FDA Grants Breakthrough Therapy Status to Idorsia’s Daridorexant for Pediatric Insomnia, Where No Approved Drugs Exist
On November 4, 2026, Idorsia said the FDA granted Breakthrough Therapy Designation to daridorexant for insomnia in patients ages 10 to under 18, backed by Phase 2 data in 165 children and teens and a planned Phase 3 start in the second half of 2027.
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