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. develops and commercializes therapies for rare neurological diseases, with WAKIX® (pitolisant) as its commercial product for adult narcolepsy-associated cataplexy. News about HRMY centers on WAKIX revenue trends, market access and payer dynamics, intellectual-property protection, and product guidance.
Company updates also cover clinical and regulatory progress across its CNS pipeline, including pitolisant lifecycle programs and candidates such as EPX-100 for Dravet syndrome and Lennox-Gastaut syndrome. Recurring announcements include quarterly results, investor-conference presentations, executive and board changes, and pipeline data presentations at medical meetings.
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.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
Summary not available.