Sarepta Therapeutics to seek FDA accelerated approval for SRP-9001 in DMD

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Sarepta Therapeutics to seek FDA accelerated approval for SRP-9001 in DMD

Sarepta Therapeutics said that it plans to file a biologics license application (BLA) with the US Food and Drug Administration (FDA) to seek accelerated approval for SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD). The investigational DMD gene therapy is being co-developed with Roche under a $2.85bn deal signed […]

Roche signs $2.85bn deal with Sarepta for SRP-9001 DND gene therapy

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Roche signs $2.85bn deal with Sarepta for SRP-9001 DND gene therapy

Roche has signed a licensing deal worth up to $2.85 billion with Sarepta Therapeutics for the exclusive ex-US commercial rights to the latter’s SRP-9001 (AAVrh74.MHCK7.micro-dystrophin), an investigational gene therapy for Duchenne muscular dystrophy (DMD). As per the agreement terms, Sarepta Therapeutics will get an upfront payment made up of $750 million in cash and $400 […]