Dyne Therapeutics (DYN +9.44%) was hardly having a bad case of the Mondays. Shares of the clinical-stage biotech were racing more than 9% higher in mid-session action, as the company delivered rather encouraging news about one of its investigational drugs.
DMD drug's solid results
Before market open, Dyne announced that its zeleciment rostudirsen -- a treatment targeting the genetic disorder Duchenne muscular dystrophy (DMD) -- had achieved its primary endpoint in a phase 1/2 clinical trial involving 86 patients. It also met its secondary endpoints.
Image source: Getty Images.
According to the healthcare company, the drug demonstrated a statistically significant increase in the production of dystrophin, a structural protein that protects muscles. The treatment also performed efficaciously when compared to a placebo.
In the press release touting the readout, Dyne said that it is now on pace to submit zeleciment rostudirsen for accelerated approval by the U.S. Food and Drug Administration (FDA) in the second quarter of next year.
NASDAQ: DYN
Key Data Points
Developing well so far
This is indisputably excellent news for Dyne and its leading drug candidate. I should caution here that there is still plenty of work to be done in the development of zeleciment rostudirsen, and FDA approval is not guaranteed. That said, the medicine is well on track to become a significant product in the DMD space in the proximate future.
