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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Sarepta’s Exondys 51 Successor On Clinical Hold, But Quick Resolution Expected
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.
Can Sarepta Beat Pfizer To A Duchenne Gene Therapy Breakthrough?
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.
Sarepta Charges Ahead With DMD Gene Therapy Despite Setback
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.