Summary: At its Investor Day on October 1, Harmony Biosciences presented a pipeline update, highlighting progress in its sleep disorder treatments. New data from the orexin-2 agonist BP1.15205 showed potential best-in-class potency, while long-term extension data for pitolisant … [Read more...]
Harmony Advances Pitolisant High-Dose Development Program
Summary: Harmony Biosciences reported strong second-quarter results and advancements in its pitolisant high-dose (HD) development program, aiming for a PDUFA date in 2028. The company highlighted revenue growth driven by Wakix and continued progress across its sleep/wake disorder … [Read more...]
Phase 3 Study of Pitolisant for Prader-Willi Syndrome Begins
Harmony Biosciences Holdings Inc initiated its world-wide section 3 registrational demo, the TEMPO research, to examine the basic safety and efficacy of pitolisant as a remedy for excessive daytime sleepiness (EDS) and behavioral indications in sufferers aged 6 yrs and more … [Read more...]