PRINCETON, NJ – (BUSINESS WIRE) – Bristol Myers Squibb (NYSE: BMY) announced today that the application for a biological license (BLA) for lysocabtagene maraleucel (smooth-cel) for the treatment of adults with relapsing or refractory large B cell lymphoma (R / R) after at least two previous therapies remain under review by the United States 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 BLA for smooth-cel and is committed to bringing this therapy to patients.
As the FDA approval for plain-cel did not occur until December 31, 2020, one of the three milestones required for the payment of the Bristol Myers Squibb Contingent Value Right (CVR) (NYSE: BMY-RT) was not met. As a result, on January 1, 2021, the Contingent Value Rights Agreement (CVR Agreement), under which CVRs were issued, automatically terminated in accordance with its terms and CVRs are no longer eligible for payment under the Agreement CVR. CVRs will no longer be traded on the NYSE.
For additional information, 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 single vision – to transform people’s lives through science. The goal of the company’s cancer research is to deliver drugs that offer each patient a better and healthier life and make healing a possibility. Based on a legacy on a wide range of cancers that have changed the expectations of survival for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are transforming data into insights that enhance their focus. Deep scientific knowledge, cutting-edge resources and discovery platforms allow the company to look at cancer from all angles. Cancer can be relentlessly controlled in many parts of a patient’s life, and Bristol Myers Squibb is committed to taking steps to address all aspects of treatment, from diagnosis to survival. Because as a leader in cancer treatment, Bristol Myers Squibb is working 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 provide innovative medicines that help patients to prevail over serious illnesses. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn,Twitter, YouTube, Facebook and Instagram.
Juno Therapeutics, Inc. is a wholly owned subsidiary of the Bristol-Myers Squibb Company. In certain countries outside 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 cautionary statement regarding forward-looking statements
This press release contains “forward-looking statements” in accordance with the meaning of the Private Securities Litigation Reform Act of 1995 with respect, among other things, to research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be considered forward-looking statements. These forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that may delay, deviate or alter any of them in the future. coming years, which are difficult to predict, may be beyond our control and may cause our future financial results, goals, plans and objectives to be materially different from those expressed or implied in the statements. These risks, assumptions, uncertainties and other factors include, among others, whether the smooth-cel will be approved by the FDA. No forward-looking statement can be guaranteed. The forward-looking statements in this press release should be assessed in conjunction with the many risks and uncertainties affecting Bristol Myers Squibb’s business and market, particularly those identified in the warning and discussion of risk factors statement in the Bristol Myers Squibb Annual Report at 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 files 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 required by applicable law, Bristol Myers Squibb assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, circumstances altered or others.
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