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 clinical-stage biopharmaceutical company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The DYN news feed highlights company announcements related to its neuromuscular pipeline, corporate strategy and financial position.
News coverage for Dyne commonly includes updates on its lead clinical programs, zeleciment rostudirsen (z-rostudirsen, DYNE-251) for Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping and zeleciment basivarsen (z-basivarsen, DYNE-101) for myotonic dystrophy type 1 (DM1). Investors can follow topline and long-term data readouts from the Phase 1/2 DELIVER and ACHIEVE trials, including biomarker results, functional endpoints, safety and tolerability findings, and regulatory milestones such as Breakthrough Therapy, Fast Track, Rare Pediatric Disease and Orphan Drug designations.
The DYN news stream also features information on Dyne’s preclinical programs in facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease, presentations at scientific and investor conferences, and corporate developments such as public offerings of common stock, loan agreements and board appointments. Periodic financial results and business updates provide additional context on cash runway, planned regulatory submissions and the company’s preparation for potential commercialization of its neuromuscular therapies.
By monitoring this page, readers can review Dyne’s press releases on clinical progress, regulatory interactions, financing transactions and conference presentations in one place. This historical record of company communications helps investors, analysts and other stakeholders understand how Dyne’s FORCE platform, pipeline and corporate activities are evolving over time.
Dyne Therapeutics (Nasdaq: DYN) will present at multiple investor conferences in November–December 2025, featuring management fireside chats and live webcasts.
Scheduled events: Guggenheim Healthcare on Nov 10, 2025 at 10:00 a.m. ET (Boston); Stifel Healthcare on Nov 11, 2025 at 9:20 a.m. ET (New York); Jefferies Global Healthcare on Nov 17, 2025 at 3:00 p.m. GMT (10:00 a.m. ET, London); and Evercore Healthcare on Dec 2, 2025 at 9:35 a.m. ET (Coral Gables).
A live webcast will be available in the Investors & Media section at investors.dyne-tx.com, with replays accessible for 90 days.
Dyne Therapeutics (NASDAQ: DYN) announced one-year Phase 1/2 ACHIEVE data for zeleciment basivarsen (z-basivarsen, DYNE-101) in adults with myotonic dystrophy type 1 (DM1). At the selected registrational dose of 6.8 mg/kg Q8W (n=6 cohort), patients showed clinically meaningful, sustained improvements in myotonia (vHOT), multiple functional tests (10MWR, 5xSTS, 9HPT), and quantitative muscle testing across upper and lower limbs. Patient-reported MDHI improved, including six CNS-related subscales, and PGI-C/CGI-C reflected reduced overall disease burden. Safety across the 6.8 mg/kg Q8W program (n=56) showed a favorable profile with no related serious treatment-emergent adverse events. Data presented at the World Muscle Society annual congress (Oct 7–11, 2025).
Dyne Therapeutics (Nasdaq: DYN) announced on Oct 2, 2025 the appointment of Brian Posner to its Board of Directors. Posner brings 35 years of executive, investment and board leadership, including roles as president and CEO of ClearBridge Advisors (a $100 billion+ asset manager) and partner at Warburg Pincus. Dyne says the appointment comes as it transitions to a fully integrated biotech poised to commercialize its first potential product in 2027. Posner currently serves on Arch Capital Group's board and has prior board experience at Biogen and Bioverativ.
Dyne Therapeutics (Nasdaq: DYN) has received Orphan Drug designation in Japan from the Ministry of Health, Labour and Welfare for DYNE-251, its treatment for Duchenne muscular dystrophy (DMD) patients with mutations amenable to exon 51 skipping.
The ongoing DELIVER Phase 1/2 clinical trial has shown sustained functional improvement through 18 months, with significant dystrophin expression. Results from the Registrational Expansion Cohort are expected in late 2025. The Japanese designation joins existing designations in the U.S. (Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug) and Europe (Orphan Drug).
The Japanese Orphan Drug status provides benefits including development cost subsidies and potential 10-year market exclusivity upon approval, applying to diseases affecting fewer than 50,000 patients in Japan.
Dyne Therapeutics (NASDAQ: DYN), a clinical-stage company specializing in treatments for genetically driven neuromuscular diseases, has announced its participation in two major healthcare investor conferences in September 2025.
Management will present at the Cantor Global Healthcare Conference on September 5, 2025, at 9:45 a.m. ET, and at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, at 9:15 a.m. ET. Both events will take place in New York.
Investors can access live webcasts of the presentations through Dyne's website, with replays available for 90 days.
Dyne Therapeutics (NASDAQ:DYN) has received FDA Breakthrough Therapy Designation for DYNE-251, targeting Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping. The designation is based on data from the ongoing DELIVER trial, where DYNE-251 demonstrated sustained functional improvement through 18 months in key measures like time to rise and stride velocity.
The company has completed enrollment of 32 patients in the DELIVER registrational expansion cohort, with data expected in late 2025. Dyne plans to submit a Biologics License Application (BLA) for U.S. accelerated approval in early 2026. DYNE-251 has also received Fast Track, Orphan Drug, and Rare Pediatric disease designations from the FDA.
Dyne Therapeutics (Nasdaq: DYN) reported significant Q2 2025 milestones and financial results. The company has strengthened its financial position, extending cash runway into Q3 2027 through a $275 million non-dilutive loan facility and a $230 million public offering. Key clinical developments include: FDA Breakthrough Therapy Designation for DYNE-101 in DM1, completed enrollment for DYNE-251's DMD trial, and advancement of DYNE-302 for FSHD.
The company reported Q2 2025 net loss of $110.9 million ($0.97 per share) and cash position of $683.9 million. R&D expenses increased to $99.2 million, up from $62.3 million year-over-year. Two potential U.S. Accelerated Approval submissions are planned: DYNE-251 in early 2026 and DYNE-101 in late 2026, with first commercial launch expected in early 2027.
Satellos Bioscience (OTCQB: MSCLF) has appointed Dr. Wildon Farwell as Chief Medical Officer to advance their muscle disease therapeutic programs. Dr. Farwell joins from Dyne Therapeutics, where he served as CMO and brings significant expertise in neuromuscular disease drug development.
Dr. Farwell's notable achievements include building Dyne's development organization and leading their DMD and DM1 programs. At Biogen, he led the development of SPINRAZA®, the first approved treatment for spinal muscular atrophy, and initiated late-stage development of QALSODY® for ALS.
In his new role, Dr. Farwell will focus on advancing SAT-3247 into a global Phase 2 clinical trial for children with Duchenne muscular dystrophy (DMD). He succeeds Dr. Jordan Dubow, who will continue as a consultant and Clinical Advisory Board chair.
[ "Appointment of highly experienced CMO with proven track record in neuromuscular disease drug development", "New CMO has successful history of regulatory approvals, including SPINRAZA®", "Progress toward Phase 2 clinical trial for SAT-3247 in DMD treatment" ]Dyne Therapeutics (NASDAQ:DYN), a clinical-stage biotech company focused on neuromuscular diseases, has successfully completed its previously announced public offering of common stock. The company sold 27,878,788 shares at $8.25 per share, including the full exercise of the underwriters' option to purchase additional shares.
The offering generated gross proceeds of approximately $230.0 million before deducting underwriting discounts, commissions, and offering expenses. Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities served as joint book-running managers, with Jones acting as co-manager for the offering.
Dyne Therapeutics (NASDAQ: DYN), a clinical-stage company specializing in genetically driven neuromuscular diseases, has announced the pricing of a public offering of 24,242,425 shares of its common stock at $8.25 per share. The offering is expected to generate gross proceeds of $200.0 million before deducting underwriting discounts and commissions.
The company has granted underwriters a 30-day option to purchase up to an additional 3,636,363 shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close around July 2, 2025. Morgan Stanley, Jefferies, Stifel, and Guggenheim Securities are serving as joint book-running managers, with Jones acting as co-manager.
[ "Expected gross proceeds of $200.0 million to strengthen company's financial position", "Additional potential proceeds through 30-day option for underwriters to purchase extra shares", "Strong institutional backing with multiple prominent investment banks as joint book-running managers" ]