Sarepta’s Next-Generation Drugs Draw Attention Amid ‘Incremental’ Approval
Amondys 45 Gets DMD Nod From FDA
The RNA drug’s accelerated approval brings Sarepta’s exon-skipping market share to nearly 30%.
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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.
As rival Phase III gene therapy trials get underway, Sarepta’s product could have the edge in safety and efficacy over its rival from Pfizer, but the chance of failure remains high.
The company plans to start its Phase III trial of SRP-9001 in the middle of this year, with a potential readout by the end of 2022.