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."

For an analyst ratings summary and ratings history on Intercept Pharmaceuticals click here. For more ratings news on Intercept Pharmaceuticals click here.

Shares of Intercept Pharmaceuticals closed at $163.83 yesterday.

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