Wedbush Upgrades Sarepta To Outperform As 'FDA Comes Up With Option C'

The FDA has requested Sarepta Therapeutics Inc SRPT for dystrophin data in the ongoing evaluation of the eteplirsen New Drug Application [NDA]. Wedbush’s Heather Behanna upgraded the rating for the company from Neutral to Outperform, while raising the price target from $14 to $36. The analyst said the eteplirsen launch could be earlier than was previously expected.

The FDA’s request presents Sarepta with a “rapid path towards accelerated approval,” analyst Heather Behanna said. She added that a statistically significant increase of dystrophin over baseline would be sufficient to secure an accelerated approval.

Increase From Baseline Could Be Enough

“We believe there is a good chance these data will demonstrate required dystrophin production and recommend shares ahead of a regulatory decision, which could come in 2016,” Behanna wrote. She explained that eteplirsen did not need to prove any threshold of dystrophin as long as it’s an amount significantly higher than baseline.

“There was an increase of dystrophin from baseline by western blot (WB) in the Phase II study, although the results were not calculated with the new, rigorous protocol. Six boys from PROMOVI were used in the “control” cohort of the 4th biopsy data; 3 of the boys had dystrophin below the limit of quantification (Figure 2). Therefore, we believe the bar is low and an increase of 2-3x baseline levels may be sufficient for approval,” the Wedbush report noted.