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PRINCETON, NJ – (BUSINESS WIRE) – Bristol Myers Squibb (NYSE: BMY) today announced that the Biologics License Application (BLA) for lisocabtagen maraleucel (liso-cel) for the treatment of adults with relapsed large B cell lymphoma or refractory (R / R) after at least two previous treatments remain under review by the US Food and Drug Administration (FDA) and the company has not received a decision. As previously announced, the FDA has not provided a new action date for this application. Bristol Myers Squibb continues to work closely with the FDA to support the ongoing review of the BLA for liso-cel and is committed to bringing this therapy to patients.
Since the FDA approval of liso-cel has not taken place by December 31, 2020, one of the three required milestones for the payment of the Bristol Myers Squibb Contingent Value Duty (CVR) (NYSE: BMY- RT) was not respected. As a result, on January 1, 2021, the Contingent Entitlement Agreement (CVR Agreement), under which CVRs were issued, automatically terminated in accordance with its terms and CVRs are no longer eligible for payment under of the CVR Agreement. CVRs will no longer trade on the NYSE.
For more information, please see: https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Statement-on-Status-of-Liso-cel-Application-and-Contingent – Value-Rights / default.aspx or call EQ Shareowner Services at 1-833-503-4131.
Bristol Myers Squibb: Creating a better future for people with cancer
Bristol Myers Squibb is inspired by a unique vision: to transform people’s lives through science. The goal of the company’s cancer research is to provide drugs that give each patient a better, healthier life and make a cure possible. Building on a legacy of a wide range of cancers that have changed the survival expectations of many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, transforming data into information that refines their purpose. Deep scientific expertise, cutting-edge capabilities and discovery platforms allow the company to look at cancer from all angles. Cancer can have a relentless grip on many aspects of a patient’s life, and Bristol Myers Squibb is committed to taking action to address all aspects of care, from diagnosis to survival. Because as a leader in cancer care, Bristol Myers Squibb works to empower all people with cancer to have a better future.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients overcome serious illnesses. For more information on Bristol Myers Squibb, visit our website BMS.com or follow us on LinkedIn,Twitter, YouTube, Facebook and Instagram.
Juno Therapeutics, Inc. is a wholly owned subsidiary of Bristol-Myers Squibb Company. In some countries outside of the United States, due to local laws, Celgene and Juno Therapeutics are referred to as Celgene, a Bristol Myers Squibb company, and Juno Therapeutics, a Bristol Myers Squibb company.
Bristol Myers Squibb Caution Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 concerning, among other things, the research, development and marketing of pharmaceutical products. All statements that are not statements of historical fact are or may be considered forward-looking statements. These forward-looking statements are based on historical performance and current expectations and projections regarding our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, deter or modify any of them. over the next few years, which are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed or implied by the statements. These risks, assumptions, uncertainties and other factors include, among other things, whether Liso-cel will be approved by the FDA. No forward-looking statement can be guaranteed. The forward-looking statements contained in this press release should be weighed together with the many risks and uncertainties that affect the business and market of Bristol Myers Squibb, particularly those identified in the disclaimer and analysis of factors of risk in Bristol Myers Squibb’s annual report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise provided by applicable law, Bristol Myers Squibb does not undertake to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changes in circumstances or otherwise.
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