No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection
Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.
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A complete response letter from the FDA in June knocked Intercept’s stock price down to 2014 levels, but perhaps the regulator is sending wider messages about NASH.
Follow-up Phase IIa data shows strong antifibrotic and NASH-resolution effects for Akero’s efruxifermin, an FGF21 analog. Analysts are calling the drug potentially best in class.