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) has received regulatory clearance from New Zealand to initiate its Phase 1/2 multiple ascending dose clinical trial for DYNE-101, targeting myotonic dystrophy type 1 (DM1). The company plans to start dosing patients in mid-2022, with additional clearances expected globally. The trial will enroll 60 to 70 adult patients to assess safety, tolerability, and muscle function. DM1 affects over 40,000 people in the U.S., and DYNE-101 aims to address this unmet medical need.
Dyne Therapeutics has announced the FDA's clearance of its Investigational New Drug (IND) application, allowing the initiation of a Phase 1/2 clinical trial for DYNE-251 targeting Duchenne muscular dystrophy (DMD) amenable to skipping exon 51. Dosing is expected to begin in mid-2022, enrolling 30 to 50 male participants aged 4 to 16. The trial aims to assess safety, tolerability, and muscle function. Dyne is also expanding its DMD program with additional therapies for other exon mutations.
Dyne Therapeutics announced management's participation in a fireside chat at the Jefferies Global Healthcare Conference on June 9, 2022, at 3:00 p.m. ET. This event will be held in New York, NY, and a live webcast will be accessible via the company’s website. Additionally, a replay will be available for 90 days post-event. Dyne Therapeutics focuses on developing life-transforming therapeutics for genetically driven muscle diseases using its proprietary FORCE™ platform.
Dyne Therapeutics (Nasdaq: DYN) announced the initiation of dosing in a clinical trial for DYNE-101, targeting myotonic dystrophy type 1 (DM1). New in vivo data showcased substantial RNA knockdown in cardiac and skeletal muscles with low monthly doses. The treatment demonstrated a favorable safety profile in preclinical studies. DYNE-101 represents a potential disease-modifying therapy for DM1, a rare genetic disorder affecting over 40,000 people in the U.S. No approved therapies currently exist for DM1, enhancing the significance of DYNE-101's potential impact.
Dyne Therapeutics (DYN) has initiated plans for patient dosing in multiple ascending dose clinical trials for DYNE-251 in Duchenne muscular dystrophy (DMD) and DYNE-101 in myotonic dystrophy type 1 (DM1). The company expects to submit its response to the FDA regarding the clinical hold letter for DYNE-251 and regulatory filings for DYNE-101 in mid-2022. As of March 31, 2022, Dyne reported cash reserves of $323.2 million to fund operations into H2 2024, with a net loss of $35.6 million for Q1 2022.
Grid Dynamics announced the launch of a fully transactional B2B and B2C commerce application for selfologi, aimed at becoming the leading cosmetic treatment platform in the Middle East. Built on a composable commerce architecture, the platform was brought to market within a year, considerably quicker than typical timelines for such projects. Emphasizing the significant demand for cosmetic treatments in the region, the platform connects nearly 300 practitioners and offers robust booking and payment features. This collaboration strengthens Grid Dynamics' position in the digital retail space.
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.
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