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 reported strong financial results for 2024, with WAKIX® (pitolisant) generating $201.3 million in net revenue for Q4 and $714.7 million for the full year, representing 23% growth in its fifth year on the market. The company reiterated its 2025 WAKIX net revenue guidance of $820-$860 million, targeting a potential $1 billion+ opportunity in narcolepsy alone.
Harmony ended 2024 with $576 million in cash, cash equivalents and investments. The company highlighted several upcoming catalysts for 2025, including topline data from its Phase 3 trial with ZYN002 in Fragile X syndrome expected in Q3, and the initiation of Phase 3 trials for Pitolisant HD formulation in narcolepsy and idiopathic hypersomnia in Q4.
The company also strengthened its patent position with a favorable settlement of its first generic litigation, giving Novugen Pharma a license to sell its generic product beginning in January 2030 or earlier under certain circumstances. Harmony's pipeline has the potential to deliver over $3 billion in net revenue as it develops innovative treatments across sleep/wake, neurobehavioral, and rare epilepsy franchises.
Harmony Biosciences (NASDAQ: HRMY) received a Refusal to File (RTF) letter from the FDA for pitolisant in treating excessive daytime sleepiness in adult patients with idiopathic hypersomnia (IH). Despite this setback, the company maintains its 2025 net revenue guidance of $820-$860 million.
The company's long-term strategy focuses on Pitolisant HD, an enhanced higher-dose formulation with patent protection until 2044. Harmony plans to initiate a Phase 3 registrational trial of Pitolisant HD in IH in Q4 2025, targeting a PDUFA date in 2028.
While the Phase 3 INTUNE Study's primary outcome didn't reach statistical significance, open-label phase data showed patient improvements five times greater than clinically meaningful levels on the Epworth Sleepiness Scale. The majority of patients maintained normal wakefulness levels beyond one year in the long-term extension study.
Harmony Biosciences (Nasdaq: HRMY) has scheduled its fourth quarter and full year 2024 financial results announcement for February 25, 2025, before U.S. financial markets open. The company will host a conference call and webcast at 8:30 a.m. ET on the same day to discuss the results.
Participants can join the call by dialing 800-445-7795 (domestic) or 785-424-1699 (international) using passcode HRMYQ424. The company recommends joining the call at least 10 minutes early. Both live and replay versions of the webcast will be available on Harmony's investor relations website.
Harmony Biosciences (HRMY) reported preliminary Q4 2024 net revenue of $201 million and full-year revenue of $714 million for WAKIX, representing 23% growth in its fifth launch year. The company provided 2025 revenue guidance of $820-860 million.
The average number of WAKIX patients increased by 300 to approximately 7,100 in Q4 2024. The company outlined key catalysts for each quarter of 2025, including an FDA decision on pitolisant sNDA for Idiopathic Hypersomnia in Q1, BP1.15205 data presentation at SLEEP 2025 in Q2, ZYN002 Phase 3 topline data for Fragile X Syndrome in Q3, and initiation of Pitolisant-HD Phase 3 trial in Q4.
The company's pipeline is expected to include up to six Phase 3 clinical programs by year-end 2025, with potential to generate over $3 billion in net revenue and deliver at least one new product or indication approval annually through 2028.
Harmony Biosciences Holdings (Nasdaq: HRMY) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. Jeffrey M. Dayno, M.D., President and CEO, will present at the conference on January 15, 2025, at 11:15 a.m. PT / 2:15 p.m. ET. Investors and interested parties can access the fireside chat webcast through Harmony's investor relations website.
Harmony Biosciences (Nasdaq: HRMY) has announced its participation in the Oppenheimer Movers in Rare Disease Summit in New York. The company's management team will engage in a fireside chat scheduled for Thursday, December 12, 2024, at 9:00 a.m. ET. Interested parties can access a webcast of the discussion through the investor relations section of Harmony's website.
Harmony Biosciences Holdings (Nasdaq: HRMY) has announced its management team's participation in two upcoming investor conferences in December 2024. The company will attend Citi's 2024 Global Healthcare Conference in Miami on Tuesday, December 3, and the Piper Sandler 36th Annual Healthcare Conference in New York City on Wednesday, December 4, at 8:30 a.m. ET. A fireside chat at the Piper Sandler conference will be webcast and available for viewing on Harmony's investor relations website.
Harmony Biosciences Holdings (Nasdaq: HRMY) announced the pricing of a public offering of 8,000,000 shares of common stock by selling shareholders Marshman Fund Trust II and Valor IV Pharma Holdings at $31.00 per share. The selling shareholders granted the underwriter a 30-day option to purchase an additional 1,200,000 shares. The company will not receive any proceeds from the offering, which is expected to close on November 1, 2024. J.P. Morgan is acting as the sole book-running manager for the offering.
Harmony Biosciences Holdings (Nasdaq: HRMY) announced that selling shareholders Marshman Fund Trust II and Valor IV Pharma Holdings, are initiating a public offering of up to 8,000,000 shares of common stock. The selling shareholders will grant underwriters a 30-day option to purchase an additional 1,200,000 shares. J.P. Morgan is acting as the sole book-running manager. Harmony Biosciences will not receive any proceeds from this offering as it is not offering any shares directly.
Harmony Biosciences (HRMY) reported Q3 2024 net revenue of $186.0 million, marking a 16% growth from Q3 2023. The company surpassed $2 billion in cumulative net revenue since WAKIX's launch in 2019. GAAP net income reached $46.1 million ($0.79 per diluted share), compared to $38.5 million in Q3 2023. The average number of WAKIX patients increased by 250 to approximately 6,800. The company maintains its 2024 net product revenue guidance of $700-720 million. Harmony's pipeline development includes advancing programs in idiopathic hypersomnia, rare epilepsies, and neurobehavioral disorders.
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