CymaBay Therapeutics Inc
CBAY · NASDAQ
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. CymaBay is developing seladelpar, a potent, selective, orally active PPARδ agonist for patients with primary biliary cholangitis (PBC). Seladelpar has received an orphan designation from the US Food and Drug administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA for early stage PBC and PRIority MEdicines status from the EMA. CymaBay is currently commencing a global, Phase 3 registration study of seladelpar for PBC. This study is a 52-week, placebo-controlled, randomized, phase 3 study to evaluate the safety and efficacy of seladelpar (RESPONSE) in patients with PBC.