Bristol-Myers Squibb Company (NYSE:BMY) stock slumped Monday after the US Food and Drug Administration delayed for three months, until May 2019, a decision on its combination drug treatment for lung cancer.
In a statement, Bristol-Myers said new data submitted by the company was viewed by the FDA as a major amendment to its drug application and extended its PDUFA date to May 20, 2019. The new information that Bristol-Myers submitted to the FDA is about the overall survival for patients whose tumors have a relatively low level of mutations.
The trial in the US is called CheckMate-227. It is an ongoing Phase 3 study of Opdivo plus another dose of a Bristo-Myers drug, Yervoy, against chemotherapy in small cell lung cancer.
As part of the ongoing EU review process, the Committee for Medicinal Products for Human Use (CHMP) requested additional information, including an overall survival (OS) analysis of Opdivo plus Yervoy in patients.
READ: Bristol-Myers Squibb's 2Q earnings beat Street on healthy sales of its blockbuster cancer drug Opdivo
The impact on Bristol shares was negative.
Bristol-Myers stock retreated 5.5% to $51.27, trading between $50.51 and $51.90.
Opdivo harnesses the body’s own immune system to fight cancer, having become an important treatment option across multiple cancers.
Bristol-Myers Squibb is a global biopharmaceutical company which tries to develop and deliver medicines that help patients over serious diseases.
The company is based in Princeton, New Jersey.
Reporting by Rene Pastor, contactable on [email protected]