Oppenheimer Doesn't See Significant Sarepta (SRPT) FDA Delay Before Approval

Oppenheimer analyst Christopher Marai weighed in on Sarepta Therapeutic (NASDAQ: SRPT) announced this morning the FDA will not make a decision on its eteplirsen NDA by the PDUFA. He continues to expect approval soon.

"We do not expect a significant delay, given the unmet need; however, we note that in oncology cases (Lynparza, Farydak) with close negative panel votes PDUFA delays of ~3-mo and ~6-mo occurred, respectively," he said.

Marai said the BioMarin's drisapersen PDUFA delay is not a relevant comparable. "Recall their PDUFA date occurred around the holiday season, and a decision was made within weeks. Unlike in SRPT's case, the panel made it clear BMRN's drug needed more work, thus we do not believe this is a relevant comparable. FDA also delayed ALXN's Kanuma's PDUFA by ~3mo and subsequently approved the drug. Recently, from the FDA perspective, it appears delays tend to be preferable to CRL's in cases of high unmet need where data supports a positive benefit/risk."

The analyst aid the delay may provide time for SRPT and FDA to negotiate a compromised label.

They envision a label inclusive of eteplirsen P2b trial cohort, framed around dystrophin production supported by 4 years of 6MWT/LOA observational data.

Further, he said approval is not precedent setting in part because SRPT offers 4-year follow-up data and FDA regularly refines approval requirements.

Outperform price target of $60.00

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 $18.44 yesterday.

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