Sarepta Leapfrogs Pfizer In The US, Launching DMD Gene Therapy Pivotal Trial
The company has initiated the first pivotal double-blind gene therapy trial in DMD in the US in a tight race with Pfizer.
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The FDA placed a hold on the Phase II study of SRP-5051, which uses the company’s next-generation peptide conjugation technology, but Sarepta thinks it can address safety questions in short order.
The FDA placed a partial hold on its clinical program for lovo-cel due to an adolescent patient experiencing anemia 18 months after treatment, raising uncertainty over filing plans.
In this week's podcast edition of Five Must-Know Things: will a new oral antiviral be transformative for COVID?; OX40 drugs gain prominence in atopic dermatitis; J&J adds pace to RSV vaccine race; Sarepta leapfrogs Pfizer in DMD gene therapy; and how real-world evidence and randomized trials might go together.