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…
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 will attend the Huntington Study Group Annual Event in Nashville, Oct 10-13, 2025
posted on October 7, 2025
SOM Biotech receives positive EMA COMP opinion on European Orphan Drug Designation for SOM3355 for treatment of Huntington’s Disease
posted on September 15, 2025
SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, today announces that the European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP) has issued a positive opinion on granting Orphan Drug Designation (ODD) for SOM3355 for the treatment of Huntington’s disease (HD). Read…
SOM is pleased to announce that End-of-Phase2 meeting with FDA is set mid-September
posted on July 30, 2025
Extremely positive findings from the PK/PD study included in the Phase2b reassuring SOM3355 cardiovascular safety beyond expectations.
posted on July 10, 2025
The PK/PD study showed that the β1-adrenergic inhibitory effect plateaus at the lower dose tested in the Phase2b study (400 mg/day). The higher dose (600 mg/day) is more efficacious in terms of chorea control while bearing a limited risk for cardiovascular safety similar to that of the lower doses.
SOM Biotech will attend Bio-Neuroscience Conference from February 25th to February 27th 2025
posted on February 17, 2025
