Sarepta (SRPT) Dystrophin Quantification Analyses Intact Despite Photo Error
Shares of Sarepta Therapeutic (NASDAQ: SRPT) traded lower on Monday after an error was found on two biopsy photographs. In the view of Leerink Swann, the errors are fixable and do not effect dystrophin quantification analyses.
"We spoke with SRPT management who stated that the publication of these photographs was an error that will be fixed in the finalized manuscript and that the dystrophin quantification analyses were NOT subject to the same error. Thus, we believe that the scientific integrity of SRPT's dystrophin quantification analysis is intact, but nonetheless anticipate that SRPT's dystrophin data may be deemed insufficient by FDA to support accelerated approval," said analyst Joseph P. Schwartz.
"While SRPT's dystrophin quantification data were not afflicted by the same mix-up as the photographs, we believe that immunostaining may not be the most accurate way to assess absolute levels of dystrophin production. We believe that Western Blot is a stronger and more relevant assay since it can assess absolute levels of protein production by mass. The argument for dystrophin as an approval supporting the surrogate endpoint is weakened by the fact that two patients who became non-ambulant relatively early in the Phase II study showed dystrophin production levels via immunostaining that were relatively on par with those that seemed to benefit on 6-minute walk," added the analyst.
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