Fragile X Syndrome
FDA grants fast-track designation to small molecule for Fragile X
The FDA has granted fast-track designation to an investigational small molecule to treat individuals with Fragile X syndrome, according to the manufacturer.
FDA grants orphan designation to Fragile X syndrome therapeutic
The FDA has granted orphan drug designation to a small molecule therapeutic for individuals with Fragile X syndrome.
FDA clears investigational new drug application for Fragile X treatment
The FDA has cleared an investigational new drug application for a small molecule therapeutic to treat those with Fragile X syndrome, according to the manufacturer.
US awards $11.4M for therapeutic to treat Fragile X-associated tremor
The U.S. Department of Defense has awarded $11.4 million to a Boston-based biotherapeutics firm to advance its novel oral prodrug of endogenous allopregananolone, LYT-300, to treat Fragile X-associated Tremor Ataxia syndrome.
Canadian biotech firm granted exemption to initiate phase 2 psilocybin study
Nova Mentis Life Science Corp. has received an exemption under Section 56 of the Health Canada Controlled Drugs and Substances Act to advance a phase 2a clinical trial examining oral microdose psilocybin therapy for fragile X syndrome.