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 Holdings, Inc. (Nasdaq: HRMY) published a white paper following its December 2020 Summit on Sleep Disruption, focusing on the challenges of excessive daytime sleepiness (EDS) in patients with rare neurological disorders. The summit gathered patients, caregivers, and advocacy leaders to discuss EDS's impact. Key findings highlight issues like increased anxiety, reduced cognitive abilities, and challenges in diagnosis and treatment. The company aims to raise awareness of EDS in rare diseases, with ongoing collaborations with advocacy groups to share insights.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced the publication of a post-hoc analysis of Phase 3 trials of pitolisant (WAKIX) in Sleep Medicine, focusing on patients with high narcolepsy symptom burdens. Results showed significant reductions in excessive daytime sleepiness (EDS) and cataplexy. For patients with high EDS, pitolisant achieved a mean change of –6.1 versus –2.3 for placebo. Moreover, 69% of patients responded positively. The treatment was well-tolerated, with common side effects including headache and nausea.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced the appointment of Sandip Kapadia as Chief Financial Officer, effective March 29, 2021. Kapadia brings over 25 years of healthcare finance experience, most recently serving as CFO at Intercept, where he raised over $700 million. He replaces Susan Drexler, who is stepping down for other opportunities. Harmony's leadership expressed confidence that Kapadia's expertise will drive long-term growth and enhance financial strategies.
Harmony Biosciences (Nasdaq: HRMY) announced it will release its fourth quarter and full year 2020 financial results on March 25, 2021 at 8:00 a.m. ET. A conference call will follow at 8:30 a.m. ET, providing insights into the company's performance in the past year. Investors can dial in or access the live webcast on their investor page. A replay will be available within 24 hours. This financial update is crucial for stakeholders tracking the company’s growth in the pharmaceutical sector focusing on rare neurological disorders.
Summary not available.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced its inclusion in the Russell 2000® and Russell 3000® Indexes, effective after market close on December 18, 2020. This milestone is expected to enhance the company’s visibility among investors and broaden its shareholder base. The Russell 3000® Index features the top 3,000 U.S. publicly traded companies, while the Russell 2000® Index focuses on the smallest-cap companies within this group.
Harmony Biosciences (HRMY) announced that the first patient has been enrolled in a Phase 2 trial assessing pitolisant for treating excessive daytime sleepiness (EDS) in patients with Prader-Willi Syndrome (PWS). This double-blind study will involve 60-70 patients across 10 U.S. sites, aiming for topline results in the first half of 2022. The trial's primary goal is to evaluate improvements in EDS, which affects over half of the 15,000 to 20,000 PWS patients in the U.S. The study represents a significant step in addressing unmet medical needs for this rare disorder.
Harmony Biosciences Holdings reported Q3 2020 net product revenue of $45.6 million, showing growth amid the COVID-19 pandemic. The approval of WAKIX for treating cataplexy in narcolepsy expands its commercial potential, as it remains the only FDA-approved treatment not classified as a controlled substance. The company is poised to initiate a Phase 2 trial for pitolisant in Prader-Willi Syndrome by year-end 2020. Cash and cash equivalents stood at $221.7 million, ensuring ongoing support for commercialization and clinical programs.
Harmony Biosciences has appointed Mark Graf and Eric Motley to its Board of Directors. Graf, a former CFO at Discover Financial Services, brings extensive financial expertise, having managed a $110 billion balance sheet. He was recognized by Institutional Investor as the top CFO in consumer financial services from 2014 to 2019. Motley, with 20 years in talent development, previously served at the White House and currently works with the Aspen Institute. Their appointments are expected to enhance the governance and strategic oversight of Harmony, focusing on innovative therapies for rare neurological disorders.
Harmony Biosciences (Nasdaq: HRMY) announced its third quarter financial results release scheduled for November 12, 2020, at 8:00 a.m. ET. A conference call will follow at 8:30 a.m. ET. Investors can join the call by calling (833) 614-1471 domestically or +1 (914) 987-7209 internationally, with a passcode of 7489154. The live and replayed webcast will be accessible on the company's investor page. Harmony focuses on developing therapies for rare neurological disorders.