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Intercept Commits To Resubmitting NASH NDA, But Analysts See Conflicting Signs

 
• By Joseph Haas

CEO Durso says Intercept is aiming to refile its NDA by end of 2021, but several departures in recent months indicate pessimism on NASH prospects to some analysts.

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Analysts wonder if Intercept is de-emphasizing NASH to focus on PBC

Market analysts have been trying to read the tea leaves regarding Intercept Pharmaceuticals, Inc.’s prospects for getting obeticholic acid (OCA) refiled for US approval in non-alcoholic steatohepatitis for months now, and while the firm’s fourth quarter/full-year 2020 earnings call on 25 February offered assurances about refiling the new drug application by year’s end, those same analysts don’t seem fully convinced.

New CEO Jerome Durso, promoted from chief operating officer on 1 January as long-time former CEO Mark Pruzanski retired and took a seat on the Intercept board, opened the investor call by noting other recent management changes

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