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 announced the opening of applications for its Patients at the Heart Program on March 18, 2022, supporting nonprofit organizations addressing challenges faced by individuals with rare neurological diseases, particularly those experiencing excessive daytime sleepiness (EDS). Since its launch in 2019, the program has awarded over $230,000 to patient-centric initiatives. The 2022 application periods are March 18 to May 20 and May 31 to August 19. Harmony aims to enhance community support for patients and their families.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced its participation in two upcoming virtual conferences. The events include the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, featuring a fireside chat from 2:40 p.m. to 3:10 p.m. ET, and 1st Annual Needham Virtual Neuroscience Forum on March 16, 2022, with a fireside chat from 8:45 a.m. to 9:25 a.m. ET. A webcast of these events will be available on Harmony's investor page.
Harmony Biosciences (HRMY) reported Q4 2021 net revenue of $91.2 million, a 62% increase year-over-year, and full-year revenue of $305.4 million, up 91%. The company achieved its first full year of profitability with net income of $22.7 million in Q4. An average of 3,800 patients were on WAKIX, driving strong demand. The Phase 3 trial for Idiopathic Hypersomnia is set to begin in H1 2022. As of year-end 2021, cash reserves stood at approximately $234 million.
Harmony Biosciences (Nasdaq: HRMY) will announce its fourth quarter and full year 2021 financial results on February 28, 2022. A conference call will follow at 8:30 a.m. ET. Investors can participate by dialing (833) 614-1471 domestically or +1 (914) 987-7209 internationally, using passcode 7277008. A replay of the call will be available within 24 hours. Harmony Biosciences focuses on innovative treatments for rare neurological diseases. For more information, visit their website.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that President and CEO John C. Jacobs will present a company update at the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, at 7:30 AM ET. Investor meetings are scheduled from January 10 to January 13, 2022. A webcast of the presentation will be available on the investor page of Harmony's website. Harmony Biosciences focuses on innovative therapies for patients with rare neurological diseases. For more information, visit www.harmonybiosciences.com.
Harmony Biosciences, a pharmaceutical company focused on rare neurological diseases, will be added to the NASDAQ Biotechnology Index on December 20, 2021. This inclusion reflects the company's progress in 2021 and highlights its commitment to innovative treatments. The NASDAQ Biotechnology Index tracks the performance of biotechnology and pharmaceutical companies listed on NASDAQ. Harmony's CEO, John C. Jacobs, stated that this achievement will enhance visibility with investors. The company aims to continue its growth and innovation in the rare neurological disease space.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced the publication of a data analysis in CNS Drugs, focusing on the efficacy of pitolisant for treating excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients. The analysis, derived from two Phase 3 trials, indicates that the response to pitolisant generally begins within the first 2-3 weeks, with significant improvements noted in the Epworth Sleepiness Scale and weekly cataplexy rates. The study reinforces pitolisant's role as an effective treatment option for narcolepsy.
Harmony Biosciences (HRMY) announced that the FDA has accepted its IND application for pitolisant to treat idiopathic hypersomnia (IH). A Phase 3 clinical trial is planned for the first half of 2022, focusing on evaluating the drug's safety and efficacy in adults. This move aims to expand pitolisant's use beyond narcolepsy, potentially addressing the needs of 30,000 to 40,000 IH patients in the U.S. Harmony is responding to significant interest from the medical community and aims to provide new treatment options for this rare neurological disorder.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) has appointed Linda Szyper to its Board of Directors. With over 30 years of experience in healthcare and pharmaceuticals, Szyper previously served as Chief Operating Officer at McCann Health. On the board, she will be part of the Nominating and Corporate Governance Committees. Szyper expressed enthusiasm about aiding Harmony's mission to develop treatments for rare diseases. Jeff Aronin, Harmony's Chairman, highlighted her operational and commercialization expertise as crucial for the company's growth.
Harmony Biosciences (Nasdaq: HRMY) announced participation in two upcoming virtual investor conferences. CEO John C. Jacobs will engage in fireside chats and host investor meetings at the Jefferies London Healthcare Conference on November 18-19 and the Piper Sandler 33rd Annual Virtual Healthcare Conference on November 22 and 30. The fireside chat audio will be available on-demand on Harmony's investor website. Harmony focuses on innovative therapies for rare neurological diseases and aims to address unmet medical needs.
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