Needham & Company Reiterates Buy on Intercept Pharma (ICPT) Following Positive FDA Panel Vote on Obeticholic Acid

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

After-Hours Stock Movers 04/07: (ICPT) (DLTH) (DEPO) Higher; (DRRX) (RT) (GPS) Lower (more...)

Today's after-hours movers:

DURECT Corporation (Nasdaq: DRRX) 21% LOWER; announced that after the PERSIST Phase 3 trial for POSIMIR® was underway and enrolling patients at multiple sites, the Company received a letter from FDA advising the Company to make a number of amendments to the PERSIST trial. One of the recommendations was to incorporate standard bupivacaine HCl as an active control. The Company had a follow-up call with the FDA this week to discuss the advice letter, as a result of which the Company has decided to... More

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

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

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.

Notable Analyst Rating Changes 4/7: (MTH) (GT) (CBRL) Upgraded; (VZ) (HOG) (FFIV) Downgraded

UPGRADES
Barclays upgrades Meritage Homes (NYSE: MTH) from Equalweight to Overweight, while moving its price target from $36 to $42.

KeyBanc raises Goodyear Tire & Rubber (Nasdaq: GT) from Sector Weight to Overweight with... More

Pre-Open Stock Movers 04/07: (SUNE) (ICPT) (OLLI) (VRX) Higher; (ALDR) (TWTR) (YHOO) Lower (more...)

Today's pre-open stock movers:

SunEdison (NYSE: SUNE) 12% HIGHER; adds to recent gains

Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) 11.8% HIGHER; gained ahead of today's FDA AdCom; currently halted.

Ollie's Bargain Outlet (NASDAQ: OLLI) 11% HIGHER; reported Q4 EPS of $0.31, $0.03 better than the analyst estimate of $0.28. Revenue for the quarter came in at $243.4 million... More

Intercept Pharma (ICPT) Halted Ahead of FDA AdCom for OCA

Intercept Pharma (NASDAQ: ICPT) is halted today ahead of an FDA adcom for its obeticholic acid (OCA) in primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC).

FDA briefing documents were recently... More

After-Hours Stock Movers 04/06: (OLLI) (APOG) (VRX) Higher; (RPTP) (ALDR) (EBAY) Lower (more...)

Ollie's Bargain Outlet (NASDAQ: OLLI) 5.7% HIGHER; reported Q4 EPS of $0.31, $0.03 better than the analyst estimate of $0.28. Revenue for the quarter came in at $243.4 million versus the consensus estimate of $239.06 million. Comparable store sales increased 5.0%.

Raptor Pharmaceuticals Corp. (NASDAQ: RPTP) 4.5% LOWER; gives back some intra-day gains... More

BMO Capital Starts Intercept Pharmaceuticals (ICPT) at Outperform

BMO Capital initiates coverage on Intercept Pharmaceuticals (NASDAQ: ICPT) with a Outperform rating and a price target of $239.00.

Analyst M. Ian Somaiya commented: "We are initiating coverage on ICPT with an Outperform rating and $239 PT. Our Outperform rating is based on our belief that OCAs approval in PBC... More

PBC Committee Opens The Door to $2.2B Opportunity For Intercept Pharma (ICPT) - Wedbush

Wedbush analyst, Liana Moussatos, reviewed the FDA's briefing documents for Intercept Pharmaceuticals (NASDAQ: ICPT) obeticholic acid (OCA) in primary biliary cholangitis (PBC) Advisory Committee meeting and does not see any major red flags for approval.

As the analyst anticipated, the FDA appears to be focused on the validity of the primary endpoints (ALP... More