Gilead Sciences, Inc. and CymaBay Therapeutics, Inc. announced today a definitive agreement whereby Gilead will acquire CymaBay for $32.50 per share in cash, amounting to a total equity value of $4.3 billion. This acquisition strategically integrates CymaBay’s leading investigational product, seladelpar, into Gilead’s extensive liver treatment portfolio, reinforcing its commitment to delivering groundbreaking medications to patients.

“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 Therapeutics.

Gilead's Chairman and CEO, Daniel O’Day, expressed enthusiasm about the collaboration, stating, “We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases.”

Primary Biliary Cholangitis (PBC), a rare chronic liver disease primarily affecting women, poses significant challenges to patients' quality of life. Symptoms include pruritus (itching) and fatigue, often leading to severe impairment of liver function. Seladelpar, an oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, demonstrates promise in regulating critical metabolic and liver disease pathways.

The United States Food and Drug Administration (FDA) has granted priority review to seladelpar, with an anticipated approval date in the third quarter of 2024. Breakthrough Therapy Designation and Orphan Drug Designation further underscore the potential of seladelpar in addressing the unmet needs of PBC patients.

In pivotal Phase 3 trials, seladelpar showcased significant efficacy over placebo, achieving statistical significance across primary composite endpoints including biochemical response and normalization of alkaline phosphatase. Notably, patients also experienced a substantial improvement in pruritus, offering a promising therapeutic avenue for those with moderate-to-severe itch.

Transaction Details

The acquisition, subject to regulatory approvals and customary closing conditions, is expected to conclude in the first quarter of 2024. Financial advisors BofA Securities, Inc. and Guggenheim Securities, LLC represent Gilead, while Centerview Partners LLC and Lazard advise CymaBay.

Upon FDA approval, the transaction is projected to bolster Gilead’s revenue growth, with earnings per share expected to be neutral in 2025 and significantly accretive thereafter.