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.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) is a commercial-stage pharmaceutical company committed to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Established in 2017 and headquartered in Plymouth Meeting, PA, Harmony focuses on rare and orphan diseases, particularly those involving the central nervous system.
Harmony's flagship product is WAKIX® (pitolisant). This molecule is specifically designed to increase histamine signaling in the brain by binding to H3 receptors. It is used for the treatment of excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy. WAKIX has been commercially available in the U.S. since Q4 2019 and continues to demonstrate strong market performance.
In recent developments, Harmony has initiated a global Phase 3 TEMPO study to evaluate pitolisant for treating EDS and behavioral symptoms in patients with Prader-Willi syndrome (PWS). The U.S. FDA granted Orphan Drug designation to pitolisant for this condition, further underscoring the potential of this therapy to address significant unmet medical needs.
The company's financial performance remains robust, with a 31% increase in net product revenue in Q4 2023 compared to the same period in 2022. Harmony’s strategic growth continues with key acquisitions, such as Epygenix Therapeutics, Inc., which expands its pipeline with promising treatments for rare forms of epilepsy like Dravet syndrome and Lennox-Gastaut syndrome.
Harmony recently announced the FDA's priority review for its supplemental New Drug Application (sNDA) for WAKIX for the treatment of EDS or cataplexy in pediatric patients aged six and older with narcolepsy. This decision highlights the pressing need for pediatric treatment options and demonstrates Harmony's commitment to broadening the clinical utility of its products.
Beyond narcolepsy, Harmony is exploring pitolisant's potential for other rare conditions, including Idiopathic Hypersomnia and Myotonic Dystrophy Type 1 (DM1). The company presented encouraging Phase 2 data showing pitolisant's efficacy in reducing EDS and fatigue in DM1 patients, paving the way for a pivotal Phase 3 study.
Harmony's collaborative efforts extend to partnerships with Bioprojet for the development of TPM-1116, an orexin-2 receptor agonist with potential applications in narcolepsy and other sleep/wake disorders. These initiatives align with the company's mission to deliver innovative treatments that improve the lives of patients living with rare neurological diseases.
For more information, please visit www.harmonybiosciences.com.
Harmony Biosciences Holdings reported a net revenue of $80.7 million for Q3 2021, marking a 77% increase compared to Q3 2020, driven by robust sales of WAKIX.
The average number of patients on WAKIX rose to approximately 3,500. Despite a GAAP net loss of $9.6 million due to a one-time charge, non-GAAP adjusted net income reached $30.4 million, or $0.51 per diluted share.
WAKIX's inclusion in the AASM updated clinical guidelines enhances its market position, as the company focuses on expanding clinical utility and acquiring new assets.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced it will release its third quarter 2021 financial results on November 9, 2021. A conference call will follow at 8:30 a.m. ET on the same day. To join, participants can dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international) using passcode 4387084. A replay will be available after the call and can be accessed until November 16, 2021. Harmony focuses on innovative therapies for rare neurological diseases and is committed to addressing unmet medical needs.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced its addition to the S&P SmallCap 600 Index, effective October 22, 2021. This milestone is seen as a recognition of the company's efforts in providing innovative therapies for rare neurological diseases. The index measures the performance of 600 small-cap U.S. companies, requiring a market cap between $850 million and $3.6 billion. CEO John C. Jacobs expressed confidence that this inclusion will enhance the company's visibility and awareness among stakeholders.
Harmony Biosciences Holdings, Inc. (HRMY) announced the winners of its Patients at the Heart and Progress at the Heart programs on the third annual World Narcolepsy Day. More than $180,000 was awarded to eight organizations supporting individuals with sleep disorders and rare diseases. The Patients at the Heart program, created in 2019, funds not-for-profits addressing challenges faced by those with excessive daytime sleepiness. The new Progress at the Heart program addresses disparities in the rare disease community.
Harmony Biosciences Holdings (Nasdaq: HRMY) announced an update from the American Academy of Sleep Medicine (AASM) that includes WAKIX® (pitolisant) as a recommended treatment for narcolepsy in adults. The updated clinical guideline published in the Journal of Clinical Sleep Medicine emphasizes WAKIX's efficacy in significantly improving excessive daytime sleepiness and cataplexy. WAKIX has been available in the U.S. since Q4 2019 and received both orphan drug and breakthrough therapy designations. This inclusion is expected to help healthcare professionals make informed treatment decisions.
Harmony Biosciences Holdings (Nasdaq: HRMY), a pharmaceutical company focused on rare neurological diseases, announced that President and CEO John C. Jacobs will engage in fireside chats and investor meetings at several upcoming virtual conferences. Key events include the Citi's 16th Annual BioPharma Virtual Conference on September 8-9, the 2021 Virtual Wells Fargo Healthcare Conference on September 10, and the 2021 Cantor Virtual Global Healthcare Conference on September 28. A live audio webcast of the fireside chat will be accessible on Harmony's investor page.
Harmony Biosciences reported a 94.2% increase in net revenue to $73.8 million for Q2 2021, up from $38 million in Q2 2020. Positive net income reached $14.1 million or $0.24 per diluted share, reversing a loss from the previous year. The company initiated a Phase 2 trial for myotonic dystrophy and acquired HBS-102, a potential first-in-class treatment for narcolepsy. Additionally, a strategic financing collaboration with Blackstone secured up to $330 million to support growth.
Harmony Biosciences (Nasdaq: HRMY) and Blackstone (NYSE: BX) announced a strategic financing collaboration worth up to $330 million. The deal includes $300 million in debt capital and a $30 million equity investment. The financing will enable Harmony to expand its portfolio focused on rare neurological diseases and reduce its annual interest expenses. The initial $200 million term loan proceeds will primarily be used to eliminate existing debt, significantly lowering Harmony's capital costs. This partnership aims to enhance the company's growth trajectory in the pharmaceutical sector.
On August 9, 2021, Harmony Biosciences (Nasdaq: HRMY) announced its acquisition of HBS-102, a potential first-in-class molecule for treating narcolepsy. The deal includes an upfront payment of $3.5 million, alongside potential milestone payments and royalties. HBS-102 targets melanin concentrating hormone (MCH) neurons, aiming to alleviate symptoms like cataplexy and REM sleep dysregulation. Harmony plans to submit an Investigational New Drug application to initiate a Phase 2 clinical trial. This acquisition marks Harmony's strategy to expand its product pipeline beyond its current offering, WAKIX®.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) will announce its second quarter 2021 financial results on August 10, 2021, at 8:00 a.m. ET. A conference call and webcast will follow at 8:30 a.m. ET. Investors can join the call by dialing (833) 614-1471 (domestic) or +1 (914) 987-7209 (international). A replay will be available within 24 hours, lasting until August 17, 2021. Harmony Biosciences focuses on developing therapies for rare neurological disorders and aims to address unmet medical needs.
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