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 (Nasdaq: HRMY) announced topline results from its Phase 2 proof-of-concept study assessing pitolisant for Prader-Willi syndrome (PWS), indicating improvements in excessive daytime sleepiness (EDS). The study, involving 65 patients, reported that patients treated with high-dose pitolisant demonstrated a clinically meaningful change in ESS-CHAD scores. Despite the positive signals, the adolescent group showed a high placebo response, limiting comparisons. Safety profiles were consistent with existing data, with 57% of patients on pitolisant reporting adverse events.
Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY) will report its third quarter 2022 financial results on November 1, 2022, before U.S. market opening. A conference call is scheduled for the same day at 8:30 a.m. ET to discuss the results. Investors can dial (800) 225-9448 domestically or +1 (203) 518-9708 internationally to participate. Harmony focuses on innovative therapies for rare neurological diseases, emphasizing the importance of empathy and innovation in their approach.
On September 22, 2022, Harmony Biosciences (NASDAQ: HRMY) announced its 2022 funding recipients for the Patients at the Heart and Progress at the Heart award programs on World Narcolepsy Day. Over the past four years, these programs have awarded a total of $380,000 to nonprofit organizations aimed at supporting people with rare neurological diseases. Recipients this year focus on enhancing community health literacy, creating peer support initiatives, and raising awareness for sleep disorders.
Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY), a pharmaceutical company dedicated to rare neurological diseases, will participate in upcoming investor conferences. These include the Wells Fargo Healthcare Conference on September 7, 2022, featuring a fireside chat at 2:35 p.m. ET and 1x1 meetings. Additionally, the Citi's 17th Annual BioPharma Conference will take place in Boston on the following day with similar 1x1 meetings. A webcast of the fireside chat will be available on Harmony's investor page.
Harmony Biosciences reported net revenue of $107.0 million for Q2 2022, up 45% from Q2 2021, driven by strong sales of WAKIX®. The average number of patients on WAKIX increased to approximately 4,300. The company also signed a new agreement with Bioprojet to develop therapeutics based on pitolisant, potentially expanding its product offerings. GAAP net income rose to $23.5 million ($0.39 per share), while total operating expenses increased by 45.4% to $55.0 million.
Harmony Biosciences Holdings, Inc. (HRMY) will release its second quarter 2022 financial results on August 2, 2022. Following the release, a conference call and live webcast will occur at 8:30 a.m. ET. Investors can join the call by dialing (800) 459-5346 for domestic or +1 (203) 518-9544 for international, referencing passcode HRMYQ222. The live and replayed webcast will be accessible on the company's investor page. Harmony focuses on developing therapies for rare neurological diseases.
Harmony Biosciences (HRMY) presented a post-hoc analysis at the SLEEP 2022 conference, demonstrating the clinical effectiveness of WAKIX® (pitolisant) for excessive daytime sleepiness (EDS) and cataplexy in adults with significant narcolepsy symptoms. The analysis pooled data from trials HARMONY 1 and CTP, showing a Cohen's d effect size for EDS of 0.80 and 1.31 for cataplexy. The number needed to treat (NNT) for EDS improvement was 3, while for cataplexy it was 2. This analysis reinforces WAKIX’s efficacy in treating patients with high symptoms of narcolepsy.
Harmony Biosciences reported net revenue of $85.3 million for Q1 2022, up 43% from Q1 2021, primarily due to strong sales of WAKIX. Cumulative revenue since WAKIX's launch surpassed $500 million. The company reported a GAAP net income of $21.5 million ($0.35 per share), compared to $7.4 million ($0.13 per share) last year. Operating expenses were $43 million, a 23.9% increase. A Phase 3 clinical trial for idiopathic hypersomnia was initiated, and Harmony maintains cash reserves of $224.5 million.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced the initiation of its Phase 3 INTUNE trial for pitolisant, aiming to assess its efficacy in treating idiopathic hypersomnia (IH), a rare neurological disorder. The trial will involve about 200 patients across 60-80 sites in the U.S., focusing on excessive daytime sleepiness (EDS) and other symptoms. With an estimated 30,000-40,000 patients diagnosed in the U.S., successful results could pave the way for regulatory approval of pitolisant for IH, expanding its therapeutic applications beyond narcolepsy.
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that it will release its first quarter 2022 financial results on May 3, 2022. The company will also hold a conference call at 8:30 a.m. ET the same day to discuss these results. Interested participants can dial (866) 342-8591 (domestic) or +1 (203) 518-9713 (international) using the passcode HRMYQ122. This provides an opportunity for stakeholders to gain insights into Harmony's financial performance and strategic direction.
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