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PLYMOUTH MEETING, Pa. - Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY), a pharmaceutical company with a current market capitalization of $2.02 billion and an excellent financial health score according to InvestingPro, has reached a settlement agreement with Lupin Limited, concluding the patent infringement case concerning a generic version of WAKIX® (pitolisant hydrochloride). The settlement will see the lawsuit in the United States District Court for the District of Delaware dismissed, with Lupin granted a license to launch its generic product no earlier than January 2030, or potentially July 2030 if pediatric exclusivity applies, with provisions for an earlier launch under specific circumstances.
Harmony asserted multiple patents related to WAKIX®, the first and only non-scheduled FDA-approved treatment for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy, and for EDS treatment in pediatric patients aged six and older with narcolepsy. The company’s strong market position is reflected in its impressive 78.34% gross profit margin and 20.62% revenue growth over the last twelve months. The settlement reinforces the strength and validity of Harmony’s intellectual property portfolio, which safeguards its sleep/wake therapeutic innovations. Harmony is also developing next-generation formulations of pitolisant, with potential exclusivity extending to 2044, to address ongoing medical needs in narcolepsy and other central disorders of hypersomnolence.
The U.S. Patent Office Patent Trial and Appeal Board, on July 31, 2024, upheld the validity of Harmony’s exclusively licensed polymorph patent for pitolisant hydrochloride for the second time by declining to institute an Ex Parte Reexamination. This decision further affirms Harmony’s patent estate’s enforceability.
Harmony continues to defend its intellectual property rights and is litigating against other companies that have filed Abbreviated New Drug Applications (ANDAs) for generic versions of WAKIX®.
WAKIX® is a selective histamine 3 (H₃) receptor antagonist/inverse agonist, with its efficacy believed to be mediated through increased synthesis and release of histamine, a wake-promoting neurotransmitter. Harmony holds an exclusive license from Bioprojet to develop, manufacture, and commercialize pitolisant in the United States.
The information in this article is based on a press release statement from Harmony Biosciences Holdings, Inc. For deeper insights into Harmony Biosciences’ financial health, growth prospects, and comprehensive analysis, access the full InvestingPro Research Report, which includes detailed metrics, Fair Value analysis, and expert insights that help investors make informed decisions. InvestingPro analysis indicates the stock is currently undervalued, with multiple additional ProTips available to subscribers.
In other recent news, Harmony Biosciences Holdings Inc. reported impressive financial results for the first quarter of 2025, with revenues reaching $184.7 million, a 20% increase year-over-year. This figure surpassed analysts’ expectations, including Oppenheimer’s estimate of $178.5 million and the consensus estimate of $182.3 million. Earnings per share (EPS) also exceeded forecasts, coming in at $1.03 compared to the expected $0.61. The company’s flagship product, Wakix, continues to drive growth, and Harmony Biosciences projects full-year revenues between $820 million and $860 million.
Oppenheimer has assumed coverage of Harmony Biosciences with an Outperform rating, maintaining a price target of $61.00, citing the strong financial performance and potential upside in the company’s neurobehavioral and epilepsy pipelines. Mizuho Securities also raised its price target for Harmony Biosciences to $48.00 from $44.00, maintaining an Outperform rating, and highlighted the company’s robust pipeline, which includes six programs expected to enter Phase 3 clinical trials by the end of 2025.
Upcoming events for Harmony Biosciences include the presentation of preclinical efficacy and safety data for BP1.15205 at the SLEEP 2025 conference and the announcement of top-line Phase 3 RECONNECT study data for ZYN-002 in Fragile X Syndrome patients, expected in the third quarter of 2025. The company continues to anticipate growth driven by its expanding product pipeline and sustained demand for Wakix, which is on track to potentially become a $1 billion product.
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