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confidence high
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materiality 0.50
Harmony Biosciences Presents Preclinical Data for BP1.15205 OX2R Agonist in Narcolepsy
Harmony Biosciences Holdings, Inc.
- Data presented at SLEEP 2025 showed significant wake-promoting and cataplexy-suppressing effects in transgenic mouse model of narcolepsy type 1.
- BP1.15205 demonstrated high potency (EC50=0.015 nM) and >600-fold selectivity over human OX1R.
- No adverse events were observed in 3-month GLP toxicity study at doses up to 300 mg/kg/day.
- First-in-human study planned for 2H 2025 with topline data anticipated in 2026.
- IMPD application with EMA being completed; IND for BP1.15205 to be filed with FDA.
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