Sarepta Therapeutics' soared by 36% in the pre-market trading following the FDA's decision to grant accelerated approval for its gene therapy, Elevidys, extending its use to include non-ambulatory patients with Duchenne muscular dystrophy (DMD). Additionally, the FDA granted traditional approval for Elevidys to treat ambulatory DMD patients who are at least four years old. This broader approval aims to increase access to Elevidys, which costs around $3.2 million per patient, positioning it as one of the most expensive drugs globally. Sarepta has commenced the ENVISION study, a phase 3 trial, to confirm Elevidys' benefits in non-ambulatory and older ambulatory patients, a requirement for maintaining its FDA approval for these groups.
The FDA's decision marks a significant expansion in the treatment of DMD, a serious muscle-weakening disease that mainly affects men in their 20s. Yesterday's FDA approval offers a potential opportunity to significantly increase the company's revenues. Sarepta's strategy includes partnering with Roche Holdings for global commercialization, excluding the US, where Sarepta will remain fully responsible for commercialization.
Source: xStation 5
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