FDA Grants Fast Track Designation to OV101 for Fragile X

The U.S. Food and Drug Administration (FDA) recently granted fast track designation to Ovid Therapeutics’ Fragile X syndrome (FXS) treatment candidate OV101 (gaboxadol). The designation accelerates the development and regulatory review of investigational medications for the treatment of serious conditions and that fill an unmet medical need.

FDA Decision Clears Way for Phase 2 Clinical Trial of BPN14770

The U.S. Food and Drug Administration (FDA) recently accepted the investigational new drug (IND) application for BPN14770, a small molecule therapeutic agent developed by Tetra Discovery Partners for the treatment of Fragile X syndrome and other autism spectrum disorders. Tetra Discovery now plans to launch a Phase 2 clinical…

Genomics Collaborative Aims to Find New Precision Medicine Methods

Boston-based FDNA has launched a global initiative to promote medical research collaborations and to develop new precision approaches for diagnosing and treating disease, including Angelman syndrome. The initiative, called Genomics Collaborative, uses computer analysis and artificial intelligence technologies to integrate genetic information with the physical and biological characteristics of a particular disease.