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 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.
Dyne Therapeutics (Nasdaq: DYN) presented new preclinical data for its FSHD program during the FSHD Society International Research Congress on June 13-14, 2024. The data highlighted DYNE-302's robust and durable suppression of the DUX4 gene and functional benefits in preclinical models. DYNE-302 leverages the FORCE™ platform and consists of a Fab fragment targeting the TfR1 receptor, conjugated to siRNA to reduce DUX4 expression. In mouse models, a single intravenous dose of DYNE-302 showed significant DUX4 reduction lasting up to three months, enhancing muscle structure and function. The data supports Dyne's innovative approach to treating FSHD and other muscle diseases.
Dyne Therapeutics (Nasdaq: DYN) has announced that its management team will participate in a fireside chat at the Jefferies Global Healthcare Conference in New York on June 6, 2024, at 3:00 p.m. ET.
The event will be live-streamed on Dyne's website, with a replay available for 90 days. Dyne Therapeutics is a clinical-stage company focused on developing treatments for genetically-driven muscle diseases.
Dyne Therapeutics (Nasdaq:DYN), a clinical-stage muscle disease company, has successfully closed its public offering of 12,075,000 shares of common stock at $31.00 per share. This includes the underwriters' full exercise of their option to purchase an additional 1,575,000 shares. The gross proceeds reached approximately $374.3 million before deducting underwriting discounts, commissions, and offering expenses. Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities acted as joint book-running managers, while Oppenheimer & Co. and Raymond James served as co-managers. The offering was conducted under a shelf registration statement filed with the SEC on March 5, 2024.
Dyne Therapeutics, a clinical-stage company focused on muscle diseases, has announced the pricing for a public offering of 10,500,000 shares of its common stock at $31.00 per share, expected to generate $325.5 million in gross proceeds. The offering is set to close around May 24, 2024, with an additional option for underwriters to buy up to 1,575,000 more shares. Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities are joint book-running managers, while Oppenheimer & Co. and Raymond James are co-managers. The offering is conducted under a previously filed S-3 registration with the SEC.
Dyne Therapeutics has announced an underwritten public offering of $300,000,000 worth of common stock. Additionally, the company may grant underwriters a 30-day option to purchase up to $45,000,000 of additional shares.
Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities are managing the offering, with Oppenheimer & Co. and Raymond James acting as co-managers. The offering's completion is subject to market conditions, and no assurance is given regarding the size or terms.
This offering is based on a shelf registration statement filed with the SEC on March 5, 2024, which became effective upon filing. The terms will be disclosed in a final prospectus supplement to be filed with the SEC.
Dyne Therapeutics reported positive clinical data from its Phase 1/2 ACHIEVE trial of DYNE-101 for myotonic dystrophy type 1 (DM1) and its Phase 1/2 DELIVER trial of DYNE-251 for Duchenne muscular dystrophy (DMD). DYNE-101 showed a 27% mean splicing correction and improvements in muscle strength and timed function tests in DM1 patients. DYNE-251 demonstrated a 7.6% mean muscle-adjusted dystrophin expression in DMD patients, significantly surpassing the standard of care levels. Both treatments exhibited favorable safety profiles, encouraging trends in functional improvements, and no serious adverse events. Dyne aims to seek expedited approvals with updates on registration pathways by the end of 2024.
Dyne Therapeutics (Nasdaq: DYN) will host a virtual investor event on May 20, 2024, at 8:00 a.m. ET to discuss new clinical data from its Phase 1/2 ACHIEVE and DELIVER trials. The ACHIEVE trial focuses on DYNE-101 for myotonic dystrophy type 1 (DM1) and has enrolled 56 patients. Efficacy data from various cohorts will be presented. The DELIVER trial evaluates DYNE-251 for Duchenne muscular dystrophy (DMD) and has enrolled 48 patients. Safety, tolerability, and efficacy data, including dystrophin expression, will be discussed.
Both trials aim to provide comprehensive pharmacokinetic and pharmacodynamic data. The event will be webcast live and available for replay for 90 days.
Dyne Therapeutics, Inc. (Nasdaq: DYN) reported financial results for Q1 2024 and recent business highlights. The company focuses on innovative therapeutics for muscle diseases, anticipating additional clinical data from the ACHIEVE and DELIVER trials in the second half of 2024. With a strong cash position, Dyne aims to initiate registrational cohorts by year-end.
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