On Monday, Harmony Biosciences Holdings Inc. (NASDAQ:HRMY) retained its Outperform rating and $56.00 price target from Oppenheimer, following the FDA's approval of WAKIX for the treatment of excessive daytime sleepiness (EDS) in pediatric narcolepsy patients. This approval marks WAKIX as the first and only non-scheduled EDS treatment option available for children aged 6 and above with narcolepsy.
The FDA's endorsement comes after a priority review of the supplemental New Drug Application (sNDA), which was supported by Phase 3 trial data from Bioprojet. Previously, the European Medicines Agency (EMA) had approved WAKIX for pediatric patients, with or without cataplexy, last year. Despite receiving a Complete Response Letter (CRL) for the cataplexy indication, analysts highlight the drug's successful adult market launch, which began with EDS treatment in August 2019, followed by the approval for cataplexy treatment in October 2020.
Analysts at Oppenheimer emphasized the significance of the pediatric approval, noting the existing familiarity that prescribers have with WAKIX from its use in adults. This is anticipated to aid in the drug's adoption for pediatric use. The narcolepsy market for pediatric patients, while small, represents a substantial commercial opportunity, with approximately 5% of the overall narcolepsy patient population.
The company's stock rating reaffirmation reflects confidence in the drug's market potential and the expected positive reception among healthcare providers who are already accustomed to prescribing WAKIX for adult patients. With the new FDA approval, Harmony Biosciences is poised to extend the reach of WAKIX to a younger demographic, further solidifying its position in the narcolepsy treatment market.
In other recent news, Harmony Biosciences received FDA approval for the pediatric use of its drug WAKIX (pitolisant) for the treatment of excessive daytime sleepiness associated with narcolepsy. The approval was based on a Phase 3 study demonstrating the safety and efficacy of the drug in pediatric patients. The company also reported a 30% increase in net revenues in Q1, reaching $154.6 million, primarily driven by the success of WAKIX.
Harmony Biosciences also revealed promising findings from a Phase 2 study of pitolisant, indicating potential efficacy in reducing symptoms of excessive daytime sleepiness and fatigue in adults with Myotonic dystrophy Type 1. In a strategic move, Harmony Biosciences acquired Epygenix Therapeutics, a firm focusing on epilepsy treatments, and TMP1116 for narcolepsy, as part of its expansion strategy.
Investment firm Needham raised its stock price target for Harmony Biosciences to $52, while a Citi analyst gave the company a Buy rating with a $48 price target. These recent developments signal confidence in the company's ongoing commercial success and future prospects.
InvestingPro Insights
Following the recent FDA approval of WAKIX for pediatric use, Harmony Biosciences Holdings Inc. (NASDAQ:HRMY) is drawing attention not just for its market potential but also for its financial health and performance metrics. InvestingPro data reveals a robust revenue growth of 30.92% over the last twelve months as of Q1 2024, underscoring the company's expanding market reach. Additionally, the company's P/E ratio stands at 13.78, with an adjusted P/E ratio of 12.17 for the same period, indicating a potentially attractive valuation for investors.
InvestingPro Tips highlight that management has been actively buying back shares, a sign of confidence in the company's value. Furthermore, Harmony holds more cash than debt, suggesting a solid balance sheet. For those interested in further insights, InvestingPro features additional tips that delve deeper into Harmony's financials and market prospects. Subscribers can access these tips and more at: https://www.investing.com/pro/HRMY. For those looking to subscribe, use the coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription. With 8 more InvestingPro Tips available, investors can gain comprehensive knowledge to inform their investment decisions.
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