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On Tuesday, Oppenheimer maintained its Outperform rating on Harmony Biosciences Holdings Inc. (NASDAQ:HRMY) with a steady price target of $61.00. Currently trading at $28.10 and near its 52-week low of $27.33, the stock appears undervalued according to InvestingPro analysis. The firm's analysts highlighted recent developments from Harmony (JO:HARJ) Biosciences regarding its drug candidate ZYN002, designed for treating fragile X syndrome (FXS).
The open-label extension (OLE) data for ZYN002, which is set to be presented at the American Academy of Neurology on April 8, 2025, has shown promising results. The study, involving 240 participants with a mean age of 9.7, reported clinically meaningful improvements in irritability-related symptoms associated with FXS. The medication was administered in weight-based dosages of 250, 500, or 750 mg/kg.
Analysts noted ZYN002's favorable safety profile, with serious adverse events (SAEs) reported at 4.6%, a discontinuation rate of 3.3%, and treatment-related adverse events (TRAEs) at 12.9%. The most common adverse event was pain at the application site, affecting 6.7% of participants.
While ZYN002's valuation is not currently reflected in Harmony Biosciences' stock, the positive update is seen as a risk-reducing factor for the FXS program. With a strong financial health score of 3.7 (GREAT) on InvestingPro and robust revenue growth of 22.8% in the last twelve months, the company maintains a solid foundation. The anticipation for the Phase 3 registrational topline data remains high, with expectations set for the third quarter of 2025.
Furthermore, Oppenheimer expressed satisfaction with the fourth-quarter 2024 performance of WAKIX, Harmony Biosciences' narcolepsy treatment, and anticipates continued momentum in sales. The firm is also closely monitoring developments in Harmony's neurobehavioral and epilepsy pipeline.
The reaffirmed Outperform rating and $61 price target reflect Oppenheimer's confidence in Harmony Biosciences' ongoing clinical programs and commercial strategies. Trading at an attractive P/E ratio of 11.2x and with analyst targets ranging from $33 to $70, the stock shows significant potential. For deeper insights into HRMY's valuation and 12 additional ProTips, visit InvestingPro, where you'll find comprehensive analysis and expert research reports.
In other recent news, Harmony Biosciences Holdings , Inc. has reported significant progress in its ongoing study of ZYN002, a synthetic cannabidiol gel for Fragile X syndrome. The study, presented at the American Academy of Neurology Annual Meeting, showed that over 60% of participants experienced meaningful behavioral improvements, offering potential hope for this rare condition. Additionally, Harmony Biosciences has announced the appointment of Ron Philip to its Board of Directors, bringing extensive biopharmaceutical experience to the company. In another leadership change, Adam Zaeske has been named the new Executive Vice President and Chief Commercial Officer, set to take on the role in 2025. Mizuho (NYSE:MFG) Securities recently raised its price target for Harmony Biosciences to $44, maintaining an Outperform rating, reflecting confidence in the company's pipeline and growth prospects. Meanwhile, H.C. Wainwright adjusted its price target to $70, maintaining a Buy rating, despite a recent FDA setback for WAKIX in idiopathic hypersomnia. Harmony Biosciences has reaffirmed its 2025 revenue guidance, projecting between $820 million and $860 million, with expectations of reaching $1 billion in sales by 2030. The company continues to focus on expanding its product offerings and advancing its clinical programs, with several key milestones anticipated in the near future.
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