Sarepta Shares Plummet as DMD Treatment Trials Face Challenges
Sarepta Therapeutics' shares lost nearly 40% of their value after the company announced that the ESSENCE trial of Vyondys 53 and Amondys 45 failed to meet its objective.
The trial aimed to confirm the efficacy of these two drugs for Duchenne muscular dystrophy (DMD), which received FDA accelerated approvals in 2019 and 2021, respectively.
According to Sarepta, the trial did not achieve statistical significance on the primary endpoint for both drugs, but the company noted
"positive and encouraging trends favouring therapy."
- Vyondys 53 (golodirsen) and Amondys 45 (casimersen) are designed for DMD patients amenable to treatment with exon 53 and exon 45 skipping therapies.
- The company suggested that the COVID-19 pandemic compromised the study, and excluding data from that period revealed a
"meaningful treatment effect."
The failure of the ESSENCE trial puts the FDA accelerated approvals of Vyondys 53 and Amondys 45 at risk, potentially leading to their removal from the market.
Author's summary: Sarepta shares drop 40% after trial failure.
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