Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection

Executive Summary

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.

You may also be interested in...



EASL Updates: Intercept Says Biomarker Data Bolster OCA’s Case For Fibrosis Benefit

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.

Quick Listen: Scrip’s Five Must-Know Things

Join us for a quick audio roundup of five useful things to know from Scrip's recent coverage of the global biopharmaceutical industry.

NASH Backlash: Intercept Delay Raises Questions

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134043

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel