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 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.
Harmony Biosciences is accepting applications for its second annual Progress at the Heart program, which provides funding to non-profit organizations addressing disparities in rare neurological diseases and sleep disorders. The program aims to improve care for underrepresented groups by supporting community programs, education initiatives, and public health policy changes. Applications are open from April 7 to May 20 and May 31 to August 19. Award notifications are expected in July and October 2022.
Harmony Biosciences Holdings, based in Plymouth Meeting, PA, will present a company update at the 21st Annual Needham Virtual Healthcare Conference on April 11, 2022. CEO John C. Jacobs will lead a fireside chat from 12:45 p.m. to 1:25 p.m. ET and participate in 1x1 meetings on the same day. Investors can access a webcast of the chat on Harmony's investor page. Harmony focuses on innovative therapies for rare neurological diseases, aiming to address unmet medical needs.
Harmony Biosciences (Nasdaq: HRMY), a pharmaceutical company focused on rare neurological diseases, has been recognized as a Great Place to Work for the fourth consecutive year, reflecting positive employee feedback on workplace culture. This recognition is based on employee surveys evaluating management, innovation, communication, and diversity. CEO John C. Jacobs emphasized that this accolade highlights the company's commitment to fostering teamwork and a fulfilling work experience, which ultimately enhances their mission to improve the lives of patients.
Harmony Biosciences announced the opening of applications for its Patients at the Heart Program on March 18, 2022, supporting nonprofit organizations addressing challenges faced by individuals with rare neurological diseases, particularly those experiencing excessive daytime sleepiness (EDS). Since its launch in 2019, the program has awarded over $230,000 to patient-centric initiatives. The 2022 application periods are March 18 to May 20 and May 31 to August 19. Harmony aims to enhance community support for patients and their families.