7%, significantly impacting investors. The Schall Law Firm is encouraging affected shareholders to participate in the investigation and discuss their rights.
Dyne Therapeutics (Nasdaq: DYN) announced key leadership appointments to drive its next phase of growth and prepare for potential commercialization. Doug Kerr, M.D., Ph.D., MBA, has been appointed chief medical officer, succeeding Wildon Farwell, M.D., MPH. Johanna Friedl-Naderer joins as chief commercial officer, and Lucia Celona as chief human resources officer.
These appointments aim to support Dyne's transition into a fully integrated biotech company, focusing on expedited approval pathways for its myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) programs. The new leaders bring extensive experience in launching rare disease therapies globally and building teams with expertise in these areas.
Simultaneously, Susanna High, MBA, chief operating officer, and Jonathan McNeill, M.D., chief business officer, are stepping down to pursue other opportunities. The company emphasizes its solid foundation and potential for future success with its clinical programs and robust pipeline for rare muscle diseases.
Dyne Therapeutics (Nasdaq: DYN) announced new clinical data from its Phase 1/2 DELIVER trial of DYNE-251 in Duchenne muscular dystrophy (DMD) patients. The trial showed unprecedented dystrophin expression and functional improvement in multiple cohorts. Key findings include:
1. Dystrophin expression: 20 mg/kg dose showed 3.71% mean absolute dystrophin expression (8.72% adjusted for muscle content).
2. Functional improvements: Meaningful improvements in NSAA, SV95C, 10-MWR, and Time to Rise from Floor.
3. Safety: Favorable profile with mostly mild or moderate adverse events.
Dyne is initiating registrational cohorts and plans to update on the path to registration by year-end 2024. The company is also progressing its ACHIEVE trial for DYNE-101 in myotonic dystrophy type 1.
Dyne Therapeutics (Nasdaq: DYN), a clinical-stage muscle disease company, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event is scheduled for September 5, 2024, at 4:05 p.m. ET in New York.
Management will engage in a fireside chat during the conference. Investors and interested parties can access a live webcast of the presentation through Dyne's website in the Investors & Media section. The replay will remain available for 90 days after the event.
This participation highlights Dyne's commitment to advancing innovative therapeutics for individuals with genetically driven muscle diseases and provides an opportunity for the company to share insights with the healthcare investment community.
Dyne Therapeutics (Nasdaq: DYN) reported positive Q2 2024 results and clinical progress. Key highlights include:
1. Compelling data from ACHIEVE (DM1) and DELIVER (DMD) trials showing impact on biomarkers and functional improvements.
2. $374 million public offering, extending cash runway into H2 2026.
3. Pursuing expedited approval pathways for both DYNE-101 and DYNE-251.
4. Demonstrated FORCE™ platform versatility in FSHD and Pompe disease models.
5. Q2 2024 financials: $778.8 million cash position, $62.3 million R&D expenses, $9.7 million G&A expenses, $65.1 million net loss ($0.70 per share).
Dyne plans to update on registration paths for both programs by end of 2024.
Dyne Therapeutics has announced new preclinical data showcasing the potential of its FORCE™ platform to deliver enzyme replacement therapy (ERT) for Pompe disease, targeting both muscle and the central nervous system (CNS). The data were presented at the New Directions in Biology and Disease of Skeletal Muscle Conference. The study demonstrated that FORCE-GAA, engineered using the FORCE platform, effectively cleared glycogen in muscle and CNS, normalized lysosomal size, reduced biomarkers of axonal injury, and showed superior efficacy compared to GAA alone. Importantly, FORCE-GAA has the potential for less frequent dosing.
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