Harmony Biosciences

What Harmony Biosciences does

Harmony Biosciences Holdings, Inc. is a publicly traded (NASDAQ: HRMY) commercial-stage pharmaceutical company founded in 2017 by Paragon Biosciences, headquartered in Plymouth Meeting, Pennsylvania. The company develops and commercializes therapies for rare neurological disorders, with a primary focus on sleep/wake conditions and rare epilepsies. Its commercial product, WAKIX (pitolisant), is a histamine-3 receptor (H3R) antagonist/inverse agonist licensed from Bioprojet and is the first and only FDA-approved non-scheduled treatment for excessive daytime sleepiness and cataplexy in narcolepsy, now approved for both adults and pediatric patients aged 6 and older following a February 2026 label expansion.

The company's pipeline targets additional indications and mechanism diversification. Sleep/wake assets include Pitolisant GR (gastro-resistant, NDA filed Q2 2026) and Pitolisant HD (higher-dose) life-cycle extensions of the lead franchise, the orexin-2 receptor agonist BP-205 (Phase 1, initiated November 2025), the MCHR1 antagonist HBS-102, and regenerative cellular therapies CBS-105 and CBS-104 developed with CiRC Biosciences. Rare epilepsy assets include EPX-100 (Phase 3 ARGUS trial in Dravet syndrome and LIGHTHOUSE in Lennox-Gastaut syndrome) and EPX-200, both acquired through the April 2024 Epygenix Therapeutics acquisition; clemizole holds FDA orphan drug and rare pediatric disease designations.

Commercially, Harmony generates revenue through WAKIX prescription sales distributed via retail and specialty pharmacies in the United States, supported by a field sales force targeting sleep specialists and neurologists, patient support programs, and patient advocacy partnerships. The company grew full-year 2025 net product revenue to $868.5 million (22% YoY), guided to $1.00-$1.04 billion for 2026, and reported a 76.55% trailing-twelve-month gross margin with GAAP net income of $158.7 million and $882.5 million in cash reserves at year-end 2025. The acquisition of Epygenix (2024) and the previously acquired Zynerba Pharmaceuticals (2023) extend the company beyond a single-asset franchise, while a December 2025 partnership with Beacon Biosignals introduces AI-driven EEG endpoints into the HBS-301 Phase 3 program.

Name

Harmony Biosciences

Legal name

Harmony Biosciences Holdings, Inc.

Website

https://harmonybiosciences.com

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

251–500 employees

Short description

Harmony Biosciences is a publicly traded commercial-stage pharmaceutical company that develops and commercializes therapies for rare neurological disorders, led by WAKIX (pitolisant), the first FDA-approved non-scheduled treatment for narcolepsy, serving approximately 8,500 patients with 2025 revenue of $868.5 million.

Ownership category

akta.pro rank

Product category

Rare Neurological Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro industry

PRIMARYHLAIAIAD

Rare Neurology & Neurodegenerative Disorder Therapies

Healthcare & Life Sciences/Pharmaceuticals/Orphan & Rare Disease Pharmaceuticals

SECONDARYHLAIACAC

Neurology & CNS Specialty Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Specialty Pharmaceuticals

SECONDARYHLAIAAAF

Neurology & Psychiatry (CNS) Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Branded (Innovator) Pharmaceuticals

SECONDARYHLAIAIAN

Rare Pediatric & Congenital Disorder Therapies

Healthcare & Life Sciences/Pharmaceuticals/Orphan & Rare Disease Pharmaceuticals

Keywords

• Rare neurological therapeutics
• Narcolepsy treatment
• CNS pharmaceuticals
• Sleep wake disorders
• Rare epilepsy drugs

Headquarters

HQ city

Plymouth Meeting

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Marketing or Sales, Personnel, Supply Chain

Revenue model

1. WAKIX (Pitolisant) Product Sales: Primary revenue driver from sales of FDA-approved WAKIX tablets for narcolepsy. The product achieved $868.5 million in full-year 2025 net product revenue, representing 22% year-over-year growth. The company guides to over $1 billion in 2026 revenue, positioning WAKIX as a blockbuster drug. Revenue is generated through prescription sales distributed through pharmacies to patients with narcolepsy and related sleep disorders.
2. Milestone Payments from Acquisitions: The company has structured acquisitions with potential milestone payments. The Epygenix Therapeutics acquisition involves up to $550 million in milestone payments based on development, regulatory, and sales targets for EPX-100 and EPX-200. The Zynerba Pharmaceuticals acquisition includes up to $140 million in potential additional payments based on milestones.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Harmony Biosciences develops and commercializes FDA-approved pharmaceutical therapies for rare neurological diseases. Its commercial product, WAKIX (pitolisant), is the first and only FDA-approved non-scheduled treatment for excessive daytime sleepiness and cataplexy in narcolepsy patients (adults and pediatric patients 6+). The company is expanding its pipeline with next-generation pitolisant formulations, orexin-2 receptor agonists, and rare epilepsy therapies acquired through M&A.

Product overview

Harmony Biosciences is a commercial-stage pharmaceutical company focused on developing and commercializing therapies for rare neurological diseases. The company's commercial product is WAKIX (pitolisant), an FDA-approved treatment for excessive daytime sleepiness and cataplexy in narcolepsy (adults and children 6+). The pipeline spans sleep/wake disorders and rare epilepsy syndromes. Next-generation pitolisant formulations include Pitolisant GR (gastro-resistant, NDA submitted Q2 2026) and Pitolisant HD (higher dose, Phase 3 planned 2027). The rare epilepsy pipeline includes EPX-100 and EPX-200 acquired from Epygenix Therapeutics (2024), plus early-stage programs (HBS-102, CBS-105, CBS-104) developed in research collaboration with CiRC Biosciences. The company also acquired Zynerba Pharmaceuticals (2023) for neuropsychiatric disorder treatments.

Differentiator

Problem solved

Functional benefit

Brands

• WAKIX: FDA-approved treatment for narcolepsy (excessive daytime sleepiness and cataplexy)
• Know Narcolepsy
• Newrology

Products and services

• WAKIX (pitolisant) FDA-approved histamine-3 receptor antagonist/inverse agonist for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy; expanded in 2026 to include pediatric patients 6 years and older. The first and only FDA-approved non-scheduled therapy for narcolepsy, distributed by prescription through retail and specialty pharmacies in the United States.
• EPX-100 (clemizole hydrochloride) Investigational compound modulating serotonin signaling by targeting central 5-hydroxytryptamine (5-HT) receptor subtypes. Granted FDA orphan drug designation for Dravet syndrome and Lennox-Gastaut syndrome, and FDA rare pediatric disease designation for both indications. Phase 3 ARGUS trial ongoing in Dravet syndrome; Phase 3 LIGHTHOUSE trial planned in LGS; approximately 50% median reduction in motor seizure frequency observed in Dravet open-label extension.
• EPX-200 (lorcaserin) Potent, oral, centrally active and selective 5HT2C agonist in IND-enabling studies. Liquid formulation of lorcaserin targeting Developmental and Epileptic Encephalopathies.

Quantifiable outcome

• Approximately 50% median reduction in countable motor seizure frequency in Dravet syndrome patients treated with EPX-100
• +2 more outcomes

Named customers1 record

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Bioprojet Societe Civile de RecherchecoreStrategic or Co-development PartnerExclusive license agreement to develop, manufacture, and commercialize pitolisant in the United States. Pitolisant was designed and developed by Bioprojet and approved in Europe by the European Medicines Agency in 2016.
• Epygenix Therapeutics, Inc.coreStrategic or Co-development PartnerAcquired in February 2024, expanding pipeline with clinical-stage drugs EPX-100 and EPX-200 for rare epilepsy treatments including Dravet syndrome and Lennox-Gastaut syndrome. Deal involves up to $550 million in milestone payments based on development, regulatory, and sales targets. Potential peak sales over $1 billion each.
• Zynerba Pharmaceuticals, Inc.coreStrategic or Co-development PartnerAcquired in August 2023 for $60 million in cash with potential additional payments up to $140 million based on milestones. Expanded portfolio with Zynerba's neuropsychiatric disorder treatments including Phase 3 clinical trial for Fragile X syndrome. The ZYN002 program was subsequently discontinued following Phase 3 trial failure.
• CiRC BiosciencesminorStrategic or Co-development PartnerResearch collaboration for CBS-105 and CBS-104, investigational novel regenerative cellular therapies aimed at replacing lost neurons and restoring function in patients with treatment-resistant narcolepsy and refractory epilepsy.

Scale indicators8 records

Recent moves13 records

Expansion highlights6 records

Direct peers

• Jazz Pharmaceuticals: Jazz commercializes Xywav and Lumryz for narcolepsy, directly competing with WAKIX in the same prescriber base of sleep specialists and neurologists. Both companies pursue CNS/rare neurology franchises with similar field-sales-driven commercialization models.
• Avadel Pharmaceuticals: Avadel's Lumryz (sodium oxybate) competes with WAKIX in narcolepsy treatment, targeting the same EDS/cataplexy patient population. Both companies are mid-cap rare neurology specialists listed on NASDAQ with single-asset commercial franchises.
• Axsome Therapeutics: Axsome is developing AXS-12 for narcolepsy alongside its CNS portfolio, positioning it as a direct therapeutic competitor to WAKIX. Both companies target rare CNS indications with novel mechanisms and pursue similar specialty-pharma growth profiles.

Broad incumbents

• Takeda Pharmaceutical: Takeda is a global rare disease and CNS player where multiple Harmony executives previously held senior roles. Its rare disease commercial infrastructure and product launches in neurology/rare epilepsy make it a structural incumbent comparable.
• Intra-Cellular Therapies: Intra-Cellular Therapies (acquired by J&J) built Caplyta for CNS indications through similar specialty sales-force-led commercialization. Its trajectory from single-asset to platform CNS franchise mirrors Harmony's strategic trajectory.
• UCB: UCB is a global biopharma with significant rare neurology and epilepsy franchises (Fintepla, Briviact, Vimpat). Its rare epilepsy focus particularly overlaps Harmony's EPX-100/EPX-200 Dravet and Lennox-Gastaut programs.
• Lundbeck: Lundbeck is a global CNS specialty pharma where Harmony's new COO Peter Anastasiou previously led North America. Its broad neurology portfolio (Vyepti, Onfi) serves as a strategic incumbent comparator for global CNS commercialization.
• Supernus Pharmaceuticals: Supernus is a CNS-focused specialty pharma with a broader neurology portfolio (Qelbree, Apokyn) targeting similar specialty prescriber channels. It serves as a comparable commercial-stage CNS specialty pharma business model with diversified revenue.

Emerging players

• Zevra Therapeutics: Zevra focuses on rare CNS diseases with arimoclomol for Niemann-Pick type C and SDX (serdexmethylphenidate) for narcolepsy. It overlaps Harmony in the rare neurology/sleep category at a smaller scale with similar orphan-drug development approach.
• BioXcel Therapeutics: BioXcel commercializes IGALMI for CNS agitation and develops BXCL501/BXCL502 in neurology/immunology. It is a comparable early-commercial rare/specialty CNS biotech targeting similar prescriber bases with a focused pipeline model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/HarmonyBio
• LinkedInlinkedin.com/company/harmonybiosciences
• Instagraminstagram.com/harmony_biosciences

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries2 records

Funding overview

Funding rounds10 records

Investors12 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Harmony Biosciences