Harmony Biosciences Reports Record Q2 2026 Revenue, Shares Positive BP-205 Phase 1 Data

PLYMOUTH MEETING, Pa., August 4, 2026

BP-205 Demonstrates Promising Phase 1 Safety and Pharmacokinetic Profile

Harmony Biosciences announced that BP-205, an investigational once-daily orexin-2 receptor agonist, achieved favorable results in its Phase 1 SAD study involving healthy volunteers. The data showed a rapid time to maximum plasma concentration (Tmax) of 30–75 minutes, a mean half-life of approximately 25 hours, predictable dose-proportional exposure, and no meaningful differences in pharmacokinetics based on age or gender, supporting convenient once-daily dosing without dose adjustments. Importantly, BP-205 was generally well tolerated, with no serious or severe treatment-emergent adverse events, and no significant cardiovascular, hepatic, or visual safety concerns observed. The most common adverse events included headache, fatigue, and diarrhea, each occurring at relatively low frequencies. Harmony believes these findings, together with previously reported preclinical evidence showing the highest potency among orexin-2 agonists currently in clinical development, reinforce BP-205’s potential to become a best-in-class therapy. The company expects multiple ascending dose (MAD) data in the fourth quarter of 2026, plans to begin a Phase 1b study in sleep-deprived healthy volunteers during Q3 2026, and intends to launch Phase 2 clinical trials across multiple CNS indications in mid-2027.

WAKIX Franchise Continues Strong Commercial Growth While Pipeline Expands

The strong financial performance reflects continued demand for WAKIX, Harmony’s approved therapy for narcolepsy, which remains the company’s primary growth driver. The company expanded its commercial infrastructure during the quarter, including field sales, reimbursement support, and patient outreach teams, while introducing an enhanced online patient support platform to improve treatment access. Harmony also continues advancing several lifecycle management programs for the pitolisant franchise, including Pitolisant GR, whose New Drug Application (NDA) has been accepted by the U.S. FDA with a target PDUFA date of April 1, 2027, and Pitolisant HD, currently in Phase 3 registrational studies for narcolepsy and idiopathic hypersomnia with topline results anticipated in 2027. Additional development programs include a Phase 3 trial evaluating WAKIX in Prader-Willi syndrome, as well as exploration of amorphous pitolisant formulations designed to expand future CNS applications. Beyond sleep disorders, Harmony is advancing EPX-100 in two global Phase 3 studies for Lennox-Gastaut syndrome and Dravet syndrome, broadening its rare neurological disease pipeline.

Financial Strength Supports Long-Term Growth and CNS Innovation

Harmony Biosciences ended the second quarter with $962.5 million in cash, cash equivalents, and investments, providing substantial financial flexibility to support pipeline expansion and strategic business development. The company reported net income of $75.4 million, or $1.28 per diluted share, while maintaining disciplined operating expenses despite expanding clinical and commercial activities. Harmony continues to prioritize acquisition and licensing opportunities involving late-stage or commercial CNS therapies expected to generate revenue between 2028 and 2032, while protecting its growing pitolisant intellectual property portfolio through formulation patents extending into the 2040s. With record commercial performance, an expanding late-stage pipeline, and positive early clinical evidence supporting BP-205’s potential as a differentiated orexin-2 agonist, Harmony Biosciences is positioning itself for sustained long-term growth across sleep disorders, epilepsy, rare neurological diseases, and broader CNS indications.

Source:Harmony Biosciences press release