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FDA Approves J&J's Akeega for Expanded Use in Prostate Cancer
ZACKS· 2025-12-15 16:51
Key Takeaways JNJ won FDA approval to expand Akeega for BRCA2-mutated metastatic castration-sensitive prostate cancer.The phase III AMPLITUDE study showed the Akeega-prednisone combo cut progression or death risk by 54%.The label expansion moves Akeega into earlier treatment, building on its 2023 approval in resistant disease.Johnson & Johnson (JNJ) announced that the FDA approved its precision therapy, Akeega (niraparib and abiraterone acetate dual-action tablet), for a second indication in prostate cancer ...
J&J Joins Pharma M&A Bandwagon, to Buy Cancer Biotech for $3.05B
ZACKS· 2025-11-18 17:06
Core Insights - Johnson & Johnson (JNJ) has announced a definitive agreement to acquire Halda Therapeutics for $3.05 billion in cash, enhancing its oncology pipeline, particularly in prostate cancer treatments [1][3][10] Acquisition Details - The acquisition will incorporate Halda's proprietary RIPTAC platform, which is focused on developing oral, targeted therapies for various solid tumors, including the lead candidate HLD-0915 for metastatic castration-resistant prostate cancer (mCRPC) [2][10] - HLD-0915 is currently in a phase I/II study and has shown promising anti-tumor activity, designed to induce selective tumor cell death and address treatment resistance mechanisms [2] Strategic Implications - This deal will bolster J&J's existing oncology portfolio, which includes established drugs like Zytiga, Erleada, and Akeega, and is expected to close in the coming months, subject to regulatory review [3][10] - J&J anticipates a dilution of approximately 15 cents to adjusted EPS in 2026 as a result of this acquisition [3] Recent M&A Activity - J&J has been actively pursuing acquisitions, completing around 60 deals in the past 18 months, including the acquisition of Intra-Cellular Therapies, which added the antidepressant Caplyta to its portfolio [4] - The pharmaceutical sector has seen a surge in M&A activity, with notable deals including Merck's acquisition of Cidara Therapeutics for $9.2 billion and Pfizer's acquisition of Metsera for approximately $10 million [5][6] Financial Performance - J&J's shares have outperformed the industry, rising 38% year-to-date compared to the industry average of 13.9% [9] - The company's shares are currently trading at a price/earnings ratio of 17.49, slightly above the industry average of 16.71 and its five-year mean of 15.65 [11] Earnings Estimates - The Zacks Consensus Estimate for J&J's 2025 earnings has increased from $10.86 to $10.87 per share, while the estimate for 2026 has risen from $11.46 to $11.48 over the past month [12]