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SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End-of-Phase 2 Meeting
Posted on October 21, 2025
SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it has received the final report on the End-of-Phase 2 Meeting held with the US Food and Drug Administration (FDA) on September 19, 2025. The Agency is aligned on the proposed Phase 3 study design followed by an open label extension (OLE) that will support the filing of a New Drug Application (NDA) for treating Huntington’s disease.