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) is a commercial-stage pharmaceutical company committed to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Established in 2017 and headquartered in Plymouth Meeting, PA, Harmony focuses on rare and orphan diseases, particularly those involving the central nervous system.
Harmony's flagship product is WAKIX® (pitolisant). This molecule is specifically designed to increase histamine signaling in the brain by binding to H3 receptors. It is used for the treatment of excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy. WAKIX has been commercially available in the U.S. since Q4 2019 and continues to demonstrate strong market performance.
In recent developments, Harmony has initiated a global Phase 3 TEMPO study to evaluate pitolisant for treating EDS and behavioral symptoms in patients with Prader-Willi syndrome (PWS). The U.S. FDA granted Orphan Drug designation to pitolisant for this condition, further underscoring the potential of this therapy to address significant unmet medical needs.
The company's financial performance remains robust, with a 31% increase in net product revenue in Q4 2023 compared to the same period in 2022. Harmony’s strategic growth continues with key acquisitions, such as Epygenix Therapeutics, Inc., which expands its pipeline with promising treatments for rare forms of epilepsy like Dravet syndrome and Lennox-Gastaut syndrome.
Harmony recently announced the FDA's priority review for its supplemental New Drug Application (sNDA) for WAKIX for the treatment of EDS or cataplexy in pediatric patients aged six and older with narcolepsy. This decision highlights the pressing need for pediatric treatment options and demonstrates Harmony's commitment to broadening the clinical utility of its products.
Beyond narcolepsy, Harmony is exploring pitolisant's potential for other rare conditions, including Idiopathic Hypersomnia and Myotonic Dystrophy Type 1 (DM1). The company presented encouraging Phase 2 data showing pitolisant's efficacy in reducing EDS and fatigue in DM1 patients, paving the way for a pivotal Phase 3 study.
Harmony's collaborative efforts extend to partnerships with Bioprojet for the development of TPM-1116, an orexin-2 receptor agonist with potential applications in narcolepsy and other sleep/wake disorders. These initiatives align with the company's mission to deliver innovative treatments that improve the lives of patients living with rare neurological diseases.
For more information, please visit www.harmonybiosciences.com.
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.
Harmony Biosciences Holdings, based in Plymouth Meeting, PA, announced a company update presentation at the Oppenheimer Rare and Orphan Disease Summit on May 21, 2021. President and CEO John C. Jacobs and Chief Medical Officer Dr. Jeffrey Dayno will host investor meetings during the event. The presentation will be accessible via a webcast on Harmony's investor page. The company focuses on developing therapies for rare neurological disorders with unmet medical needs.
Harmony Biosciences (HRMY) reported a strong start to 2021, achieving a net product revenue of $59.7 million for Q1, compared to $19.8 million in Q1 2020. This marks profitability with a net income of $7.4 million, a significant turnaround from a net loss of $38.6 million last year. The growth is attributed to increased demand for WAKIX, now approved for both excessive daytime sleepiness and cataplexy in narcolepsy. Cash reserves stand at $141.2 million and clinical trials for other indications are ongoing, positioning the company for future development.
Harmony Biosciences (Nasdaq: HRMY) announced that data from its WAKIX® (pitolisant) clinical development program will be presented at the 2021 American Psychiatric Association Annual Meeting from May 1-3. WAKIX is approved for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy. Presentations will cover the efficacy and safety of WAKIX in narcolepsy patients, including data from pivotal clinical trials. Harmony aims to enhance understanding of narcolepsy's impact on mental health, as noted by Chief Medical Officer Jeffrey Dayno.
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