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 (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.
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.
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