EU and US could reach trade deal this weekend - Reuters
PRINCETON, N.J. - The European Commission has approved Breyanzi, a treatment developed by Bristol Myers Squibb (NYSE:BMY), a pharmaceutical giant with $48.3 billion in revenue and an impressive 75% gross profit margin, for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. According to InvestingPro analysis, BMY maintains its position as a prominent player in the Pharmaceuticals industry. The approval, applicable across the European Union and additional European Economic Area countries, is based on the Phase 2 TRANSCEND FL study, which showed a high overall response rate of 97.1% and a complete response rate of 94.2% among patients.
Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, has demonstrated rapid and durable responses, with 75.7% of patients still in response at 18 months. The safety profile of Breyanzi was consistent with previous clinical trials, showing no new safety concerns. The treatment is already approved in the EU for other lymphoma types and has received similar approvals in the United States, Japan, Switzerland, the UK, and Canada.
Follicular lymphoma, a type of non-Hodgkin lymphoma, remains incurable, often leading to relapses post front-line therapy. Breyanzi aims to address the unmet need for more durable treatment options. The therapy involves reengineering a patient’s own T cells to target and fight cancer cells.
The TRANSCEND FL study is the largest to evaluate a CAR T cell therapy in patients with indolent non-Hodgkin lymphoma, including follicular lymphoma. The study’s primary outcome measure was overall response rate, with secondary measures including complete response rate, duration of response, and progression-free survival.
This information is based on a press release statement from Bristol Myers Squibb. Currently trading near its 52-week high, InvestingPro analysis suggests the stock is fairly valued. For deeper insights into BMY’s financial health and growth prospects, including 10+ additional ProTips and comprehensive valuation metrics, explore the full Pro Research Report available on InvestingPro.
In other recent news, Bristol Myers Squibb has announced the acquisition of 2seventy bio for approximately $286 million. This acquisition is poised to enhance Bristol Myers Squibb’s portfolio, particularly with 2seventy bio’s focus on Abecma, a therapy for multiple myeloma. Additionally, the European Commission has approved the Opdivo-Yervoy combination as a first-line treatment for advanced liver cancer, marking a significant development in available therapeutic options in Europe. The approval is based on the Phase 3 CheckMate -9DW study, which showed improved overall survival rates for patients using this combination therapy.
Moreover, Bristol Myers Squibb has declared its latest quarterly dividends, offering $0.62 per share on common stock and $0.50 per share on convertible preferred stock, reflecting the company’s financial health. The U.S. FDA has also accepted a supplemental biologics license application for Opdivo combined with Yervoy for treating certain types of colorectal cancer, granting it Breakthrough Therapy Designation and Priority Review status. This application is supported by the CheckMate -8HW clinical trial, which demonstrated superior progression-free survival for the combination therapy.
In analyst observations, BTIG’s Jonathan Krinsky noted that previous resistance for Bristol Myers Squibb is now acting as support, indicating potential stability in the healthcare sector. These developments collectively highlight Bristol Myers Squibb’s ongoing strategic initiatives and regulatory advancements.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.