FDA Briefing Docs Offer Positives and Negatives for Sarepta (SRPT) - Baird
Baird analyst, Brian Skorney, published a note this morning highlighting his interpretation of the FDA Briefing Documents on BioMarin's (NASDAQ: BMRN) drisapersen filed Friday. He still believes that Sarepta (NASDAQ: SRPT) has only a 35% chance of getting approval for eteplirsen but with the loss of a competitor, he believes it will still warrants a $50 share price by the end of 2016.
The analyst believes FDA's criticism of drisapersen applies to BioMarin's entire DMD platform, as the phosphorothioate oligo class appears to only cause harm as a DMD therapy. Leading him to believe it will never make it to market but even if it does, the black box warning and precipitous drops in platelet count render it non-competitive.
Looking through the drisapersen briefing documents, one of the more significant issues in the eteplirsen briefing documents will be related to protein quantification. Although eteplirsen seems to be producing dystrophin (in contrast to drisapersen), they are not confident that the quantity is going to be impressive to FDA.
"Our eteplirsen approval odds stand at 35%" while he has taken his drisapersen approval odds down virtually to zero.
No change to Outperform rating or $47 PT.
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Shares of Sarepta Therapeutic closed at $33.36 yesterday.