Dyne Therapeutics receives FDA Priority Review for z-rostudirsen in DMD, with a potential U.S. launch in Q1 2027. DYN demonstrates best-in-class dystrophin expression in registrational trials, targeting a $3.5bn market for exon 51 skipping DMD patients. Robust pipeline includes z-basivarsen for DM1, with pivotal data expected Q1 2027 and potential accelerated approval/launch in 2028.
DYN shares jump after the company files a BLA with the FDA for z-rostudirsen in Duchenne muscular dystrophy.
Dyne Therapeutics, Inc. retains a Strong Buy rating, driven by clinical progress in DM1 and DMD programs targeting significant unmet needs. DYN expects to file a BLA for z-rostudirsen in DMD exon 51 skipping patients in Q2 2026, with potential commercialization by Q1 2027. Top-line data from the phase 1/2 ACHIEVE REC study in DM1 is anticipated in Q1 2027, supporting future accelerated approval filings.
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
| CE Curtis Ellergodt Rothschild Investment LLC | 170 | $3,402.75 | $4,049.4 | $646.65 | 19% |
Farallon Capital Farallon Capital Management LLC | 10,000 | $359,200 | $239,850 | -$119,350 | -33.23% |
| BG Bart Gancher Intech Investment Management LLC | 29,600 | $309,616 | $705,960 | $396,344 | 128.01% |
| KAC Kimberly A. Clarke Stoneridge Investment Partners LLC | 16,611 | $301,000 | $396,172.35 | $95,172.35 | 31.62% |
John H. Burbank III Passport Capital LLC | 813,449 | $15.91M | $19.4M | $3.49M | 21.93% |
| Biotechnology Industry | Healthcare Sector | John G. Cox CEO | NASDAQ (NGS) Exchange | 26818M108 CUSIP |
| US Country | 263 Employees | - Last Dividend | - Last Split | 17 Sep 2020 IPO Date |
Dyne Therapeutics, Inc. is a pioneering clinical-stage biotechnology company committed to the advancement of therapeutics for genetically driven muscle diseases. Incorporated in 2017 and based in Waltham, Massachusetts, Dyne Therapeutics is at the forefront of developing innovative treatments aimed at addressing the unmet needs in muscle disease care. With a strong focus on utilizing cutting-edge technology and research, the company has positioned itself as a leader in the fight against debilitating muscle diseases in the United States.
This program targets myotonic dystrophy type 1 (DM1), a genetic disorder that affects musculoskeletal, cardiac, and central nervous systems, leading to progressive muscle loss and weakness. Dyne Therapeutics is working to develop therapeutics that can modify the disease course, aiming to restore muscular function and improve quality of life for patients suffering from DM1.
Focusing on Duchenne muscular dystrophy (DMD), a severe type of muscular dystrophy characterized by rapid progression of muscle degeneration that leads to loss of ambulation and life-threatening cardiopulmonary complications. Dyne's approach seeks to halt or reverse the muscle damage associated with DMD, providing hope for individuals and families affected by this devastating condition.
Targets facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder marked by progressive weakening and loss of skeletal muscles. Dyne's therapeutic solutions are designed to slow down the progression of FSHD, focusing on enhancing muscle function and slowing disease progression using its innovative FORCE platform.
Dedicated to the development of treatments for less common skeletal muscle, and cardiac and metabolic muscle diseases, this program leverages the FORCE platform to deliver disease-modifying therapeutics. It aims to address the complex needs of patients suffering from these rare conditions, offering hope through targeted, effective treatments.