08:53 AM EDT, 09/12/2022 (MT Newswires) -- Acadia Pharmaceuticals (ACAD) said Monday that the US Food and Drug Administration has accepted for filing the company's new-drug application of trofinetide for Rett syndrome.
The drugmaker said that the application has been granted priority review and given a prescription drug user fee act action date of March 12.
The new-drug application is backed by findings from a late-stage study that assessed the efficacy and safety of trofinetide compared with placebo in 187 girls and young women aged 5 to 20 years old with Rett syndrome.
Rett syndrome is a multisystem neurodevelopmental disorder that causes loss of language and hand function skills, as well as gait impairment and development of hand stereotypes. It happens in one out of every 10,000 to 15,000 female births worldwide, the company said.
The company's shares were up by approximately 1.3% in recent premarket activity.
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