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Intercept Shares Skyrocket on NASH Trial Data, Galectin Shares Jump Too

By  +Follow January 9, 2014 9:39AM
Tickers Mentioned:

Even those that have been around the market for decades don’t often see the type of move that shares of Intercept Pharmaceuticals, Inc. (ICPT) are making on Thursday. Shares have ballooned to add more than $4 billion to the market capitalization of Intercept on positive news from a Phase 2 clinical trial.

ICPT Could Have Effective Treatment for Fatty Liver Disease

The company said that the FLINT trial of its lead drug candidate obeticholic acid, or OCA, for the treatment of nonalcoholic steatohepatitis, or “NASH” or fatty liver disease as its more often called, was halted early because a planned interim analysis showed that it has met its primary efficacy endpoint. NASH is a chronic liver condition caused by excessive fat accumulation in the liver that can lead to fibrosis (scarring) and can progress into cirrhosis (severe scarring) and eventually liver failure.

There are no approved drugs for NASH, which has grown to epidemic proportions in the U.S., with about 12 percent of the population estimated to have the disease. Worse yet, it’s a silent killer, often not presenting symptoms until advanced stages.

Double-Blind Trial for OCA Stopped Early

The double-blind, placebo-controlled trial enrolled 283 patients with NASH (verified by a liver biopsy) across 8 U.S. sites.  Patients were either treated with a 25 mg dose of obeticholic acid or given a placebo for 72 weeks. Biopsies were taken again at the end of the trial and compared to the initial biopsies utilizing a NAFLD (Non-Alcoholic Fatty Liver Disease) Activity Score. The analysis of the data showed patients in the treatment arm to have a “highly statistically significant improvement” in the primary histological endpoint.

"The unexpected early stopping of FLINT due to OCA meeting the primary endpoint with such high significance is a major milestone," said Dr. Mark Pruzanski, chief executive of Intercept.

Intercept, an expert in bile acid chemistry, is evaluating OCA in three separate Phase 2 clinical trials (for portal hypertension, NASH and bile acid diarrhea) and a Phase 3 trial for primary biliary cirrhosis. The company currently does not have any approved drugs in its portfolio, so the lofty valuation is based on speculation that Intercept can bring a liver drug to market, likely resulting in blockbuster sales given the massive unmet medical need.

Shares of ICPT are trading ahead by 273 percent at $269.70 in Thursday action after closing Wednesday at $72.39. Shares printed as high at $305 in morning action (+318%).

GALT Also on the Rise on Fatty Liver Disease Treatment

Also making a run today is Galectin Therapeutics (GALT) , a pioneer in the industry space that is conducting a Phase 1 trial of GR-MD-02 in NASH patients with advancedfibrosis under a Fast Track designation that was granted by the U.S. FDA in August. 

Why the share appreciation for Galectin upon the Intercept news?  For starters, Intercept is putting a bright spotlight on the void on pharmacy shelves for drugs to treat fatty liver disease and subsequent, more serious diseases and the massive market potential of successfully developing a new drug.  Secondly, Galectin has a patent on a treatment for NASH that includes GR-MD-02 in combination with obeticholic acid, so OCA demonstrating efficacy could be valuable to Galectin in the future. Thirdly, there is still an important difference in the Phase 1 trial for NASH that is being conducted by Galectin and the Phase 2 trial of Intercept that is certainly worth noting.

Simply put, Intercept’s trial enrolled NASH patients with minimal fibrosis and Galectin is enrolling NASH patients with advanced fibrosis. That’s an important distinction because of the slow-developing nature of NASH that begins with little to no scarring before progressing to cirrhosis, meaning that the degree of scarring has a meaningful impact on clinical consequences. Pre-clinical research by Galectin showed GR-MD-02 to reverse fibrosis and cirrhosis in animal models, an effect that it is now being evaluated in humans, which could be more clinically significant than Intercept’s results.

That’s by no means to downplay the importance of Intercept’s clinical data or how valuable it can be to the company and the millions of people with fatty liver disease. It is, though, an explanation of a relevant difference between the two target indications and a highlight of the potential future growth in valuation of Galectin, being that its market cap is 96-percent less than that of Intercept.

The last update from Galectin in November said that 5 of 8 patients in first cohort of the blinded Phase 1 trial have been enrolled and infused with GR-MD-02. At the time of the update, no serious adverse advents had been reported. Data from the first cohort is anticipated early this year, which could serve as a catalytic moment for the company.

Shares of GALT are ahead by 46 percent in Thursday trading, climbing up to $12.37, equating to a market capitalization of approximately $226 million. 

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions.

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Results for icpt
James DiPlata
6 Mar 15 14:24:40
RT @OsirisWealth: Great week $BIDU 400% $LL 200% $AAPL 150% $GPRO 300% $ICPT 200% $WYNN 100% $SPY 150% $AMZN 150% $NFLX 150% could've been …
6 Mar 15 14:02:14
RT @OsirisWealth: Great week $BIDU 400% $LL 200% $AAPL 150% $GPRO 300% $ICPT 200% $WYNN 100% $SPY 150% $AMZN 150% $NFLX 150% could've been …
6 Mar 15 13:46:27
RGDO trial ending this month . Phase 1 CVC https://t.co/2wZ2vt5tmR $ICPT mkt value and compare this one. Multi bagged possible
Osiris Trading
6 Mar 15 13:33:51
Great week $BIDU 400% $LL 200% $AAPL 150% $GPRO 300% $ICPT 200% $WYNN 100% $SPY 150% $AMZN 150% $NFLX 150% could've been at least 500%.
6 Mar 15 13:07:03
Longest consecutive sequence of trades with increasing prices on 3/5 was 34 $ICPT trades that started at 16:43:30.546
6 Mar 15 12:51:39
$CLDN $CONN $ICPT $JMEI $OHRP $RGLS $SHAK $SMTC $ZU autocharts @ http://t.co/cLiki3R0GR
6 Mar 15 12:36:38
$ADXS $BLUE $ICPT $KYTH $MEIP $NVGN $SHAK $TSRO $WBAI autocharts @ http://t.co/cLiki3R0GR
Stocks News&Markets
6 Mar 15 12:01:28
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6 Mar 15 11:53:33
$ICPT volatility elevated as shares trend higher
6 Mar 15 11:29:39
$ANTH $AXAS $CPE $CPRX $ENOC $GERN $HZNP $ICPT $KYTH autocharts @ http://t.co/cLiki3R0GR
Russell Barbour
6 Mar 15 11:07:26
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6 Mar 15 10:54:53
Stocks that are up on my watchlist $ICPT $HLF $CTRP
Trader's World News
6 Mar 15 10:47:01
RT @DanZanger: $ICPT $BLUE $ HABT $AAPL $YY $RARE and others not phased
Dan Zanger
6 Mar 15 10:46:31
$ICPT $BLUE $ HABT $AAPL $YY $RARE and others not phased
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6 Mar 15 10:41:42
clayton: ICPT 264.83 Intercept Pharmaceuticals Inc $ICPT http://t.co/WiUhh3V4kc
Investors Hangout
6 Mar 15 10:41:42
clayton: ICPT 264.83 Intercept Pharmaceuticals Inc $ICPT http://t.co/Oa0Dr7jvWm
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6 Mar 15 10:41:35
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biotech 2050
6 Mar 15 10:36:09
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6 Mar 15 10:35:52
RT @dougheuringaria: @dougheuringaria RBC Other companies we see that might fit into synergies: $ICPT $VRTX $BMRN $RCPT $ESPR $UTHR $PTCT $…
6 Mar 15 10:33:16
ICPT 264.83 Intercept Pharmaceuticals Inc $ICPT added to my watch list. Right now with ICPT I am watching the http://t.co/BbUPh4ueIO
6 Mar 15 10:32:54
$ICPT ICPT 264.83 Intercept Pharmaceuticals Inc $ICPT stock added to my watch list. Right now with ICPT I am watchin http://t.co/PfIbmDeVoS
6 Mar 15 10:11:36
6 Mar 15 10:01:26
$ICPT holding higher too
Stock Wars
6 Mar 15 09:00:01
U.S. Active (Stock Wars): $AAPL +1.6%, $BAC +2.66%, $PBYI -2.7%, $ICPT +2.61%, $CLDN +16.96% http://t.co/jdoP0QgKi5 #StockWars
Russell Barbour
6 Mar 15 08:48:04
http://t.co/8zZ54HeadF <-- *REVIEW* TIMFundamentals Part Deux $ICPT $SLV $ABX $GDXJ $JNUG $SWKS
6 Mar 15 08:09:23
@citronvolant Résultats à analyser en détail pr déterminer le marché potentiel réel (délais) & si ok PT flooré à celui des brokers sur $ICPT
6 Mar 15 07:51:41
Right now ICPT is number 32 for the largest percentage gain out of 250 stocks. $ICPT ICPT is up +19.65% in the http://t.co/b2yhPyd9nD
6 Mar 15 07:51:19
$ICPT ICPT Stock is number 32 for the largest percentage gain out of 250 stocks. $ICPT ICPT is up +19.65% in the las http://t.co/CMVMOeX9NH
Lucky Jimmy
6 Mar 15 07:38:41
ICPT Stock up +1.22% percent Today $ICPT High is at 269.65 and the Low 262.01 with current volume of 144,905. http://t.co/dWmfvny60z
Lucky Jimmy
6 Mar 15 07:38:19
$ICPT ICPT up +1.22% percent Today $ICPT Stock High is at 269.65 and the Low 262.01 with current volume of 144,905. http://t.co/zbrOo08RdD
tom blanc
6 Mar 15 07:18:53
RT @HTFirstcapital: $ICPT $GNFT I figured that owning both names is the best way to go! sitting on a nice gain on $ICPT, but joined the $GN…
6 Mar 15 07:16:49
$ICPT weekly snapshot, beautiful FW b/o could consolidate here for a bit then 300/350 and then space into new highs.
6 Mar 15 07:16:02
$ICPT: Revenue Update on Intercept Pharmaceuticals, Inc.: http://t.co/Wtxlq6wGMw
Breaking News
6 Mar 15 07:05:03
$ICPT: Intercept Pharmaceuticals, Inc. Witness Large Inflow of Money: http://t.co/LymNgF2dvh
Breaking News Now
6 Mar 15 07:04:12
$ICPT: Intercept Pharmaceuticals, Inc. Witness Large Inflow of Money: http://t.co/7sMloIxIV6
6 Mar 15 07:02:14
$ICPT: Intercept Pharmaceuticals, Inc. Witness Large Inflow of Money: http://t.co/ZwkDDo5XOY
Trader's World News
6 Mar 15 06:40:00
$RWLK needs to fix their capital structure so it is more investor friendly. This stock is not liquid like $ICPT , $ISRG , $PCLN, etc.
Analyst Ratings
6 Mar 15 06:16:11
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6 Mar 15 05:45:13
Two of my favs getting PT bumps. $GOOGL 682 $ICPT 515
Sleek Money
6 Mar 15 04:50:12
Intercept Pharmaceuticals PT Set at $515.00 by BMO Capital Markets $ICPT http://t.co/YxU0dtGXFQ
Breaking News
6 Mar 15 04:46:02
$ICPT: Intercept Pharmaceuticals PT Set at $515.00 by BMO Capital ...: http://t.co/zUw1brd6kB
6 Mar 15 04:35:10
chartguy89: 2015 Trending Stocks: ICPT -1.99% Stock Charts $ICPT Intercept http://t.co/WxvSJeMw6V
6 Mar 15 04:32:26
ICPT -1.99% Stock Charts $ICPT Intercept Pharmaceuticals Inc. (NASDAQ) Last Updated: 03/06/2015 06:32:26 ICPT http://t.co/U4AhvXG7mJ
6 Mar 15 00:58:26
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6 Mar 15 00:30:01
$ICPT - ICPT - A speculative bet - https://t.co/jM00r716Fs
5 Mar 15 23:39:42
5 Mar 15 22:44:29
ICPT -1.99% Stock Charts $ICPT Intercept Pharmaceuticals Inc. (NASDAQ) Any opinions on ICPT? Please reply to t http://t.co/NAHeliW7q5
5 Mar 15 21:06:02
$ICPT: Will Intercept Pharma Outperform? These Analysts Think So: http://t.co/7NZXWvzZOR
Chet Stedman
5 Mar 15 20:48:12
$PCYC Feb/March 2015 could very possibly be the $ICPT of Jan 2014 in terms of what happens in the months afterwards....just a thought
By  +Follow January 9, 2014 9:39AM



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