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. (HRMY) delivers innovative therapies for rare neurological and central nervous system disorders, with a focus on sleep/wake conditions. This page provides authorized updates on clinical developments, regulatory milestones, and corporate announcements directly impacting the company serves.
Investors and healthcare professionals will find timely updates on WAKIX commercialization, pipeline advancements in rare epilepsies, and strategic collaborations. Content includes earnings reports, FDA filings, research publications, and partnership announcements—all verified through primary sources.
Key coverage areas include pediatric narcolepsy treatment expansions, orexin receptor agonist trials, and neurobehavioral disorder research. Bookmark this page for consolidated access to Harmony Biosciences' progress in transforming care for underserved patient populations through novel therapeutic mechanisms.
Harmony Biosciences Holdings, Inc. (HRMY) has launched the Progress at the Heart grant program aimed at addressing disparities in access to healthcare for patients with sleep disorders, especially within underrepresented communities. Announced on April 7, 2021, the initiative will allocate up to $125,000 in grants by September 2021, focusing on community- and education-based solutions. Two application rounds are open from April 7 to May 31 and June 1 to August 20. This program underscores Harmony's commitment to enhancing equality of care for rare disease and sleep disorder patients.
Harmony Biosciences (HRMY) announced total revenue of $160 million for 2020, with $56 million generated in Q4. The FDA expanded the approval of WAKIX for treating cataplexy in adults with narcolepsy. Harmony reported a net loss of $36.9 million for the year but achieved significant growth in net product revenue, increasing from $6 million in 2019. Cash reserves rose to $228.6 million compared to $24.5 million in the prior year. The company is advancing clinical trials, including a Phase 2 trial for Prader-Willi Syndrome.
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.
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.
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