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Biotech Stocks Facing FDA Decision In October 2022

AstraZeneca PLC
AstraZeneca PLC

The FDA decision on AstraZeneca PLC’s (AZN) investigational drug Tremelimumab in combination with its blockbuster drug Imfinzi (Durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma is due in the fourth quarter of this year.

This novel dose and schedule of the combination is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).

In a phase III trial, dubbed HIMALAYA, there was an unprecedented three-year overall survival in the setting with a single priming dose of Tremelimumab added to Imfinzi, according to the company.

Hepatocellular carcinoma is the most common type of liver cancer. Approximately 26,000 people in the U.S. are diagnosed with this cancer each year.

Bayer’s Nexavar, Eisai’s Lenvima, and Genentech’s Tecentriq in combination with Avastin are some of the approved drugs for advanced hepatocellular carcinoma.

AZN closed Thursday’s (Sep.29,2022) trading at $54.91, up 0.40%.