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ARTICLE | Product Development

Akero’s NASH readout spreads worries to others in class

Despite miss on fibrosis endpoint, biotech touts strong performance on disease resolution, says totality of data support Phase III start

October 10, 2023 10:24 PM UTC

Investors are interpreting a disappointing readout for Akero’s NASH candidate as troublesome for the FGF21 class, although it’s possible that the therapy will show deepening efficacy in cirrhotic patients as the trial continues toward completion.

Akero Therapeutics Inc. (NASDAQ:AKRO) lost about $1.7 billion in market cap Tuesday after reporting that neither dose of efruxifermin led to significant improvements in fibrosis among patients at the F4 stage of non-alcoholic steatohepatitis, missing the Phase IIb SYMMETRY study’s primary endpoint. At 36 weeks, the trial’s 50 mg dose led to at least one stage of fibrosis improvement in 24% of patients, and its 28 mg low dose did so in 22%; both showed a non-significant trend compared with 14% for placebo...

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