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) 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.
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.
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