Harmony Biosciences Holdings (HRMY) Company Report

Harmony Biosciences reported record patient additions for WAKIX in Q3, with a 500-patient increase, bringing the total to 8,100 patients on therapy, and anticipates WAKIX to be a $1 billion-plus opportunity.
The company is advancing its Pitolisant franchise with Pitolisant GR (gastro-resistant) expected to have its NDA submitted early next year for a target PDUFA in Q1 2027, and Pitolisant HD (high-dose) initiating two Phase 3 trials for narcolepsy and idiopathic hypersomnia, targeting a PDUFA in 2028.
Harmony's orexin agonist is in Phase 1 clinical trials, with initial clinical data expected in 2026, aiming for a potentially best-in-class profile with high potency and selectivity.
In pediatric epilepsies, Harmony's EPX-100 (clemizole) is in Phase 3 trials for Dravet and Lennox-Gastaut syndromes, with top-line data expected in late 2026.

1 day ago

Transcript

Harmony Biosciences Reports Record WAKIX Patient Adds and Pipeline Advancements

HRMY

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Harmony Biosciences reported record patient additions for WAKIX in Q3, with a 500-patient increase, the highest since launch, following a 400-patient increase in Q2.
The company is progressing its pipeline, with Pitolisant GR (gastro-resistant) targeting NDA submission early next year for a Q1 2027 PDUFA and Pitolisant HD (high-dose) initiating Phase 3 trials for narcolepsy and idiopathic hypersomnia with a target PDUFA in 2028.
Harmony has started a Phase 1 PK/PD program for its orexin-2 agonist, with clinical data expected in 2026, aiming for a best-in-class profile.
EPX-100 (clemizole hydrochloride) is in Phase 3 for Dravet and Lennox-Gastaut syndromes, with top-line data expected in late 2026 and initial open-label efficacy data to be presented soon.
Management anticipates minimal short-term impact on WAKIX from Takeda's orexin launch in late 2026/early 2027 and expects Xyrem generics to primarily affect the oxybate market.

1 day ago

Transcript

Harmony Biosciences Discusses WAKIX Growth, Pipeline Progress, and Market Dynamics

HRMY

Product Launch

Revenue Acceleration/Inflection

New Projects/Investments

WAKIX continues its strong performance, with Q3 patient adds reaching a record 500, driven by its differentiated profile as the only non-scheduled treatment option and improved patient access.
Harmony Biosciences expects minimal short-term impact on WAKIX from upcoming Xyrem generics and Takeda's NT1-only orexin agonist, oveporexton, which is anticipated to launch in late 2026/2027.
The company is progressing its pipeline with an orexin-2 agonist in Phase I (clinical data expected in 2026) , pitolisant GR (NDA submission early 2026, targeting Q1 2027 launch) , and pitolisant HD (initiating two Phase III trials for narcolepsy and IH with a target PDUFA in 2028).
Harmony's clemizole (EPX-100) is in Phase III for Dravet and Lennox-Gastaut, with top-line data expected in late 2026 and initial efficacy data from the open-label extension to be presented next week.

1 day ago

Transcript

Harmony Biosciences Provides Business Update at Evercore Conference

HRMY

Guidance Update

Product Launch

New Projects/Investments

Harmony Biosciences reported strong performance for Wakix, increasing its full-year guidance to $845 million-$865 million for the year, driven by significant patient increases in Q2 and Q3.
The company is expanding its pitolisant franchise with two new formulations: pitolisant GR, targeting a PDUFA in Q1 2027, and pitolisant HD, targeting a PDUFA in 2028, both designed to extend the franchise into the mid-2040s.
Harmony's pipeline includes an orexin-2 agonist currently in Phase I studies and EPX-100 in Phase III for Dravet syndrome and Lennox-Gastaut.
The company is profitable and self-funding its pipeline, with plans for six programs in registrational trials next year, and is actively pursuing business development for commercial-stage assets.
The ZYN002 program for Fragile X is currently on hold, with an assessment of the path forward expected by year-end or early next year.

2 days ago

Transcript

Harmony Biosciences Provides Business Update, Raises Guidance, and Details Pipeline Progress

HRMY

Guidance Update

New Projects/Investments

M&A

Harmony Biosciences (HRMY) reported strong underlying demand for Wakix, with a 500-patient increase in Q3 and 900 patient adds over Q2 and Q3, leading to an increased full-year guidance from $820-$860 million to $845-$865 million.
The company is advancing its life cycle management for pitolisant with a gastro-resistant (GR) formulation targeting a PDUFA in Q1 2027 and a high-dose (HD) formulation targeting a PDUFA in 2028.
HRMY is profitable and self-funding its pipeline, which includes orexin-2 agonists in Phase 1 and EPX-100 in Phase 3 for epilepsy.
The ZYN002 (Cannabidiol Gel) program for Fragile X is currently on hold following a disappointing Phase 3 readout, with an assessment expected by year-end or early next year.

2 days ago

Transcript

Harmony Biosciences Updates on Wakix Performance and Pipeline Progress

HRMY

Guidance Update

Product Launch

New Projects/Investments

Harmony Biosciences is building on its strong commercial business with Wakix, which is projected to be a $1 billion-plus opportunity in narcolepsy alone.
The company increased its Wakix revenue guidance for the year to $845 million to $865 million, driven by strong patient growth, including 500 patient adds in Q3.
Life cycle management for Pitolisant includes a gastro-resistant (GR) formulation with a PDUFA target in Q1 2027 and a high-dose (HD) formulation with a PDUFA target in 2028, aimed at expanding the franchise.
The pipeline features an orexin-2 agonist (15205) in Phase 1 clinical studies and EPX-100 in Phase 3 for Dravet syndrome and Lennox-Gastaut.
The ZYN002 (Cannabidiol Gel) program is on hold pending a full data assessment, with an update expected by year-end or early next year.

2 days ago

Transcript

Harmony Biosciences Announces Positive Pitolisant GR Study Results, 2026 NDA Submission, and Patent Extension

HRMY

Product Launch

New Projects/Investments

Earnings

Harmony Biosciences Holdings announced positive results from pivotal bioequivalence and dosing optimization studies for its pitolisant gastro-resistant (GR) formulation, confirming it is bioequivalent to WAKIX tablets with no new safety or tolerability issues.
The company plans to submit a New Drug Application (NDA) for pitolisant GR in early 2026, targeting a PDUFA date in the first quarter of 2027.
Utility patent applications have been filed, potentially extending exclusivity for pitolisant GR to 2044.
These developments, alongside strong financial results for the third quarter of 2025 that surpassed market expectations, support the pitolisant franchise's momentum towards blockbuster status.

Nov 24, 2025, 1:16 PM

Morningstar

Harmony Biosciences Reaffirms 2025 Revenue Guidance and Advances Pipeline

HRMY

Earnings

Guidance Update

New Projects/Investments

Harmony Biosciences reaffirmed its fiscal year 2025 revenue guidance between $845 million and $865 million.
The company reported strong third-quarter 2025 revenue of approximately $239.45 million, marking a 28.7% year-over-year increase, and adjusted earnings per share of $1.08.
Harmony maintains robust financial health with a gross margin of 78.34% and over $400 million in cash and investments at quarter-end.
The company plans to initiate Phase 3 trials for Pitolisant HD and dose the first subject for a potential best-in-class orexin 2 agonist (BP1.15205) in Q4 2025.

Nov 4, 2025, 2:19 PM

Morningstar

Harmony Biosciences Reports Strong Q3 2025 Results and Raises Full-Year Guidance

HRMY

Earnings

Guidance Update

New Projects/Investments

Harmony Biosciences reported net revenue of $239.5 million for Q3 2025, marking a 29% year-over-year growth. This performance was driven by a record 500 average new patient adds for Wakix, resulting in an average of 8,100 patients on Wakix by the end of the quarter.
The company raised its full-year 2025 net revenue guidance to a range of $845 million to $865 million.
Harmony's balance sheet ended Q3 2025 with approximately $778 million in cash, cash equivalents, and investments, following $106 million in cash generation during the quarter.
The Investigational New Drug (IND) application for Pitolacin HD was submitted to the FDA, with plans to initiate two Phase III trials in narcolepsy and idiopathic hypersomnia in Q4 2025, targeting PDUFA dates in 2028.
The ZYN-two Phase III ReConnect study in Fragile X syndrome did not meet its primary endpoint, leading to a pause in the ZYN002 program for 22q deletion syndrome.

Nov 4, 2025, 1:30 PM

Transcript

Harmony Biosciences Announces Strong Q3 2025 Results and Raised Full-Year Guidance

HRMY

Earnings

Guidance Update

Revenue Acceleration/Inflection

Harmony Biosciences reported net product revenue of $239.5 million for Q3 2025, representing a 29% increase year-over-year, and Non-GAAP adjusted net income of $63.5 million.
The company raised its 2025 full-year revenue guidance to $845 million - $865 million.
WAKIX® continued its growth, reaching 8,800 average patients in Q3 2025, with approximately 500 average patient adds marking the highest quarterly increase since launch.
Harmony Biosciences plans to initiate Phase 3 registrational trials for Pitolisant HD in narcolepsy and idiopathic hypersomnia in Q4 2025 , and expects topline data from Pitolisant GR's pivotal bioequivalence study in Q4 2025.
The ZYN002 Phase 3 RECONNECT study in Fragile X syndrome did not meet its primary endpoint, primarily due to a higher-than-expected placebo response rate, leading to a pause in the 22q11.2 deletion syndrome program pending full data review.

Nov 4, 2025, 1:30 PM

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Earnings Transcripts

Quarterly earnings call transcripts for Harmony Biosciences Holdings.

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