Harmony Biosciences announced a collaboration with Beacon Biosignals to integrate the FDA‑cleared Waveband EEG headband and AI algorithms into its Phase 3 studies of HBS‑301 for narcolepsy and idiopathic hypersomnia. The partnership will add objective, at‑home EEG measurements to the traditional Epworth Sleepiness Scale, aiming to provide a more precise assessment of excessive daytime sleepiness and nighttime sleep quality.
The move reflects Harmony’s strategy to strengthen the evidentiary basis for regulatory submissions and to differentiate its pipeline in the rare‑neurology market. By capturing continuous, objective sleep data, the company hopes to identify biomarkers, refine dose selection, and support subgroup analyses that could accelerate approval timelines and improve market adoption.
Beacon’s Waveband platform, previously known as Dreem 3S, received FDA 510(k) clearance under K223539 and has been deployed in real‑world sleep studies. Its integration into Harmony’s trials represents a shift toward precision medicine and aligns with the FDA’s growing acceptance of digital health technologies in clinical research.
The partnership comes as Harmony reported a strong Q3 2025 earnings beat, with revenue of $239.5 million up 29% YoY and adjusted EPS of $1.08 versus analyst expectations of $0.74. The earnings surge was driven by robust sales of its flagship narcolepsy drug WAKIX, which added 500 patients to the U.S. patient base and pushed the company toward blockbuster status. Management cited disciplined cost control and a favorable mix of high‑margin product sales as key contributors to the upside.
In the same quarter, Harmony raised its full‑year 2025 revenue guidance to $845–$865 million from $820–$860 million, signaling confidence in continued demand for WAKIX and the potential upside from the new partnership. The company’s cash position remained strong at $778.4 million, providing flexibility to invest in the Phase 3 program and future pipeline assets.
Analysts noted that the partnership could enhance the robustness of HBS‑301’s clinical data, potentially reducing the risk of regulatory setbacks and improving payer confidence. The objective EEG endpoints may also support more granular efficacy claims, which could translate into better reimbursement outcomes and broader market penetration for Harmony’s narcolepsy and hypersomnia therapies.
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