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.
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.
Harmony Biosciences Holdings, based in Plymouth Meeting, PA, will present a company update at the 21st Annual Needham Virtual Healthcare Conference on April 11, 2022. CEO John C. Jacobs will lead a fireside chat from 12:45 p.m. to 1:25 p.m. ET and participate in 1x1 meetings on the same day. Investors can access a webcast of the chat on Harmony's investor page. Harmony focuses on innovative therapies for rare neurological diseases, aiming to address unmet medical needs.
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