CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, announced today that the Food and Drug Administration (FDA) lifted clinical holds on seladelpar for all three Investigational New Drug (IND) Applications in Nonalcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis (PSC).

"This is a pivotal event for seladelpar, which had garnered a high degree of patient interest based on its promising potential for anti-cholestatic, anti-inflammatory and reduced symptom burden in patients with PBC. We are gratified and energized to be able to once again advance seladelpar into a registrational program to confirm its benefit. It is our unwavering goal to one day make it available to patients with PBC, and potentially for other chronic, inflammatory liver diseases,” said Sujal Shah, Chief Executive Officer of CymaBay. “We look forward to working with the medical and patient advocacy communities and with regulators to re-initiate development of seladelpar.”

On November 25, 2019, CymaBay halted all clinical trials of seladelpar after atypical histologic findings with no clinical or laboratory correlates were identified at the planned end-of treatment biopsy review of a 52-week Phase 2 NASH study. The FDA concurred with this decision and placed all active INDs for seladelpar on clinical hold. CymaBay committed to an in-depth investigation of these findings and comprehensive safety evaluation that concluded with an independent, expert panel review involving some of the world’s leading liver pathologists and hepatologists. The expert panel found no clinical, biochemical or histological evidence of seladelpar-related liver injury in the Phase 2 NASH study and unanimously supported re-initiating clinical development of seladelpar pending approval by the FDA. Based on the results of the investigation and the expert panel conclusions, FDA concluded that clinical trials for NASH, PBC and PSC may resume.