Gilead’s $4.3B Acquisition of CymaBay Yields FDA Approval for Autoimmune Liver Disease Treatment

Gilead's Acquisition:
Gilead Sciences acquired CymaBay for $4.3 billion, gaining ownership of seladelpar, a drug candidate for primary biliary cholangitis (PBC), an autoimmune liver disease.

FDA Approval:
The FDA approved seladelpar for the treatment of PBC, following positive results from Phase III RESPONSE and ENHANCE studies, as well as the long-term open-label ASSURE trial.

Mechanism of Action:
Seladelpar is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist that works by blocking the PPARδ protein, which is central to lipid metabolism and inflammation, helping regulate the immune response in PBC patients.

Clinical Benefits:
Interim late-stage data from the ASSURE trial showed a significant reduction in pruritus and normalization of alkaline phosphatase levels in patients treated with seladelpar.

Financial Impact:
Gilead paid $320 million to buy out the royalty deal with J&J for seladelpar, eliminating the need to pay up to an 8% royalty on net sales.