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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. To read our full disclosure, please go to: http://www.equities.com/disclaimer


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Results for icpt
Joe Librescu
1 Sep 15 00:57:31
@GeryDIVRY @VERBEECK_A $ICPT for sure it is misvalued compared to the $GNFT and $GLMD
Joe Librescu
1 Sep 15 00:40:59
@VERBEECK_A @GeryDIVRY for sure $ICPT and $GILD drugs are late state NASH drugs
Mariano Battaglia
31 Aug 15 21:56:07
RT @asclepiacap: RBC List of upcoming 2015 “events” in coverage and estimated impact $BIIB $XNPT $ARWR $DYAX $CELG $BMRN $ICPT $CELG http:/…
PharmaCompass
31 Aug 15 18:55:00
RT @ScripDonnaDC: #FDA sets #leapyear PDUFA (Feb 29, 2016) for $ICPT's obeticholic acid under priority review http://t.co/ghEKd38jYw #pha…
afha
31 Aug 15 18:51:39
RT @adamfeuerstein: $NK had worst August for biotech stocks which matter -41% $CLDX -35% $ZIOP -30% $OPK -30% $OVAS -29% $ICPT -28% $ONCE…
PennyStock Zone
31 Aug 15 18:37:13
http://t.co/AAlC0qvEgC <-- Checkout my blog on how to make money trading #stocks $UUP $HABT $MR $ICPT $DUST
Armando Uribe
31 Aug 15 18:32:44
RT @adamfeuerstein: $NK had worst August for biotech stocks which matter -41% $CLDX -35% $ZIOP -30% $OPK -30% $OVAS -29% $ICPT -28% $ONCE…
Jim
31 Aug 15 18:32:44
RT @AmConsumerNews: Intercept Pharmaceuticals Stock Rating Reaffirmed by Wedbush $ICPT http://t.co/nQ7U0rh7ZQ #acn
Zach Rohelier
31 Aug 15 18:19:17
$GILD terrible trading lately. I do not follow $icpt that closely but sure does seem like it would fit the $gild profile if it works
Mark Punyanitya
31 Aug 15 17:50:24
RT @GeryDIVRY: $GNFTF $ICPT as soon the GENFIT phase 3 confirmed by the agency .. you can bet on a CV protective drug on the NASH market ..
Biotech Beat
31 Aug 15 17:48:42
RT @adamfeuerstein: $NK had worst August for biotech stocks which matter -41% $CLDX -35% $ZIOP -30% $OPK -30% $OVAS -29% $ICPT -28% $ONCE…
Ariful Islam Kazi
31 Aug 15 17:48:15
RT @adamfeuerstein: $NK had worst August for biotech stocks which matter -41% $CLDX -35% $ZIOP -30% $OPK -30% $OVAS -29% $ICPT -28% $ONCE…
Achidi
31 Aug 15 17:36:26
RT @asclepiacap: RBC List of upcoming 2015 “events” in coverage and estimated impact $BIIB $XNPT $ARWR $DYAX $CELG $BMRN $ICPT $CELG http:/…
andreas
31 Aug 15 17:18:54
RBC List of upcoming 2015 “events” in coverage and estimated impact $BIIB $XNPT $ARWR $DYAX $CELG $BMRN $ICPT $CELG http://t.co/hO4q5uvcLF
Russell Barbour
31 Aug 15 17:07:24
Millionaire trading student http://t.co/GSuqF6jxy8 made millions learning to trade from http://t.co/ui9ZEGEOU8 $AAPL $CNAT $ICPT
Dakota Financial
31 Aug 15 16:55:37
Wedbush Reaffirms “Buy” Rating for Intercept Pharmaceuticals $ICPT http://t.co/LQy5Qi4gGM
MAISA
31 Aug 15 16:52:47
$ICPT FDA has set a target date of February 29, 2016 to take action under the Prescription Drug User Fee Act.
MAISA
31 Aug 15 16:52:37
$ICPT Gets FDA Priority Review For Primary Biliary Cirrhosis Treatment
Consumer News
31 Aug 15 16:50:57
Intercept Pharmaceuticals Stock Rating Reaffirmed by Wedbush $ICPT http://t.co/nQ7U0rh7ZQ #acn
US Banking News
31 Aug 15 16:46:00
Wedbush Reaffirms “Buy” Rating for Intercept Pharmaceuticals $ICPT http://t.co/jGQnScsKSd
Ticker Report
31 Aug 15 16:40:50
Wedbush Reaffirms “Buy” Rating for Intercept Pharmaceuticals $ICPT http://t.co/iouqp0Tgo4
US Consumer News
31 Aug 15 16:33:19
Intercept Pharmaceuticals's buy rating reiterated at Wedbush. http://t.co/anHD44jLj3 $ICPT #ICPT
FlamingoTradingPtnrs
31 Aug 15 16:31:00
RT @adamfeuerstein: $NK had worst August for biotech stocks which matter -41% $CLDX -35% $ZIOP -30% $OPK -30% $OVAS -29% $ICPT -28% $ONCE…
FirstToMarkets
31 Aug 15 16:30:07
Intercept Pharmaceuticals, Inc. Reiterated Rating by Wedbush Morgan (Ranked 60th) to Buy $ICPT #ICPT http://t.co/urir2RiTjj
StockNewsWires
31 Aug 15 16:30:04
$ICPT: Wedbush Reaffirms “Buy” Rating for Intercept Pharmaceuticals (ICPT): http://t.co/HjN4hu1bVt
MarketBeatCom
31 Aug 15 16:25:12
Intercept Pharmaceuticals's buy rating reiterated at Wedbush. http://t.co/RSLkOnPXUZ $ICPT #ICPT
emmanuel
31 Aug 15 15:05:24
RT @GeryDIVRY: $ICPT patients who started statins treatment during the FLINT study (26) could have jeopardize all the results ... http://t.…
Jeffrey Blake
31 Aug 15 14:03:44
$ICPT Monday Morning Pre-Market Insights: Seadrill Ltd (SDRL), Intercept ... http://t.co/IKPaAAtGEA
GROSSE14
31 Aug 15 13:54:56
RT @GeryDIVRY: $ICPT patients who started statins treatment during the FLINT study (26) could have jeopardize all the results ... http://t.…
GROSSE14
31 Aug 15 13:52:37
RT @GeryDIVRY: $GNFTF $ICPT as soon the GENFIT phase 3 confirmed by the agency .. you can bet on a CV protective drug on the NASH market ..
shmittahcapital
31 Aug 15 13:49:26
@adamfeuerstein out of $icpt $cldx $once which one is the best value here?
Gotham City Capital
31 Aug 15 13:48:25
RT @BioStocks: $ICPT FDA Accepts NDA for OCA. Grants Priority Review. PDUFA 02/29/16
Hard Money
31 Aug 15 13:45:47
RT @dougheuringaria: Barclays $ICPT Granting of Priority Review Provides Some Encouragement around the Drug’s Profile http://t.co/FUUGJtu0Io
Quartermaster
31 Aug 15 13:43:31
RT @adamfeuerstein: $NK had worst August for biotech stocks which matter -41% $CLDX -35% $ZIOP -30% $OPK -30% $OVAS -29% $ICPT -28% $ONCE…
Adam Feuerstein
31 Aug 15 13:39:47
$NK had worst August for biotech stocks which matter -41% $CLDX -35% $ZIOP -30% $OPK -30% $OVAS -29% $ICPT -28% $ONCE -27% $XON -26%
Seeking Alpha Alerts
31 Aug 15 13:26:04
@miimosas $icpt Biotech Review (Part 2 Of 3): New Coverage Of Some Mid-Caps With Update On Intercept http://t.co/2JibhNIuU2
Seeking Alpha Alerts
31 Aug 15 13:26:03
@rcmudphud $icpt Biotech Review (Part 2 Of 3): New Coverage Of Some Mid-Caps With Update On Intercept http://t.co/2JibhNIuU2
Seeking Alpha Alerts
31 Aug 15 13:26:03
@JankEarl $icpt Biotech Review (Part 2 Of 3): New Coverage Of Some Mid-Caps With Update On Intercept http://t.co/2JibhNIuU2
Seeking Alpha Alerts
31 Aug 15 13:26:03
@jbdynamite $icpt Biotech Review (Part 2 Of 3): New Coverage Of Some Mid-Caps With Update On Intercept http://t.co/2JibhNIuU2
Soph.ie
31 Aug 15 13:18:32
RT @GeryDIVRY: $GNFT $ICPT $GILD $RPTP $GLMD $TBRA Topo on NASH market, if you can't read french , use a translator http://t.co/XG7btX3QI4
Joe Librescu
31 Aug 15 13:10:03
@GeryDIVRY correct .. $ICPT saves them on 1 side and kills them on the other no?
Biotech Supernova
31 Aug 15 13:05:55
RT @dougheuringaria: Barclays $ICPT Granting of Priority Review Provides Some Encouragement around the Drug’s Profile http://t.co/FUUGJtu0Io
dougheuring
31 Aug 15 12:58:36
Barclays $ICPT Granting of Priority Review Provides Some Encouragement around the Drug’s Profile http://t.co/FUUGJtu0Io
Hard Money
31 Aug 15 12:41:07
Buying some $icpt into the close if it can hold 9 DMA currently around $189. Wedbush PT $485 double and a half. Good risk/reward
Ben73
31 Aug 15 12:23:33
RT @GeryDIVRY: @GeryDIVRY $ICPT 54% of the patients in FLINT were under statins at the end .. if statins reduce fibrosis .. OCA effect need…
Smarter Analyst
31 Aug 15 11:49:26
$ICPT Wedbush Maintains Outperform on Intercept Pharmaceuticals on Back of FDA Priority Review for OCA http://t.co/RgGoniN1DW
SCRIP Intelligence
31 Aug 15 10:31:40
RT @ScripDonnaDC: #FDA sets #leapyear PDUFA (Feb 29, 2016) for $ICPT's obeticholic acid under priority review http://t.co/ghEKd38jYw #pha…
Joe Librescu
31 Aug 15 10:27:46
@GeryDIVRY and how is $gnft able to overcome? of course $ICPT drug is increasing cholesterol correct?
Stocksguru99
31 Aug 15 10:24:26
Gains Over 2500% In one Trade.. Subscribe Here! http://t.co/n4FmW1UTLN .. $ICPT $SCHL $AMSG
Yu Zhu
31 Aug 15 10:18:23
RT @svKatface: Asking 'What's the big deal about $ICPT getting Priority Review from the FDA?!' Read this: http://t.co/O7X2tDvScl
				
				
By  +Follow January 9, 2014 9:39AM
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