CymaBay, based in the US near San Francisco, California, has developed the investigational drug seladelpar, which is currently in clinical Phase 3. Seladelpar is intended for the treatment of primary biliary cholangitis (PBC), a rare, chronic liver disease mainly affecting women. Progression of PBC is associated with an increased risk of liver-related mortality.

The US Food and Drug Administration (FDA) has accepted a New Drug Application for seladelpar and granted priority review.

“We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” said Daniel O’Day, chairman and CEO of Gilead. “Building on the strong research and development work by the CymaBay team to date, we have the potential to address a significant unmet need for people living with PBC and expand on our existing broad range of transformational therapies,” O’Day added.

“Today’s agreement with Gilead is the culmination of years of focus and determination at CymaBay to advance seladelpar and bring new hope to people living with PBC and their families,” said Sujal Shah, president and CEO at CymaBay. “Now that seladelpar has achieved priority review with the FDA, we are excited that Gilead, with its long-standing commitment to patients with liver disease, can apply its regulatory and commercial expertise to bring seladelpar as quickly as possible to people with PBC.”

The transaction has been approved by the boards of directors of both Gilead and CymaBay and is expected to close in the first quarter of 2024, subject to regulatory approvals and other customary closing conditions.