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

By  +Follow January 9, 2014 9:39AM
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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
Eyang Sukur
25 Oct 14 12:18:46
RT Eyang Sukur KhooForex : RT Chayton Falke ChaytonFalke : Top Twenty Recent Exits #18: Covered $ICPT short for a 13.18% gain in 25 days...
Eyang Sukur
25 Oct 14 12:18:07
RT Chayton Falke ChaytonFalke : Top Twenty Recent Exits #18: Covered $ICPT short for a 13.18% gain in 25 days! #trading #ICPT #forex #st...
Chayton Falke
25 Oct 14 12:15:02
Top Twenty Recent Exits #18: Covered $ICPT short for a 13.18% gain in 25 days! #trading #ICPT #forex #stocks
Dan
25 Oct 14 10:16:15
$ICPT OI for maturity 10/24/2014. 220.00 Highest put. 250.00 Highest call. http://t.co/Rz01JazfAe
Dan
25 Oct 14 10:08:03
$ICPT Max Pain is 220.00 for maturity 10/24/2014. Last close = 237.65. http://t.co/vAu8kbfQcr
Chayton Falke
25 Oct 14 02:15:02
Top Twenty Recent Exits #18: Covered $ICPT short for a 13.18% gain in 25 days! #trading #ICPT #forex #stocks
Anthony Felli
24 Oct 14 22:39:33
$AGIO overall better data than news that catapulted $ICPT. $PCYC move will pale in comparison. $AGIO will be a MONSTER.
John Turner
24 Oct 14 14:00:58
$ICPT Intercept Pharmaceuticals Inc. (ICPT) Has Spiked To The Upside http://t.co/hlYQxk0XGO
Paul Wulfsberg
24 Oct 14 13:34:40
@Rebuy27 @jmk Missed shorting $GPRO again, I was aiming for $85, peaked at $84.32! But $ICPT's recovery has me in a good mood anyways.
TipRanks
24 Oct 14 12:59:41
5-star analyst Ian Somaiya from Nomura Holdings reiterated a BUY on $ICPT. Ian has a 66.7% success rate http://t.co/JhrnRhs3WP
JMK
24 Oct 14 12:56:16
@howardlindzon very cool,thx. Unless $ICPT is acquired in next few days (I own calls) I can't afford trip. but thanks again, very cool of u
Wall Street Watkins
24 Oct 14 12:03:02
RT @Eternity100000: $PBYI + $ICPT - they both report in early November .. both LOW floats and can move like $PCLN ...question is which one …
Eternity101
24 Oct 14 11:53:45
$PBYI + $ICPT - they both report in early November .. both LOW floats and can move like $PCLN ...question is which one for b/o &/buy out)
Ticker Report
24 Oct 14 11:14:15
Intercept Pharmaceuticals Given Buy Rating at Nomura $ICPT http://t.co/Zud7zLmnxX
Venator
24 Oct 14 10:19:09
$ICPT tsk tsk. Those who sold 'here' don't know how to Follow the Money!! http://t.co/dQCWFgLK92
Eternity101
24 Oct 14 09:22:52
hmmm.. $PBYI down & $ICPT up
Venator
24 Oct 14 08:49:42
"Volume came back from her java break... and she be feeling LIVELY! http://t.co/03xQ9jE1en" (whoops - $ICPT )
Les
24 Oct 14 08:45:22
$ICPT range play, something I suggested before it overshot to $170. Could see $300 again. http://t.co/0OCdsCz6I8
MikeE
24 Oct 14 08:40:40
RT @Hubon: $ICPT bear trap http://t.co/McllrlCGV9
Call Me Baloo
24 Oct 14 08:13:55
$ICPT bear trap http://t.co/McllrlCGV9
Andrew Rocco
24 Oct 14 08:13:39
$ICPT something's up
Venator
24 Oct 14 08:11:49
$ICPT Wow, price up so much am going to raise my "Broker, dont lend my shares to Shortie" GTC sell limit orders!
moderneconomist.com
24 Oct 14 08:03:17
RT @tymorapro: $ICPT: 1mRunaway+:1 [+3%,.2%offHi], 4NearHi, 3mMv:+3, 7:2Accel+, allTFs+; TLM:1.9; ILM:5.1, DyVol:53T:0.2x:0.1x, DyRng:4.4%:…
Les
24 Oct 14 08:02:31
$ICPT oh man LOLLL still holding, my biggest winner so far in the last 2 weeks. http://t.co/g5NVPXDaWA
Abhishek Shetty
24 Oct 14 08:00:16
$ICPT .GOOD BREAKOUT ABOVE $240.00..VOLUMES COMING NOW..COULD SEE LEVELS OF $260.00-275.00 HERE..
wayne
24 Oct 14 07:59:00
$ICPT wth
Abhishek Shetty
24 Oct 14 07:58:32
$ICPT GOOD BOUNCE FROM $230.00 TO $240.00..WOW..NOW UP 4% @$240.00..SOMETHING WORTH NOTICING HERE..
Alexander Morris
24 Oct 14 07:57:03
$ICPT: 1mRunaway+:1 [+3%,.2%offHi], 4NearHi, 3mMv:+3, 7:2Accel+, allTFs+; TLM:1.9; ILM:5.1, DyVol:53T:0.2x:0.1x, DyRng:4.4%:1.1x:0.7x,
R4inb0w
24 Oct 14 07:52:00
RT @GeryDIVRY: Genfit $GNFT is the biggest performance 2014 (~ +300%) in the 100 biggest biotechs in the world 2th is Intercept $ICPT (+24…
Gery DIVRY
24 Oct 14 07:50:27
Genfit $GNFT is the biggest performance 2014 (~ +300%) in the 100 biggest biotechs in the world 2th is Intercept $ICPT (+240%).
Venator
24 Oct 14 07:35:57
$ICPT Hello, Volume? Hello? Are you there?......... (Gone out to grab a coffee)
Gery DIVRY
24 Oct 14 07:21:59
RT @Sachakin: Genfit $GNFT est la plus forte progression 2014 (~ +300%) parmi les 100 plus grosses biotechs mondiales devant.. Intercept $I…
Waxeng
24 Oct 14 06:12:54
$ICPT and $OTIV it's gonna be good based on future business forcast.
David Fourneau
24 Oct 14 01:26:28
RT @Sachakin: Genfit $GNFT est la plus forte progression 2014 (~ +300%) parmi les 100 plus grosses biotechs mondiales devant.. Intercept $I…
Penny Stock Secret
23 Oct 14 23:34:29
The Hottest Way to Make Millions From Stock Market.Click HERE http://t.co/SVqoMkrw2z .. $ICPT $SCHL $AMSG
Sebastien Remy
23 Oct 14 21:49:05
RT @Sachakin: Genfit $GNFT est la plus forte progression 2014 (~ +300%) parmi les 100 plus grosses biotechs mondiales devant.. Intercept $I…
wininstocks2014
23 Oct 14 14:55:26
ICPT 229.49 Stock Charts $ICPT Intercept Pharmaceuticals Inc. (NASDAQ) Last Updated: 10/23/2014 16:55:25 ICPT http://t.co/i8U5tIMhJ1
Yu Zhu
23 Oct 14 13:11:47
RT @scienceinvestme: RT @svKatface agree $icpt. How many stx U own that has average $pt by analyst with over 100% upside potential?. #fat…
Venator
23 Oct 14 13:03:13
RT @scienceinvestme: RT @svKatface agree $icpt. How many stx U own that has average $pt by analyst with over 100% upside potential?. #fat…
InsiderTradingWire
23 Oct 14 13:02:30
$ICPT | Intercept Pharmac is down 20% since we reported $17,989,207 of insider selling on 08/19/2014. Did you ... - http://t.co/aZUdqvMq2J
12Stocks.com
23 Oct 14 13:01:32
SmallCap #Stocks Trend $SUNE $YELP $NRF $ALGN $AYI $HAIN $CSGP $PTC $ARCP $RAD $USG $ICPT $TRGP $PACW more@ http://t.co/dBUiSJIjp0
12Stocks.com
23 Oct 14 13:01:15
Smallcap #Stocks Performance $SUNE $CSGP $ATHN $MIDD $ICPT $ALGN $PTC $AYI $HAIN $TRGP $ARCP $PACW $NRF more@ http://t.co/dBUiSJIjp0
Venator
23 Oct 14 12:30:24
$ICPT dang, i jinxed it?
Venator
23 Oct 14 12:23:34
$ICPT found support today at 230, aftr a volume buyer (5500 shs) popped it over that, around 10:30. http://t.co/4avgnkR7SE
Jim
23 Oct 14 11:49:10
RT @svKatface agree $icpt. How many stx U own that has average $pt by analyst with over 100% upside potential?. #fattyliverbabyboomers
lololebreton
23 Oct 14 11:41:15
RT @Sachakin: Genfit $GNFT est la plus forte progression 2014 (~ +300%) parmi les 100 plus grosses biotechs mondiales devant.. Intercept $I…
Adrian
23 Oct 14 11:07:31
$ICPT and $AWLCF both look good. long awlcf
Venator
23 Oct 14 10:49:16
Funny, on many stock people buy cuz avePT is,say, $10-20 from currrent price. $ICPT 's ave PT is up **$250 from here! http://t.co/X2qWh2IewN
Aurelien
23 Oct 14 09:57:48
RT @Sachakin: Genfit $GNFT est la plus forte progression 2014 (~ +300%) parmi les 100 plus grosses biotechs mondiales devant.. Intercept $I…
DOGE4321
23 Oct 14 09:27:50
RT @Sachakin: Genfit $GNFT est la plus forte progression 2014 (~ +300%) parmi les 100 plus grosses biotechs mondiales devant.. Intercept $I…
				
				
By  +Follow January 9, 2014 9:39AM
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