PRINCETON, N.J. - The U.S. Food and Drug Administration (FDA) has updated the Prescription Drug User Fee Act (PDUFA) goal date for the review of Bristol Myers (NYSE:BMY) Squibb's subcutaneous formulation of Opdivo, co-formulated with Halozyme (NASDAQ:HALO)'s recombinant human hyaluronidase (rHuPH20). The new goal date for completion of the review is December 29, 2024.
This biologics license application pertains to the use of subcutaneous nivolumab across all previously approved adult solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
The application is supported by data from the CheckMate -67T trial, which is the first Phase 3 study of the subcutaneous formulation of nivolumab. The trial aimed to demonstrate noninferior pharmacokinetics, efficacy, and consistent safety compared to its intravenous formulation. If approved, subcutaneous nivolumab could become the first subcutaneously administered PD-1 inhibitor.
CheckMate -67T is a Phase 3 randomized, open-label trial that compared subcutaneous administration of Opdivo co-formulated with Halozyme's rHuPH20 to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. The trial enrolled a total of 495 patients and focused on pharmacokinetics and objective response rate (ORR) as co-primary endpoints.
Bristol Myers Squibb, a global biopharmaceutical company, is focused on developing and delivering medicines for serious diseases, with a particular emphasis on cancer treatment. The company aims to provide each patient with a healthier life and to work towards making a cure a possibility.
InvestingPro Insights
As Bristol Myers Squibb (BMY) awaits the FDA's decision on its subcutaneous formulation of Opdivo, investors are eyeing the company's financial health and market performance. According to real-time data available on InvestingPro, Bristol Myers Squibb has a market capitalization of $87.9 billion, reflecting its substantial size within the pharmaceutical industry. With a robust gross profit margin of 76.03% over the last twelve months as of Q1 2024, the company demonstrates its ability to maintain high profitability amidst its research and development endeavors.
While the company's revenue saw a slight decline of 0.68% over the last twelve months as of Q1 2024, it still reported a significant gross profit of $34.62 billion, underscoring its financial resilience. Additionally, the company pays a considerable dividend to shareholders, with a dividend yield of 5.54% and a track record of maintaining dividend payments for 54 consecutive years, which could appeal to income-focused investors.
InvestingPro Tips suggest that Bristol Myers Squibb's stock is currently in oversold territory according to the Relative Strength Index (RSI), which may indicate a potential buying opportunity for investors. Moreover, the company is a prominent player in the Pharmaceuticals industry, which might provide a level of stability and predictability in its stock performance. For those interested in further analysis, there are 12 additional InvestingPro Tips available, which can be accessed through InvestingPro's platform. Investors can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription to gain deeper insights into Bristol Myers Squibb's performance and prospects.
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