On Feb. 20, Wedbush financial analyst Andreas Argyrides restated his price target for Sarepta Therapeutics (SRPT 1.08%) stock, claiming that its shares would reach $224, rising 73% in the process. Argyrides' calculation is likely that Sarepta will successfully navigate a major upcoming regulatory catalyst pertaining to the size of the addressable market of its newest medicine, a gene therapy called Elevidys that's approved to treat Duchenne muscular dystrophy (DMD) in people between the ages of four and five who can still walk.
In a nutshell, it's trying to get Elevidys approved to treat people with DMD regardless of their age or how well they are dealing with the debilitating mobility impacts of the illness. In early March, the company will preliminarily hear from regulators at the Food and Drug Administration (FDA) regarding whether Elevidys is eligible to have its list of approved indications expanded. The final verdict will arrive sometime in late June or perhaps early August.
Why Elevidys matters a lot to shareholders
With its four medicines for DMD on the market, and more than 40 programs for various indications in its pipeline, the regulatory decision about Elevidys is more important than it may seem at first. In 2023 alone, the drug brought in $200 million in revenue out of the company's total haul of more than $1.1 billion, one-upping its own expectations and contributing to the top line's growth of 36% year-over-year.
Remember, that sum is only from sales to a very small subset of patients with DMD; overall, the condition is thought to affect as many as 1 in 3,500 male newborns per year. If Argyrides' estimate is correct and the FDA rules in the company's favor, Sarepta will become a much more valuable business overnight, and its stock will need to rise to reflect that.
