Buy Rating for Sarepta Therapeutics’ Elevidys Supported by Positive Regulatory Signals

Analyst Uy Ear from Mizuho Securities reiterated a Buy rating on Sarepta Therapeutics (SRPT – Research Report) and keeping the price target at $145.00.

Uy Ear has given his Buy rating due to a combination of factors related to the regulatory prospects of Sarepta Therapeutics’ gene therapy, Elevidys. The receipt of a draft label for the drug is viewed as a strong positive indicator, as such action suggests endorsement by high-profile FDA officials and implies a collaborative stance between the agency and Sarepta. Moreover, the expert consulted by Mizuho Securities highlighted the precedent set by the FDA’s approval of Lamzede, despite its failure to meet the primary endpoint, which bodes well for Elevidys given the similar pattern of secondary endpoint efficacy.
Furthermore, the speed at which the FDA is reviewing Elevidys’ supplemental application signals the agency’s prioritization of the review, enhancing the likelihood of a favorable outcome. The draft label’s early issuance, involvement of significant FDA figures, and the FDA’s willingness to work with sponsors to address high unmet medical needs all contribute to the optimism surrounding the potential label expansion for Elevidys, thereby supporting the Buy rating.

In another report released on May 14, Oppenheimer also upgraded the stock to a Buy with a $180.00 price target.

SRPT’s price has also changed dramatically for the past six months – from $83.760 to $132.500, which is a 58.19% increase.

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Sarepta Therapeutics (SRPT) Company Description:

Sarepta Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which is engaged in the discovery and development of therapeutics for the treatment of rare diseases. The company was founded on July 22, 1980 and is headquartered in Cambridge, MA.