Crispr Therapeutics shares tumble after significant earnings miss
Investing.com -- BMO Capital and Piper Sandler downgraded Sarepta Therapeutics (NASDAQ:SRPT) after the company reported a second death linked to its gene therapy Elevidys in a non-ambulatory Duchenne muscular dystrophy (DMD) patient.
Shares of the company are down around 35% in premarket trading.
BMO cut its rating to Market Perform, citing heightened uncertainty, while Piper downgraded Sarepta to Neutral, saying the fatality could further disrupt uptake and commercial momentum for Elevidys.
Both brokerage noted that while the treatment remains available for ambulatory patients, broader concerns around safety and regulatory scrutiny could weigh on near-term performance.
Sarepta said over the weekend it has suspended commercial shipments of Elevidys in the non-ambulatory setting and paused dosing in its confirmatory ENVISION trial.
The company plans to implement an enhanced immunosuppressive regimen that includes sirolimus and will seek FDA approval to resume treatment.
BMO said the death, the second linked to acute liver failure in non-ambulatory patients, was not unexpected given known risks with AAV-based gene therapies, but added that the timing increases investor concerns.
Sarepta shares dropped 27% after the first death in March. BMO lowered its price target to $70, warning of risks to 2025 revenue guidance and potential regulatory action affecting non-ambulatory approval.
Piper Sandler cut its price target to $36 from $55 and slashed peak Elevidys sales estimates to $1.7 billion from $2.4 billion.
The firm said commercial use in the ambulatory population could also be negatively impacted as confidence in the therapy is reevaluated.
Sarepta is scheduled to host a conference call Monday morning to provide further details.