After Avidity Biosciences (RNA) announced topline results from the dose escalation portion of the FORTITUDE trial and that it has received written confirmation from the FDA on an accelerated approval pathway for del-brax in Facioscapulohumeral Muscular Dystrophy, H.C. Wainwright said “the most important takeaway from Avidity’s call today” was the identification of cDUX as the surrogate endpoint that might lead to the accelerated approval of del-brax. If the FORTITUDE biomarker trial is able to replicate the data from the Phase 1/2 trial, supported by an equally persuasive natural history data, there “might be a clear path for accelerated approval for del-brax,” says the analyst, who keeps a Buy rating on Avidity shares.
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