Needham & Company Reiterates Buy on Intercept Pharma (ICPT) Following Positive FDA Panel Vote on Obeticholic Acid
Needham & Company reiterated a Buy rating and $350.00 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) following an FDA panel vote in favor of Obeticholic Acid approval.
Analyst Alan Carr commented, "The FDA Gastrointestinal Drugs Advisory Committee voted yesterday 17-0 in favor of Obeticholic Acid (OCA; Ocaliva) approval for treatment of Primary Biliary Cirrhosis (PBC). The committee did not object to use of ALP as a surrogate endpoint for accelerated approval. Changes to ongoing COBALT Phase 3b trial are a possibility in order to further explore efficacy as monotherapy and in patients with more severe PBC and/ or more severe liver disease (e.g. Child Class B and C). Although the FDA appeared open to use in patients with decompensated cirrhosis, the committee was more hesitant. Regardless, this represents <10% of PBC patient population. We expect FDA to approve the drug by 5/29/16 PDUFA date and assume launch shortly thereafter in Jun 2016. We reiterate BUY."
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Shares of Intercept Pharmaceuticals closed at $163.83 yesterday.