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On Tuesday, Mizuho (NYSE:MFG) Securities reiterated its Outperform rating and $42.00 price target for Harmony Biosciences Holdings Inc. (NASDAQ:HRMY), which currently trades at $35.28. The company’s stock has seen analyst targets ranging from $31 to $75, with InvestingPro analysis suggesting the stock is currently undervalued. The endorsement comes as Bicycle Therapeutics plc (NASDAQ:BCYC) shared its fourth-quarter and full-year 2024 business updates earlier in the day.Want deeper insights? InvestingPro reveals 10 additional investment tips for HRMY, including strong cash flow metrics and robust financial health indicators. Access the comprehensive Pro Research Report covering what really matters about HRMY and 1,400+ other top stocks.
Bicycle Therapeutics, recognized for its innovative clinical pipeline that includes Bicycle-Toxin Conjugates (BTC) and Bicycle-radio conjugates (BRC) targeting solid tumors, is advancing its lead program, zelenectide pevedotin (Zele; formerly known as BT8009), in a global Phase 2/3 registrational study named Duravelo-2. This study is exploring the efficacy of Zele in combination with pembrolizumab for patients with metastatic urothelial cancer (mUC) in the frontline setting.
In addition to the combination therapy, Zele is also undergoing evaluation as a monotherapy in the Duravelo-2 trial for late-line mUC treatment. Bicycle Therapeutics plans to finalize the dosing regimen for Zele between 5 mg/m2 weekly and 6 mg/m2 biweekly with a one-week break in the second half of 2025.
The company’s pipeline further includes several Phase 1/2 trials for Zele targeting NECTIN-4 gene-amplified solid tumors set to commence in 2025. Moreover, Bicycle expects to release human imaging data from two of its BRC programs, targeting MT1-MMP and EphA2, in the middle and latter part of 2025. The first BRC program is slated to enter clinical trials in 2026.
Bicycle Therapeutics is also progressing with two other programs: a BTC against Eph2A (BT5528) and an immune agonist targeting Nectin-4 (BT7480), both currently in clinical stages. Updates on the BT5528 program are anticipated in the fourth quarter of 2025.
As of the end of the fourth quarter, Bicycle Therapeutics reported a robust financial position with approximately $880 million in cash reserves. These funds are expected to sustain the company’s operations well into the second half of 2027, ensuring the continuity of its research and development endeavors. Meanwhile, Harmony (JO:HARJ) Biosciences demonstrates strong financial health with a current ratio of 3.24 and impressive revenue growth of 25.8% in the last twelve months. According to InvestingPro data, the company maintains healthy profitability with a gross margin of 78.7% and generates substantial free cash flow, positioning it well in the biotechnology sector.
In other recent news, Harmony Biosciences Holdings reported its fourth-quarter 2024 earnings, surpassing expectations with an earnings per share (EPS) of $1.08, significantly above the forecasted $0.69. The company also reported net revenue of $201.3 million, exceeding the anticipated $198.6 million, marking a 20% increase compared to the previous year. Harmony Biosciences provided strong revenue guidance for 2025, projecting between $820 million and $860 million. The company continues to focus on expanding its pipeline with promising drug candidates targeting rare neurological disorders, including its narcolepsy drug, WAKIX. Analysts have noted the company’s operational efficiency, as evidenced by its ability to consistently surpass market expectations. The company also announced its first generic settlement agreement with Novogen Pharma, granting a license to sell a generic version of its drug beginning in 2030. Harmony Biosciences is advancing its late-stage pipeline, anticipating multiple product launches in the coming years, and remains committed to defending its intellectual property portfolio vigorously.
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