FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva™ (obeticholic acid) for the Treatment of PBC

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

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

(Updated - April 8, 2016 9:25 AM EDT)

Morgan Stanley downgraded Intercept Pharmaceuticals (NASDAQ: ICPT) from Equalweight to Underweight with a price target of $80 (prior $100). Cautious comments from analyst Andrew S Berens followed a favorable FDA panel vote supporting approval of Ocaliva in PBC. Berens believes concerns raised in the panel could impact the drug's label and eventual launch. He also thinks restrictions in cirrhotics could impact Ocaliva's potential in NASH.

"The panel unanimously recommended to approve the drug based on the surrogate endpoint used in the Phase 3 trial, but failed to... 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 Pharma (ICPT) to Resume Trading at 5:30 PM ET

Intercept Pharma (NASDAQ: ICPT) to Resume Trading at 5:30 PM ET