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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
YK
21 Sep 14 09:35:37
RT @R4inb0w_: Kepler Cheuvreux Biotech Roundtable: "Will a French biotech enter the Blockbuster Select Club?" JF Mouney CEO of #GENFIT talk…
Hung Tran, MS, MD
20 Sep 14 20:48:10
$MNKD $BABA $NHTC $VVUS $ARNA $OREX $ICPT $ITMN $ICPT $TSLA $GMCR $KERX "Investing is most intelligent when it's most business like." Graham
Prashant Jain
20 Sep 14 09:37:56
@justinburkhard1 thats cool. I just got out of UGAZ..will get back in again next week. In $ICPT and $HTBX (short). Any bio with news on hzn?
avidresearch
20 Sep 14 06:59:27
@arshavin_k no position in $ICPT. May enter in 2015.
U K
20 Sep 14 06:56:00
@avidresearch Are you long $ICPT? I snagged some yesterday after that drop for AASLD. Hope I didnot jump early.
karmaswimswami
19 Sep 14 19:03:26
@Lin_ling_88 @dougheuringaria ..it will stun street. Liver docs totally ho-hum about $ICPT's obeticholic acid. Tachyphylaxis! Gallstones!
BioInvestor
19 Sep 14 16:18:24
$oxgn a stock under $3 That Should Be Trading over $15.00 soon ! http://t.co/VQb5dqmQiv $ICPT $PBYI $IDIX $QCOR $ACAD $atrs $bmrn
Dan
19 Sep 14 15:12:03
$ICPT OI for maturity 09/20/2014. 225.00 Highest put. 300.00 Highest call. http://t.co/RvVpLSlWoU
ethan
19 Sep 14 13:49:56
RT @dougheuringaria: $icpt $gnft GenFit will report Phase IIB data in NASH in early 2015 but we don't expect it to be as good as ICPT. htt…
Venator
19 Sep 14 13:03:19
$ICPT Martini time.
Venator
19 Sep 14 13:00:05
$ICPT Out of my 261.9 at 259 :-( but maybe I should be happy - some bigger buyer came right near EOD and scooped all open sells.
BuyersStrike
19 Sep 14 12:58:32
To the morons out there wondering if $GILD would buy $ICPT. Um, no. $GILD mgmt smart enough to use Google....
Antoine hajjar
19 Sep 14 11:59:05
RT @SashaDamouni: $GILD simtuzumab - may cause liver enzyme elevation in high dose - will be focus in Phase 2 readouts: Bloomberg Intellige…
Daily Contracts
19 Sep 14 11:41:01
Real-Time feed of company contracts, original agreements and executive updates from Intercept Pharmaceuticals $ICPT http://t.co/K84XvqdhHA
Zilverztar
19 Sep 14 11:08:08
RT @R4inb0w_: "NASH Is Biotech's Next Hot Target" Newsflow on #Bloomberg by Liz Krutoholow #GENFIT #GFT505 $GNFT $ICPT $GILD http://t.co/2L…
Carine
19 Sep 14 11:03:28
RT @R4inb0w_: "NASH Is Biotech's Next Hot Target" Newsflow on #Bloomberg by Liz Krutoholow #GENFIT #GFT505 $GNFT $ICPT $GILD http://t.co/2L…
maxime mignot
19 Sep 14 10:26:28
RT @R4inb0w_: "NASH Is Biotech's Next Hot Target" Newsflow on #Bloomberg by Liz Krutoholow #GENFIT #GFT505 $GNFT $ICPT $GILD http://t.co/2L…
Daniel De Oliveira
19 Sep 14 10:25:24
RT @R4inb0w_: "NASH Is Biotech's Next Hot Target" Newsflow on #Bloomberg by Liz Krutoholow #GENFIT #GFT505 $GNFT $ICPT $GILD http://t.co/2L…
Daily Contracts
19 Sep 14 10:13:00
Real-Time feed of company contracts, original agreements and executive updates from Intercept Pharmaceuticals $ICPT http://t.co/K84XvqdhHA
Venator
19 Sep 14 09:40:07
Everyone should sell Everything and just buy $BABA ,up 42% day1 -support Chi economy! Oh -- already happening? $ICPT $NFLX $TASR $TSLA $AAPL
Venator
19 Sep 14 09:36:56
$ICPT Price now between the gap between 8/11 and 8/12 - which days closed (approx) 237 and 277, respectively. Nervously
WKRB News
19 Sep 14 09:33:59
Intercept Pharmaceuticals CMO David Shapiro Sells 4,000 Shares $ICPT http://t.co/h6uyHro7ZD
Ani Anirudhan
19 Sep 14 09:31:13
$ICPT at 50DMA support http://t.co/JA8oIFS2c7
R4inb0w
19 Sep 14 09:21:40
"NASH Is Biotech's Next Hot Target" Newsflow on #Bloomberg by Liz Krutoholow #GENFIT #GFT505 $GNFT $ICPT $GILD http://t.co/2LrjTLZVTa
Dan
19 Sep 14 08:12:02
$ICPT OI for maturity 09/20/2014. 225.00 Highest put. 300.00 Highest call. http://t.co/RvVpLSlWoU
Dan
19 Sep 14 08:00:10
$ICPT Max Pain is 272.50 for maturity 09/20/2014. Last close = 262.09. http://t.co/GlwKahjY40
Venator
19 Sep 14 07:06:44
$ICPT ok I picked some up at 261.8 (unbelievable!) but it is on the tiniest of short leases.
dougheuring
19 Sep 14 07:04:59
RT @SashaDamouni: $GILD simtuzumab - may cause liver enzyme elevation in high dose - will be focus in Phase 2 readouts: Bloomberg Intellige…
Gery DIVRY
19 Sep 14 07:01:17
@svkatface $ICPT you know why .. they loosed the lead on NASH…
Venator
19 Sep 14 06:56:16
$ICPT I know its a small float but the trades are gyrating wildly... and widely. eg 262 and then next one 261.2
Ani Anirudhan
19 Sep 14 06:56:08
$ICPT gap fill near 240. now well in the gap... http://t.co/3DaNsQy7nx
Simon Lackner
19 Sep 14 06:53:58
RT @SashaDamouni: $GILD simtuzumab - may cause liver enzyme elevation in high dose - will be focus in Phase 2 readouts: Bloomberg Intellige…
Sasha Damouni
19 Sep 14 06:51:54
$GILD simtuzumab - may cause liver enzyme elevation in high dose - will be focus in Phase 2 readouts: Bloomberg Intelligence; AASLD? $ICPT
1 TRADER
19 Sep 14 06:38:53
added $ICPT 265
Stock Signaling
19 Sep 14 06:31:27
Upgraded Stocks Active in Pre-Market: $CNQR $ARCB $BLDP $VECO $VNET $AVNR $CNVR $JDSU $NDLS $FEYE $CSIQ $INFN $ICPT $VRTX $SNDK #spy #stock
1 TRADER
19 Sep 14 06:18:46
$ICPT will add 20 sh at a time fwiw
Dan
18 Sep 14 16:12:16
$ICPT high open interest range is 225.00 to 300.00 for option expiration 09/20/2014. http://t.co/RvVpLSlWoU
Dan
18 Sep 14 16:00:08
$ICPT Max Pain = 272.50. Maturity = 09/20/2014. Previous close = 266.88. http://t.co/GlwKahjY40
Daily Contracts
18 Sep 14 14:57:01
Real-Time feed of company contracts, original agreements and executive updates from Intercept Pharmaceuticals $ICPT http://t.co/K84XvqdhHA
BS
18 Sep 14 12:57:21
#NAFLD #NASH #LIVER DISEASE $GNFT $ICPT The New Public Health Alert.... Fatty Liver Disease: http://t.co/6eFpSGjxcp via @YouTube
Venator
18 Sep 14 12:57:02
$ICPT Useful to review & think about the 9 mo, VERY interesting chart. I made a few comments... . http://t.co/jkgJjElFt1
Venator
18 Sep 14 12:22:51
$ICPT Hey look at the trolls coming out of the woodwork! hi guys
avidresearch
18 Sep 14 12:03:37
$ICPT almost filled the gap from the FLINT Topline results
Large Void Bot
18 Sep 14 12:00:26
Popular: $AOL, $BTU, $CODE, $RIG, $ICPT, $TRP, $WLL, $COST, $TLM
Venator
18 Sep 14 10:30:20
$ICPT whoops forgot to add graph. http://t.co/59mdkJ06f9
Venator
18 Sep 14 10:27:40
$ICPT Maximum Pain for maturity Saturday is $ 272.5. Thx, http://t.co/LjdkJ5WjCh
Eternity101
18 Sep 14 10:06:22
$BLUE .. this one keeps going higher - NOT under many radar screens ..feel it will be a $ICPT - $PBYI type of move one of these days
1 TRADER
18 Sep 14 09:24:51
buying sm LT #swing in $ICPT 269 . will accumulate
Venator
18 Sep 14 09:17:36
$ICPT So hopefully BofA will have good things to report... tho I cant imagine them upping their PT ($872 in Jan, groan!)
Venator
18 Sep 14 09:15:22
FYI re BofA MerLy Conf: Dr. R.McMinn-- $ICPT Dir ofStrategy--prior job was director at BofAML & lead research analyst, covering biotech.
				
				
By  +Follow January 9, 2014 9:39AM
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