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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, a leader in muscle disease treatments, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 9:00 a.m. ET. The event can be accessed via a live webcast on the company’s website, with a replay available for 90 days. Dyne is committed to developing innovative therapeutics for genetically driven muscle diseases, utilizing its proprietary FORCE™ platform. Its portfolio includes therapies for myotonic dystrophy type 1, Duchenne muscular dystrophy, and facioscapulohumeral muscular dystrophy.
Dyne Therapeutics (Nasdaq: DYN) presents new preclinical data on its myotonic dystrophy type 1 (DM1) program at the ASGCT Annual Meeting. The results show a robust, sustained reduction in toxic DMPK RNA across multiple muscles after administering their lead candidate in a novel hTfR1/DMSXL mouse model. Key findings include a 51% drop in diaphragm DMPK levels after four weeks. The DM1 candidate successfully reduced DMPK RNA in human patient cells, likely positioning Dyne well for future clinical trials targeted for Q4 2021 to Q4 2022.
Dyne Therapeutics, focused on muscle disease therapeutics, reported Q1 2021 results showing a net loss of $25 million, or $0.50 per share, compared to a $7.9 million loss in Q1 2020. The cash position stood at $483.1 million, ensuring a runway into H2 2024. R&D expenses surged to $18.6 million from $6.1 million year-over-year, while G&A expenses rose to $6.5 million from $1.8 million. The company is set to submit INDs for DM1, DMD, and FSHD programs between Q4 2021 and Q4 2022 and will present new data at the upcoming ASGCT Annual Meeting.
Dyne Therapeutics (Nasdaq: DYN) announced it will showcase new preclinical data on its myotonic dystrophy type 1 (DM1) program at the American Society of Gene & Cell Therapy meeting, running from May 11-14, 2021. Key presentations include a scientific symposium and an oral presentation detailing the effectiveness of their FORCE™ platform in knocking down toxic RNA in DM1 models. A live webcast featuring expert Dr. Charles Thornton will follow on May 14, 2021, at 4 p.m. ET to discuss the DM1 program and its challenges. The archived webcast will be accessible for 90 days.
Dyne Therapeutics reported significant advancements in its muscle disease therapeutics, particularly in its DM1, DMD, and FSHD programs. The company announced a net loss of $28.6 million for Q4 2020 and $59.4 million for the full year, with cash reserves of $345.3 million expected to last into H2 2024. Recent preclinical data showed robust RNA knockdown capabilities in their DM1 candidate. Additionally, leadership enhancements and a successful public offering raised over $550 million in 2020, supporting ongoing clinical developments.
Dyne Therapeutics (DYN) has appointed Dr. Wildon Farwell as Chief Medical Officer, bringing extensive experience in developing oligonucleotide therapies. Previously with Biogen, he played crucial roles in the approval of SPINRAZA and led the development of tofersen. His expertise is expected to enhance Dyne's clinical strategy as it advances programs for myotonic dystrophy type 1, Duchenne muscular dystrophy, and facioscapulohumeral muscular dystrophy. This leadership change underscores Dyne's commitment to transforming care for rare muscle diseases.
Dyne Therapeutics has appointed Ashish Dugar as Senior Vice President and Global Head of Medical Affairs. Dr. Dugar brings over 20 years of experience in medical affairs and drug development, previously holding significant roles at Sarepta Therapeutics, Intra-Cellular Therapies, and Roche. His expertise includes building medical affairs organizations and a focus on rare muscle diseases. Dyne's CEO highlighted Dr. Dugar's critical role in advancing the company's therapeutic programs, particularly in muscle diseases using the proprietary FORCE™ platform.
Dyne Therapeutics (Nasdaq: DYN) announced a public offering of 6,000,000 shares at $28.00 each, with potential gross proceeds of approximately $168 million. The offering includes a 30-day option for underwriters to purchase an additional 900,000 shares. The closing is set for January 25, 2021, subject to customary conditions. The proceeds will support Dyne's development of innovative therapeutics for muscle diseases driven by genetics, utilizing its proprietary FORCE™ platform.
Dyne Therapeutics (Nasdaq: DYN) announced significant preclinical data revealing effective RNA knockdown of toxic DMPK associated with myotonic dystrophy type 1 (DM1). Utilizing its FORCE™ platform and an innovative mouse model, the company achieved up to 60% reduction of toxic DMPK RNA in muscle tissues. This progress reinforces the potential for targeted therapies aimed at DM1, with IND submissions for DM1, DMD, and FSHD expected between Q4 2021 and Q4 2022. The advancements align with Dyne's goal of addressing unmet medical needs in muscle diseases.
Dyne Therapeutics (DYN) announced that CEO Joshua Brumm and CSO Romesh Subramanian will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 10:00 a.m. ET. The presentation will focus on the company's dedication to developing innovative therapeutics for genetically driven muscle diseases using its proprietary FORCE™ platform.
A live webcast will be accessible on the company's Investors & Media website, with a replay available for 90 days post-presentation.
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