Nova Seeks Orphan Drug Status in US for Psilocybin, Hallucinogenic Therapy

Nova Seeks Orphan Drug Status in US for Psilocybin, Hallucinogenic Therapy

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Nova Seeks Orphan Drug Status in US for Psilocybin, Hallucinogenic Therapy

Nova Mentis has filed an application for orphan drug designation with the U.S. Food and Drug Administration (FDA) for psilocybin, its investigational psychedelic therapy for fragile X syndrome. Recently, psilocybin received orphan drug designation from the European Medicines Agency (EMA), which offers financial incentives for potential rare disease treatments. Nova also plans to launch a Phase 2 study with psilocybin in fragile X. Psilocybin is a tryptamine derivative, a group of naturally occurring molecules known for their hallucinogenic and…

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