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PLYMOUTH MEETING, Pa. - Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY), a profitable biotech company with $745 million in revenue and a market capitalization of $2.06 billion, plans to start first-in-human trials of BP1.15205, an experimental orexin 2 receptor (OX2R) agonist targeting narcolepsy and related sleep disorders, in the second half of 2025, with topline data expected in 2026. According to InvestingPro analysis, the company appears undervalued based on its Fair Value calculations.
The company, which maintains impressive gross profit margins of 78.34% and has demonstrated strong revenue growth of 20.62% over the last twelve months, announced Wednesday that preclinical data being presented at the Annual Meeting of the Associated Professional Sleep Societies shows the drug candidate demonstrated significant wake-promoting and cataplexy-suppressing effects in a mouse model of narcolepsy type 1.
Laboratory studies indicate BP1.15205 is highly potent with an EC50 of 0.015 nM and shows more than 600-fold selectivity for the OX2R receptor over OX1R. The compound produced wake-promoting effects at doses as low as 0.03 mg/kg in animal testing.
Three-month toxicity studies revealed no adverse events at doses up to 300 mg/kg/day, according to the company’s statement.
"BP1.15205 is a new and unique chemical scaffold optimized for high potency," said Kumar Budur, Chief Medical and Scientific Officer at Harmony Biosciences. The company, which received a "GREAT" financial health score from InvestingPro analysts, is preparing regulatory submissions to both European and U.S. authorities. Get access to 6 more exclusive ProTips and comprehensive analysis in the Pro Research Report.
Narcolepsy affects approximately 170,000 Americans and is characterized by excessive daytime sleepiness and cataplexy. The condition is typically caused by the loss of hypocretin/orexin, a neuropeptide that supports sleep-wake stability.
The information in this article is based on a press release from Harmony Biosciences.
In other recent news, Harmony Biosciences has reported strong financial results for the first quarter of 2025, with revenues reaching $184.7 million, surpassing analyst estimates. This represents a 20% year-over-year growth, driven by the continued success of Wakix, their flagship treatment for narcolepsy. The company’s earnings per share also exceeded expectations, coming in at $1.03 compared to the forecasted $0.61. Analysts from Oppenheimer have assumed coverage of Harmony Biosciences with an Outperform rating, citing the company’s robust financial performance and potential for patient growth. Mizuho Securities also raised its price target for the company to $48, maintaining an Outperform rating due to the promising outlook of Wakix and the company’s pipeline. Additionally, Harmony Biosciences has settled a patent litigation case with Lupin Limited, allowing Lupin to launch a generic version of Wakix no earlier than 2030. The U.S. Patent Office upheld the validity of Harmony’s polymorph patent for pitolisant hydrochloride, reinforcing the company’s intellectual property position. Harmony continues to focus on developing next-generation formulations of pitolisant and advancing its late-stage clinical pipeline.
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