Sarepta shares hit as Mizuho, Leerink warn on FDA rift, credibility risk

Published 21/07/2025, 19:42
© Reuters.

Investing.com -- Sarepta Therapeutics came under pressure after two brokerages slashed their price targets and downgraded the stock, flagging mounting safety, regulatory, and credibility concerns around its gene therapy platform following a third patient death.

Mizuho (NYSE:MFG) cut Sarepta (NASDAQ:SRPT) to Neutral from Buy and halved its price target to $14 from $40, citing the risk that the fatal liver failure case.

The firm also pointed to the FDA’s abrupt reversal on July 19, when the agency asked Sarepta to halt shipments of Elevidys after initially supporting its continued use with a black box warning.

Mizuho also removed SRP-9003 from its model and raised the discount rate across Sarepta’s pipeline to reflect heightened risk.

Leerink went further, downgrading the stock to Market Perform from Outperform and cutting its target to $10 from $45, warning that Elevidys could face full market withdrawal.

The firm said it could no longer recommend Sarepta “under any circumstances,” citing management’s dismissal of the third death’s materiality and lack of transparency on safety signals.

Leerink questioned whether the company could still identify a viable patient population and noted that Sarepta may become a regulatory cautionary tale under new FDA leadership.

"We have significant concerns with management’s credibility, and it is plausible that Elevidys may be entirely removed from the market," analysts at Leerink said.

Both brokerages reduced their longer-term sales forecasts for Elevidys and flagged growing investor skepticism about the company’s pipeline viability and ability to manage safety risks.

Shares of Sarepta were down 4.4% at $13.42.

 

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.