Sarepta sinks after FDA rejects DMD therapy

Sarepta dropped $15.61 (13%) to $104.70 in after hours trading Monday, losing over $1.1 billion in market cap, after FDA issued a complete response letter for golodirsen, the biotech's second exon skipping therapy for Duchenne muscular dystrophy.

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said the agency cited injection site infection risk and renal toxicity in the CRL. The toxicities were seen in a preclinical model and at doses that were 10 times higher than the dose used in clinical trials, which had no renal toxicity safety signal, the company said. It plans to request a meeting with FDA "immediately."...