Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) says it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for obeticholic acid (OCA) its treatment of fibrosis due to nonalcoholoic steatohepatitis (NASH). The stock was crushed early on Monday.
The CRL indicated that, based on the data the FDA has reviewed to date, the agency determined that the predicted benefit of OCA remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.
Going forward, the FDA recommends that Intercept Pharma submit additional post-interim analysis efficacy and safety data from the ongoing Regenerate study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue.
Previously, the company noted that, based on the FDA’s decision to postpone a tentatively scheduled advisory committee meeting, it was expected that the FDA’s review of its NDA would extend beyond the PDUFA goal date.
OCA is the only investigational NASH drug with Breakthrough Therapy designation, and it has uniquely demonstrated reproducible ability to reverse or otherwise stabilize liver fibrosis in patients with advanced fibrosis due to NASH.
Intercept Pharma stock closed Friday at $77.49, in a 52-week range of $47.57 to $125.00. The consensus price target is $143.22. Following the announcement, the stock was down about 37% at $48.48 in early trading indications Monday.
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