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Stock Market & Financial Investment News

News Breaks
August 12, 2014
10:15 EDTCNAT, ICPTIntercept surges after reporting data for liver disease drug OCA
Shares of drug developer Intercept Pharmaceuticals (ICPT) are sharply higher after data from a trial of its liver disease drug OCA showed improved safety as well as a statistical benefit in reversing liver fibrosis. WHAT'S NEW: In a regulatory filing last night, Intercept disclosed that the National Institute of Diabetes and Digestive and Kidney Diseases, or NIDDK, recently provided the company with a draft manuscript intended for publication that describes the results from the FLINT trial of the company's obeticholic acid, or OCA. The drug is being studied as a treatment for late stage nonalcoholic steatohepatitis, also known as NASH, which affects about 8M people in the U.S. each year and causes victims to die unless they receive liver transplants. The proportion of patients meeting the FLINT primary histological endpoint, defined as a decrease in the NAFLD Activity Score of at least two points with no worsening of fibrosis, was 46% in the OCA treatment group and 21% in the placebo treatment group, the draft manuscript stated. WHAT'S NOTABLE: In late May, shares of Intercept Pharmaceuticals dropped following allegations that the company knew last January that the FLINT trial was halted partially due to patients' abnormal cholesterol levels, but did not disclose the information to investors. ANALYST OPINION: Leerink analyst Joseph Schwartz upgraded shares of Intercept to Outperform from Market Perform after the company provided more detailed top-line FLINT data in its quarterly filing. The analyst said he was encouraged by the removal of the prior imbalance in serious adverse events and that the magnitude of adverse lipid changes was also less than expected. Schwartz increased his estimate that the drug will succeed in being approved as a NASH treatment to an 85% chance from a prior 60% chance and raised his price target on the stock to $445 from $270. Following the trial data, Citibank also issued a note to investors with positive commentary on Intercept. Citi analyst Jonathan Eckard said the biggest surprise in the disclosure was that the updated assessment of the safety data by the NIH, which concluded that there was not an imbalance of cardiovascular events. He viewed this as "a big win" that meaningfully improves the drug's regulatory path. Eckard added that physician sentiment on the drug's potential for fibrosis benefit were very low and he expects that the trial results will cause a "significant shift" in the outlook for OCA among doctors. Citi maintain its Buy rating and $693 price target on shares of Intercept. ANOTHER TO WATCH: Conatus Pharmaceuticals initiated a Phase 2 trial of its own drug, emricasan, in patients with NAFLD including patients with NASH in March and expects top-line results from the Phase 2 trial in the second half of 2014. PRICE ACTION: In early trading, shares of Intercept advanced $70.65, or 29.79%, to $307.92, while Conatus gained 36c, or 4.78%, to $7.90.
News For ICPT;CNAT From The Last 14 Days
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November 14, 2014
15:22 EDTICPTIntercept CEO says company 'very well-positioned' in terms of balance sheet
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11:03 EDTCNATConatus management to meet with Roth Capital
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November 12, 2014
16:09 EDTCNATConatus reports Q3 EPS (42c), consensus (44c)
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12:00 EDTICPTKOLs say 'remains to be seen' if OCA can get accelerated approval, says Leerink
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11:55 EDTICPTIntercept not part of talks with journals, says Deutsche Bank
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November 11, 2014
12:00 EDTICPTIntercept results said to be rejected by New England Journal, Bloomberg says
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November 10, 2014
08:36 EDTICPTIntercept price target lowered to $125 from $172 at FBR Capital
FBR Capital lowered its price target for Intercept shares to $125 saying its talks with experts and cardiologists indicate the company's OCA drug is unlikely to be a "silver bullet" for the treatment of nonalcoholic steatohepatitis. FBR notes that while OCA appears to improve the liver, the drug worsens many of the other derangements like lipid and glucose homeostasis. FBR decreased the probability of success in NASH to 55% from 60%, and lowered its peak OCA sales estimate to $5.2B. It keeps an Underperform rating on Intercept shares.

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