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Harmony Biosciences Receives U.S. Food and Drug Administration Approval for WAKIX® (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy. “We are excited to achieve this im.

Harmony Biosciences Guides to Over $1 Billion in WAKIX® Revenue in 2026; Advancing Robust Late-Stage Pipeline With Potential for Long-term Value Creation

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced strong preliminary, unaudited net product revenue for Q4 and full year 2025 of approximately $243 million and $868 million, respectively. The company continues to build on six consecutive years of revenue growth. On track to extend the pitolisant franchise, Harmony fortifies its profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term gro.

Beacon Biosignals Announces Partnership with Harmony Biosciences to Advance Objective Clinical Endpoints in Hypersomnia Conditions Through Quantitative EEG

BOSTON, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Beacon Biosignals, a leader in AI-driven neurophysiology and precision drug development, today announced a collaboration with Harmony Biosciences (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for rare neurological disorders, to incorporate quantitative electroencephalography (EEG) measurements into two of Harmony's Phase 3 studies of HBS-301 for Narcolepsy and Idiopathic Hypersomnia. The collaboration will support Harmony's primary objective of assessing excessive daytime sleepiness (EDS) by complementing traditional patient-reported outcomes, such as the Epworth Sleepiness Scale (ESS), with objective sleep EEG data.