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
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CymaBay Therapeutics, Inc. (NASDAQ:CBAY) has initiated a Phase 3b/4 study, AFFIRM, to evaluate the effect of seladelpar on clinical outcomes in patients with cirrhosis due to primary biliary cholangitis (PBC). The study is designed to fulfill post-marketing requirements of the accelerated approval pathway for seladelpar. The study will enroll approximately 192 patients and will last for three years.
September 21, 2023 | 12:08 pm
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CymaBay's initiation of the AFFIRM study could potentially lead to the accelerated approval of seladelpar, which would be a significant milestone for the company.
The initiation of the AFFIRM study is a significant step for CymaBay as it could potentially lead to the accelerated approval of seladelpar. This would be a major milestone for the company and could have a positive impact on its stock price in the short term.
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