RBC Sees Odds on Sarepta (SRPT) 9:1 Against
RBC Capital analyst, Simos Simeonidis, threw in the towel on Sarepta Therapeutics (NASDAQ: SRPT) and cut the PT to $7.50. He poses a path for approval but admits that the odds are 9:1 against. The analyst maintained a Sector Perform rating.
The hope for approval for SRPT had relied on its 4-year data and the rebuttal to key conclusions in the January FDA briefing documents. The new documents reiterated FDA's strong views that eteplirsen has not provided sufficient evidence of its efficacy, and criticized both the natural history and dystrophin data. We continue to expect a CRL for eteplirsen by the May 26th PDUFA date.
FDA just isn't buying Sarepta's arguments and is doubling down on the negative view of the data:
1) First of all, there are no voting questions, so there will be no pressure to the panelists to vote Yes or No for approval in front of an (understandably) charged audience
2) The reviewers are strongly disputing all of the arguments posted by Sarepta in their rebuttal to the agency. FDA does not appear to be giving an inch to the arguments put forth by the company, doubling down on its view that the trials are too small to be able to draw any valid conclusions from, and that the results are uninterpretable
3) The agency continues to strongly criticize both the natural history dataset and the dystrophin data, and to disregard the resulting data as essentially meaningless
The (very unlikely) path to approval would be if senior FDA officials decide, because of personal views and/or due to political pressure, to grant approval. This could play out in two ways:
1) on Monday at the panel, by having the discussion steered in a direction that benefits eteplirsen
2) even if we have, as we expect, a negative panel discussion, but we still get to a surprising approval decision by the May 26th PDUFA date.
For an analyst ratings summary and ratings history on Sarepta Therapeutic click here. For more ratings news on Sarepta Therapeutic click here.
Shares of Sarepta Therapeutic closed at $11.02 yesterday.