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) 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.
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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.
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