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CymaBay Halts Study On Lead Clinical Program, Stock Crashes

CymaBay Halts Study On Lead Clinical Program, Stock Crashes

CymaBay Therapeutics Inc (NASDAQ: CBAY) shares are losing more than 75% of their value Monday after the company said it's halting the development of its lead drug, seladelpar.

What Happened

CymaBay said it is terminating two studies involving its lead liver drug seladelpar: a Phase 2b study in non-alcoholic steatohepatitis, or NASH, and a Phase 2 study in primary sclerosing cholangitis.

The company also said it putting on hold late-stage studies of the candidate in patients with primary biliary cholangitis pending further review and follow-up.

CymaBay said the decision to discontinue the studies was based on atypical histological findings from the histological assessments of the first tranche of liver biopsies in the Phase 2b study in NASH.

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The findings included histology characterized as an interface hepatitis presentation with or without biliary injury.

"The atypical histological findings in the NASH Phase 2b clinical study of seladelpar were observed in patients who demonstrated on-study improvement or stabilization of their biochemical measures of inflammation and liver injury and no liver-related adverse events after 52 weeks of treatment," CymaBay CEO Sujal Shah said in a statement. 

Why It's Important

Seladelpar is CymaBay's lead drug evaluated for multiple indications in mid- and late-stage studies.

CymaBay said it has initiated investigative actions to better understand the findings.

The stock was down 75.95% at $1.34 at the time of publication. 


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