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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
PennyStock Zone
23 Nov 14 04:51:23
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PHARMD
22 Nov 14 17:39:37
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Venator
22 Nov 14 15:26:50
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22 Nov 14 15:06:25
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Golf TheSimpleTruth
22 Nov 14 02:49:02
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Shomik Ghosh
22 Nov 14 02:46:50
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Golf TheSimpleTruth
22 Nov 14 02:42:44
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PennyStock Zone
22 Nov 14 01:39:11
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21 Nov 14 20:20:32
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Berkutchi
21 Nov 14 14:47:11
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DCam
21 Nov 14 13:27:19
RT @Skipjackrick: Great week. +$12,173 in gains this week. Holding a bag in $ICPT -$2K and a few other winners over the weekend. $KWK lo…
Rick
21 Nov 14 13:24:56
Great week. +$12,173 in gains this week. Holding a bag in $ICPT -$2K and a few other winners over the weekend. $KWK looking nice
Rick
21 Nov 14 13:00:10
@Skipjackrick $ICPT going to hold these DEC calls just a little longer. I'm getting smoked on them right now. Down $2K loss. For now
InterCooler
21 Nov 14 09:48:38
Insider Selling: Intercept Pharmaceuticals CMO Sells 4,790 Shares of Stock $ICPT http://t.co/BJkR6GCwPR
Stefanie Ilgenfritz
21 Nov 14 09:41:07
RT @pharmalot: Up and Down the Ladder: Job Changes... the latest comings & goings.. recognize anyone? http://t.co/TKmXIWq9p8 #pharma $SNY $…
WSJ Health News
21 Nov 14 09:41:06
RT @pharmalot: Up and Down the Ladder: Job Changes... the latest comings & goings.. recognize anyone? http://t.co/TKmXIWq9p8 #pharma $SNY $…
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21 Nov 14 07:57:33
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Large Void Bot
21 Nov 14 06:36:10
Daily Reversal (09:36): $ICPT Last: 157.50; pHigh: 157.50; rVol: 0.298; pClose: 156.00; LOD: 156.2800; Perf: 1.0%
pharmalot
21 Nov 14 06:16:08
Up and Down the Ladder: Job Changes... the latest comings & goings.. recognize anyone? http://t.co/TKmXIWq9p8 #pharma $SNY $ICPT $ABLX
Jim
21 Nov 14 05:43:25
RT @CaptainFuture__: RBC 11/21: $ICPT On the road...we predict 5 catalysts for 2015 that could reverse sentiment here Read more: http://t.…
zipjet
21 Nov 14 05:18:22
Biotech Values: RBC 11/21: $ICPT On the road...we predict 5 http://t.co/YRFCAJ1UVd
On Time Picks
21 Nov 14 04:11:54
ariadndndough : RBC 11/21: $ICPT On the road...we predict 5: ariadndndough http://t.co/HgxoXzkJWk
dougheuring
21 Nov 14 03:11:24
RT @CaptainFuture__: RBC 11/21: $ICPT On the road...we predict 5 catalysts for 2015 that could reverse sentiment here Read more: http://t.…
Captain Sequence
21 Nov 14 01:40:14
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21 Nov 14 00:45:44
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Carine
20 Nov 14 22:23:43
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Bruce Leeroy
20 Nov 14 20:18:45
$ICPT looks like it could get a bounce here...way oversold on the daily chart! http://t.co/2UqJv2X89d
Eternity101
20 Nov 14 19:46:51
$ICPT RESISTANCE: 159.39 162.56 165.76 169.00 172.26 SUPPORT: 150.06 147.01 144.00 141.01 138.06 woof woof ?? or... ?
Woll Street
20 Nov 14 17:30:42
Bio stocks feel heavy here... may get short term pullback soon... $JAZZ $GILD $ICPT $BIIB etc... $CELG looks ok still..
Peter Green
20 Nov 14 14:46:29
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BS
20 Nov 14 14:21:11
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R4inb0w
20 Nov 14 14:16:53
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PennyStock Zone
20 Nov 14 13:28:44
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Mehrdad Ketabchi
20 Nov 14 09:54:06
Sold $icpt
wayne
20 Nov 14 09:37:00
$ICPT out this morning at 157.2
GPI
20 Nov 14 09:30:30
$icpt speculative buying here, tgt $165
The Legacy News
20 Nov 14 08:45:44
Insider Selling: Intercept Pharmaceuticals CMO Sells 4,790 Shares of Stock $ICPT http://t.co/cccBAsXuvK
InsiderTradingWire
20 Nov 14 07:30:10
$ICPT | Intercept Pharmac is down 47% since we reported $33,161,087 of insider selling on 08/28/2014. Did you ... - http://t.co/zMruEdUuJi
Jim
20 Nov 14 07:18:48
RT @R4inb0w_: $GILD #NASH Gilead pays $125M for an FDA priority review voucher: faster FDA approval of any type of drug http://t.co/bedNpOL…
Mehrdad Ketabchi
20 Nov 14 06:40:51
Bought $icpt
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20 Nov 14 06:38:20
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Cisc@
20 Nov 14 06:20:57
RT @agoraphile38: Intercept Pharmaceuticals Inc (NASDAQ:ICPT) Under Investigation over Possible Securities Laws Violations http://t.co/voSd…
lololebreton
20 Nov 14 06:16:51
RT @agoraphile38: Intercept Pharmaceuticals Inc (NASDAQ:ICPT) Under Investigation over Possible Securities Laws Violations http://t.co/voSd…
Daniel De Oliveira
20 Nov 14 06:09:39
RT @agoraphile38: Intercept Pharmaceuticals Inc (NASDAQ:ICPT) Under Investigation over Possible Securities Laws Violations http://t.co/voSd…
Red Acre Investments
20 Nov 14 05:57:39
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Patrick
20 Nov 14 05:24:33
RT @NathanAhron: $icpt insiders continue to sell down here (via 10b51)
NathanAaron
20 Nov 14 05:08:44
$icpt insiders continue to sell down here (via 10b51)
seb hg
20 Nov 14 04:48:19
RT @R4inb0w_: $GILD #NASH Gilead pays $125M for an FDA priority review voucher: faster FDA approval of any type of drug http://t.co/bedNpOL…
				
				
By  +Follow January 9, 2014 9:39AM
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