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 (Nasdaq: HRMY) announced participation in two upcoming virtual investor conferences. CEO John C. Jacobs will engage in fireside chats and host investor meetings at the Jefferies London Healthcare Conference on November 18-19 and the Piper Sandler 33rd Annual Virtual Healthcare Conference on November 22 and 30. The fireside chat audio will be available on-demand on Harmony's investor website. Harmony focuses on innovative therapies for rare neurological diseases and aims to address unmet medical needs.
Harmony Biosciences Holdings reported a net revenue of $80.7 million for Q3 2021, marking a 77% increase compared to Q3 2020, driven by robust sales of WAKIX.
The average number of patients on WAKIX rose to approximately 3,500. Despite a GAAP net loss of $9.6 million due to a one-time charge, non-GAAP adjusted net income reached $30.4 million, or $0.51 per diluted share.
WAKIX's inclusion in the AASM updated clinical guidelines enhances its market position, as the company focuses on expanding clinical utility and acquiring new assets.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced it will release its third quarter 2021 financial results on November 9, 2021. A conference call will follow at 8:30 a.m. ET on the same day. To join, participants can dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international) using passcode 4387084. A replay will be available after the call and can be accessed until November 16, 2021. Harmony focuses on innovative therapies for rare neurological diseases and is committed to addressing unmet medical needs.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced its addition to the S&P SmallCap 600 Index, effective October 22, 2021. This milestone is seen as a recognition of the company's efforts in providing innovative therapies for rare neurological diseases. The index measures the performance of 600 small-cap U.S. companies, requiring a market cap between $850 million and $3.6 billion. CEO John C. Jacobs expressed confidence that this inclusion will enhance the company's visibility and awareness among stakeholders.
Harmony Biosciences Holdings, Inc. (HRMY) announced the winners of its Patients at the Heart and Progress at the Heart programs on the third annual World Narcolepsy Day. More than $180,000 was awarded to eight organizations supporting individuals with sleep disorders and rare diseases. The Patients at the Heart program, created in 2019, funds not-for-profits addressing challenges faced by those with excessive daytime sleepiness. The new Progress at the Heart program addresses disparities in the rare disease community.
Harmony Biosciences Holdings (Nasdaq: HRMY) announced an update from the American Academy of Sleep Medicine (AASM) that includes WAKIX® (pitolisant) as a recommended treatment for narcolepsy in adults. The updated clinical guideline published in the Journal of Clinical Sleep Medicine emphasizes WAKIX's efficacy in significantly improving excessive daytime sleepiness and cataplexy. WAKIX has been available in the U.S. since Q4 2019 and received both orphan drug and breakthrough therapy designations. This inclusion is expected to help healthcare professionals make informed treatment decisions.
Harmony Biosciences Holdings (Nasdaq: HRMY), a pharmaceutical company focused on rare neurological diseases, announced that President and CEO John C. Jacobs will engage in fireside chats and investor meetings at several upcoming virtual conferences. Key events include the Citi's 16th Annual BioPharma Virtual Conference on September 8-9, the 2021 Virtual Wells Fargo Healthcare Conference on September 10, and the 2021 Cantor Virtual Global Healthcare Conference on September 28. A live audio webcast of the fireside chat will be accessible on Harmony's investor page.
Harmony Biosciences reported a 94.2% increase in net revenue to $73.8 million for Q2 2021, up from $38 million in Q2 2020. Positive net income reached $14.1 million or $0.24 per diluted share, reversing a loss from the previous year. The company initiated a Phase 2 trial for myotonic dystrophy and acquired HBS-102, a potential first-in-class treatment for narcolepsy. Additionally, a strategic financing collaboration with Blackstone secured up to $330 million to support growth.
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®.
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