BioCentury
ARTICLE | Clinical News

Additional study needed for RedHill's Crohn disease candidate

August 3, 2018 5:18 PM UTC

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) said another Phase III trial is "most likely to be required" to support an NDA submission to FDA for Crohn disease candidate RHB-104.

On a conference call to discuss data from the Phase III MAP US trial of RHB-104, the company said it will have to show efficacy at 52 weeks to support the candidate's approval. RedHill did not disclose when it plans to start an additional trial, but said it plans to meet with FDA to discuss next steps...

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RedHill Biopharma Ltd.