H.C. Wainwright Reiterates Sarepta (SRPT) at Sell, $0 price target, 'major blow to Sarepta'

H.C. Wainwright analyst Mitchell S. Kapoor reiterated a Sell rating and $0 price target on Sarepta Therapeutics (NASDAQ: SRPT).

The analyst commented: "Sarepta's partner, Roche temporarily stopped shipping ELEVIDYS in six countries that base their approval on the FDA's decision-making (Japan/Brazil not affected). This follows Sarepta’s reversal in the U.S., where the company paused ELEVIDYS shipments after resisting the FDA’s initial withdrawal request. See As We Expected, ELEVIDYS Withdrawn From U.S. Market and Zero Intrinsic Value After ELEVIDYS U.S. Market Removal. More importantly, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is in the final stretch of its monthly meeting, which concludes tomorrow. ELEVIDYS is among the therapies up for review (see agenda), with a CHMP recommendation slated for Friday—another potential catalyst for downside in Sarepta's stock price, depending on the agency’s stance. Historically, FDA and EMA decisions are closely aligned, giving us little reason to expect ELEVIDYS will secure approval for ambulatory patients ages 3–7. EU approval would likely require the highly unlikely scenario of the FDA reversing course, permitting relaunch of ELEVIDYS in the U.S. Even then, in our view the damage is done—ELEVIDYS now carries a tarnished reputation, and both physicians and patient advocacy groups are increasingly aware of its questionable efficacy and associated risk of death. While the CHMP recommendation is not final, the EMA rarely deviates from the CHMP. We view this update as a major blow to Sarepta, reinforcing the sense that the ELEVIDYS franchise is winding down. A negative decision Friday would mark yet another major setback, cutting off a key path to ex-U.S. royalty revenue from Roche and putting renewed pressure on the stock. We reiterate our Sell rating and 12-month price target of $0."

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 $12.88 yesterday.

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