Financial Performance and Growth - Harmony Biosciences anticipates net revenue between $1 billion and $1.04 billion for 2026[16] - The company's revenue has grown consistently year-over-year, with $714.7 million in 2024, $868 million in 2025, and projected growth into 2026[52] - WAKIX net revenue has shown significant growth from $160 million in 2020 to over $1 billion projected for 2026[15] Pitolisant Franchise Strategy - The company is focused on growing the WAKIX franchise, extending it with Pitolisant GR, and expanding it with Pitolisant HD[8] - Pitolisant GR has the potential to extend the pitolisant franchise with utility patents filed to 2044[9] - Pitolisant HD has the potential to expand the pitolisant patient base into new indications[9] Pipeline Development - A Phase 1 clinical PK data for BP1.15205, a potential best-in-class Orexin 2 Receptor (OX2R) Agonist, is anticipated in mid-2026[42] - Topline data from ongoing global Phase 3 trials for EPX-100 in Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) are anticipated in 1H 2027[45, 47] - The company submitted an NDA for Pitolisant GR in Q2 2026, with an anticipated PDUFA date in Q1 2027[31] Market Opportunity - There are approximately 170,000 people living with narcolepsy in the U S, with over 50% undiagnosed[22]

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Financial Performance - Preliminary unaudited net product revenue for Q4 2025 was approximately $243 million, compared to $201.3 million for the same period in 2024, representing a growth of ~21%[6] - Full year 2025 net product revenue was approximately $868 million, compared to $714.7 million for 2024, indicating a year-on-year growth of ~21%[6] - WAKIX is projected to achieve net revenue between $1.0 billion to $1.04 billion for the full year ending December 31, 2026, on track for blockbuster status in narcolepsy[6] Product Development and Pipeline - The average number of patients using WAKIX increased by ~400 to approximately 8,500 in Q4 2025, marking the third consecutive quarter of ~400+ patient additions[6] - The pitolisant franchise is expected to extend into the 2040s with next-gen formulations, including a gastro-resistant version (Pitolisant GR) anticipated for NDA submission in Q2 2026[6] - Five ongoing Phase 3 registrational clinical trials are in progress for five distinct CNS indications, reinforcing the robustness of the late-stage pipeline[6] - The Phase 3 topline data readout for Pitolisant in Prader-Willi Syndrome (PWS) is expected in the second half of 2026, supporting pediatric exclusivity for WAKIX[6] - The orexin-2 receptor agonist (BP1.15205) is currently in a Phase 1 trial, with clinical data expected in mid-2026[6] - The ZYN002 program in Fragile X syndrome is being phased out, and Harmony is no longer pursuing a 22q deletion syndrome indication[7] Company Strategy and Focus - Harmony Biosciences is positioned as a profitable, self-funding biotech with a strong balance sheet, ready to expand its commercial portfolio and pipeline[4] - Harmony Biosciences is focused on developing therapies for rare neurological diseases with significant unmet medical needs[26] - The company is developing EPX-100 (clemizole hydrochloride) for Dravet syndrome and Lennox-Gastaut syndrome, targeting central 5-hydroxytryptamine receptors[23] - Harmony plans to submit a New Drug Application (NDA) for pitolisant GR and aims to extend the pitolisant franchise into the 2040s[27] - The company emphasizes the importance of market acceptance and clinical utility for its product candidates, including pitolisant[28] - Harmony is committed to exploring the therapeutic potential of pitolisant in additional indications, including pitolisant GR and pitolisant HD[28] - The company is focused on identifying and integrating additional products with significant commercial potential[28] - Harmony acknowledges the risks associated with commercialization efforts and the competitive landscape in the pharmaceutical industry[28] - The company has a vision of combining empathy and innovation to foster therapeutic advancements for patients[26] Disease Focus - Dravet syndrome has an estimated incidence rate of 1 in 15,700, with approximately 85% of cases caused by SCN1A gene mutations[24] - Lennox-Gastaut syndrome affects around 48,000 patients in the U.S., characterized by multiple seizure types and developmental issues[25]

Core Viewpoint - Harmony Biosciences Holdings, Inc. reported strong preliminary, unaudited net product revenue for Q4 and full year 2025, indicating continued growth and profitability in the biotech sector [1] Financial Performance - The company announced Q4 2025 net product revenue of approximately $243 million [1] - Full year 2025 net product revenue reached approximately $868 million [1] - Harmony has achieved six consecutive years of revenue growth, demonstrating a solid financial trajectory [1] Business Strategy - Harmony is on track to extend the pitolisant franchise, which is a key component of its product portfolio [1] - The company is positioning itself as a profitable, self-funding biotech entity with a robust late-stage pipeline [1] - Strong long-term growth prospects are highlighted, reinforcing the company's strategic direction [1]

Core Viewpoint - Investors are evaluating the value opportunities presented by Harmony Biosciences Holdings, Inc. (HRMY) and Liquidia Corporation (LQDA) in the Medical - Biomedical and Genetics sector [1] Group 1: Zacks Rank and Earnings Estimates - HRMY has a Zacks Rank of 2 (Buy), indicating a more favorable earnings estimate revision trend compared to LQDA, which has a Zacks Rank of 3 (Hold) [3] - The stronger earnings estimate revision activity for HRMY suggests an improving analyst outlook, making it a more attractive option for investors [3] Group 2: Valuation Metrics - HRMY has a forward P/E ratio of 10.09, significantly lower than LQDA's forward P/E of 37.43, indicating that HRMY may be undervalued [5] - The PEG ratio for HRMY is 0.39, while LQDA's PEG ratio is 1.03, suggesting that HRMY offers better value relative to its expected earnings growth [5] - HRMY's P/B ratio is 2.59, contrasting sharply with LQDA's P/B of 122.26, further highlighting HRMY's relative undervaluation [6] Group 3: Value Grades - HRMY has been assigned a Value grade of A, while LQDA has a Value grade of D, indicating that HRMY is viewed more favorably by value investors [6] - The combination of Zacks Rank and Style Scores indicates that HRMY is the better investment option compared to LQDA at this time [6]

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced its participation in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. Jeffrey M. Dayno, M.D., President and Chief Executive Officer, is scheduled to present at the conference on Tuesday, January 13, 2026, at 4:30 p.m. PT / 7:30 p.m. ET. A webcast of the presentation will be available on the investor page of Harmony's website at https://ir.harmonybiosciences.com/. About Ha. ...

Core Insights - Beacon Biosignals and Harmony Biosciences have announced a collaboration to integrate quantitative EEG measurements into Harmony's Phase 3 studies for HBS-301 targeting Narcolepsy and Idiopathic Hypersomnia [1][2] Group 1: Collaboration Details - The collaboration aims to enhance the assessment of excessive daytime sleepiness (EDS) by incorporating objective EEG data alongside traditional patient-reported outcomes like the Epworth Sleepiness Scale (ESS) [2] - Beacon's FDA 510(k)-cleared Waveband EEG headband will be utilized to capture at-home brain data over consecutive nights, providing continuous EEG data to assess daytime sleepiness [3] Group 2: Objectives and Benefits - The integration of objective sleep EEG data is expected to improve the precision and interpretability of treatment outcomes, potentially accelerating the development of better therapies for hypersomnia disorders [4] - The collaboration seeks to bring new levels of objectivity and reliability to clinical endpoints, enhancing the evaluation of treatment benefits for patients with hypersomnia disorders [4] Group 3: Clinical Context - Narcolepsy and Idiopathic Hypersomnia are characterized by severe excessive daytime sleepiness, with current trial measures relying heavily on subjective patient-reported scales, which may not fully capture the disease burden [4] - The addition of quantitative EEG-based endpoints allows for a more robust characterization of sleep patterns, aiding in the identification of EEG biomarkers for dose selection and efficacy assessment [4] Group 4: Company Profiles - Beacon Biosignals specializes in AI-driven neurophysiology and precision drug development, utilizing wearable EEG technology to capture and analyze neural data for advancements in neurology and sleep medicine [6] - Harmony Biosciences focuses on developing innovative therapies for rare neurological disorders, with a portfolio that includes FDA-approved treatments for narcolepsy and a pipeline targeting sleep/wake disorders and epilepsy [7]

"The ARGUS trial is one of the most advanced development programs in the 5-HT2 (serotonin) agonist class and the effectiveness, safety and tolerability data of EPX-100 dosed BID from the open-label extension study are very encouraging,†said Kumar Budur, MD, MS, Chief Medical and Scientific Officer at Harmony Biosciences. "These initial results support the advancement of our epilepsy franchise as we progress toward the topline data readout from the ARGUS trial in 2026.†EPX-100 is being evaluated as an inve ...

Harmony Biosciences FY Conference Summary Company Overview - **Company**: Harmony Biosciences (NasdaqGM:HRMY) - **Key Product**: WAKIX, a treatment for narcolepsy Industry Insights - **Market Size**: Approximately 80,000 diagnosed narcolepsy patients, with an additional 80,000 to 90,000 undiagnosed patients, indicating significant growth potential in the narcolepsy treatment market [10][10] - **Polypharmacy**: The narcolepsy market is characterized by high polypharmacy, with patients often on multiple therapies [8][8] Key Product Performance - **WAKIX Growth**: - Achieved a record increase of 500 patients in Q3, the highest since launch, following a steady growth pattern of adding 100 to 400 patients per quarter over the last six years [5][5] - Currently, 8,100 patients are on WAKIX therapy, indicating substantial room for growth in a market of 80,000 diagnosed patients [10][10] Competitive Landscape - **Oxybate Generics**: Anticipation of multiple Xyrem generics entering the market next year, which may lower costs for oxybate therapy but is expected to have limited impact on WAKIX due to its unique non-scheduled status [22][22] - **Orexin Agonists**: - Takeda's orexin agonist is expected to launch in late 2026, but the impact on WAKIX is anticipated to be small initially, with a gradual effect over time [28][28] - WAKIX is perceived as well-tolerated and effective, maintaining a strong position among healthcare providers [27][27] Future Developments - **Orexin Agonist Program**: Harmony has initiated a phase one PK/PD program for its own orexin agonist, with plans to accelerate to phase two and three based on initial data [30][30] - **Next-Gen Pitolisant**: - A gastro-resistant formulation of Pitolisant (Pitolisant GR) is on track for NDA submission in early 2027, aiming to improve patient adherence and outcomes [41][41] - A high-dose formulation (Pitolisant HD) is also in development, with phase three trials for narcolepsy and idiopathic hypersomnia set to begin [44][44] Clinical Insights - **Fatigue Management**: Fatigue, a common issue in narcolepsy, will be a secondary outcome in clinical trials for both narcolepsy and idiopathic hypersomnia, aiming to differentiate the product further [45][45] - **Clemizole for Pediatric Epilepsies**: Harmony is in phase three trials for clemizole hydrochloride in Dravet and Lennox-Gastaut syndromes, with top-line data expected in late 2026 [50][50] Conclusion - Harmony Biosciences is positioned for growth in the narcolepsy market with WAKIX, while also exploring new opportunities with orexin agonists and next-generation formulations of Pitolisant. The company is actively addressing unmet medical needs in both narcolepsy and pediatric epilepsy markets.

Harmony Biosciences FY Conference Summary Company Overview - **Company**: Harmony Biosciences (NasdaqGM:HRMY) - **Industry**: Biotechnology, specifically focusing on treatments for narcolepsy and epilepsy Key Points and Arguments Business Performance and Growth - Harmony Biosciences has established a strong commercial foundation, particularly with its product Wakix, which targets narcolepsy and is projected to be a $1 billion-plus opportunity in this market [2][3] - The company is profitable and self-funding its activities, allowing for continued growth in both its pipeline and commercial portfolio [3][4] Wakix Franchise - Wakix has shown consistent performance with a steady increase in patient numbers, reporting an increase of 400 patients in Q2 and 500 patients in Q3, leading to an upward revision of revenue guidance from $820-$860 million to $845-$865 million for the year [6][7] - The product is differentiated as the only non-scheduled treatment for narcolepsy, which is well tolerated and has a unique mechanism of action [8][10] - The company plans to maintain its competitive edge through life cycle management strategies, including new formulations such as gastro-resistant (GR) and high-dose (HD) versions of pitolisant [10][11] Pipeline Developments - Harmony is advancing its pipeline with new formulations and additional assets, including orexin-2 agonists currently in phase one clinical trials and EPX-100 for epilepsy in phase three trials [3][4] - Upcoming data presentations at the American Epilepsy Society meeting are expected to provide new efficacy data for EPX-100 [3] Market Dynamics and Competitive Position - The narcolepsy market is characterized by a high discontinuation rate of 30%-50% for medications, but once patients are stabilized on Wakix, they tend to remain on therapy [17] - The company emphasizes that Wakix's unique profile will remain competitive despite the introduction of generics in the market [15][16] Future Strategies - The GR formulation aims to provide a faster therapeutic effect without the need for titration, while the HD formulation targets improved efficacy and new indications for fatigue in narcolepsy patients [11][19] - Harmony is also exploring business development opportunities to expand its commercial portfolio and pipeline further [34] Challenges and Considerations - The company is currently assessing the future of its Cannabidiol Gel (ZYN002) program following disappointing phase three results, with plans to provide updates after a thorough data review [31][32] - The transition from a single product focus to a multi-franchise business model requires careful organizational growth to ensure all programs receive adequate attention [33] Additional Important Insights - The company has a robust commercial engine and is looking to leverage its balance sheet to drive further value through business development [34] - The ongoing clinical trials and product developments are expected to enhance Harmony's position in the biotechnology sector, particularly in the treatment of sleep disorders and epilepsy [3][4]