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News Breaks
April 12, 2014
20:04 EDTICPTIntercept reports additional positive data from POISE trial at EASL
Intercept Pharmaceuticals announced efficacy and safety results from the Phase 3 POISE trial of obeticholic acid, OCA, for the treatment of primary biliary cirrhosis, PBC, to be presented in a late-breaker session at the International Liver Congress of the European Association for the Study of the Liver, EASL. OCA, Intercept's lead product candidate, is a bile acid analog and first-in-class agonist of the farnesoid X receptor, FXR in development for PBC, nonalcoholic steatohepatitis, NASH, and other liver and intestinal diseases. As previously reported, the POISE trial met its primary endpoint with high statistical significance, demonstrating OCA's efficacy on a composite liver biochemical endpoint which has been shown to strongly correlate with improved clinical outcomes. The proportion of patients meeting the POISE primary endpoint was: 10% in the placebo group, 47% in the 10 mg OCA group and 46% in the 5-10 mg OCA group. New data in the presentation show that OCA treated patients achieved a highly statistically significant reduction in alkaline phosphatase, ALP, as early as two weeks, with a peak effect achieved by six months.Pruritus, generally mild to moderate, was the most frequently reported adverse event in the POISE trial. However, only 1% of the patients in the OCA 5-10 mg titration group discontinued therapy due to pruritus after moving up to the 10 mg dose, as compared to seven, 10%, of the patients in the 10 mg OCA group. Additional data presented show that the incidence and severity of OCA related pruritus diminishes with time on therapy. Specifically, pruritus scores were no different from placebo in both OCA treatment groups during the second half of the trial.
News For ICPT From The Last 14 Days
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February 12, 2016
16:24 EDTICPTOn The Fly: Top stock stories for Friday
Stocks began the session in positive territory and never looked back. The early catalyst was a rally in oil prices, which continued moving higher throughout the day and settled up more than 12%. The rally was spurred by comments that came to light late in the day yesterday from the United Arab Emirates' energy minister, who said the Organization of the Petroleum Exporting Countries was willing to cooperate on an output cut. Despite today's strong performance by each of the major equity indexes, the market still had a down week, as today's rally came on the heels of four very tough days. U.S. markets will be closed Monday for President's Day, but Chinese markets will reopen after being closed all of this week for their celebration of New Year. ECONOMIC EVENTS: In the U.S., retail sales increased 0.2% in January, versus expectations for an increase of 0.1%. Import prices dropped 1.1%, while export prices fell 0.8% last month. The University of Michigan's consumer sentiment index fell to 90.7 in the preliminary February print, versus expectations for a 92.3 reading. In Europe, the euro zone's gross domestic product grew by 0.3% in the last three months of 2015, meeting expectations. In Asia, Japan suffered another ugly day, with its key indexes each falling about 5%, after the market reopened following a one-day holiday. COMPANY NEWS: Shares of Jack Dorsey's point-of-sale payment firm Square (SQ) advanced 7.9% to $9.30 after credit card giant Visa (V) disclosed details about the stake it holds in the company. Visa, which made an investment in the start-up prior to its IPO, disclosed in a filing that it owns Class B shares of Square that could be converted into about 3.52M Class A shares, which would leave Visa with about 10% of that class of shares. Shares of Twitter (TWTR), which is also headed by Jack Dorsey, followed Square higher, rising 11% to $15.89... Also rising were shares of JPMorgan (JPM), which gained 8.3% to close at $57.46 after CEO Jamie Dimon disclosed he bought 500,000 shares of the bank's stock in the open market yesterday. MAJOR MOVERS: Among the noteworthy gainers was Intercept Pharmaceuticals (ICPT), which jumped 27.5% to $120.22 after Reuters reported that the company received interest from potential suitors and is now exploring a possible sale. Also higher was Groupon (GRPN), which rallied 29% to $2.89 after the Internet deal service operator reported better than expected quarterly results. Among the notable losers was Pandora (P), which fell 12% to $7.99 after the company reported lower than expected fourth quarter earnings after last night's closing bell. The pullback comes on the heels of the stock's 8.5% advance yesterday after the New York Times said the music service operator has held talks about selling the company. On the company's earnings conference call last night, Pandora's management said that they won't comment on any potential sale of the company, adding that they are "very confident" in their ability to continue to drive significant value for holders. Also lower after reporting quarterly results was videogame maker Activision Blizzard (ATVI), which slid 7.9%. Meanwhile, shares of L Brands (LB) fell 2.5% after announcing that Victoria's Secret CEO Sharen Jester Turney will resign. INDEXES: The Dow rose 313.66, or 2.0%, to 15,973.84, the Nasdaq gained 70.68, or 1.66%, to 4,337.51, and the S&P 500 added 35.70, or 1.95%, to 1,864.78.
13:55 EDTICPTRBC thinks Intercept values itself more than any bidder can pay
RBC Capital analyst Michael Yee believes Intercept Pharmaceuticals (ICPT) thinks it is worth more than a bidder would be willing to pay at this time. Suitor interest is not surprising given Intercept's pending approval in the summer, but a near-term takeover is unlikely since the FDA hasn't even held a panel meeting for the company's lead drug OCA, Yee tell investors in a research note after Reuters reported that the company received interest and is exploring a possible sale. The analyst thinks Intercept could be synergistic for companies like Gilead (GILD), Merck (MRK), Bristol-Myers (BMY), Sanofi (SNY) and AstraZeneca (AZN). Yee has an Outperform rating on stock with a $300 price target. Intercept is rallying 25%, or $24.07, to $118.36 in afternoon trading.
13:49 EDTICPTIntercept deal could drag biotech sector out of doldrums, says Oppenheimer
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13:29 EDTICPTIntercept sale unlikely before FDA panel meeting, says Wells Fargo
12:51 EDTICPTIntercept said to explore sale after suitors reportedly come calling
Shares of Intercept Pharmaceuticals (ICPT), which has often been rumored in the past to be a potential takeover target, are surging in afternoon trading after Reuters reported that the company is exploring a potential sale. WHAT'S NEW: Reuters, citing people familiar with the matter, said the company, which focuses on treatments for liver disease, has been working with investment banker advisors to explore a sale after receiving interest from other companies. PRIOR CHATTER: Earlier this week, United Kingdom blog Proactive Investors discussed "reheated rumors" of a takeover of Intercept, which claimed the company was teaming up with CenterView Partners to advise on a sale. It mentioned AstraZeneca (AZN) as a possible suitor now that Shire (SHPG) has reached an agreement to acquire Baxalta (BXLT). On February 2, the U.K.'s Daily Mail said rumors that several big-name pharmaceutical companies were interested in Intercept had been "doing the rounds again," noting that trader chatter pointed to purported interest from Shire, Gilead (GILD), Bristol-Myers (BMY) and Pfizer (PFE). WHAT'S NOTABLE: Yesterday, the FDA issued a notice to announce a forthcoming meeting of the Gastrointestinal Drugs Advisory Committee to discuss the new drug application for obeticholic acid oral tablets submitted by Intercept Pharmaceuticals, proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. PRICE ACTION: In afternoon trading, Intercept jumped 35% to $127.85 per share. Reference Link
12:20 EDTICPTIntercept jumps 8%, halted for circuit breaker after Reuters says exploring sale
12:19 EDTICPTIntercept explores sales after receiving interest, Reuters reports
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February 11, 2016
09:01 EDTICPTFDA panel to meet April 7 to discuss Intercept NDA for obeticholic acid
The FDA issued a notice to announce a forthcoming meeting of the Gastrointestinal Drugs Advisory Committee to discuss the new drug application for obeticholic acid oral tablets submitted by Intercept Pharmaceuticals, Inc., proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. The FDA said it intends to make background material available to the public no later than 2 business days before the meeting, which is scheduled to be held on April 7. Reference Link
February 9, 2016
09:56 EDTICPTIntercept higher following report of vague takeover chatter
Shares of Intercept Pharmaceuticals (ICPT) are moving after United Kingdom blog Proactive Investors discussed "reheated rumours" of a takeover. "Vague talk" has Intercept teaming up with CenterView Partners to advise on a sale, the blog states. It mentions AstraZeneca (AZN) as a possible suitor now that Shire (SHPG) has reached an agreement to acquire Baxalta (BXLT). Shares of Intercept, which is developing treatments for chronic liver diseases, are up 4% to $97.39 in early trading.
09:50 EDTICPTIntercept rumored to be working with advisor on sale, Proactive Investors says
There was "vague talk" in the market that Intercept (ICPT) has hired CenterView Partners as an advisor to explore a sale and "attention is said to have switched" to AstraZeneca (AZN) as one of a number of possible buyers, according to Proactive Investors. Reference Link
February 2, 2016
09:46 EDTICPTIntercept rumored to draw interest from many suitors, Daily Mail says
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