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 April 24, 2023, Harmony Biosciences (Nasdaq: HRMY) appointed Jeffrey M. Dayno, M.D., as President and Chief Executive Officer. Dr. Dayno, who has been with the company since its inception in 2017 and has served as Interim CEO since January 2023, aims to enhance the WAKIX franchise, targeting both narcolepsy and potential new indications. The Board supports his vision for growth, anticipating a $1 billion market opportunity for WAKIX. Harmony focuses on developing therapies for rare neurological diseases and has been successful in obtaining FDA approval for WAKIX, which has been available in the U.S. since Q4 2019. The company emphasizes its commitment to innovative treatments for patients, as highlighted by Dr. Dayno's extensive experience in the field.
Harmony Biosciences Holdings (NASDAQ: HRMY) announced that it will release its first quarter 2023 financial results on May 2, 2023, before the U.S. financial markets open. A conference call will be held on the same day at 8:30 a.m. ET to discuss the results. Investors can participate by dialing (800) 343-4136 for domestic calls or +1 (203) 518-9843 for international calls, referencing passcode HRMYQ123. The live and replayed webcast will be accessible on the company’s investor page.
Harmony Biosciences focuses on developing therapies for rare neurological diseases, emphasizing innovation and empathy. Established in 2017 and headquartered in Plymouth Meeting, PA, the company aims to improve the lives of patients suffering from these conditions.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced an accelerated timeline for its Phase 3 INTUNE study investigating pitolisant for idiopathic hypersomnia (IH). Enrollment is expected to conclude in Q2 2023, with topline data anticipated in Q4 2023. The study aims to assess pitolisant's safety and efficacy against placebo in approximately 200 IH patients across 60 clinical sites in the U.S. An interim analysis confirmed that the trial can proceed with its initial sample size. Harmony's WAKIX, a treatment for narcolepsy, shows promise in addressing the significant unmet needs of IH patients.
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.