Intercept Pharmaceuticals Inc.'s shares look set for a weak open Monday after the biopharmaceutical company said top-line data from its late-stage trial of patients with compensated cirrhosis will be delayed.
Intercept said the data is now expected in the first quarter of next year, rather than near the end of this year as previously anticipated.
In premarket trading, the shares were 4.3% lower after ending Friday at $17.14, down more than 30% since the end of last year.
Michelle Berrey, the company's chief medical officer and president of research and development, said Intercept teams continue to receive data and are working toward locking the database for the study.
"As a result of the magnitude and complexity of these analyses and recognizing that we are relying on external parties for information and services, we expect these analyses, including the completion of biopsy readings and safety adjudications, to continue into the first quarter of 2022," she said.
The company said Reverse is the only active late-stage Phase 3 study in patients with compensated cirrhosis due to NASH, a serious disease for which there are no approved pharmacologic therapies. The liver biopsy samples from Reverse are being evaluated utilizing a new consensus methodology, it said.
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