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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
Peter Bardens
2 Sep 14 14:01:02
$ICPT Intercept Pharmaceuticals, Inc. Finally Releases FLINT Trial Data http://t.co/kNmG9NgOYK
Venator
2 Sep 14 12:43:16
$ICPT Small addition at 285.5 .
Stock Considerations
2 Sep 14 12:31:18
RT @ThinkingAlpha: $ICPT big mover YTD, here is the #chart run continue? Draw your own conclusion on the Forum @ http://t.co/OpfXXnNf0b htt…
Thinking Alpha
2 Sep 14 12:30:16
$ICPT big mover YTD, here is the #chart run continue? Draw your own conclusion on the Forum @ http://t.co/OpfXXnNf0b http://t.co/FEdAHZgONp
PPBI
2 Sep 14 12:27:07
RT @IBDinvestors: Meet 4 biotech stocks that might be bought soon http://t.co/RU7UekN50f $ACHN $GILD $PBYI $ICPT
Daily Contracts
2 Sep 14 12:07:00
Real-Time feed of company contracts, original agreements and executive updates from Intercept Pharmaceuticals $ICPT http://t.co/K84XvqdhHA
Daily Contracts
2 Sep 14 11:50:00
Real-Time feed of company contracts, original agreements and executive updates from Intercept Pharmaceuticals $ICPT http://t.co/K84XvqdhHA
Market News Desk
2 Sep 14 11:25:29
$ICPT: Intercept Pharmaceuticals: Curb Your Enthusiasm? http://t.co/kM7hPg3Ryd http://t.co/5NR7PNDEDE
Investors Hangout
2 Sep 14 10:56:26
clayton: $ICPT 289.72 http://t.co/DBrhZE79EV
Investors Hangout
2 Sep 14 10:56:26
clayton: $ICPT 289.72 http://t.co/OL6u4fGpXH
dougheuring
2 Sep 14 10:28:25
Bmo $ICPT at Outperform $515 PT reflects OCA peak sales in NASH of $5 billion in 2025 with a 2H18 launch and a 70% likelihood of success.
clayton
2 Sep 14 10:26:47
$ICPT 289.72 http://t.co/Q0FGjUa8OE
lookn4wins
2 Sep 14 10:03:47
$HD 50 Simple Moving Average $HD Most recent stock chart and technical analysis. $PBYI $GTAT $EPI $WFM $ICPT $ http://t.co/y68mC9HwXv
Jim
2 Sep 14 09:44:30
RT @MelissaLeeCNBC: $ARWR $ICPT $ACHN- 3 biotech takeout targets with 100% upside in next 6 months: Deutsche Bank's Robyn Karnauskas tells …
Market News
2 Sep 14 09:25:30
$ICPT: Intercept Pharmaceuticals Posts Earnings, Pipeline in Focus http://t.co/iezxQxz8UN http://t.co/PjBNsFM38X
Tom Silver
2 Sep 14 09:23:47
Bmo $ICPT NASH Treater Feedback Suggests Larger Potential Opportunity for OCA,Based on NASH-treater feedback that at least 100K new patients
Investors Hangout
2 Sep 14 08:48:30
clayton: $ICPT 289.72 http://t.co/2IPIAeAsUC
Investors Hangout
2 Sep 14 08:48:25
clayton: $ICPT 289.72 http://t.co/RgcAhx2OCk
J
2 Sep 14 08:31:16
RT @ThinkingAlpha: Stocks w/ huge YTD impacts: $BIOF $ITMN $PEIX $SMTP $ICPT $RDNT $CBMG $PLUG $ACHN $PTX $EMES $CTP $FOLD $LIVE Discuss ht…
clayton
2 Sep 14 08:30:18
$ICPT 289.72 http://t.co/vXRCGWtpPU
Thinking Alpha
2 Sep 14 08:30:16
Stocks w/ huge YTD impacts: $BIOF $ITMN $PEIX $SMTP $ICPT $RDNT $CBMG $PLUG $ACHN $PTX $EMES $CTP $FOLD $LIVE Discuss http://t.co/OpfXXnNf0b
Market Compass
2 Sep 14 06:25:32
$ICPT: Biotech Bounce Gets More Fuel From InterMune Deal http://t.co/8Rvk14SHoq http://t.co/DVYoWznNBq
Swing Trade Alerts
2 Sep 14 06:18:28
IBD:Intercept Pharma has no product, but its valuation has topped more than $6 billion. Why? http://t.co/cbvav8i1by $ICPT $GILD $ACHN
WKRB News
2 Sep 14 06:13:30
Insider Selling: David Shapiro Sells 10,000 Shares of Intercept Pharmaceuticals Stock $ICPT http://t.co/SZIrVwirE3
Market Headlines
2 Sep 14 05:25:38
$ICPT: Intercept Pharmaceuticals: Curb Your Enthusiasm? http://t.co/T0GoKvBzxk http://t.co/5KtNj7WHPn
Samuel Brown
2 Sep 14 05:01:06
$ICPT Intercept Pharmaceuticals, Inc. Finally Releases FLINT Trial Data http://t.co/QlbLoYn8KF
Don Fishback
2 Sep 14 04:50:35
1 Month Decrease in ATM IV (Point change) $ARWR, $ICPT, $GRPN, $EXPE, $UBNT http://t.co/WAe18T8FFI
OptionApps
2 Sep 14 04:50:34
1 Month Decrease in ATM IV (Point change) $ARWR, $ICPT, $GRPN, $EXPE, $UBNT http://t.co/ewqMLYJzjG
Stock Signaling
2 Sep 14 01:01:07
Insider Buys: $PSEC $CBR $FCN $ADVS $GWR $VSAT $HRL $CNMD $OPK $HGR $AN $SPDC $UBSI $GILD $ICPT http://t.co/Vtx6dLy0Nw #stocks #wallstreet
Stock Signaling
2 Sep 14 00:01:03
Watchlist: $BAC $TSLA $BWP $AVGO $TRP $JCP $ITMN $ICPT $IVZ $IG $SCHW $BPZ $BMO $ACHN $JPM http://t.co/Vtx6dLy0Nw #analyst #investors #nyse
Stock Signaling
1 Sep 14 22:31:04
Healthcare Sector: Upgrades: $ACHN $IPXL $ENZ $ICPT $LBMH http://t.co/Vtx6dLy0Nw #trading #swingtrading #markets #stocks #spy #trader #mkt
Bulls vs Bears
1 Sep 14 21:25:29
$ICPT: Intercept to Present at Upcoming Investor Conferences http://t.co/KSrRbMWkG4 http://t.co/4dQYoPGRzK
Brad Loncar
1 Sep 14 20:53:39
@LoveSpringChick It would be more like IPF b/c NASH is a more recent phenomenon. In terms of stocks, sure $BLUE could rock like $ITNM $ICPT.
Eternity101
1 Sep 14 20:15:32
...but MY DREAM was SUR.R E A L & am sticking 2 my guns. something BIIIIG going 2 happen to THAT stock -- more than $PBYI & $ICPT did ..also
EUGENIO SOCORRO
1 Sep 14 19:48:50
Watch List: $ICPT $ARWR $NG $CCIH $DHRM
Eternity101
1 Sep 14 18:39:42
had an AWESOME dream this a.m.. NEVER in my whole life did I EVER dream about a stock. apparently I had it & it did a $PBYI $ICPT like move
Scott Spencer
1 Sep 14 16:53:09
$ICPT $GILD $ACHN $MRK $PBYI $RCPT $CELG $TEVA biotech buyout rumors intensifying... http://t.co/ErRFq9ELcz
16
1 Sep 14 16:28:19
RT @Keithwinwins: 4 #Biotech That Might Be Bought Soon http://t.co/TaEKP2uZRu #IBDNews via @IBDinvestors $ACHN $ICPT $GILD $PBYI $RCPT
Ryan York
1 Sep 14 16:26:47
RT @IBDinvestors: Intercept Pharma has no product, but its valuation has topped more than $6 billion. Why? http://t.co/Er4NemOeCB $ICPT $GI…
Financial Headlines
1 Sep 14 16:25:31
$ICPT: Roses in the Market... http://t.co/aUty04LQR2 http://t.co/E2Zz7gw78D
16
1 Sep 14 16:13:21
RT @NyOptions: Meet 4 biotech stocks that might be bought soon http://t.co/Z56GKyclxo $ACHN $GILD $PBYI $ICPT
Rex J. Weinheimer
1 Sep 14 16:10:43
RT @IBDinvestors: Intercept Pharma has no product, but its valuation has topped more than $6 billion. Why? http://t.co/Er4NemOeCB $ICPT $GI…
Ani Anirudhan
1 Sep 14 16:08:49
RT @IBDinvestors: Intercept Pharma has no product, but its valuation has topped more than $6 billion. Why? http://t.co/Er4NemOeCB $ICPT $GI…
Evener Investment
1 Sep 14 16:05:17
RT @IBDinvestors: Intercept Pharma has no product, but its valuation has topped more than $6 billion. Why? http://t.co/Er4NemOeCB $ICPT $GI…
John Michael
1 Sep 14 16:02:01
RT @IBDinvestors: Intercept Pharma has no product, but its valuation has topped more than $6 billion. Why? http://t.co/Er4NemOeCB $ICPT $GI…
Investors.com
1 Sep 14 16:00:58
Intercept Pharma has no product, but its valuation has topped more than $6 billion. Why? http://t.co/Er4NemOeCB $ICPT $GILD $ACHN
Keith Win
1 Sep 14 15:26:36
4 #Biotech That Might Be Bought Soon http://t.co/TaEKP2uZRu #IBDNews via @IBDinvestors $ACHN $ICPT $GILD $PBYI $RCPT
lottiee1012
1 Sep 14 14:41:21
RT @InsiderWire: David Shapiro, CMO and EVP - Development of Intercept Pharmac Sells $2,852,619 Worth of $ICPT - #Form4 ... - http://t.co/5…
Daytradeya
1 Sep 14 14:12:02
@IBDinvestors: Meet 4 biotech stocks that might be bought soon http://t.co/i8rdLJYfpj $ACHN $GILD $PBYI $ICPT
Krishna
1 Sep 14 11:11:32
RT @CashRocket: Fun to watch: Day Trading for $13,436 in one hour - Meir Barak http://t.co/7xPVso2bg7 via @youtube $ICPT
				
				
By  +Follow January 9, 2014 9:39AM
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