Sarepta’s stock price may be recovering.
Share prices appear to be reversing course after they dropped significantly earlier this month after FDA raised new concerns about the safety of the company’s gene therapy Elevidys. As Pharmaceutical Executive previously reported, FDA asked the company to halt shipments of the drug and place all clinical trials on hold while it investigated three deaths of patients taking the drug. After rejecting these calls, Sarepta announced on July 21 it would voluntarily pause shipments of the drug within the US.
Key Takeaways
- Sarepta announced that it is resuming shipments in the US of Elvidys after receiving clearance to do so from FDA.
- Stock prices, while they have not fully recovered, rose on the announcement.
- Sarepta is still facing challenges, including a class action lawsuit from investors.
Why did Sarepta halt shipments of Elevidys in the US?
At the time, Sarepta issued multiple statements stating that no new safety signals had emerged amongst patients taking Elevidys. The company’s stock dropped about 36% in one day, however, and analysts downgraded the company.
On Friday, July 25, FDA issued a statement that it was investigating the death of an 8-year-old boy in Brazil who had been taking Elevidys.1 According to the agency’s statement, the death occurred on June 7 of this year. Later that same day, however, Sarepta fired back with its own statement that clarified that the boy’s death had been ruled unrelated to the treatment.2 The company also stated that it had reported the incident to FDA on June 18.