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Harmony Biosciences Holdings, Inc. - HRMY STOCK NEWS

Welcome to our dedicated page for Harmony Biosciences Holdings news (Ticker: HRMY), a resource for investors and traders seeking the latest updates and insights on Harmony Biosciences Holdings stock.

Company Overview

Harmony Biosciences Holdings, Inc. is a commercial-stage pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological and central nervous system (CNS) disorders. The company is driven by a mission to address unmet medical needs in areas such as sleep disorders, rare epilepsies, and neurobehavioral conditions, harnessing cutting-edge science and novel mechanisms of action.

Core Technology and Therapeutic Focus

The company’s portfolio is anchored by its flagship product, WAKIX (pitolisant), a first-in-class medication designed to modulate histamine signaling in the brain through selective H3 receptor antagonism/inverse agonism. This unique mode of action increases histamine synthesis and release, which in turn promotes wakefulness. WAKIX is approved for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, including recent approvals expanding its use into pediatric populations. Industry keywords such as "rare neurological diseases", "novel treatment options", and "CNS disorders" are integral to understanding its critical role in modern therapeutics.

Pipeline and Strategic Initiatives

Beyond WAKIX, Harmony Biosciences has developed a diversified pipeline driven by a combination of internal research and strategic collaborations. The company has advanced several drug candidates aimed at further addressing sleep/wake imbalances and rare neurological disorders. Notable candidates include an innovative oral orexin-2 receptor agonist currently under license, which targets sleep/wake disorders through a different pathway compared to WAKIX, as well as other CNS assets such as investigational therapies in rare epilepsy and neurobehavioral disorders. Recent acquisitions have broadened the company’s reach, integrating complementary technologies and expertise to strengthen its position in treating conditions like Dravet syndrome and Lennox-Gastaut syndrome.

Innovation and Market Position

Harmony Biosciences stands out due to its commitment to therapeutic innovation and leveraging novel pharmacological approaches. Its strategic use of licensing relationships and acquisitions bolsters its late-stage pipeline, positioning the company to deliver a continuous stream of new treatment options. The company’s success is rooted in its scientific expertise, demonstrated by its ability to transform complex biological insights into effective therapies, and its robust clinical programs, which are designed to meet the challenges of patient populations that have historically had few or no treatment options. This multi-faceted approach not only underscores the company’s commitment to patient care but also highlights its competitive differentiation in a niche yet impactful sector of the pharmaceutical industry.

Operational Strategy and Commitment to Patients

At the heart of Harmony Biosciences is a deep-seated commitment to patients and healthcare professionals. The company emphasizes transparency, ongoing clinical research, and a patient-centric development model. By combining advanced drug discovery methodologies with a clear understanding of unmet medical needs, Harmony Biosciences continuously refines its therapeutic strategies, ensuring that each step in development is underpinned by rigorous scientific evaluation and regulatory adherence.

Industry Terminology and Competitive Insights

Utilizing technical terms such as "H3 receptor antagonism", "orexin receptor agonism", and "phenotype-based drug screening", Harmony Biosciences demonstrates a high level of expertise that resonates with both clinical researchers and investment analysts. The company’s competitive advantage is further enhanced by its self-funding business model and strong internal synergies across its diverse pipeline. This positions the firm distinctively within the biotech landscape focused on rare and orphan diseases.

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Harmony Biosciences Holdings, Inc. (HRMY) to participate in fireside chat at Needham Virtual Healthcare Conference. Webcast available on Harmony's investor page.
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Harmony Biosciences Holdings, Inc. (HRMY) announced its participation in upcoming investor conferences like Leerink Partners Global Biopharma Conference and Barclays Global Healthcare Conference. The management team will engage in fireside chats on March 11 and 12, 2024, respectively.
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Harmony Biosciences Holdings, Inc. reports net revenue growth of over 30% for the fourth quarter and full year 2023, with WAKIX® generating $168.4 million and $582.0 million, respectively. The FDA granted priority review for WAKIX in pediatric narcolepsy, with a PDUFA date of June 21, 2024. Harmony also received Orphan Drug Designation for pitolisant to treat Prader-Willi Syndrome.
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Harmony Biosciences Holdings, Inc. receives FDA priority review for WAKIX® tablets for pediatric narcolepsy treatment, with a PDUFA date set for June 21, 2024. The FDA's decision accelerates the approval process for a new treatment option, highlighting the urgent need for innovative therapies in pediatric narcolepsy.
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Harmony Biosciences Receives FDA Orphan Drug Designation for Pitolisant in Prader-Willi Syndrome Treatment
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Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) will report fourth quarter and full year 2023 financial results on February 22, 2024. A conference call and live webcast will be hosted to discuss the results. The call details and webcast link are available on the investor page of the company's website.
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Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) reported preliminary net revenue of ~$168 million for the fourth quarter and ~$582 million for the full year 2023, representing growth of ~31% and ~33%, respectively. The average number of patients on WAKIX increased to ~6,150, with 2024 net product revenue projected between $700 -$720 million. The company also announced a $50 million common stock repurchase in the fourth quarter, bringing the 2023 total to $100 million, with plans to continue opportunistic share repurchases in 2024.
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Harmony Biosciences Holdings, Inc. (HRMY) to Present at 42nd Annual J.P. Morgan Healthcare Conference
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Harmony Biosciences Holdings, Inc. (HRMY) announces positive topline results from Phase 2 study evaluating pitolisant in adult patients with myotonic dystrophy type 1 (DM1), demonstrating clinically meaningful improvements in excessive daytime sleepiness and fatigue. The study also showed a clear and consistent dose-response with no new safety signals detected.
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Harmony Biosciences Holdings, Inc. (HRMY) to present caregiver-reported impacts of 22q11.2 deletion syndrome and data from the Phase 2 INSPIRE trial at the American College of Neuropsychopharmacology Annual Meeting. The company aims to develop innovative therapies for rare neurological diseases, including 22q, with ZYN002 as a potential treatment for anxiety and irritable behavioral symptoms.
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FAQ

What is the current stock price of Harmony Biosciences Holdings (HRMY)?

The current stock price of Harmony Biosciences Holdings (HRMY) is $28.46 as of April 18, 2025.

What is the market cap of Harmony Biosciences Holdings (HRMY)?

The market cap of Harmony Biosciences Holdings (HRMY) is approximately 1.7B.

What is the primary focus of Harmony Biosciences Holdings, Inc.?

The company is focused on developing and commercializing innovative therapies for rare neurological and CNS disorders, including sleep disorders such as narcolepsy.

What is WAKIX and what does it treat?

WAKIX (pitolisant) is a first-in-class medication that functions as a selective H3 receptor antagonist/inverse agonist. It is used for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.

How does the company generate revenue?

Revenue is generated through the commercialization of its approved therapies, strategic licensing agreements, and by advancing a robust pipeline of investigational drug candidates designed to meet significant unmet medical needs.

What makes Harmony Biosciences' approach unique?

The company differentiates itself by leveraging novel mechanisms of action, such as histamine receptor modulation and orexin receptor agonism, and by integrating strategic acquisitions to expand its pipeline into rare epilepsies and neurobehavioral disorders.

How does Harmony Biosciences support its patient-centric model?

The company is committed to ensuring that patients are at the center of its research and commercialization efforts, providing detailed clinical data, transparent information, and robust patient outreach to address unmet needs in rare diseases.

What role do strategic acquisitions play in the company’s growth?

Strategic acquisitions have allowed Harmony Biosciences to diversify its pipeline, add novel therapeutic assets, and enhance its expertise in treating complex CNS disorders, thereby strengthening its competitive position.

How does Harmony Biosciences incorporate scientific expertise in its operations?

The company integrates advanced drug discovery techniques and employs precise pharmacological terminology, such as H3 receptor antagonism, demonstrating extensive industry expertise and a deep scientific understanding.

How does Harmony Biosciences maintain credibility in the biotech sector?

Through rigorous clinical research, transparent communication with healthcare professionals, and a strong track record of product development, Harmony Biosciences upholds high standards of expertise, experience, authoritativeness, and trustworthiness.
Harmony Biosciences Holdings, Inc.

Nasdaq:HRMY

HRMY Rankings

HRMY Stock Data

1.67B
43.57M
11.56%
97.69%
6.79%
Biotechnology
Pharmaceutical Preparations
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United States
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