Sarepta Therapeutics (NASDAQ:SRPT) encountered significant market pressure on Monday, reporting a second death associated with its Duchenne muscular dystrophy gene therapy, Elevidys, in a non-ambulatory patient. Shares fell almost 35% in premarket trading, extending a downward trend that began after the first fatality reported in March.

Analysts Downgrade the Stock

Two major analysts have taken action following this tragic news: BMO Capital Markets and Piper Sandler

• BMO downgraded the stock to Market Perform, reducing the price target to $70 while warning of potential negative impacts on Sarepta’s revenue guidance for 2025 and broader regulatory challenges.

• Piper Sandler also lowered its rating to Neutral, slashing the price target to $36 from $55. This revision includes a reduction in peak estimated sales for Elevidys from $2.4 billion to $1.7 billion due to increasing hesitation among physicians and regulators.

Investors can access Sarepta’s long-term financial projections through the Entreprenerdly API, which tracks revenue and net income advancements over time.

Clinical Developments and Corporate Response

Sarepta confirmed that it is:

• Suspending shipments of Elevidys for non-ambulatory patients.

• Pausing dosing in its ENVISION trial.

• Proposing an enhanced immunosuppressive regimen (which includes sirolimus) and seeking FDA approval to resume treatments.

Despite these challenges, Elevidys remains accessible for ambulatory patients, although analysts caution that confidence in its safety profile needs to be reassessed.

Market History and Performance Review

The latest fatality, similar to the previous one in March, was attributed to acute liver failure—a recognized risk associated with AAV-based gene therapies. Although this outcome could have been anticipated from a scientific viewpoint, the timing places considerable pressure on Sarepta’s immediate outlook, particularly given the volatile performance of the stock within the current year.

For an in-depth analysis of Sarepta’s earnings momentum, refer to the Entreprenerdly API to explore quarterly and annual earnings trends.

Considerations for Investors

The future of Sarepta depends on forthcoming regulatory decisions and the capability to restore trust in Elevidys, especially within the non-ambulatory population. As clarity unfolds, investor scrutiny of the stock is expected to remain heightened.