MDGL - Investors Eye CymaBay's AFFIRM Study As Regulatory Uncertainties Ease | Benzinga
Thursday, CymaBay Therapeutics Inc (NASDAQ: CBAY) initiated the AFFIRM Phase 3b/4 confirmatory study to evaluate the effect of seladelpar on clinical outcomes in patients with compensated cirrhosis due to primary biliary cholangitis (PBC).
The AFFIRM study will enroll approximately 192 patients with PBC who have compensated cirrhosis.
William Blair (Reiterates Outperform rating) writes that the commencement of the confirmatory study alleviates a regulatory concern that has loomed over the entire industry.
This concern primarily ...