Morgan Stanley Cuts Intercept (ICPT) to Underweight on Ocaliva Label/Launch Concerns, NASH Read-Through

FBR Capital Remains on Sidelines with Intercept Pharmaceuticals (ICPT) Following FDA Panel Backing

FBR Capital analyst Vernon Bernardino reiterated a Market Perform rating and $192 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) after the FDA's Gastrointestinal (GI) Drugs Advisory Committee (GIDAC) supported accelerated approval of obeticholic acid (OCA) as a treatment for primary biliary cholangitis (PBC).

Bernardino commented,... More

Oppenheimer Reiterates $309 PT on Intercept Pharma (ICPT) Following FDA Panel Backing

The Gastrointestinal Drugs Advisory Committee of the FDA met to discuss the safety/efficacy of Intercept Pharmaceuticals' (NASDAQ: ICPT) Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis. The panel voted 17-0 in favor of recommending approval of Ocaliva in PBC based on the strong effects of the drug on ALP. The positive opinion by FDA on the appropriateness... More

Wedbush Reiterates Outperform, $423 PT on Intercept (ICPT) Following FDA Panel Backing

Wedbush analyst Liana Moussatos reiterated an Outperform rating and $423 acquisition value on Intercept Pharmaceuticals (NASDAQ: ICPT) after the Gastrointestinal Drugs Advisory Committee (GIDAC) voted unanimously (17 yes, 0 no, 0 abstain) in favor of accelerated approval for OCA (trade name Ocaliva ) as second line treatment for primary biliary cholangitis (PBC).

Moussatos commented, "PBC is a... More

Panel Backing of OCA was Expected, Leerink Partners Says; Remains Sidelined

Leerink Partners analyst Joseph Schwartz reiterated a Market Perform and $144 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) following a unanimous FDA AdCom vote for OCA approval. The analyst said the positive panel outcome was already incorporated in its investment thesis.

Schwartz commented, "the Gastrointestinal... More

Intercept (ICPT) AdCom Couldn't Have Gone Better, Baird Says; Notes Gilead (GILD) Exec in the Audience

Baird analyst Brian Skorney reiterated an Outperform rating and $332 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) following a positive FDA AdCom. The firm is confident in OCA will be approved on or before the May 29 PDUFA date.

Skorney commented, "To say it couldnt have gone... More

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... More

Intercept (ICPT) Announces Unanimous FDA Committee Recommendation for Accelerated Approval of OCA as PBC Treatment

Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) announced that the U.S. Food and Drug Administration (FDA)s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). The target date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is May 29, 2016. The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines. If approved, Ocaliva would be the first new treatment... More

Intercept Pharma's (ICPT) OCA wins FDA panel backing in PBC

(Updated - April 7, 2016 3:51 PM EDT)

Intercept Pharma (NASDAQ: ICPT) OCA wins FDA panel backing in PBC.

UPDATE - The FDA voted 17-0 that the Intercept drug should be approved.

For briefing docs posted ahead of today's meeting, click here.

Shares of Intercept are currently halted.