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 (Nasdaq: HRMY) and Blackstone (NYSE: BX) announced a strategic financing collaboration worth up to $330 million. The deal includes $300 million in debt capital and a $30 million equity investment. The financing will enable Harmony to expand its portfolio focused on rare neurological diseases and reduce its annual interest expenses. The initial $200 million term loan proceeds will primarily be used to eliminate existing debt, significantly lowering Harmony's capital costs. This partnership aims to enhance the company's growth trajectory in the pharmaceutical sector.
On August 9, 2021, Harmony Biosciences (Nasdaq: HRMY) announced its acquisition of HBS-102, a potential first-in-class molecule for treating narcolepsy. The deal includes an upfront payment of $3.5 million, alongside potential milestone payments and royalties. HBS-102 targets melanin concentrating hormone (MCH) neurons, aiming to alleviate symptoms like cataplexy and REM sleep dysregulation. Harmony plans to submit an Investigational New Drug application to initiate a Phase 2 clinical trial. This acquisition marks Harmony's strategy to expand its product pipeline beyond its current offering, WAKIX®.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) will announce its second quarter 2021 financial results on August 10, 2021, at 8:00 a.m. ET. A conference call and webcast will follow at 8:30 a.m. ET. Investors can join the call by dialing (833) 614-1471 (domestic) or +1 (914) 987-7209 (international). A replay will be available within 24 hours, lasting until August 17, 2021. Harmony Biosciences focuses on developing therapies for rare neurological disorders and aims to address unmet medical needs.
Harmony Biosciences Holdings (Nasdaq: HRMY) announced the initiation of a Phase 2 clinical trial to evaluate the safety and efficacy of pitolisant for excessive daytime sleepiness (EDS) and non-muscular symptoms in adult patients with type 1 myotonic dystrophy (DM1). Approximately 135 patients will receive low-dose, high-dose, or placebo pitolisant in a randomized study. The trial aims to address significant unmet medical needs as there are currently no approved treatments for DM1. Topline results are expected in the second half of 2022.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced a new analysis of WAKIX® (pitolisant) presented at SLEEP 2021, emphasizing its clinical effectiveness for excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. The analysis revealed a number needed to treat (NNT) of 5 for EDS at week 8 in the HARMONY 1 trial and an NNT of 3 for EDS and cataplexy at week 7 in the HARMONY CTP trial. Harmony's Chief Medical Officer highlighted the importance of these findings for treating patients with narcolepsy.
On June 9, 2021, Harmony Biosciences (Nasdaq: HRMY) announced that applications for its Patients at the Heart Grant Program are now open. This competitive grant initiative aims to support organizations addressing the challenges faced by individuals with sleep disorders and rare diseases experiencing excessive daytime sleepiness (EDS). The program, launched in 2019, has previously funded innovative patient-centric initiatives. Applications are accepted until August 20, 2021, and recipients will be announced in September 2021. For more details, visit Harmony's website.
Harmony Biosciences (Nasdaq: HRMY) announced on June 7, 2021 that two post-hoc analyses of WAKIX® (pitolisant) will be presented at the 35th Annual Meeting of the Associated Professional Sleep Societies from June 10-13. The first analysis evaluates the number needed to treat (NNT) and effect size for WAKIX in treating cataplexy and excessive daytime sleepiness in narcolepsy patients. The second focuses on cataplexy frequency data. WAKIX, FDA-approved since Q4 2019, targets excessive sleepiness and cataplexy, with significant data available from June 9 to November 30.
Harmony Biosciences Holdings (Nasdaq: HRMY) announced participation in three upcoming investor conferences. President and CEO John Jacobs will host fireside chats at:
- Jefferies Healthcare Conference on June 2, 2021, at 2:30 PM ET
- Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021, at 3:50 PM ET
- Raymond James Human Health Innovation Conference on June 21, 2021, at 3:20 PM ET
Live webcasts will be available on Harmony's investor page. The company focuses on innovative therapies for rare neurological disorders.
Harmony Biosciences announced the appointment of John C. Jacobs as a member of the Life Sciences Pennsylvania's Board of Directors, effective May 6, 2021. Under his leadership, Harmony has focused on innovative therapies for rare neurological disorders. Jacobs brings almost three decades of experience in the pharmaceutical sector, enhancing his ability to support local patient communities and advance the life sciences industry in Pennsylvania. His appointment underscores Harmony’s commitment to leadership within the sector and aims to bolster the company’s influence and initiatives in the region.
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