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) generates a steady flow of news centered on its commercial performance with WAKIX (pitolisant) and the advancement of a late-stage CNS pipeline. Recent press releases highlight preliminary and reported net product revenue for WAKIX, multi-year revenue growth, and guidance updates that frame the company’s evolution as a profitable, self-funding biotech focused on rare neurological diseases.
Investors following HRMY news can track updates on WAKIX in narcolepsy, including disclosures about average treated patient numbers, franchise growth and efforts to extend the pitolisant lifecycle through next-generation formulations such as pitolisant gastro-resistant (GR) and pitolisant high dose (HD). News items also cover clinical and regulatory milestones, such as pivotal bioequivalence results for pitolisant GR, Phase 3 trial plans and timelines, and the role of these formulations in potentially expanding indications and supporting additional exclusivity.
Harmony Biosciences’ news flow also features developments in its broader pipeline. This includes initiation and progress of the Phase 1 trial for BP1.15205, an investigational orexin-2 receptor agonist for central disorders of hypersomnolence, and Phase 3 ARGUS and LIGHTHOUSE trials evaluating EPX-100 (clemizole hydrochloride) in Dravet syndrome and Lennox–Gastaut syndrome. The company reports open-label extension data suggesting clinically meaningful seizure reductions and favorable tolerability for EPX-100, as well as program status for EPX-200 and ZYN002, including the outcome of the RECONNECT study in Fragile X syndrome.
Additional HRMY news includes participation in major healthcare and investor conferences, such as the J.P. Morgan Healthcare Conference and other sector events, where Harmony’s management presents commercial results, pipeline updates and strategic priorities. For investors, analysts and observers of rare neurological disease therapeutics, the HRMY news page offers a centralized view of earnings announcements, guidance changes, clinical trial readouts and portfolio decisions that shape the company’s trajectory.
Harmony Biosciences (Nasdaq: HRMY), a pharmaceutical company focused on rare neurological diseases, has been recognized as a Great Place to Work for the fourth consecutive year, reflecting positive employee feedback on workplace culture. This recognition is based on employee surveys evaluating management, innovation, communication, and diversity. CEO John C. Jacobs emphasized that this accolade highlights the company's commitment to fostering teamwork and a fulfilling work experience, which ultimately enhances their mission to improve the lives of patients.
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.
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