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On September 11, 2023, Sarepta’s President and CEO gave remarks concerning the Company’s research. One topic raised was Elevidys – the Company’s novel treatment for boys with Duchenne Muscular Dystrophy – and the associated EMBARK Phase III study. The remarks focused on metrics on the NSAA scale as the study’s endpoint. Additionally, the remarks give the impression that the EMBARK data demonstrated statistically significant improvements on the NSAA scale due to Elevidys treatment.
On October 30, 2023, the Company announced EMBARK results. Elevidys failed to show a statistically significant NSAA benefit. Rather, the Company argued for Elevidys’ efficacy based on secondary endpoints which had not previously been disclosed to investors. Analysts expressed surprise at the Company’s use of such secondary endpoints in light of the primary endpoint failure.
Following this news, SRPT stock price fell by $40.31 per share – or approximately 37.4% — within one day of the news.