Idorsia seen up after FDA breakthrough designation for pediatric insomnia drug

By Reuters News07:46 (UTC), 4 November 2026 Updated

** Shares in Swiss biopharmaceutical company Idorsia IDIA.S are seen up about 4.2% in premarket trading after the US FDA granted Breakthrough Therapy Designation to daridorexant for pediatric insomnia disorder

** The company said the designation recognizes positive clinical evidence and a significant unmet medical need, with no FDA-approved drug treatments currently available for pediatric insomnia

** Idorsia plans to start a Phase 3 study in pediatric insomnia in the second half of 2027

** Shares were up about 2% year-to-date at Tuesday's close

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