Yesterday, Intercept Pharmaceuticals Inc (NASDAQ: ICPT ) announced data from the new interim analysis of the Phase 3 REGENERATE trial evaluating obeticholic acid in nonalcoholic steatohepatitis (NASH).
Needham writes that the efficacy results were similar to the initial results announced in February 2019.
Core cardiovascular and renal events were low and balanced across treatment arms, but hepatic events were higher.
According to the management, these events were manageable, with the majority mild in severity.
A pre-submission meeting with the FDA is planned this month, with resubmission anticipated.
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