Upcoming ELEVIDYS And Gene Therapy Updates Will Restore Patient Trust

Sarepta Therapeutics’ price target remains under pressure due to persistent safety concerns and regulatory uncertainty surrounding Elevidys, limited market scope after clinical setbacks and halted non-ambulatory development, and skepticism about long-term cash generation, resulting in a maintained consensus analyst price target of $23.84.

Analyst Commentary

• Continued safety concerns surrounding Elevidys, particularly following patient deaths and serious adverse events (notably acute liver failure in non-ambulatory patients and new adverse event reports), have caused repeated reductions in revenue forecasts and increased uncertainty about regulatory approval and commercial uptake.
• Bearish analysts remain focused on ongoing regulatory scrutiny, including the risk of further FDA restrictions or label modifications, as well as unresolved questions around the need for enhanced immunosuppressive protocols and continued investigations into Elevidys' safety.
• Sarepta’s recent debt refinancing has improved short-term liquidity, easing immediate financial risk, but skepticism persists regarding the company's long-term cash generation potential and overall capital allocation judgement, heightened by the loss-making divestiture of Arrowhead shares.
• While the resumption of Elevidys shipments for ambulatory DMD patients following the lifting of clinical holds has removed a “worst-case” market withdrawal scenario and provided some relief for short-term sentiment, analysts remain cautious on the pace of patient/provider adoption and the sustainability of future sales, especially with ongoing safety overhangs and non-ambulatory dosing halted.
• Bullish analysts see Sarepta’s exon-skipping franchise as undervalued and note upside potential if Elevidys overcomes regulatory obstacles and regains DMD community confidence, though price targets have been materially reduced to reflect a smaller, ambulatory-only market opportunity and increased operational risk.

What's in the News

• The FDA requested Sarepta halt all shipments of Elevidys after a third patient death, leading to a steep ~39% decline in Sarepta’s share price (Reuters, 2025-07-18).
• FDA officials described Sarepta’s path to relaunching Elevidys as “arduous and treacherous,” with the agency unwilling to permit sales until safety concerns—especially regarding fatal liver failures—are convincingly addressed; new studies are likely required (STAT, Bloomberg, Endpoints, 2025-07-22/24).
• Roche asserted a Brazilian patient death was unrelated to Elevidys and reported no treatment-related fatalities among approximately 760 ambulatory DMD patients treated to date (Bloomberg, Reuters, 2025-07-24/29).
• Following the FDA’s removal of the voluntary hold, Roche is prepared to resume shipments of Elevidys for ambulatory DMD patients outside the U.S. (Bloomberg, Reuters, 2025-07-29).
• Sarepta confirmed it intends to honor milestone commitments of up to $300M to Arrowhead for ARO-DM1 development, following Arrowhead’s public pressure; Sarepta shares jumped 9% intraday (Bloomberg, 2025-07-28).

Valuation Changes

Summary of Valuation Changes for Sarepta Therapeutics

• The Consensus Analyst Price Target remained effectively unchanged, at $23.84.
• The Future P/E for Sarepta Therapeutics remained effectively unchanged, moving only marginally from 18.02x to 17.85x.
• The Consensus Revenue Growth forecasts for Sarepta Therapeutics remained effectively unchanged, at -17.0% per annum.