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.
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Dyne Therapeutics (DYN) announced promising developments on March 10, 2022, regarding its clinical trials for DYNE-251 and DYNE-101, aimed at treating Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1). The company reported a cash position of $376.6 million, sufficient to fund operations into the second half of 2024. However, it faced a net loss in Q4 2021 of $51.8 million, up from $28.6 million in Q4 2020, reflecting increased R&D expenses totaling $42.3 million. Clinical trial patient dosing is anticipated to start in mid-2022.
Dyne Therapeutics has appointed Carlo Incerti, M.D., to its Board of Directors, enhancing its leadership in developing therapeutic solutions for muscle diseases. Dr. Incerti brings over 30 years of experience in biopharmaceuticals, particularly in rare disease drug development, having previously worked at Sanofi Genzyme. His expertise aligns with Dyne’s focus on innovative therapeutics for genetically driven muscle diseases, utilizing the FORCE platform. This appointment is expected to strengthen Dyne's strategic direction as the company prepares for its initial clinical trials in the coming year.
Dyne Therapeutics (Nasdaq: DYN) announced on January 18, 2022, that the FDA has placed a clinical hold on its IND application for DYNE-251, targeting Duchenne muscular dystrophy (DMD) due to requested additional clinical information. The company plans to respond with data by Q2 2022, aiming to commence a Phase 1/2 trial mid-year if FDA approval is granted. Additionally, Dyne anticipates submitting an IND for DYNE-101 for myotonic dystrophy type 1 in Q1 2022, with plans to begin a clinical trial by mid-2022.
Dyne Therapeutics (Nasdaq: DYN) announced that its CEO, Joshua Brumm, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 2:15 p.m. ET. This event will provide insights into Dyne's advancements in innovative therapeutics for muscle diseases. A live webcast can be accessed on their website, with a replay available for 30 days post-event. Dyne focuses on therapies for genetically driven diseases, leveraging its proprietary FORCE™ platform to tackle muscle tissue delivery challenges.
Dyne Therapeutics has submitted an Investigational New Drug (IND) application for DYNE-251, targeting Duchenne muscular dystrophy (DMD) patients with mutations suitable for exon 51 skipping. This marks a significant milestone for the company, which aims to initiate patient dosing in clinical trials by mid-2022. The upcoming Phase 1/2 trial plans to enroll 30-40 patients aged 4 to 16, focusing on safety and efficacy metrics. In addition to DYNE-251, Dyne is also developing treatments targeting other DMD-related mutations.
Dyne Therapeutics (Nasdaq: DYN) announced advancements in its leading therapeutic candidates during Q3 2021, with IND submissions for DYNE-251 in DMD expected in Q4 2021 and DYNE-101 in DM1 anticipated in Q1 2022. Recent in vivo data demonstrated significant dystrophin restoration and toxic RNA knockdown. Despite a net loss of $42.6 million for Q3, the company holds $407.5 million in cash, funding operations into mid-2024. Upcoming investor events will further highlight its commitment to developing transformative therapies for genetically driven muscle diseases.
Dyne Therapeutics (DYN) held its inaugural Research and Development Day, announcing the planned submissions of Investigational New Drug (IND) applications for DYNE-251 in Duchenne muscular dystrophy (DMD) by Q4 2021 and DYNE-101 in myotonic dystrophy type 1 (DM1) by Q1 2022. The event featured expert commentary from Dr. Valeria Sansone and Dr. John Day, highlighting the urgency of advancing therapies for these underserved conditions. The company is also preparing to submit an IND for DYNE-301 in facioscapulohumeral muscular dystrophy (FSHD) in H2 2022.
Dyne Therapeutics announced significant findings at the 2021 Muscle Study Group meeting, showcasing the effectiveness of DYNE-251 in treating Duchenne muscular dystrophy (DMD). In mdx mouse models, a single dose achieved 90% dystrophin restoration in the diaphragm and 78% in the heart, with over 80% dystrophin-positive fibers. In non-human primates, DYNE-251 demonstrated 52% and 43% exon 51 skipping in the diaphragm and heart, respectively. The platform, FORCE™, shows potential for less frequent dosing compared to current therapies, aiming to advance to clinical studies.
Dyne Therapeutics (Nasdaq: DYN) is hosting a virtual Research and Development Day on October 13, 2021, from 8:00 – 10:30 a.m. ET. The event, titled “The Muscle to Move to the Clinic”, will showcase preclinical data for the company’s programs targeting myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD). Leading experts, including Dr. Valeria Sansone and Dr. John Day, will present updates and discuss advancing these programs into clinical trials. A live webcast will be available with a replay for 90 days.
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