Sarepta Therapeutics has put in place several initiatives to help its gene therapy Elevidys return to growth, but recovery will take a long time, according to company executives.
Sarepta Therapeutics is taking a conservative approach to predicting the future and wants others to do the same. The embattled biotech asked analysts on a Q1 earnings call Wednesday to “exercise prudence” before raising their expectations and projections for its recovery.
This is despite CEO Doug Ingram telling investors that the company is “in a great place” financially, with enough resources to keep advancing its pipeline without having to sell off stock for capital.
Sarpeta is coming off a difficult 2025. Its flagship product, the Duchenne muscular dystrophy gene therapy Elevidys, was linked to one patient death in March 2025 and to another in June that year. The mortalities kicked off a back-and-forth with the FDA, which after a third death linked to a related product asked the company to stop U.S. shipments of Elevidys. Sarepta initially said no but eventually agreed.
After less than two weeks, Elevidys shipments resumed, with the FDA later adding a boxed warning that flags a risk of death. The regulator also limited the drug’s use only to those who are able to walk and are 4 years of age and older.
In the aftermath of the Sarepta saga, which also saw the short-lived exit of then-biologics chief Vinay Prasad, demand for Elevidys has been slow to pick back up. In Q1 of this year, the gene therapy made $102 million in revenue, down 7% since Q4 2025, according to Jefferies, but still beating the consensus forecast of $96 million.
To help re-energize the market, Sarepta has rolled out a slew of aggressive commercial initiatives, Ingram said on Wednesday’s call. These include expanding the company’s salesforce to more actively engage doctors and rolling out new educational resources meant for both patients and physicians. These new materials, according to Chief Commercial Officer Patrick Moss, incorporate new long-term efficacy and safety data from the Phase 3 EMBARK study, which in January found that Elevidys preserved muscle and functional performance over three years of follow-up.
The effort is paying off, Ingram said, but the path to Elevidys’ return to growth will be a long one.
Moss agreed: “Last quarter, I said we are seeing green shoots—early signals that give us confidence we are headed in the right direction—and the team is squarely focused on delivering the efficacy message to drive demand,” he told investors. Still, “it will take time to see the potential impact of my team’s actions reflected in sales.”
While Elevidys commanded most of the analysts’ interest during Sarepta’s call, the company also provided key updates for its siRNA pipeline. Sarepta is building up to additional data for SRP-1001 in facioscapulohumeral muscular dystrophy type 1 (FSHD) and SRP-1003 in myotonic dystrophy type 1 (DM1) in the second half of the year, according to its Wednesday release.
A readout in March showed that SRP-1001 resulted in a 90% to 93% decrease in the expression of genes that are abnormally upregulated in FSHD, while SRP-1003 gained an early edge over other therapies from competing companies.
These data gave Jefferies confidence in these assets. “These compounds could show superior efficacy/safety and provide less-frequent dosing” in their target indications, analysts wrote to investors on Wednesday.
Elevidys pivoted to siRNA development in July last year, after the Elevidys deaths.
