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, Inc. (NASDAQ: HRMY) will report its third quarter 2022 financial results on November 1, 2022, before U.S. market opening. A conference call is scheduled for the same day at 8:30 a.m. ET to discuss the results. Investors can dial (800) 225-9448 domestically or +1 (203) 518-9708 internationally to participate. Harmony focuses on innovative therapies for rare neurological diseases, emphasizing the importance of empathy and innovation in their approach.
On September 22, 2022, Harmony Biosciences (NASDAQ: HRMY) announced its 2022 funding recipients for the Patients at the Heart and Progress at the Heart award programs on World Narcolepsy Day. Over the past four years, these programs have awarded a total of $380,000 to nonprofit organizations aimed at supporting people with rare neurological diseases. Recipients this year focus on enhancing community health literacy, creating peer support initiatives, and raising awareness for sleep disorders.
Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY), a pharmaceutical company dedicated to rare neurological diseases, will participate in upcoming investor conferences. These include the Wells Fargo Healthcare Conference on September 7, 2022, featuring a fireside chat at 2:35 p.m. ET and 1x1 meetings. Additionally, the Citi's 17th Annual BioPharma Conference will take place in Boston on the following day with similar 1x1 meetings. A webcast of the fireside chat will be available on Harmony's investor page.
Harmony Biosciences reported net revenue of $107.0 million for Q2 2022, up 45% from Q2 2021, driven by strong sales of WAKIX®. The average number of patients on WAKIX increased to approximately 4,300. The company also signed a new agreement with Bioprojet to develop therapeutics based on pitolisant, potentially expanding its product offerings. GAAP net income rose to $23.5 million ($0.39 per share), while total operating expenses increased by 45.4% to $55.0 million.
Harmony Biosciences Holdings, Inc. (HRMY) will release its second quarter 2022 financial results on August 2, 2022. Following the release, a conference call and live webcast will occur at 8:30 a.m. ET. Investors can join the call by dialing (800) 459-5346 for domestic or +1 (203) 518-9544 for international, referencing passcode HRMYQ222. The live and replayed webcast will be accessible on the company's investor page. Harmony focuses on developing therapies for rare neurological diseases.
Harmony Biosciences (HRMY) presented a post-hoc analysis at the SLEEP 2022 conference, demonstrating the clinical effectiveness of WAKIX® (pitolisant) for excessive daytime sleepiness (EDS) and cataplexy in adults with significant narcolepsy symptoms. The analysis pooled data from trials HARMONY 1 and CTP, showing a Cohen's d effect size for EDS of 0.80 and 1.31 for cataplexy. The number needed to treat (NNT) for EDS improvement was 3, while for cataplexy it was 2. This analysis reinforces WAKIX’s efficacy in treating patients with high symptoms of narcolepsy.
Harmony Biosciences reported net revenue of $85.3 million for Q1 2022, up 43% from Q1 2021, primarily due to strong sales of WAKIX. Cumulative revenue since WAKIX's launch surpassed $500 million. The company reported a GAAP net income of $21.5 million ($0.35 per share), compared to $7.4 million ($0.13 per share) last year. Operating expenses were $43 million, a 23.9% increase. A Phase 3 clinical trial for idiopathic hypersomnia was initiated, and Harmony maintains cash reserves of $224.5 million.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced the initiation of its Phase 3 INTUNE trial for pitolisant, aiming to assess its efficacy in treating idiopathic hypersomnia (IH), a rare neurological disorder. The trial will involve about 200 patients across 60-80 sites in the U.S., focusing on excessive daytime sleepiness (EDS) and other symptoms. With an estimated 30,000-40,000 patients diagnosed in the U.S., successful results could pave the way for regulatory approval of pitolisant for IH, expanding its therapeutic applications beyond narcolepsy.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that it will release its first quarter 2022 financial results on May 3, 2022. The company will also hold a conference call at 8:30 a.m. ET the same day to discuss these results. Interested participants can dial (866) 342-8591 (domestic) or +1 (203) 518-9713 (international) using the passcode HRMYQ122. This provides an opportunity for stakeholders to gain insights into Harmony's financial performance and strategic direction.
Harmony Biosciences is accepting applications for its second annual Progress at the Heart program, which provides funding to non-profit organizations addressing disparities in rare neurological diseases and sleep disorders. The program aims to improve care for underrepresented groups by supporting community programs, education initiatives, and public health policy changes. Applications are open from April 7 to May 20 and May 31 to August 19. Award notifications are expected in July and October 2022.
FAQ
What is the current stock price of Harmony Biosciences Holdings (HRMY)?
What is the market cap of Harmony Biosciences Holdings (HRMY)?
What is Harmony Biosciences' main product?
What recent studies has Harmony Biosciences initiated?
What significant acquisitions has Harmony Biosciences made?
What recent FDA approvals or reviews has Harmony Biosciences received?
What conditions is Harmony Biosciences exploring with pitolisant?
Where is Harmony Biosciences headquartered?
What are some key financial highlights for Harmony Biosciences?
What partnerships is Harmony Biosciences involved in?
How can I get more information about Harmony Biosciences?
What is the mission of Harmony Biosciences?
