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) is a commercial-stage pharmaceutical company committed to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Established in 2017 and headquartered in Plymouth Meeting, PA, Harmony focuses on rare and orphan diseases, particularly those involving the central nervous system.
Harmony's flagship product is WAKIX® (pitolisant). This molecule is specifically designed to increase histamine signaling in the brain by binding to H3 receptors. It is used for the treatment of excessive daytime sleepiness (EDS) and cataplexy in adult patients with narcolepsy. WAKIX has been commercially available in the U.S. since Q4 2019 and continues to demonstrate strong market performance.
In recent developments, Harmony has initiated a global Phase 3 TEMPO study to evaluate pitolisant for treating EDS and behavioral symptoms in patients with Prader-Willi syndrome (PWS). The U.S. FDA granted Orphan Drug designation to pitolisant for this condition, further underscoring the potential of this therapy to address significant unmet medical needs.
The company's financial performance remains robust, with a 31% increase in net product revenue in Q4 2023 compared to the same period in 2022. Harmony’s strategic growth continues with key acquisitions, such as Epygenix Therapeutics, Inc., which expands its pipeline with promising treatments for rare forms of epilepsy like Dravet syndrome and Lennox-Gastaut syndrome.
Harmony recently announced the FDA's priority review for its supplemental New Drug Application (sNDA) for WAKIX for the treatment of EDS or cataplexy in pediatric patients aged six and older with narcolepsy. This decision highlights the pressing need for pediatric treatment options and demonstrates Harmony's commitment to broadening the clinical utility of its products.
Beyond narcolepsy, Harmony is exploring pitolisant's potential for other rare conditions, including Idiopathic Hypersomnia and Myotonic Dystrophy Type 1 (DM1). The company presented encouraging Phase 2 data showing pitolisant's efficacy in reducing EDS and fatigue in DM1 patients, paving the way for a pivotal Phase 3 study.
Harmony's collaborative efforts extend to partnerships with Bioprojet for the development of TPM-1116, an orexin-2 receptor agonist with potential applications in narcolepsy and other sleep/wake disorders. These initiatives align with the company's mission to deliver innovative treatments that improve the lives of patients living with rare neurological diseases.
For more information, please visit www.harmonybiosciences.com.
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.
Harmony Biosciences Holdings (Nasdaq: HRMY) has announced it will report its third quarter 2024 financial results on Tuesday, October 29, 2024, before the 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.
To participate in the call, investors can dial (800) 245-3047 (domestic) or (203) 518-9765 (international) and use the passcode HRMYQ324. It is advised to dial in at least 10 minutes before the call starts. A live and replay webcast of the call will be available on the investor page of Harmony's website at https://ir.harmonybiosciences.com/.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) presented a comprehensive pipeline update at its Investor Day event, showcasing new data and program updates. Key highlights include:
1. Orexin-2 agonist program: BP1.15205 demonstrated greater potency compared to other orexin-2 agonists.
2. Pitolisant in Idiopathic Hypersomnia: Long-Term Extension study showed sustained efficacy.
3. Pitolisant-HD program: Preliminary data confirmed safety up to five times the highest labeled dose of WAKIX.
4. Fragile X syndrome program: Phase 3 RECONNECT study on track for topline data in mid-2025.
5. EPX-100 development program: Favorable risk/benefit profile for Dravet syndrome and Lennox-Gastaut syndrome.
Harmony aims to deliver one or more new product or indication launches each year over the next five years, potentially generating over $3 billion in annual revenue.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) will host its first Investor Day on October 1, 2024, at 8:30 a.m. ET in New York City. The event will showcase the company's robust, late-stage pipeline to investors and research analysts. Key highlights include:
- New data on pitolisant for idiopathic hypersomnia (IH)
- Updates on pitolisant-HD development program
- New data on BP1.15205, a potential best-in-class orexin-2 agonist
- Scientific rationale for ZYN002 and EPX100 in Phase 3 trials
- Market potential for late-stage pipeline assets
The company's portfolio now includes three orphan/rare CNS franchises, each with potential peak sales of $1B - $2B. Investors can attend in person or virtually by registering through Harmony's Investor Relations.
Harmony Biosciences Holdings (Nasdaq: HRMY) has announced its participation in two upcoming investor conferences. The company's management team will be present at:
1. The Wells Fargo 2024 Healthcare Conference in Boston, with a fireside chat scheduled for Thursday, September 5, 2024, at 9:30 a.m. ET.
2. The 2024 Cantor Global Healthcare Conference in New York City, featuring a fireside chat on Tuesday, September 17, 2024, at 3:05 p.m. ET.
Investors and interested parties can access webcasts of both fireside chats through the investor page of Harmony's website at https://ir.harmonybiosciences.com/.
Harmony Biosciences (HRMY) reported strong Q2 2024 financial results, with WAKIX® (pitolisant) net revenue of $172.8 million, representing 29% year-over-year growth. The company is advancing its pitolisant high-dose program with an expected PDUFA date in 2028, potentially extending the franchise beyond 2040. Key highlights include:
- WAKIX patent upheld by USPTO
- FDA approval for WAKIX in pediatric narcolepsy
- On track for sNDA submission for idiopathic hypersomnia in Q4 2024
- Average number of WAKIX patients increased to ~6,550
- Reiterates 2024 net product revenue guidance of $700-$720 million
The company reported GAAP net income of $11.6 million and non-GAAP adjusted net income of $60.6 million for Q2 2024.
Harmony Biosciences Holdings (Nasdaq: HRMY) has announced that it will release its second quarter 2024 financial results on Tuesday, August 6, 2024, before the 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. Interested parties can participate in the call by dialing (800) 225-9448 (domestic) or (203) 518-9708 (international) and using the passcode HRMYQ224. It is advised to dial in at least 10 minutes before the call starts. A live and replay webcast of the call will be available on the investor page of Harmony Biosciences' website.
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