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The New Drug Application submission is supported by data from a pair of phase 3 studies, a long-term open-label study, and prior phase 2 studies. Cymabay has also requested Priority Review of the NDA.
CymaBay Therapeutics, Inc. , a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug...
Results from RESPONSE show seladelpar may improve measures of disease activity and reduce symptom burden in patients with PBC.
Interim analysis of ongoing Phase 2 study shows combination of OCA 5-10 mg + bezafibrate 400 mg improved levels of multiple biochemical markers associated with clinical outcomes in PBC including ALP,... | June 7, 2023
Primary Biliary Cholangitis is a rare, progressive, chronic autoimmune disease of the liver in which the small bile ducts are gradually destroyed, causing bile and other toxins to build up in the liver (known as cholestasis).