Also known as: Harmony, Harmony Biosciences
Harmony Biosciences is a commercial-stage pharmaceutical company focused on therapies for patients with rare neurological diseases. Its lead commercial product is WAKIX (pitolisant), and it is advancing additional clinical programs in related indications. Founded in 2017, the company is headquartered in Plymouth Meeting, Pennsylvania and listed on Nasdaq as HRMY.
The FDA approved Lupin's generic pitolisant tablets as bioequivalent to WAKIX, and approved Harmony Biosciences' WAKIX for pediatric cataplexy, making it the first non-controlled treatment for both pediatric and adult narcolepsy patients.
The FDA has approved WAKIX for cataplexy in pediatric narcolepsy patients, making it the first non-scheduled treatment for all ages. Harmony Biosciences reported 2025 WAKIX revenue of $868.5 million and projects 2026 sales over $1 billion, nearing blockbuster status.
The FDA has approved Harmony Biosciences' Wakix (pitolisant) for treating cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA has approved pitolisant tablets for treating cataplexy in pediatric patients aged 6 and older with narcolepsy, making it the only non-scheduled therapy approved for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA approved Harmony Biosciences' supplemental new drug application for WAKIX (pitolisant) to treat cataplexy in pediatric patients 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
