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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

Results for icpt
TradersTopNews
18 Apr 14 23:14:10
$ICPT Short Interest in Intercept Pharmaceuticals Decreases By 36.0% (ICPT) http://t.co/4sVbRfIBKP
Stock Herald
18 Apr 14 23:13:05
$ICPT: INTERCEPT 96 HOUR DEADLINE ALERT: Approximately 96 Hours Remain; Forme... http://t.co/XHAvTWQET2
Informer
18 Apr 14 22:07:05
$ICPT: INTERCEPT 96 HOUR DEADLINE ALERT: Approximately 96 Hours Remain; Forme... http://t.co/ix0ScgQsDB
GavinGreenberg
18 Apr 14 21:06:36
$ICPT: INTERCEPT 96 HOUR DEADLINE ALERT: Approximately 96 Hours Remain; Forme... http://t.co/1iBKxRA9Qa
Stock Herald
18 Apr 14 20:02:35
$ICPT: INTERCEPT 96 HOUR DEADLINE ALERT: Approximately 96 Hours Remain; Forme... http://t.co/XHAvTWQET2
Colin Kuberski
18 Apr 14 19:48:04
$ICPT INTERCEPT 96 HOUR DEADLINE ALERT: Approximately 96 Hours Remain ... http://t.co/JTDTzb6af3
Colin Kuberski
18 Apr 14 19:43:04
$ICPT INTERCEPT 96 HOUR DEADLINE ALERT: Approximately 96 Hours Remain; Former Louisiana Attorney General and Kahn Swick & Foti, LLC...
Informer
18 Apr 14 19:23:03
$ICPT: INTERCEPT 96 HOUR DEADLINE ALERT: Approximately 96 Hours Remain; Forme... http://t.co/ix0ScgQsDB
stocknews247
18 Apr 14 19:17:05
$ICPT - INTERCEPT 96 HOUR DEADLINE ALERT: Approximately 96 Hours Remain; Forme... -> http://t.co/hX8EUs0m3Z #stock #stocks #stockaction
StockNews
18 Apr 14 19:01:03
$ICPT - INTERCEPT 96 HOUR DEADLINE ALERT: Approximately 96 Hours Remain; Former Louisiana Attorney General http://t.co/DZlI2olJbK
Stocks to Buy
18 Apr 14 15:37:32
IsoRay $ISR remains the Top Stock in 2014, Up 380% - http://t.co/NybeQADnr8 … #Stocks $PLUG $BIOF $LIVE $VRS $ICPT $PEIX $RDNT $BLDP $VTNR
Charts and Carts
18 Apr 14 12:46:40
Short term: Ride $MINE run through more multiples, take profits and buy more $SRPT. Sarepta should be a hockeystick breakthrough like $ICPT.
Kevin F.
18 Apr 14 11:52:06
@OptionsHawk dope, look forward to see it flying like $ICPT $REGN $BIIB
Ticker Report
18 Apr 14 08:57:22
Insider Selling: Intercept Pharmaceuticals CEO Sells 10,000 Shares of Stock $ICPT http://t.co/YW6bLRwqfe
Donte Dallas
18 Apr 14 06:28:51
$ICPT INTERCEPT PHARMACEUTICALS INC Files SEC form 8-K, Change in Di http://t.co/DykPmbWC30
Okim59
18 Apr 14 04:54:54
RT @Stock_Tracker1: Intercept Pharmaceuticals Inc (ICPT) 240.10 $ICPT Nasdaq stocks posting largest percentage decreases AP - Wed http://t…
Colin Kuberski
18 Apr 14 04:38:06
$ICPT INTERCEPT PHARMACEUTICALS INC Files SEC form 8-K, Change in Directors or Principal Officers http://t.co/Aogek3eMwV
InsiderTradingWire
18 Apr 14 04:00:39
Mark Pruzanski, CEO & Pres of Intercept Pharmac Sells $2,148,573 Worth of $ICPT - #Form4 #InsiderTrading - http://t.co/ZT7TEANMN9
Boaz Boulstridge
18 Apr 14 03:04:38
$ICPT INTERCEPT PHARMACEUTICALS INC Files SEC form 8-K, Change in Di http://t.co/wpXM9tIIAE
Stock_Tracker
18 Apr 14 01:39:04
Intercept Pharmaceuticals Inc (ICPT) 240.10 $ICPT Nasdaq stocks posting largest percentage decreases AP - Wed http://t.co/Gh5VcS6MVF
Okim59
17 Apr 14 22:48:59
RT @AmericanBanking: Intercept Pharmaceuticals Short Interest Down 36.0% in March $ICPT http://t.co/7xKPQPRgaG
TradersTopNews
17 Apr 14 22:46:33
$ICPT Intercept Pharmaceuticals Short Interest Down 36.0% in March (ICPT) http://t.co/VGT7ue1Goa
Ticker Report
17 Apr 14 22:25:43
Intercept Pharmaceuticals Short Interest Down 36.0% in March $ICPT http://t.co/deEwCMhAxP
US Banking News
17 Apr 14 22:23:47
Intercept Pharmaceuticals Short Interest Down 36.0% in March $ICPT http://t.co/7xKPQPRgaG
TradersTopNews
17 Apr 14 20:17:06
$ICPT Insider Selling: Intercept Pharmaceuticals CEO Sells 10000 Shares of Stock (ICPT) http://t.co/SMf7Jjf19g
US Banking News
17 Apr 14 19:37:40
Insider Selling: Intercept Pharmaceuticals CEO Sells 10,000 Shares of Stock $ICPT http://t.co/EDA2XEWLIK
Yvrbear
17 Apr 14 17:50:39
@gagan_rawal @MKerryFuller $icpt $tts $nq very nice three stocks to own for the LT, despite your Stevie likes buying and flipping.
Gagan Rawal
17 Apr 14 16:24:19
@MKerryFuller Right SAC liquidated $icpt, $tts $nq, to name a few.
GavinGreenberg
17 Apr 14 15:01:37
$ICPT: INTERCEPT PHARMACEUTICALS INC Files SEC form 8-K, Change in Directors ... http://t.co/GTzK9UpVRc
Stock Herald
17 Apr 14 14:55:35
$ICPT: INTERCEPT PHARMACEUTICALS INC Files SEC form 8-K, Change in Directors ... http://t.co/Wl0AZZe4Nq
LoveStockNews
17 Apr 14 14:42:34
$ICPT - INTERCEPT PHARMACEUTICALS INC Files SEC form 8-K, Change in Directors ... -> http://t.co/OpJUKK4cID #stock #stocks #stockaction
StockNews
17 Apr 14 13:49:39
$ICPT - Current Report Filing (8-k) http://t.co/Nfi4IsrwK2
4-traders.com
17 Apr 14 13:35:09
INTERCEPT PHARMACEUTICALS : Change in Directors or Principal Officers (form 8-K) http://t.co/p7BGOFNfEs $ICPT
Ethan
17 Apr 14 13:19:51
$ICPT --- Bears losing steam? Spinning top.
Carine
17 Apr 14 12:51:01
$GNFT $ICPT @genfit_pharma
Ethan
17 Apr 14 12:39:20
$ICPT - 239.90 EOD guess
Legend Boulstridge
17 Apr 14 12:33:46
$ICPT Positive Results on Inter http://t.co/qf4i93tj0b
The Amazing Seven
17 Apr 14 11:29:26
$ICPT Positive Results on Inter http://t.co/pAz37F1MbB
US_proptrader
17 Apr 14 10:32:34
$DANG $DUST $ICPT $ITMN $LIVE $P $PEIX $SINA $TWTR autocharts @ http://t.co/kn4mViMgNq
US_proptrader
17 Apr 14 09:45:34
$DDD $DUST $ICPT $KNDI $LIVE $MHR $NQ $SINA $WNR autocharts @ http://t.co/kn4mViMgNq
Frederick Martin
17 Apr 14 09:32:55
RT @johnwelshtrades: $CNAT will also be effected by $ICPT binary update in July.
More Ant
17 Apr 14 08:00:39
RT @Catalystrader: $ICPT, I don't think this beast can be kept in the cage much longer, looking for sharp reversal bounce to $300+ soon eno…
Catalyst Trader
17 Apr 14 07:54:48
$ICPT, I don't think this beast can be kept in the cage much longer, looking for sharp reversal bounce to $300+ soon enough.
Derald Muniz
17 Apr 14 07:52:08
$ICPT chart updated, continues to hold this Horz Supp line. remain S in 50/50 Basket w/ Bear Collar http://t.co/X5lRfXdNoo
Elite Day Trader
17 Apr 14 07:40:29
$ICPT Bull Market Gainer http://t.co/igqHlBYc0Z
John Welsh
17 Apr 14 07:36:30
$CNAT will also be effected by $ICPT binary update in July.
TakingStock614
17 Apr 14 07:30:35
$ICPT has room here to run 264-271 range.
Ethan
17 Apr 14 07:22:06
Line in the sand, in my opinion, is 260. $icpt Not saying we are going there. That’s when this thing stops looking like it’s dying.
Anthony Nguyen
17 Apr 14 06:51:20
loving the volatility crush today in earnings plays on $GOOGL and $CMG all working out. $FB, $ICPT and $UVXY also holding up well enough.
Kermit Bailey
17 Apr 14 06:03:20
$ICPT Positive Results on Inter http://t.co/RV368trNKz
				
				
By  +Follow January 9, 2014 9:39AM
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