CymaBay Starts Phase 3b/4 Study in Cirrhosis due to Primary Biliary Cholangitis

 AFFIRM is a unique event-driven, fixed-duration design intended to reduce the challenges for patient participation

Data will be used to support post-marketing regulatory requirements for seladelpar’s accelerated approval pathway

https://www.biospace.com/article/releases/cymabay-initiates-affirm-a-phase-3b-4-study-evaluating-the-effect-of-seladelpar-on-clinical-outcomes-in-patients-with-cirrhosis-due-to-primary-biliary-cholangitis/