PLYMOUTH MEETING, Pa. - Harmony Biosciences Holdings , Inc. (NASDAQ:HRMY) announced its strategic acquisition of Epygenix Therapeutics, Inc., a move that integrates a rare epilepsy franchise into its late-stage pipeline of central nervous system (CNS) assets. The acquisition includes the promising drug candidate, clemizole hydrochloride (EPX-100), which is currently undergoing a pivotal registrational clinical trial for Dravet syndrome and is expected to enter Phase 3 trials for Lennox-Gastaut syndrome in the second half of 2024.
Clemizole hydrochloride is an oral serotonin (5HT2) agonist with the potential to improve daily functioning in patients with Dravet syndrome and Lennox-Gastaut syndrome, rare forms of epilepsy. Both conditions have been granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the FDA, indicating the significance of developing effective treatments.
Harmony Biosciences paid $35 million in cash for Epygenix, with additional payments up to $130 million contingent on development and regulatory milestones. Moreover, sales milestones could trigger further payments up to $515 million.
Jeffrey M. Dayno, M.D., President and CEO of Harmony Biosciences, emphasized the value of the acquisition, stating it reinforces their leadership in sleep/wake and neurobehavioral disorders. He pointed out that each CNS franchise has the potential to achieve US peak sales of $1 billion to $2 billion.
Alex Yang, Chair and CEO of Epygenix Therapeutics, expressed confidence in Harmony's drug development and commercialization capabilities to fulfill the potential of these treatments for families affected by Dravet and Lennox-Gastaut syndromes.
EPX-100's progression to a pivotal trial for Dravet syndrome and the planned Phase 3 trial for Lennox-Gastaut syndrome highlight Harmony Biosciences' commitment to addressing unmet needs in rare neurological diseases. The acquisition is poised to leverage the company's expertise in CNS to bring new therapies to patients.
The information reported is based on a press release statement from Harmony Biosciences.
InvestingPro Insights
Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) has been making strategic moves to strengthen its position in the central nervous system (CNS) therapeutic area, as evidenced by its recent acquisition of Epygenix Therapeutics, Inc. Investors monitoring HRMY's financial health will find several positive indicators that could underpin the company's strategic decisions and future potential.
InvestingPro data highlights Harmony Biosciences' robust financial metrics, with a market capitalization of $1.66 billion and an attractive price-to-earnings (P/E) ratio of 12.1 based on the last twelve months as of Q4 2023. This P/E ratio suggests that the company is valued reasonably relative to its earnings. Furthermore, the company's revenue growth has been impressive, with a 32.93% increase over the last twelve months as of Q4 2023, indicating a strong business expansion.
An InvestingPro Tip worth noting is that management has been actively buying back shares, a sign that the company's leadership is confident in its future prospects and believes the shares are undervalued. Additionally, Harmony holds more cash than debt on its balance sheet, providing financial stability and flexibility, which can be crucial when pursuing acquisitions and investing in research and development.
For investors seeking more detailed analysis and additional insights, InvestingPro offers a range of tips for Harmony Biosciences. As of now, there are 7 additional InvestingPro Tips available, which can help investors make more informed decisions. For example, analysts predict the company will be profitable this year, and it has been profitable over the last twelve months. These insights are particularly relevant for investors considering the company's potential for sustained growth and profitability following its recent acquisition.
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