FDA grants Breakthrough Therapy Designation to Idorsia's daridorexant for pediatric insomnia

Idorsia Pharmaceuticals announced the FDA granted Breakthrough Therapy Designation to daridorexant for pediatric insomnia disorder, intended to expedite development and review. The company said the milestone supports a path toward a Phase 3 program planned to start in the second half of 2027.

Detected & updated continuously · Source: Nebula