CymaBay Says Clinical Hold Lifted On Seladelpar INDs In NASH, PBC And PSC; Stock Up

(RTTNews) - CymaBay Therapeutics Inc. (CBAY) said that the U.S. Food and Drug Administration lifted clinical holds on seladelpar for all three Investigational New Drug (IND) Applications in Nonalcoholic Steatohepatitis or NASH, Primary Biliary Cholangitis or PBC and Primary Sclerosing Cholangitis or PSC.

In Thursday pre-market trade, CBAY was trading at $4.58, up $1.07 or 30.48%.

In November 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.

The company said 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 investigation and expert panel conclusions, FDA concluded that clinical trials for NASH, PBC and PSC may resume.