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 Holdings (HRMY) will report third quarter 2026 financial results on November 4, 2026, before U.S. financial markets open. The company will host a conference call and webcast that day at 8:30 a.m. ET to discuss the results. Live and replay webcasts will be available on its investor website.
Harmony Biosciences (HRMY) appointed Peter Anastasiou as president and chief executive officer, effective January 1, 2027, in a planned succession. Anastasiou, currently senior executive vice president and chief operating officer, will also join the board. Jeffrey M. Dayno will retire as president and CEO and leave the board on December 31, 2026. He will serve as a non-executive advisor throughout 2027.
Harmony reiterated 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion. The company remains on track to report BP-205 multiple ascending dose study data in Q4 2026 and does not currently expect changes to commercial and pipeline milestone timing. Its priorities remain growing the pitolisant franchise, advancing its central nervous system pipeline led by BP-205, deploying capital through asset transactions, and protecting WAKIX exclusivity.
Harmony Biosciences (Nasdaq: HRMY) will present a poster on its ongoing HBS-301 Phase 3 trials at European Narcolepsy Days on October 2–3, 2026. The meeting takes place in Bern, Switzerland, with poster presentations scheduled for October 2 at 16:30 and October 3 at 12:30, both CEST.
The poster covers ONSTRIDE-1 in adults with narcolepsy and ONSTRIDE-2 in adults with idiopathic hypersomnia. Both studies are randomized, double-blind and placebo-controlled. HBS-301 is an investigational formulation of enteric-coated pitolisant being developed to treat excessive daytime sleepiness and other symptoms.
Harmony Biosciences (HRMY) will present encore data on its investigational therapy EPX-100 (clemizole hydrochloride) at the 16th European Epilepsy Congress in Athens, Greece, held from September 5-9, 2026.
The company will share preliminary results from the open-label extension phase of the ARGUS study evaluating EPX-100 as adjunctive therapy in Dravet syndrome, and data from a drug-drug interaction study of EPX-100 with clinical probe substrates for selected CYP enzymes. Both posters (P0342 and P0331) are scheduled for September 6, from 2:00-3:00 pm EEST. EPX-100 is an orally administered liquid formulation in development for Dravet syndrome and Lennox-Gastaut syndrome, targeting central 5-hydroxytryptamine receptors to modulate serotonin signaling, and was identified using a phenotype-based zebrafish screening platform.
Harmony Biosciences (Nasdaq: HRMY) announced that its management team will participate in a fireside chat at the 2026 Cantor Global Healthcare Conference/b) in New York on . A live webcast will be accessible via the investor page of the Harmony Biosciences website.
The company focuses on developing and commercializing therapies for patients with rare neurological diseases and is headquartered in Plymouth Meeting, Pennsylvania.
Harmony Biosciences (Nasdaq: HRMY) announced that its management team will participate in a fireside chat at the Piper Sandler Virtual CNS Symposium on Thursday, August 13, 2026, at 1:30 p.m. ET. A live webcast will be accessible via the investor page of the Harmony Biosciences website.
Harmony Biosciences is a pharmaceutical company focused on developing and commercializing therapies for patients with rare neurological diseases with unmet medical needs, headquartered in Plymouth Meeting, Pennsylvania.
Harmony Biosciences (Nasdaq: HRMY) reported Q2 2026 WAKIX net product revenue of $261.3 million, up 30% year over year, with approximately 8,950 average patients, and reiterated 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion, according to the company.
Q2 2026 net income was $75.4 million, or $1.28 diluted EPS, versus $39.8 million, or $0.68, in Q2 2025. Cost of product sold rose to $63.2 million (24.2% of revenue), mainly from new Novitium-related royalties. Harmony ended June 30, 2026 with $962.5 million in cash, cash equivalents and investments.
The company shared Phase 1 single ascending dose data for BP-205 showing favorable pharmacokinetics, dose-proportional exposure and general tolerability, with no serious or severe treatment-emergent adverse events. The BP-205 IND is open in the US, with Phase 1b and Phase 2 studies planned from 2026–2027, and multiple pitolisant lifecycle and epilepsy programs progressing toward key 2027–2028 readouts and potential PDUFA decisions.
Harmony Biosciences (Nasdaq: HRMY) will report its second quarter 2026 financial results on Tuesday, August 4, 2026, before U.S. market open. The company will host a conference call and live webcast that day at 8:30 a.m. ET for investors and analysts.
Harmony Biosciences (Nasdaq: HRMY) preannounced preliminary, unaudited Q2 2026 net product revenue for WAKIX of approximately $261 million, a new quarterly record. This reflects 30% year-over-year growth and 21% sequential growth versus Q1, driven by continued demand and commercial execution.
Based on first-half performance and current trends, Harmony reaffirmed its full-year 2026 net product revenue guidance of $1.0 billion to $1.04 billion. The company also announced that CFO Glenn Reicin stepped down effective July 16, 2026, and appointed Stephen Mollichella, SVP and Controller, as Interim Principal Financial Officer. Harmony stated that the CFO transition does not stem from any disagreement on operations, policies, or practices and is not expected to affect performance or momentum. Full Q2 2026 results and a business update are scheduled for August 4, 2026.
Paragon Biosciences closed the sale of its portfolio company Emalex Biosciences to Teva Pharmaceutical, underscoring its model of advancing registration-ready central nervous system assets. Emalex developed ecopipam, an investigational Tourette syndrome treatment with NDA submission planned for the second half of 2026.
The deal includes $700 million in cash, up to $200 million in commercial milestone payments, and net-sales-based royalties, all subject to regulatory approval. Phase 3 data in Tourette syndrome showed reduced time to relapse versus placebo and maintained clinically meaningful tic improvement.