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Neuren Pharmaceuticals (ASX: NEU) has been granted the chance to talk to the U.S. Food and Drug Administration (FDA) about some of the positive indicators that may be expected from its upcoming Phase 3 clinical trial program for a drug to treat multiple childhood genetic conditions.
The FDA has granted Neuren a Type C meeting – set for early April 2025 – to explore the efficacy endpoints of the trial program for candidate NNZ-2591.
This comes after a Type B End of Phase 2 meeting with the government agency, in which key features of the trial were discussed and agreed to.
NNZ-2591 is the company’s second drug candidate, which is in development with a focus on treating some neurodevelopmental disorders. During the Phase 2 clinical trial, it revealed positive results regarding Phelan-McDermid syndrome, Pitt-Hopkins syndrome, and Angelman syndrome.
CEO Jon Pilcher said Neuren was looking forward to a positive discussion with the FDA.
“Having a confirmed Type C meeting now establishes a clear timetable and in parallel we are continuing all our preparations, planning for mid-year commencement of the first ever Phase 3 trial for children with Phelan-McDermid syndrome,” he aid.
Neuren shares have been trading at $13.93.
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