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EMA rates Bristol Myers Squibb’s subcutaneous Opdivo By

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PRINCETON, NJ – Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency (EMA) has begun reviewing the company’s application for a subcutaneous (under the skin) injection form of Opdivo, a drug used to treat several types of diseases. cancer in adults. If approved, this new formulation could significantly reduce the time it takes to treat patients.

The application is based on the results of the Phase 3 CheckMate -67T study, which showed that the subcutaneous version of nivolumab is not inferior in pharmacokinetics to the intravenous form – how the drug is absorbed, distributed, metabolized and excreted in the body. and efficiency.

The study’s primary endpoints, namely 28-day mean serum concentration and steady-state trough serum concentration, showed comparable results between the two formulations. Furthermore, the objective response rate, an important secondary endpoint, was also non-inferior to the subcutaneous version.

Patients in the study were adults with advanced or metastatic clear cell renal cell carcinoma (ccRCC), a type of kidney cancer, who had received up to two prior systemic therapies. The subcutaneous injection, which can be administered in 3 to 5 minutes, provides the same quality of care as the intravenous form but with a much shorter administration time, potentially improving the patient experience by reducing time spent in infusion centers.

The safety profile of subcutaneous nivolumab was consistent with that of its intravenous counterpart. Results of the CheckMate -67T study were presented at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, and additional safety analyzes and patient-reported outcomes were shared at the 2024 ASCO Annual Meeting.

Opdivo works by blocking the immune system’s programmed death-1 (PD-1), a mechanism that cancer cells use to avoid being attacked by the body’s immune system. By blocking PD-1, Opdivo works to restore the immune system’s ability to detect and fight tumor cells.

Bristol Myers Squibb is committed to improving the patient experience and is actively working on innovative formulations across its portfolio. Validation of the application at EMA starts the centralized evaluation process. The evaluation will determine whether the subcutaneous form of nivolumab is approved for use in the European Union.

This news is based on a press release from Bristol Myers Squibb.

In other recent news, Bristol Myers Squibb has been taking active steps in its development and operations. The company announced the appointment of Michael R. McMullen to the board of directors, expanding the board to 11 members. A seasoned executive, McMullen brings a wealth of experience from his previous role as CEO of Agilent Technologies.

Bristol Myers Squibb also reported significant progress in drug development. The US Food and Drug Administration (FDA) granted Augtyro accelerated approval for certain patients with solid tumors. In addition, Breyanz was approved by the FDA for the treatment of broad-spectrum lymphoma, making it the only CAR T-cell therapy to treat four different subtypes of non-Hodgkin’s lymphoma.

Financially, the company’s board approved a quarterly dividend payment for both common and preferred shares. However, Bristol Myers Squibb and Sanofi have been ordered to pay more than $916 million to the state of Hawaii over allegations that non-white patients were not adequately warned about the potential health risks associated with the blood thinner Plavix. Both companies plan to appeal the decision.

Citi maintained its buy rating on Bristol Myers Squibb shares, citing the company’s financial condition and the potential of its pipeline.

These are recent events in the company’s journey, reflecting the company’s ongoing drug development efforts and its financial decisions.

InvestmentPro Insights

As Bristol Myers Squibb (NYSE: BMY ) focuses on improving cancer treatment with a new subcutaneous injection form of Opdivo, the company’s financial health and market performance remain important factors for investors. Bristol Myers Squibb has a market capitalization of $83.19 billion and demonstrates its significant position in the pharmaceutical industry. The InvestingPro tip highlights the company’s aggressive share buyback strategy, which shows that management is confident in the company’s value and future prospects.

Despite a slight decline in revenue growth over the trailing twelve months from Q1 2024, at -0.68%, the company’s gross margin remains strong at 76.03%, indicating its ability to maintain the profitability of its operations. Additionally, Bristol Myers Squibb offers a substantial dividend yield of 5.85%, reflecting its commitment to returning value to shareholders. This point is further underscored by its impressive 54 consecutive year dividend payout history – an InvestingPro tip that income-oriented investors will love. particularly attractive.

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