Biotech Stocks Facing FDA Decision In July Updated

Bristol-Myers Squibb
Bristol-Myers Squibb

Bristol-Myers Squibb Co.’s (BMY) supplemental Biologics License Application for Opdivo in combination with Yervoy for previously treated patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer awaits the FDA decision on July 10, 2018.

Colorectal cancer (CRC) is cancer that develops in the colon or the rectum. Approximately 15% of CRC patients and 4-5% of metastatic CRC patients have MSI-H or dMMR biomarkers.

DNA mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors.

The conventional chemotherapy is of little use for patients with MSI-H or dMMR metastatic CRC.

Opdivo and Yervoy are blockbuster drugs of Bristol-Myers. In 2017, the global sales of Opdivo were $4.95 billion, up 31% over 2016, and that of Yervoy totaled $1.24 billion, up 18% over 2016.

BMY closed Friday’s trading at $55.34, up 0.07%.