Bristol Myers (NYSE:BMY) Squibb's (BMS) experimental treatment for advanced clear cell renal cell carcinoma (ccRCC) has achieved its primary and secondary targets in the Checkmate-67T Phase III study. The trial assessed a subcutaneous formulation of nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor, mixed with Halozyme’s proprietary recombinant human hyaluronidase enzyme.
This single injection administration demonstrated noninferiority in time-averaged serum concentration, trough serum concentration at steady state, and overall response rate compared to intravenous Opdivo. The trial involved 495 patients who had previously undergone systemic treatment. Gina Fusaro, BMS's vice president, suggested this new option could transform patient treatment experience, given the low survival rates associated with kidney cancer.
The safety profile of subcutaneous nivolumab matched that of the intravenous dose, and the treatment was administered in under five minutes. BMS is set to discuss regulatory submissions for nivolumab with health authorities.
The company had previously halted testing an auto-injected version of the treatment, as announced by CMO Samit Hirawat. With the success of this subcutaneous version, Opdivo, which generated $8.25 billion in 2022 sales for BMS, could have its patent protection extended beyond 2028.
BMS plans to present these results at a medical conference. The company also shared data from the POETYK PSO trial of Sotyktu (deucravacitinib) for treating moderate-to-severe plaque psoriasis.
According to the latest data from InvestingPro, BMS has a market capitalization of 118.6 billion USD and a P/E ratio of 15.02, indicating a balanced valuation. The company's revenue for the last twelve months was 45.19 billion USD, despite a slight decline of 4.15%. The company has also maintained a strong gross profit margin of 77.63%.
As per InvestingPro Tips, BMS has a high earnings quality, with free cash flow exceeding net income. It also has a strong shareholder yield, owing to the management's aggressive buyback of shares. This has been a contributing factor to the company's profitability over the last twelve months. Furthermore, BMS is a prominent player in the Pharmaceuticals industry, trading at a low P/E ratio relative to near-term earnings growth.
The company has also maintained dividend payments for 53 consecutive years, demonstrating its commitment to rewarding its shareholders. This information, along with 11 additional tips, can be found on the InvestingPro platform, which provides real-time metrics and tips for investors. For more information, visit InvestingPro.
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