Harmony Biosciences Q2 revenue up 16% YoY to $200.5mln.

• Harmony Biosciences Q2 2025 revenue: $200.5M (+16% YoY) • Wakix franchise grows with 7,600 average patients • Phase 3 RECONNECT study in Fragile X Syndrome on track • First-in-human trial for BP1.15205 in 2H 2025 • Next-gen pitolisant HD trials in Q4 2025 • Idiopathic Hypersomnia and Narcolepsy targeted indications.

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) has reported robust financial results for the second quarter of 2025, showcasing a 16% year-over-year (YoY) growth in revenue. The company's net product revenue reached $200.5 million, a significant increase from the $172.8 million reported in the same period last year [1].

The growth was primarily driven by the strong performance of the WAKIX® franchise, which saw an increase in the number of average patients to 7,600 from 7,200 in the previous quarter. This growth reflects the continued organic demand within the large narcolepsy market opportunity, which has approximately 80,000 diagnosed patients in the U.S. [1].

Harmony Biosciences is also making significant strides in its clinical trials. The company has announced that it is on track to announce topline data from its phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome in the third quarter of 2025. The RECONNECT study is designed to confirm the statistically significant and clinically meaningful findings from the prespecified analysis of the primary outcome in the subgroup of patients with complete methylation from the Phase 2/3 CONNECT study [1].

Additionally, Harmony Biosciences is set to commence a first-in-human study for BP1.15205 in the second half of 2025, with clinical data anticipated in 2026. The company is also preparing to initiate phase 3 registrational trials for pitolisant HD in both narcolepsy and idiopathic hypersomnia (IH) in the fourth quarter of 2025, with target dates for regulatory approval in 2028 [1].

These advancements in clinical trials, combined with the strong financial performance, position Harmony Biosciences as a leader in the biotechnology sector. The company continues to build a commercially durable business with a robust pipeline and clear path to delivering long-term value for patients, providers, and shareholders alike.

References:
[1] https://www.theglobeandmail.com/investing/markets/markets-news/Business%20Wire/33882661/harmony-biosciences-reports-strong-q2-2025-financial-results-and-reaffirms-2025-revenue-guidance-on-track-to-announce-fragile-x-topline-data-from-phase-3-registrational-trial-in-q3-2025/