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Sarepta Therapeutics Inc (NASDAQ:SRPT) shares are plunging in extended trading Monday after the company reported third-quarter results and provided an update on its ESSENCE study.
What To Know: Sarepta reported third-quarter revenue of $399.36 million, beating analyst estimates of $338.71 million, according to Benzinga Pro. The company reported a third-quarter adjusted loss of 13 cents per share, beating estimates for a loss of 81 cents per share.
In connection with earnings, Sarepta said it completed its Phase 3 ESSENCE study evaluating the efficacy and safety of AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen) compared to placebo in patients with Duchenne muscular dystrophy amenable to exon 45 or 53 skipping.
The company said topline results showed that both gene therapies failed to meet the primary goal in the late-stage study. Numerical trends favored treatment versus placebo, but did not meet statistical significance.
“While the ESSENCE study did not meet statistical significance on its primary endpoint, we believe the results demonstrated a clear treatment effect, showing clinically meaningful functional outcomes for people with Duchenne who have mutations amenable to skipping exons 45 or 53. These topline findings reinforce the potential impact of these therapies to slow muscle weakness and other symptoms,” said Louise Rodino-Klapac, president of research and development, and technical operations at Sarepta.
Sarepta said it plans to schedule a meeting with the U.S. Food and Drug Administration (FDA) to discuss the possibility of converting from accelerated to traditional approval.
The company is currently discussing its third-quarter results and ESSENCE study update on a call with investors and analysts that started at 4:30 p.m. ET.
SRPT Price Action: Sarepta shares were down 24.74% in after-hours, trading at $17.99 at the time of publication on Monday, according to Benzinga Pro.
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