Idorsia Ltd (IDIA.SW, IDIA),a commercial-stage biopharmaceutical company,on Monday announced positive top-line results from its Phase 2 dose-finding study evaluating 10, 25, and 50 mg doses of Daridorexant, its investigational dual orexin receptor antagonist (DORA) in paediatric patients aged 10 to 18 years with insomnia disorder.
Following the news IDIA.SW is surging 5.55%, at 3.23 Swiss Francs.
Pediatric insomnia is characterized by difficulty initiating or maintaining sleep that is perceived as a problem by the child or caregiver due to its severity, chronicity, frequency, and the significant daytime impairment it causes for the child or the family.
Company Profile
The company focuses on discovering, developing, and commercializing drugs, with a pipeline targeting CNS, cardiovascular, immune disorders, and rare diseases.
Idorsia offers QUVIVIQ (Daridorexant) for the treatment of insomnia for adult patients and is currently in phase 2 clinical trial for the treatment of paediatric insomnia.
QUVIVIQ is marketed by Idorsia in the US, Canada, and multiple European countries, and is available in Japan, Hong Kong, and China through commercial partnerships.
The company's product pipeline also includes Lucerastat which is in phase 3 clinical trial to treat Fabry disease; IDOR-1117-2520, which is in phase 1 clinical program to treat psoriasis.
Study Highlights
The primary objective of the Phase 2 study was to characterize the dose-response relationship of Daridorexant on objective total sleep time (TST), using polysomnography (PSG).
The study enrolled children with insomnia disorder aged 10-11 years (21%) and 12-17 years (79%), including those with a history of neurodevelopmental disorders, such as Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD).
Patients were randomized in a 1:1:1:1 ratio to 10, 25, or 50 mg daridorexant, or placebo for a treatment period of 2 weeks, with 165 patients receiving study medication.
Key Findings and Upcoming Milestones
Analysis of the primary endpoint demonstrated a statistically significant dose dependent improvement in TST from baseline on Day 1.
It was also accompanied by additional dose-dependent improvements across multiple objective and subjective sleep parameters.
According to the firm, the study confirmed the excellent safety and tolerability profile of Daridorexant for the first time in pediatric patients as young as ten at the highest dose tested.
Idorsia will now engage with health authorities to discuss next steps in pediatric insomnia and to initiate discussions on a new potential investigation pathway for children with neurodevelopmental disorders.
Idorsia is scheduled to host an investor webcast to discuss the study on March 31, at 15:00hrs CEST.
IDIA.SW has traded between 0.85 Swiss francs and 4.85 Swiss Francs in the last year. The stock closed Friday's trade at 3.06 Francs.
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