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 (Nasdaq: HRMY) will participate in several upcoming investor conferences. These events include the Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023, and the Needham Neuroscience Forum on March 15, 2023, both held virtually, along with the Jefferies Biotech on the Bay Summit in Miami, FL on March 17, 2023. The fireside chats will be available for webcast on Harmony's investor page. This participation highlights Harmony's commitment to advancing therapies for rare neurological diseases.
Harmony Biosciences (NASDAQ: HRMY) has reopened applications for its Patients at the Heart and Progress at the Heart funding programs on February 28, 2023, coinciding with Rare Disease Day. These programs aim to support nonprofit organizations focused on patient-centric initiatives for rare neurological diseases and sleep disorders. Since their launch, these initiatives have funded diverse projects, including educational programs and caregiver retreats, to address the unique challenges faced by patients. Both programs are designed to promote equality and effective messaging within these communities.
Harmony Biosciences Holdings (HRMY) reported a 41% increase in WAKIX net revenue for Q4 2022, totaling $128.3 million, and 43% growth for the full year at $437.9 million. The company achieved a GAAP net income of $181.5 million, with a significant tax benefit contributing to profits. Operating expenses grew, with R&D expenses rising 133.4% to $70.9 million. Ongoing clinical trials, including the Phase 3 IH study, show strong patient enrollment. The company aims to advance programs for Prader-Willi Syndrome and Myotonic Dystrophy, with upcoming clinical data expected in late 2023. Harmony reported cash reserves of $345.7 million as of year-end 2022.
Harmony Biosciences Holdings (NASDAQ: HRMY) has received the Great Place to Work® recognition for the fifth consecutive year, based on employee feedback that reflects the company's strong workplace culture. This certification highlights Harmony's commitment to creating an innovative and inclusive environment, as stated by Interim CEO Jeffrey M. Dayno, M.D. Additionally, Harmony was previously recognized as a 'Best Workplace in BioPharma' in 2022 and ranked 4th on Forbes' list of 'America's Best Mid-Sized Companies' in 2023. The company focuses on developing therapies for rare neurological diseases.
Harmony Biosciences (NASDAQ: HRMY) will announce its fourth quarter and full year 2022 financial results on February 21, 2023, before U.S. market opening. A conference call will follow at 8:30 a.m. ET for discussing the results. Investors can participate by calling (800) 225-9448 domestically or +1 (203) 518-9708 internationally, with recommended early dial-in. Harmony specializes in therapies for rare neurological diseases and was established in 2017. The company believes in innovative science translating to therapeutic possibilities for patients. Investors can access the live webcast on their investor page.
Harmony Biosciences announced the resignation of John C. Jacobs as President and CEO, effective immediately, to pursue another opportunity. Jeffrey M. Dayno, MD, previously Chief Medical Officer, has been appointed as interim CEO. Jeff Aronin, the founder, will transition to Executive Chairman, guiding the management team. Dayno expressed intention to continue executing the company's growth strategy focused on narcolepsy and expanding clinical utility. The Board remains confident in the company's strong underlying business and strategic direction.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that President and CEO John C. Jacobs will present at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 4:30 p.m. PT / 7:30 p.m. ET. The live audio webcast of the presentation will be available on the investor page of Harmony's website. Harmony focuses on developing innovative therapies for rare neurological diseases, emphasizing the importance of empathy and innovation in improving patient lives.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) will engage in a fireside chat and individual investor meetings at the Piper Sandler 34th Annual Healthcare Conference on November 30, 2022, at 9:00 am ET in New York, NY. A webcast of this chat will be accessible on Harmony's investor webpage. The company, based in Plymouth Meeting, PA, focuses on innovative therapies for rare neurological diseases, emphasizing patient-centric solutions since its establishment in 2017.
Harmony reported third-quarter 2022 net revenues of $117.2 million, a 45% increase from the previous year, driven by strong sales of WAKIX. The average number of patients on WAKIX rose to approximately 4,600. The company achieved a GAAP net income of $87.9 million, or $1.44 per diluted share, a significant turnaround from a net loss of $9.6 million in Q3 2021. R&D expenses surged by 245.4% to $40.5 million due to an initial licensing fee. Ongoing clinical trials show positive momentum, especially in Prader-Willi Syndrome and Idiopathic Hypersomnia.
Harmony Biosciences (Nasdaq: HRMY) announced topline results from its Phase 2 proof-of-concept study assessing pitolisant for Prader-Willi syndrome (PWS), indicating improvements in excessive daytime sleepiness (EDS). The study, involving 65 patients, reported that patients treated with high-dose pitolisant demonstrated a clinically meaningful change in ESS-CHAD scores. Despite the positive signals, the adolescent group showed a high placebo response, limiting comparisons. Safety profiles were consistent with existing data, with 57% of patients on pitolisant reporting adverse events.
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