FDA approves Sarepta's eteplirsen, first DMD drug

Sarepta Therapeutics Inc. (NASDAQ:SRPT) soared $20.79 (74%) to $48.94 on Monday after FDA granted accelerated approval to the company's Exondys 51 eteplirsen ( AVI-4658) to treat Duchenne muscular dystrophy (DMD) amendable to exon 51 skipping.

Sarepta will price the drug at an expected net annual cost of $300,000 for a 25 kg boy, taking into account changes in weight-based dosing over time and expected compliance rates. A 2 mL vial of the drug will cost $1,600, and a 10 mL vial will cost $8,000. The approved dose is 30 mg/kg once weekly. ...