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, a pharmaceutical company focused on rare neurological diseases, will be added to the NASDAQ Biotechnology Index on December 20, 2021. This inclusion reflects the company's progress in 2021 and highlights its commitment to innovative treatments. The NASDAQ Biotechnology Index tracks the performance of biotechnology and pharmaceutical companies listed on NASDAQ. Harmony's CEO, John C. Jacobs, stated that this achievement will enhance visibility with investors. The company aims to continue its growth and innovation in the rare neurological disease space.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced the publication of a data analysis in CNS Drugs, focusing on the efficacy of pitolisant for treating excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients. The analysis, derived from two Phase 3 trials, indicates that the response to pitolisant generally begins within the first 2-3 weeks, with significant improvements noted in the Epworth Sleepiness Scale and weekly cataplexy rates. The study reinforces pitolisant's role as an effective treatment option for narcolepsy.
Harmony Biosciences (HRMY) announced that the FDA has accepted its IND application for pitolisant to treat idiopathic hypersomnia (IH). A Phase 3 clinical trial is planned for the first half of 2022, focusing on evaluating the drug's safety and efficacy in adults. This move aims to expand pitolisant's use beyond narcolepsy, potentially addressing the needs of 30,000 to 40,000 IH patients in the U.S. Harmony is responding to significant interest from the medical community and aims to provide new treatment options for this rare neurological disorder.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) has appointed Linda Szyper to its Board of Directors. With over 30 years of experience in healthcare and pharmaceuticals, Szyper previously served as Chief Operating Officer at McCann Health. On the board, she will be part of the Nominating and Corporate Governance Committees. Szyper expressed enthusiasm about aiding Harmony's mission to develop treatments for rare diseases. Jeff Aronin, Harmony's Chairman, highlighted her operational and commercialization expertise as crucial for the company's growth.
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.