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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
Daily Contracts
22 Oct 14 12:59:36
Real-Time feed of company contracts, original agreements and executive updates from Intercept Pharmaceuticals $ICPT http://t.co/K84XvqdhHA
Jim
22 Oct 14 12:26:36
RT @SmarterAnalyst: $ICPT Deutsche Bank Reiterates Buy On Intercept Pharmaceuticals, $500 PT http://t.co/Ps5nuKrJt8
Smarter Analyst
22 Oct 14 12:09:03
$ICPT Deutsche Bank Reiterates Buy On Intercept Pharmaceuticals, $500 PT http://t.co/Ps5nuKrJt8
Venator
22 Oct 14 11:29:12
Has my ticker parade has been stuck for past hour...? lol $TSLA $NFLX $ACHN $ICPT $FB
US Banking News
22 Oct 14 06:13:41
Intercept Pharmaceuticals Gets Average Rating of Buy from Analysts $ICPT http://t.co/8Llmm0LASC
CapCube 2.0
21 Oct 14 12:10:23
Stocks in the red today: $CMG $OCN $ICPT $CLF $ANR $GDP $PBR to name a few .... $CMG is sweetness ....
Cornholio
21 Oct 14 11:41:25
@OptionsHawk someone is going to take $ACHN & $ICPT out eventually
Tom Wrigley
21 Oct 14 10:04:56
Some nLod in Healthcare / Biotech related stocks $ICPT $WBMD $CLVS $CBST $MDAS $UTHR $ATHN
Venator
21 Oct 14 09:32:04
$ICPT Picked up some at 227.5, may sell in combo with 223s of last week. Or, may hold along with others.
Peter Rumble
21 Oct 14 03:01:54
$ICPT is strong buy with bullish reversal last week, all targets 500$, very undervalued $SPY $IBB $GILD $ISRG
Eternity101
20 Oct 14 21:40:28
$ICPT -- what was that all about AH ?
Joe
20 Oct 14 21:37:25
@Opinterest Would help expand their multiple. But who are good candidates? $icpt $cnat? Not sure the pickings are so good right now?
Les
20 Oct 14 21:11:38
$ICPT stop raised. holding from $185/190. http://t.co/jNVRLyCG5q
InsiderTradingWire
20 Oct 14 19:30:48
$ICPT | Intercept Pharmac is down 22% since we reported $33,161,087 of insider selling on 08/28/2014. Did you ... - http://t.co/NT63ZCgfzW
Venator
20 Oct 14 09:19:53
@Rebuy27 That showed courage... but maybe better word is 'conviction'! $ICPT
Yu Zhu
20 Oct 14 09:13:47
RT @ScripMandy: @chasingthealpha Even if $ICPT NASH data publication is phenomenal, $200-plus stock may not last. Will be competition in th…
Venator
20 Oct 14 08:57:54
Wish I hadn't been such a deer-in-the-headlights at 180 last week! $ICPT
Yu Zhu
20 Oct 14 08:56:30
RT @svKatface: $ICPT Added some more in my IRA acct, at 232.
Venator
20 Oct 14 08:56:07
$ICPT Added some more in my IRA acct, at 232.
Bryon Franzen
20 Oct 14 08:49:38
RT @biotrader4gain: @biotrader4gain $ICPT and $CNAT doing very well... that's why i am adding swinging $OCRX
BioAlert
20 Oct 14 07:40:28
@biotrader4gain $ICPT and $CNAT doing very well... that's why i am adding swinging $OCRX
BioAlert
20 Oct 14 07:27:25
$CNAT .. $ICPT doing well.. $CNAT trying to break that $7 line.
Venator
20 Oct 14 07:18:32
$ICPT Hit +$ 12 in first 45 minutes... ok, I'll stop the blow-by-blow ;->
$$$ Money $$$
20 Oct 14 07:17:14
$ICPT 235.85 nice continues bullish chart
Venator
20 Oct 14 07:05:48
$ICPT Anybody day trading this? +9 after 30 minutes...
R4inb0w
20 Oct 14 01:02:04
#NASH competition : update of an Interesting chart $GNFT vs $ICPT & others (1 Year) #GENFIT #GFT505 http://t.co/PVhDJywIOJ
joshwin
19 Oct 14 23:02:13
RT @chasingthealpha: $ICPT any buys ever? Cashing out 2020 options http://t.co/KOpOK9xDtF
Big Money
19 Oct 14 15:30:35
ALL NEW TO $ICPT please be aware of the info!!!! http://t.co/RGtTE3UNf4
maxime mignot
19 Oct 14 14:23:58
RT @R4inb0w_: $GNFT #NASH #Liverdisease Ytd, Oct.16 Publication of research results by #GENFIT : http://t.co/WzrAQqo5hk $ICPT http://t.co/R…
Carine
19 Oct 14 14:01:06
RT @R4inb0w_: $GNFT #NASH #Liverdisease Ytd, Oct.16 Publication of research results by #GENFIT : http://t.co/WzrAQqo5hk $ICPT http://t.co/R…
Mandy Jackson
19 Oct 14 12:32:56
@chasingthealpha Even if $ICPT NASH data publication is phenomenal, $200-plus stock may not last. Will be competition in that space.
Shomik Ghosh
19 Oct 14 12:32:53
@chasingthealpha seems like $icpt is more automatic selling, smaller lots as % of holdings, $blue is troublesome though
Patrick
19 Oct 14 12:16:12
$ICPT any buys ever? Cashing out 2020 options http://t.co/KOpOK9xDtF
TickerChirp
19 Oct 14 11:54:04
Prevalent Tweets for $ICPT (INTERCEPT PHARMA INC symbol icpt) on 10/19/2014 http://t.co/u1HeX4X35K
jakubowski eric
19 Oct 14 03:20:40
RT @R4inb0w_: #Genfit : new patents allowed for #GFT505 in United States and China http://t.co/VkFNfs22OK #Health (via @IBNMoney_com #USA) …
R4inb0w
19 Oct 14 02:03:31
#Genfit : new patents allowed for #GFT505 in United States and China http://t.co/VkFNfs22OK #Health (via @IBNMoney_com #USA) #NASH $ICPT
Stocks News&Markets
18 Oct 14 13:01:01
lx21 made $158,909 on $ICPT -Check it out! http://t.co/SwHWlMUioP Learn #howtotrade http://t.co/axK8SMSgo9 $COCO $HDSN $BIOF $DLIA $LIME
chris lathem
17 Oct 14 17:20:51
I should have tweeted this swing on $ICPT Monday night. ~$50/share profit if sold near today's high. $260ish nxt wk? http://t.co/dqEizDrsoR
Venator
17 Oct 14 13:03:12
$ICPT Appears the magnet of Max Pain (230) got the edge over Harry's fib target (205), this time.
Will
17 Oct 14 11:36:04
Anyone know when $ICPT next catalyst since AASLD is no longer in play?
Tom Wrigley
17 Oct 14 11:14:32
Losing Some Higher Beta (nLod) $PCLN $GOOG $GOOGL $TSLA $MELI $BABA $GWPH $JD $BWLD $WYNN $BLOX $GPRO $ICPT $OVTI $MBLY etc ..
Venator
17 Oct 14 11:01:26
$ICPT Max Pain for maturity 2mrw is 230. http://t.co/EftlVZ9wHZ
Yu Zhu
17 Oct 14 10:25:50
RT @svKatface: Is ok,its Friday, plus $ICPT's delish aroma th past 2days,attracted every swing&day tradr for miles. http://t.co/LKG6oMVyx2
Venator
17 Oct 14 10:12:02
Is ok,its Friday, plus $ICPT's delish aroma th past 2days,attracted every swing&day tradr for miles. http://t.co/LKG6oMVyx2
DOGE4321
17 Oct 14 10:08:15
RT @R4inb0w_: $GNFT #GENFIT : after grant of an American patent for #GFT505 in #NASH, USPTO has allowed patent in hepatic fibrosis (Reuters…
Daniel De Oliveira
17 Oct 14 10:03:01
RT @R4inb0w_: $GNFT #GENFIT : after grant of an American patent for #GFT505 in #NASH, USPTO has allowed patent in hepatic fibrosis (Reuters…
Stocks News&Markets
17 Oct 14 10:01:00
lx21 made $15,427 on $ICPT -Check it out! http://t.co/cIuXaVKgd0 Learn #howtotrade http://t.co/axK8SMSgo9 $BUR $RADA $WLB $IBIO $DLIA
R4inb0w
17 Oct 14 09:57:51
$GNFT #GENFIT : after grant of an American patent for #GFT505 in #NASH, USPTO has allowed patent in hepatic fibrosis (Reuters) $ICPT $GILD
Lauren Holmes
17 Oct 14 09:19:13
$ICPT Possible $250's at lunch time...and $258 closing. For More Detail connect here http://t.co/IhJaUAjPfb
BS
17 Oct 14 09:09:20
RT @R4inb0w_: $GNFT #NASH #Liverdisease Ytd, Oct.16 Publication of research results by #GENFIT : http://t.co/WzrAQqo5hk $ICPT http://t.co/…
				
				
By  +Follow January 9, 2014 9:39AM
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