Sarepta Therapeutics (SRPT -14.2%) is down on more than double normal volume as selling accelerates from this morning when the company announced its plan to increase enrollment in a study of DMD gene therapy SRP-9001 that will extend its development timeline.
The culprit appears to be the appearance of SRP-9001 on the FDA’s Adverse Event Reporting System, although more information is needed to assess whether it means anything since this is a customary requirement for drug makers and healthcare providers.
Update: In a statement, the company says that the one adverse event, rhabdomyolysis, from Study 102 was erroneously reported. The DMD patient presented with dark urine and elevated creatine phosphokinase levels two weeks after infusion with SRP-9001 and was otherwise asymptomatic. He was hospitalized for observation, discharged the next day and test results returned to normal. Rhabdomyolysis, a condition resulting from muscle injury in which the kidneys cannot remove waste and concentrated urine, is a risk associated with DMD.
Shares are currently down 8% after a brief halt of trading.
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