Sarepta Therapeutics' FDA Adcomm Puts Some Risk, With Potential Approval: Analyst

Thursday afternoon, the FDA announced holding an advisory committee meeting related to Sarepta Therapeutics Inc's SRPT SRP-9001 (delandistrogene moxeparvovec) marketing application.
On the call, management highlighted that the decision was solely to discuss the surrogate endpoint and that there were no new outstanding issues and no new data or analyses that triggered the change in decision.
William Blair writes that the fall in share price is an overreaction given that Ad Com was expected before the company updated its fourth-quarter call.
Sarepta's vector is clean, especially compared to competitors, which have all seen major safety issues, including signs of complement activation, writes William Blair's analyst.
Needham writes that the committee will focus on the relationship between micro-dystrophin expression and clinical benefit.
The analyst expects potential approval positively but also acknowledges the increased risk that there will not be an accelerated approval of SRP-9001.
The analyst reiterated the Buy Rating but lowered the price target to $160 from $200.
Price Action: SRPT shares are down 17.80% at $123.05 on the last check Friday.

Analyst Calendar