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 (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.
On June 25, 2024, Harmony Biosciences announced that the FDA denied a Citizen Petition filed by a short seller, which challenged the safety and efficacy of WAKIX (pitolisant) for treating excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. The FDA confirmed WAKIX's favorable benefit-risk profile, rejecting the petition's requests, including the drug's withdrawal and transition to a Compassionate Use Program. Furthermore, the FDA had recently approved a supplemental New Drug Application (sNDA) for WAKIX, extending its use to pediatric patients aged 6 and older with narcolepsy. Harmony Biosciences plans to launch at least one new product or indication annually over the next five years and aims to extend the pitolisant franchise beyond 2040 with next-generation formulations.
Harmony Biosciences (Nasdaq: HRMY) has received FDA approval for its drug WAKIX® (pitolisant) to treat excessive daytime sleepiness (EDS) in pediatric patients aged 6 years and older with narcolepsy. This approval follows a Phase 3 study by Bioprojet, which also led to European Medicines Agency approval for the same use last year. While WAKIX will now be available for pediatric EDS, FDA has issued a complete response for its use in treating cataplexy in this age group. WAKIX, first approved in 2019 for adult narcolepsy, is the only FDA-approved non-scheduled treatment for this condition. The company plans to discuss further pathways for cataplexy treatment in pediatric patients with the FDA.
Harmony Biosciences (Nasdaq: HRMY) has reported positive data from its Phase 2 study on pitolisant for treating excessive daytime sleepiness (EDS) and fatigue in myotonic dystrophy type 1 (DM1) patients. The study showed significant improvement in EDS and fatigue symptoms with higher doses of pitolisant compared to placebo. The results encourage further development of pitolisant using the Next-Generation 2 (NG2) formulation for a pivotal Phase 3 study. The study included a randomized, double-blind, placebo-controlled design with a total of 25 participants. Both primary and secondary efficacy endpoints indicated greater mean improvements for pitolisant over placebo, and adverse event rates were similar across groups. Pitolisant, marketed as WAKIX® in the U.S., is currently FDA approved for narcolepsy-related EDS and cataplexy but remains investigational for DM1.
Harmony Biosciences announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference.
The event will take place on June 10, 2024, in Miami Beach, FL.
The management team will engage in a fireside chat at 9:20 a.m. ET.
Investors can access a webcast of the session on Harmony's investor relations page.
Harmony Biosciences Holdings, Inc. reported strong first-quarter financial results with a net revenue growth of 30% year-over-year. The company is accelerating its growth strategy by extending the revenue potential of its Pitolisant franchise beyond 2040. They are strengthening their sleep/wake leadership with new drug applications for Pitolisant in Idiopathic Hypersomnia, pediatric exclusivity, and positive pharmacokinetic data on next-generation formulations. Harmony is also diversifying into rare epilepsy through an acquisition, reiterating 2024 net product revenue guidance of $700 - $720 million. The company expects to launch new products or indications annually over the next five years, with multi-billion-dollar revenue potential extending beyond 2040.
Harmony Biosciences acquired Epygenix Therapeutics, Inc., adding a rare epilepsy franchise to its CNS pipeline. The lead candidate, EPX-100, is in a pivotal trial for Dravet Syndrome with topline data expected in 2026. EPX-100 holds Orphan Drug and Rare Pediatric Disease designations. Harmony paid $35 million in cash with potential payments up to $130 million based on milestones.
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