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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Intercept and Axcella provide updated data on their NASH programs at the International Liver Conference, while CymaBay offers the full dataset for seladelpar in PBC.
Join us for a quick audio roundup of five useful things to know from Scrip's recent coverage of the global biopharmaceutical industry.
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.