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Harmony Biosciences
Harmony Biosciences (HRMY) investor relations material
Harmony Biosciences 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.44th Annual J.P. Morgan Healthcare Conference summary14 Jan, 2026
Strategic growth drivers and outlook for 2026
Momentum into 2026 is driven by WAKIX performance, a robust late-stage pipeline, and a strong financial profile.
WAKIX is on track to surpass $1 billion in net revenue, achieving blockbuster status in narcolepsy.
Five phase III programs are advancing toward five distinct CNS indications, setting up multiple catalysts.
The company is self-funding, with a strong balance sheet enabling further pipeline expansion and commercial diversification.
Commercial execution improvements and expansion of field teams are planned for 2026.
Pitolisant franchise expansion and innovation
WAKIX remains the only non-controlled substance approved for narcolepsy, with a differentiated profile and broad utility.
Pitolisant GR targets patients with GI symptoms, offering a gastro-resistant formulation and no need for titration.
Pitolisant HD, a high-dose formulation, aims to address refractory symptoms and drive greater efficacy.
New indications pursued include fatigue in narcolepsy and sleep inertia in idiopathic hypersomnia.
Utility patents extend franchise protection to mid-2040s; pediatric exclusivity could extend WAKIX LOE to Q3 2030.
Clinical development and regulatory milestones
NDA for pitolisant GR is on track for Q2 submission, with an anticipated PDUFA in Q1 2027.
Two pivotal phase III trials for pitolisant HD in narcolepsy and IH began in Q4 2025, with top-line data expected in 2027 and PDUFA in 2028.
Prader-Willi syndrome phase III top-line data expected in the second half of this year, supporting pediatric exclusivity.
Four anticipated PDUFA dates in 2028 for pitolisant HD (narcolepsy, IH) and EPX-100 (Dravet, LGS).
Orexin-2 agonist phase I clinical PK data expected mid-2026.
Pitolisant GR/HD: key patient benefits?
BP1.15205: Future growth contribution?
Capture undiagnosed narcolepsy patients: strategy?
What specific commercial enhancements drive WAKIX growth?
How will PITOLISANT HD differentiate in the market?
What is Harmony's capital deployment strategy?
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Charter amendments seek to modernize governance and establish one share, one vote by 2026.
Next Harmony Biosciences earnings date
Q4 202517 Feb, 2026
Harmony Biosciences
Next Harmony Biosciences earnings date
Q4 202517 Feb, 2026
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Frequently asked questions
Harmony Biosciences Holdings, Inc. is a commercial-stage pharmaceutical company that develops and sells novel therapies for people with rare diseases. It offers Naurex, an investigational drug to treat depression; Wakix, an oral treatment for excessive sleepiness; SPRITAM rapidly disintegrated tablets to treat nighttime seizures; and EVKOTEBO for prevention of recurrent seizures in people with partial-onset epilepsy. The company was formerly known as Axsome Therapeutics, Inc. and changed its name to Harmony Biosciences Holdings, Inc. in January 2019. Harmony Biosciences Holdings, Inc. was founded in 2017and is headquartered in Plymouth Meeting, Pennsylvania.
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