Ahead Of Fda Decision

Gilead Sciences Pays $320 Million to Acquire Liver Disease Drug Seladelpar

Ahead of FDA Decision

Gilead Sciences, Inc. (NASDAQ: GILD) has agreed to acquire CymaBay Therapeutics, Inc. (NASDAQ: CBAY) for $43 billion. The deal includes seladelpar, a liver disease drug that is currently under review by the U.S. Food and Drug Administration (FDA). Gilead paid $320 million to Johnson & Johnson (NYSE: JNJ) to exit an 18-year-old collaboration agreement.

Seladelpar for Primary Biliary Cholangitis

Seladelpar is a potential treatment for primary biliary cholangitis (PBC), a chronic liver disease that affects the bile ducts. The drug is designed to reduce inflammation and itching, and improve cholestasis (the slowing or stalling of bile flow).

In a Phase 3 clinical trial, seladelpar met its primary endpoint of reducing alkaline phosphatase (ALP) levels, a marker of liver damage. The drug also improved other measures of liver function, including bilirubin levels and liver stiffness.

FDA Decision Expected Soon

The FDA is expected to make a decision on seladelpar's New Drug Application (NDA) in the coming months. If approved, seladelpar would be the first new drug approved for PBC in over 20 years.

Gilead's Liver Disease Portfolio

Gilead is a leading developer of drugs for liver diseases. The company's portfolio includes Harvoni, Epclusa, and Veklury, which are used to treat hepatitis C virus (HCV) infection.

The acquisition of seladelpar will expand Gilead's liver disease portfolio and give the company a potential new treatment for PBC.

Sources

• Gilead Sciences to Acquire CymaBay Therapeutics
• CymaBay Soars on $4.3B Gilead Deal as Seladelpar Nears FDA Review
• Gilead to Acquire CymaBay Therapeutics