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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. 

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Results for icpt
PennyStock Zone
30 Jul 15 16:57:04
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InsiderTradingWire
30 Jul 15 15:47:15
$ICPT | Intercept Pharmaceuticals, Inc. is down 17% since we reported $1,456,667 of insider selling on ... - http://t.co/8P9GclNMzF
dailystockplays.com
30 Jul 15 15:33:30
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30 Jul 15 15:14:07
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30 Jul 15 14:45:03
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TheHunter
30 Jul 15 13:02:33
@pbmech @redacre $crbp is next $icpt
PennyStock Zone
30 Jul 15 12:36:05
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UIC Club
30 Jul 15 11:42:23
@canuck2usa $ICPT Aug. 270? Thank you
DK1
30 Jul 15 11:26:33
$ICPT bought some Aug calls (small) for now
PennyStock Zone
30 Jul 15 07:37:05
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Jordi Xiol
30 Jul 15 07:06:16
SA article suggests $GILD main potential acquisition targets are $ICPT and $CLVS: http://t.co/Tqi21b9jZk
InvestWithConf
30 Jul 15 03:22:02
$ICPT is rated BUY, 51.2% upside by Wall Street analysts based on average ratings/targets http://t.co/JJdID1331x http://t.co/WOf0AJ8wys
Bleecker
30 Jul 15 02:46:19
cela expliquerait les ventes des insiders $ICPT ? quoi? j'ai dit une bêtise? ;-)) https://t.co/jbmjcoVICI
Gery DIVRY
30 Jul 15 02:36:26
@tootix yes . CV risk is on the table for NASH patients .. incredible that $ICPT phase 3 do not plan CVOT with their induced LDL increase ?
True about ...
30 Jul 15 02:23:45
RT @Tootix: $ICPT $GNFT $GILD #NASH #NAFLD A multisystem disease ! Journal Of Hepatology http://t.co/sMZGxOEBmo @GeryDIVRY http://t.co/WZ…
TooTiX
30 Jul 15 02:20:05
$ICPT $GNFT $GILD #NASH #NAFLD A multisystem disease ! Journal Of Hepatology http://t.co/sMZGxOEBmo @GeryDIVRY http://t.co/WZJIR2J67L
TooTiX
30 Jul 15 02:16:03
RT @GeryDIVRY: $ICPT $GNFT An ideal drug candidate for NASH should reduce hepatic inflammation and liver cell injury,
TooTiX
30 Jul 15 02:15:56
RT @GeryDIVRY: $ICPT $GNFTF an impressive topic on NAFLD NASH . increased risks in CV, diabetes and kidney disease http://t.co/qcDBNoWuLR
Jean-Yves
30 Jul 15 01:13:04
RT @GeryDIVRY: $ICPT $GNFT An ideal drug candidate for NASH should reduce hepatic inflammation and liver cell injury,
V.S. Schulz
30 Jul 15 01:09:27
RT @GeryDIVRY: $ICPT $GNFTF an impressive topic on NAFLD NASH . increased risks in CV, diabetes and kidney disease http://t.co/qcDBNoWuLR
Gery DIVRY
30 Jul 15 01:08:43
$ICPT $GNFT An ideal drug candidate for NASH should reduce hepatic inflammation and liver cell injury,
Gery DIVRY
30 Jul 15 00:54:26
$ICPT $GNFTF an impressive topic on NAFLD NASH . increased risks in CV, diabetes and kidney disease http://t.co/qcDBNoWuLR
Ponty
29 Jul 15 19:17:59
@redacre same thing for $PRQR. "IF" they show efficacy in CF, it will be a repeat of $ICPT, regardless of Ph1b/2b/3 etc.
BreakingStocksNews
29 Jul 15 14:21:02
$ICPT: Intercept to Report Second Quarter 2015 Financial Results on ...: http://t.co/3jCh4g2lwb
Daniel De Oliveira
29 Jul 15 14:07:22
@SeekingAlpha @okim59 pffff bah alors là s'ils rachètent $icpt v'là la bad news !
Tigre Blanc
29 Jul 15 14:06:43
RT @GeryDIVRY: during the last 6 month , the $ICPT insiders have sold 60% of their shares ?? do they know something we dont know ? http://t…
AlphaStreet
29 Jul 15 13:22:16
$ICPT announced it will conduct a conference call and audio webcast on Wednesday, August 5, 2015 at 4:30 p.m. ET to discuss 2Q15 results.
GNWLive
29 Jul 15 13:07:39
Intercept to Report Second Quarter 2015 Financial Results on August 5 and Present at Upcoming Conferences $ICPT http://t.co/i6XQq1pY3J
MyAllies Trading
29 Jul 15 13:05:33
$ICPT Intercept to Report Second Quarter 2015 Financial Results on August 5 and Present at Upcoming Conferences http://t.co/GAKKCLCfAA
NASDAQStocks
29 Jul 15 12:45:18
Visit http://t.co/dObsQpoZJP for info on $GPRO, $AMZN, $ICPT and $ARIA - #NASDAQ http://t.co/CJeMwxx7KZ
dominic
29 Jul 15 11:13:13
$GILd breaking low..the biotech's are garbage. BTW if $GILD buys any1 it will be $ICPT $GILD wants to rule in Liver disease.
PennyStock Zone
29 Jul 15 09:57:56
http://t.co/T1OENoRe1I <- Fous4x2 review invest in your #trading education! $ABEV $ICPT $AA $AMBA #stocks $FB $TWTR
jjjj
29 Jul 15 09:04:55
RT @SeekingAlpha: Gilead's Next Big Acquisition: Where Will They Expand? http://t.co/yyHoYM488s $AZN $CLVS $ICPT $GILD
Tchoung Tchoung
29 Jul 15 09:02:12
RT @SeekingAlpha: Gilead's Next Big Acquisition: Where Will They Expand? http://t.co/yyHoYM488s $AZN $CLVS $ICPT $GILD
Okim59
29 Jul 15 09:01:18
RT @SeekingAlpha: Gilead's Next Big Acquisition: Where Will They Expand? http://t.co/yyHoYM488s $AZN $CLVS $ICPT $GILD
#HelpYouGetGAINS
29 Jul 15 08:22:50
Gilead's Next Big Acquisition: Where Will They Expand? http://t.co/b3jSw2V092 … $AZN $CLVS $ICPT $GILD
Biotech Investor
29 Jul 15 08:16:45
Gilead's Next Big Acquisition: Where Will They Expand? http://t.co/gsmppA5aCQ $AZN $CLVS $ICPT $GILD
Healthcare Stocks
29 Jul 15 08:16:44
Gilead's Next Big Acquisition: Where Will They Expand? http://t.co/GgTftkn37y $AZN $CLVS $ICPT $GILD
Long & Short Ideas
29 Jul 15 08:16:44
Gilead's Next Big Acquisition: Where Will They Expand? http://t.co/8FXmjTEcBK $AZN $CLVS $ICPT $GILD
Seeking Alpha
29 Jul 15 08:16:44
Gilead's Next Big Acquisition: Where Will They Expand? http://t.co/yyHoYM488s $AZN $CLVS $ICPT $GILD
Clément d'Espagnac
29 Jul 15 06:30:42
RT @GeryDIVRY: during the last 6 month , the $ICPT insiders have sold 60% of their shares ?? do they know something we dont know ? http://t…
Don H
29 Jul 15 04:56:24
RT @dougheuringaria: Select list of US Biotech companies with un-partnered late stage assets $ACAD $RCPT $ICPT $BLUE http://t.co/dgpa4i7uJK
Le_Palinzard
29 Jul 15 04:31:24
RT @okim59: $Genfit... -3.80% Janvier.. -0.54%1 semaine.. -32.88% 6 mois $ICPT.... +86.50% Janvier... +1.54% 1 semaine. +62.15% 6 m…
Christophe Loizeau
29 Jul 15 04:09:36
RT @GeryDIVRY: during the last 6 month , the $ICPT insiders have sold 60% of their shares ?? do they know something we dont know ? http://t…
Clément d'Espagnac
29 Jul 15 03:52:51
@GeryDIVRY mais enfin, il faut bien qu'ils protègent leur portefeuille plein d' $ICPT comme ils le peuvent.
Mark Punyanitya
29 Jul 15 02:49:06
RT @GeryDIVRY: during the last 6 month , the $ICPT insiders have sold 60% of their shares ?? do they know something we dont know ? http://t…
ProVesting
28 Jul 15 23:51:02
$ICPT: Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) Short Interest Update: http://t.co/kmYeGRXB4x
Gooser
28 Jul 15 23:50:46
RT @dougheuringaria: Select list of US Biotech companies with un-partnered late stage assets $ACAD $RCPT $ICPT $BLUE http://t.co/dgpa4i7uJK
TooTiX
28 Jul 15 23:36:40
RT @GeryDIVRY: @adamfeuerstein $ICPT $GNFTF did you noticed that ? http://t.co/xbjS4u0Tj9
Soph.ie
28 Jul 15 23:36:26
RT @GeryDIVRY: $GNFT $ICPT $GNFTF Preparing the respecting Phases III you should notice that : http://t.co/IJvbzXeJCR
				
				
By  +Follow January 9, 2014 9:39AM
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