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 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 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
SOM Biotech announces the presentation of the Phase2b study results
posted on February 6, 2025
SOM Biotech presents the Phase 2b study results with SOM3355 demonstrating a unique profile with robust improvements of chorea in Huntington's Disease Patients and a safe profile with no somnolence, no akathisia and no impact on depression, suicidality or cognition. Read More
SOM Biotech will attend JP Morgan Healthcare Conference from January 13th to January 16th 2025
posted on January 10, 2025
