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NGM’s closely-watched NASH prospect flops, cutting shares in half and spurring R&D rethink

A phase 2b trial of NGM Biopharmaceuticals’ aldafermin in nonalcoholic steatohepatitis (NASH) has missed [1] its primary endpoint, sending shares in the biotech tumbling. NGM has pulled plans to enter phase 3 in light of the midstage failure of the FGF19 analog.

California-based NGM ramped up expectations for aldafermin last year when it delivered midphase data linking the drug to a significant reduction in absolute liver fat content and improvements on a clutch of other measures. Yet, like other NASH drug developers before it, NGM has now found that a positive biomarker result can fail to translate into improvements in histology outcomes.

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