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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
Abhishek Shetty
30 Aug 14 08:31:35
$ICPT LOOKING EXCELLENT ON THE CHARTS..GOOD CONSOLIDATION SEEN AROUND $290-300 LEVELS..COULD SEE TGTS OF 340-360 IN THE NEXT 2-3 WEEKS..
Stock Market News
29 Aug 14 21:25:26
$ICPT: 4 Biotechs That Might Be Bought Soon http://t.co/tM0lscqyZj http://t.co/0L3j29uAeh
Danny Boy
29 Aug 14 21:11:25
RT @dougheuringaria: IBD: 4 Biotechs That Might Be Bought Soon $icpt $pbyi $rcpt $itmn http://t.co/A1LbbVs10M
dougheuring
29 Aug 14 20:35:01
IBD: 4 Biotechs That Might Be Bought Soon $icpt $pbyi $rcpt $itmn http://t.co/A1LbbVs10M
InterCooler
29 Aug 14 19:35:18
Intercept Pharmaceuticals CMO David Shapiro Sells 10,000 Shares $ICPT http://t.co/GN8Y58sEnS
US Banking News
29 Aug 14 19:28:48
Insider Selling: David Shapiro Sells 10,000 Shares of Intercept Pharmaceuticals Stock $ICPT http://t.co/lOo2NyfVks
Stock Signaling
29 Aug 14 15:31:28
Upgraded Stocks Active After Hours: $JCP $CHL $OVTI $DSW $LCI $JPM $PGR $AFSI $BMO $ARUN $ICPT $ACHN $MBI $SPLK $ARE http://t.co/Vtx6dLy0Nw
Arab_Zanger
29 Aug 14 15:02:27
RT @bo3bo32: @bo3bo32 $ICPT 100%
Catalyst Trader
29 Aug 14 14:27:44
@given2tweet On Schwab $ICPT is not marginable. Also insane. Only good thing is keeps investor base more stable
GerardMontane
29 Aug 14 13:26:52
RT @BioInvestor2013: $oxgn a stock under $3 That Should Be Trading over $15.00 !! http://t.co/VQb5dqmQiv $ICPT $PBYI $IDIX $QCOR …
Biz Headlines
29 Aug 14 13:25:34
$ICPT: Biotech Bounce Gets More Fuel From InterMune Deal http://t.co/ZfeHivxCZO http://t.co/nBkoBW8oRu
BioInvestor
29 Aug 14 12:57:42
$oxgn a stock under $3 That Should Be Trading over $15.00 !! http://t.co/VQb5dqmQiv $ICPT $PBYI $IDIX $QCOR $ACAD $atrs $bmrn
Wall Street Monitor
29 Aug 14 12:25:31
$ICPT: Intercept to Present at Upcoming Investor Conferences http://t.co/xgigCkRNyv http://t.co/ihADcHMhY9
InterCooler
29 Aug 14 12:21:19
Intercept Pharmaceuticals Director Orbimed Advisors Llc Sells 111,258 Shares $ICPT http://t.co/Lddbn2GIsC
Market Headlines
29 Aug 14 11:25:33
$ICPT: Intercept Pharmaceuticals: Curb Your Enthusiasm? http://t.co/T0GoKvBzxk http://t.co/1jd5Seyq8q
DR.THOMPSON
29 Aug 14 11:21:05
@dsobek @sharkbiotech @olddoggnewtrix so is $ICPT silly low or silly high ;)
Stock Signaling
29 Aug 14 09:31:03
Visual Stock Comparison Tool: http://t.co/Vtx6dLy0Nw : $SPLK $SLCA $AEO $AEGR $YGE $ARO $ECOM $ICPT $ARWR $ITMN $FOLD $TSLA $QIHU $X $JRJC
Amy Reeves
29 Aug 14 09:02:43
Something to debate over the weekend: which biotech will be bought next? http://t.co/Lsrpceh0Ln $ACHN $ICPT $PBYI $RCPT $ITMN $GILD
Lucretia
29 Aug 14 09:00:38
$ICPT Intercept Pharmaceuticals, Inc. Finally Releases FLINT Trial Data http://t.co/pvr9hpNhTK
stockassassin
29 Aug 14 07:46:16
nice bio day for my port $MDVN $AMGN $REGN $ICPT $NPSP $ARWR $ECYT $BLUE $KITE $BMRN
Stock Market News
29 Aug 14 07:25:34
$ICPT: [video] Stock Pops & Drops: ICPT, TSL, NUAN, RAX http://t.co/iCTP5ryA2A http://t.co/x5kb19yXZS
CumbucoTrader
29 Aug 14 06:38:43
currently long $TSLA $ARWR, short $AEO, watching $ICPT
TalkMarkets
29 Aug 14 06:38:01
Morning Call $BIG $CWST $MBT $SSYS $STRI $ICPT $BKW $OVTI $AVGO $FRED http://t.co/2VKkNa6rNf
Stock Signaling
29 Aug 14 06:31:21
Upgraded Stocks Active in Pre-Market: $TSLA $GOLD $ACHN $ITMN $ICPT $ARUN $QUNR $TFM $AINV $ANAC $FB $GRPN $CSIQ $AMAT $SQNM #spy #trading
Robin Murray MD CFII
29 Aug 14 05:43:41
EXCELLENT #profit this month on our #Biotech picks $BIB #ULTRA #ETF $ITMN $ICPT $AGN $CELG continue to trim&trail. http://t.co/tJtk0LBsqN
Irma Doucet
29 Aug 14 05:31:13
$ICPT Intercept Pharmaceuticals, Inc. Finally Releases FLINT Trial Data http://t.co/riCq2qRPW4
Don Fishback
29 Aug 14 04:50:04
1 Month Decrease in ATM IV (Point change) $ICPT, $WTW, $GRPN, $ZU, $UBNT http://t.co/YrumYcK17U
OptionApps
29 Aug 14 04:50:04
1 Month Decrease in ATM IV (Point change) $ICPT, $WTW, $GRPN, $ZU, $UBNT http://t.co/sISuJVlOpu
Financial Headlines
28 Aug 14 23:25:31
$ICPT: Intercept to Present at Upcoming Investor Conferences http://t.co/QwB4cyd8Tz http://t.co/Wcq0Glrf8Z
Lrry Keho
28 Aug 14 23:08:43
" We Are in a Period of Enlightenment http://t.co/UoF80DfdRk via @The_Real_Fly $GILD $ACHN $ICPT $HCLP $PLUG""
Stock Signaling
28 Aug 14 22:31:13
Healthcare Sector: Upgrades: $LCI $OCLS $THC $ITMN $ELGX $ICPT $ENZ $IPXL $ACHN $HNSN $ZFGN $UTHR $POZN $ILMN $ENZN http://t.co/Vtx6dLy0Nw
howardlindzon
28 Aug 14 17:11:50
RT @StockTwits: GREAT read--> We Are in a Period of Enlightenment http://t.co/ZiAzUsnFvk via @The_Real_Fly $GILD $ACHN $ICPT $HCLP $PLUG
Stock Signaling
28 Aug 14 15:31:31
Upgraded Stocks Active After Hours: $DSW $LCI $JPM $PGR $AFSI $BMO $ARUN $ICPT $ACHN $MBI $SPLK $ARE $SFM $TFM $QUNR http://t.co/Vtx6dLy0Nw
Scott Thomas
28 Aug 14 15:28:30
Now I see news $ICPT HF cuts position . Orbimed .
FilingsAnalysis
28 Aug 14 15:25:04
$ICPT, 13D filed by Orbimed Advisors LLC http://t.co/1dOmjQENa3
Tim
28 Aug 14 15:23:10
RT @stockstobuy: BioFuel Energy $BIOF is the Top Stock in 2014, Up 620% - http://t.co/2J9lDWjrzq #Stocks $VRS $ISR $PEIX $UBIC $ICPT $RDNT …
Stocks to Buy
28 Aug 14 15:19:42
BioFuel Energy $BIOF is the Top Stock in 2014, Up 620% - http://t.co/2J9lDWjrzq #Stocks $VRS $ISR $PEIX $UBIC $ICPT $RDNT $PLUG $ACHN
Forex Spain
28 Aug 14 15:08:23
RT @StockTwits: GREAT read--> We Are in a Period of Enlightenment http://t.co/ZiAzUsnFvk via @The_Real_Fly $GILD $ACHN $ICPT $HCLP $PLUG
EscueladeTrading
28 Aug 14 15:04:42
RT @StockTwits: GREAT read--> We Are in a Period of Enlightenment http://t.co/ZiAzUsnFvk via @The_Real_Fly $GILD $ACHN $ICPT $HCLP $PLUG
Alberto Fernández
28 Aug 14 15:04:36
RT @StockTwits: GREAT read--> We Are in a Period of Enlightenment http://t.co/ZiAzUsnFvk via @The_Real_Fly $GILD $ACHN $ICPT $HCLP $PLUG
YouAreTrader
28 Aug 14 15:03:43
RT @StockTwits: GREAT read--> We Are in a Period of Enlightenment http://t.co/ZiAzUsnFvk via @The_Real_Fly $GILD $ACHN $ICPT $HCLP $PLUG
Market Profile
28 Aug 14 15:01:58
RT @StockTwits: GREAT read--> We Are in a Period of Enlightenment http://t.co/ZiAzUsnFvk via @The_Real_Fly $GILD $ACHN $ICPT $HCLP $PLUG
Catalyst Trader
28 Aug 14 14:57:25
RT @whalewisdom: New SC 13D/A from ORBIMED ADVISORS LLC concerning $ICPT. See details at http://t.co/yxxJGlKF7h
Business Headlines
28 Aug 14 14:25:30
$ICPT: Roses in the Market... http://t.co/bybpVWSVUs http://t.co/H75iJkuNyX
StockNews
28 Aug 14 13:55:23
$ICPT - Amended Statement of Beneficial Ownership (sc 13d/a) http://t.co/H12pjTHAc8
whalewisdom
28 Aug 14 13:55:10
New SC 13D/A from ORBIMED ADVISORS LLC concerning $ICPT. See details at http://t.co/yxxJGlKF7h
InsiderTradingWire
28 Aug 14 13:55:08
13D Alert for INTERCEPT PHARMACEUTICALS INC - $ICPT - #13D #insidertrading - http://t.co/S2gMDnOXXX
StockTwits
28 Aug 14 13:40:09
GREAT read--> We Are in a Period of Enlightenment http://t.co/ZiAzUsnFvk via @The_Real_Fly $GILD $ACHN $ICPT $HCLP $PLUG
Antonio Costa
28 Aug 14 12:56:57
$ICPT new intraday low ... watch $PBYI and $MDVN
Sleek Money
28 Aug 14 11:26:15
Intercept Pharmaceuticals Director Unloads $33,161,559 in Stock $ICPT http://t.co/9DxqxyvjYW
				
				
By  +Follow January 9, 2014 9:39AM
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