"RTF is Highly Unlikely, 50/50 Probability of Approval for 9001" - Cowen Reiterates Sarepta (SRPT) at Ouperform with $114 Price Target

Cowen analyst Ritu Baral reiterated an Outperform rating and $114.00 price target on Sarepta Therapeutics (NASDAQ: SRPT), following the company's announcement of plans to file 9001 Biologics License Application (BLA) in Fall 2022.

The analyst comments: 'SRPT announced this AM they will file the '9001 BLA in Fall 2022 based on the totality of clinical data thus far, including new expression/function correlation analysis requested (and seen) by FDA. The filing will be for all-age amenable ambulatory DMD. We strongly believe SRPT has buy-in from senior FDA leadership across centers, so an RTF is unlikely. Ph3 EMBARK is still on track for 2H23 data.

Given the seniority of FDA leadership (across centers) that appears to support the reviewability of SRPT's BLA and the tenor of agency conversation and written communications, we think an RTF is highly unlikely. We are conservatively pegging our current probability of approval at 50/50, supported by the strength of the totality of '9001 data (strength and durability) but in the absence of regulatory diligence checks we are currently planning."

For an analyst ratings summary and ratings history on Sarepta Therapeutics click here. For more ratings news on Sarepta Therapeutics click here.

Shares of Sarepta Therapeutics closed at $85.93 yesterday.

By Vlad Schepkov

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