Sarepta Prepared For DMD Gene Therapy Launch Despite Regulatory Setbacks

As Q1 Earnings Beat Expectations

03 May 2023

• By Ayisha Sharma

Despite obstacles on the regulatory path for the firm’s Duchenne muscular dystrophy gene therapy, analysts and Sarepta itself seem confident about accelerated approval prospects, with plans already in place for launch.

Child with chalk outline of muscles behind him — SRP-9001 Is Designed To Improve Muscle Strength And Function • Source: Shutterstock

Sarepta Therapeutics, Inc. appears largely unfazed by recent controversies that have beset its Roche Holding AG-partnered Duchenne muscular dystrophy (DMD) gene therapy candidate, SRP-9001, with commercial activities underway for an anticipated launch later this month pending a US Food and Drug Administration advisory committee meeting.

During its Q1 earnings, the firm claimed it could become profitable as soon as next year on the condition that...

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