Harmony Biosciences' Q2 2025: Unraveling Contradictions in ZYN002 and WAKIX Strategies

ZYN002 study design and primary endpoint, WAKIX payer coverage and generic competition, ZYN002 Phase 3 study timing and design, Pitolisant HD trial design and competition, and timing of ZYN002 approval are the key contradictions discussed in Harmony Biosciences Holdings' latest 2025Q2 earnings call.



Double-Digit Revenue Growth:
- Harmony Biosciences Holdings reported $200.5 million in second-quarter net revenue, representing a 16% increase year-over-year.
- This growth was driven by the ongoing success of WAKIX in narcolepsy, with an addition of 400 average patients during the quarter.

Pipeline Advancements and Clinical Trials:
- Harmony's pipeline includes 8 innovative assets across 13 development programs, with up to 6 Phase III trials expected by the year's end.
- The company is on track for major clinical catalysts, such as the top-line data for ZYN002 in Fragile X syndrome later this quarter.

Commercial Performance and Market Positioning:
- WAKIX delivered $200.5 million in net sales for the quarter, representing a 16% year-over-year growth.
- The product's unique position as the only non-scheduled treatment, strong payer coverage, and robust commercial execution contributed to its sustained growth.

Product Expansion and Future Opportunities:
- Harmony is developing next-generation formulations of pitolisant, including high-dose and gastro-resistant versions, which aim to extend the pitolisant franchise.
- Initiation of Phase III trials for these formulations is expected in the fourth quarter of 2025.

Research Collaboration and Strategic Investments:
- The company entered into a research collaboration with Circ Biosciences, focusing on novel regenerative cellular therapies for refractory epilepsy and narcolepsy.
- This strategic alignment with the current pipeline aims to deliver innovative treatments for serious neurological disorders.