Gilead Sciences, Inc. has agreed to acquire CymaBay Therapeutics, Inc. for $4.3 billion, expanding its portfolio with seladelpar, a treatment for primary biliary cholangitis (PBC), including pruritus. The transaction, valuing CymaBay’s shares at $32.50 each in cash, will complement Gilead’s existing liver disease portfolio and reaffirm its commitment to liver health.
Seladelpar, an investigational oral PPARδ agonist, is anticipated to receive FDA approval in the third quarter of 2024, having already received priority review. Demonstrating a best-in-disease profile for second-line PBC in Phase 3 trials, seladelpar targets critical metabolic and liver disease pathways, offering potential relief for PBC symptoms like itching and fatigue.
Daniel O’Day, Chairman and CEO of Gilead Sciences, expressed the company’s eagerness to advance seladelpar, utilizing expertise in liver disease treatment to address the unmet needs of PBC patients. He recognized the significant work done by CymaBay in developing seladelpar, aiming to add it to Gilead’s range of therapeutic options.
PBC primarily affects women over 40 and can lead to liver malfunction and reduced quality of life. With the FDA granting seladelpar Breakthrough Therapy Designation for pruritus treatment in PBC patients without or with compensated cirrhosis, as well as Orphan Drug Designation in the U.S. and PRIME status in Europe, seladelpar represents a marked advancement in PBC therapy.
The Phase 3 RESPONSE trial showcased seladelpar’s efficacy, achieving statistical significance over placebo in primary composite endpoints and showing a substantial reduction in pruritus among patients with moderate-to-severe symptoms.
CymaBay’s President and CEO, Sujal Shah, views the agreement with Gilead as the result of years dedicated to developing seladelpar and a step toward bringing new treatment opportunities to PBC patients and their families.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
