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Intercept Shares Skyrocket on NASH Trial Data, Galectin Shares Jump Too

By  +Follow January 9, 2014 9:39AM
Tickers Mentioned:

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
Technical Charting
30 Oct 14 10:31:46
@Technical_Chart Need to add $GOOG $AMZN $NFLX $QQQ $ICPT $ISRG to that short list
30 Oct 14 10:20:26
$ICPT buyout or big gap up coming soon. Just a hunch.
30 Oct 14 10:18:04
long $ICPT Nov14 260 call @ 18.85 for small hold http://t.co/2Zj3Cyd4cP
30 Oct 14 10:10:09
$ICPT Lightened my margin with a sell at 259 (+$13). Hated to do it so early, but $NFLX is killing me post-ER.
30 Oct 14 10:03:50
$LAKE and $SMED announce increases in revenue due to #Ebola related business activity. $ICPT investors read: http://t.co/vxKje2CxK4 #stocks
Samuel Brown
30 Oct 14 10:02:15
$ICPT Commit To Buy Intercept Pharmaceuticals At $150, Earn 12% Using Options http://t.co/rje14oZawz
Peter Rumble
30 Oct 14 09:39:19
$ICPT is flying again, 300$ next
Stocks News&Markets
30 Oct 14 09:00:59
lx21 made $116,781 on $ICPT -Check it out! http://t.co/laSfXOyPZL Learn #howtotrade http://t.co/axK8SMSgo9 $PDII $BBSI $IBIO $ABMD $JDST
Yu Zhu
30 Oct 14 08:40:15
RT @svKatface: $ICPT Time 4an intelligent observation: "Yeah Baby!" Nice vol buy of 4000+shares (that would be nothing4 many co's but is …
Yu Zhu
30 Oct 14 08:37:54
RT @svKatface: $ICPT Volume is really low (i.e., "normal"). MUST have more volume to ensure this trend continues.
30 Oct 14 08:32:48
$ICPT Volume is really low (i.e., "normal"). MUST have more volume to ensure this trend continues.
30 Oct 14 08:06:33
$ICPT Time 4an intelligent observation: "Yeah Baby!" Nice vol buy of 4000+shares (that would be nothing4 many co's but is good news here)
Stock Relay
30 Oct 14 02:07:41
wininstocks2014: Stock Charts: ICPT 250.33 Stock Charts $ICPT Intercept http://t.co/whKcePfVyi
29 Oct 14 20:31:56
Looking to $ICPT $CAMT $OTIV potential November cash machine.
Rick Cavalieri
29 Oct 14 15:16:36
RT @SAlphaTrending: The Time Is Now For Northwest Biotherapeutics http://t.co/cySEUWKJ1O $AAPL #APPLE $JAZZ $ICPT $PCYC $NWBO
Seeking Alpha
29 Oct 14 12:30:00
The Time Is Now For Northwest Biotherapeutics http://t.co/cySEUWKJ1O $AAPL #APPLE $JAZZ $ICPT $PCYC $NWBO
Seeking Alpha
29 Oct 14 12:16:47
The Time Is Now For Northwest Biotherapeutics http://t.co/SCtGLjDDyw $AAPL #APPLE $JAZZ $ICPT $PCYC $NWBO
Stocks News&Markets
29 Oct 14 11:01:55
lx21 made $15,427 on $ICPT -Check it out! http://t.co/cIuXaVKgd0 Learn #howtotrade http://t.co/axK8SMSgo9 $ONCY $SHLDR $MCGC $COOL $AMED
29 Oct 14 08:41:31
$ICPT needs to get past 250 and the Retails who pee their pants in excitement there and sell.
29 Oct 14 08:33:12
Firstx I notice this, viaFidelity: "Ned DavisResearchGroup upgrades $ICPT from SELL to NEUTRAL. BY Investrs Analyst Actions-private 10/27"
29 Oct 14 08:26:52
$ICPT Remember $ICPT is expected to publish in major journal by year end.
Yu Zhu
29 Oct 14 08:02:01
RT @svKatface: $ICPT a green survivor in a sea of red. barely!
29 Oct 14 08:01:11
$ICPT a green survivor in a sea of red. barely!
Abhishek Shetty
29 Oct 14 07:02:12
29 Oct 14 05:02:08
The Top in Twitter About $ICPT (Intercept Pharma Inc symbol ICPT) on 10/29/2014 http://t.co/QKPHVuDWSj
Stock Relay
29 Oct 14 04:33:12
stockblaster14: Stock Alerts: Intercept Pharmaceuticals Inc (ICPT) 246.59 $ICPT http://t.co/X07uFXj73p
Stocks to Buy
28 Oct 14 14:09:04
RadNet $RDNT remains the Top Stock in 2014, Up 447% http://t.co/FTwph2zfof #Stocks $VIMC $GRBK $VRS $PTX $ICPT $ACHN $ISR $IBIO $AVNR $AGIO
John Turner
28 Oct 14 10:31:34
$ICPT Intercept Pharmaceuticals Inc. (ICPT) Has Spiked To The Upside http://t.co/uUO9FZEaZb
28 Oct 14 08:54:52
Another "mystery" with $KITE is they are running trial with NIH. How much data they and we are going to get, Ask $ICPT
28 Oct 14 08:35:55
$ICPT My $ 227 lot is trying to get my attention, but I am ignoring it! Holding.
Llunwerth Burnard
28 Oct 14 08:31:57
Super Stock Screener rates $ICPT as a Strong Sell t,co/csahc9XG8A
28 Oct 14 08:23:10
Bio in focus $ibio $apt $nlnk $srpt $achn $cnat $cytr $dvax $icpt $tsro $cocp
28 Oct 14 07:44:29
$MSTX huge blocks traded in these days and funds increasing their stakes $CPRX $OXGN $IBB $ACHN $ICPT $ISR $IBIO $KNDI $TSLA $AAPL $RMTI
Jennifer Rhodes
28 Oct 14 07:40:56
@VikramKhanna_ $ICPT falls just out of your range but beats $RCPT on performance
28 Oct 14 07:36:23
$ICPT Is acting well. Sooner or later someone will be looking at this for acquisition. Next resistance is the 50Day MAV
28 Oct 14 07:35:40
$ICPT Now up up $52/share since posted LOLLL LOVE IT #CASHCOW
Branden Muhl
28 Oct 14 07:35:02
$RCPT can easily attain $130 by 2Q15 & $340 LT. Similar cos w pipeline within a drug $PCYC $MDVN $PBYI $ICPT all found their way to $5B+ cap
28 Oct 14 06:58:57
$ICPT Nice early move up with some volume - just what Longs want to see. http://t.co/3t0ske2Ohf
28 Oct 14 06:24:01
$ICPT pulled back!
Brent Gaynor
28 Oct 14 05:49:53
If $ibb pre-market is any indication, $regn $icpt $gild should be up first hour at least.
Nico Salvatore Enea
27 Oct 14 22:47:38
I have the eery feeling the employees of $SRPT feel like LTCM employees back in the day before the implosion. OR it could be $ICPT makings
Woll Street
27 Oct 14 20:10:01
$ICPT nice look too...
Stocks to Buy
27 Oct 14 16:26:03
RadNet $RDNT is the Top Stock in 2014, Up 429% - http://t.co/FTwph2zfof #Stocks $VIMC $BIOF $IBIO $PTX $VRS $ICPT $ISR $ACHN $AVNR $AGIO
Chayton Falke
27 Oct 14 14:15:03
Top Twenty Recent Exits #18: Covered $ICPT short for a 13.18% gain in 25 days! #trading #ICPT #forex #stocks
27 Oct 14 13:53:26
@LifeSciAdvisors $RCPT Shorts Could be in huge trouble here Could pull a $PBYI $ICPT
27 Oct 14 13:53:16
@VikramKhanna_ $RCPT Shorts Could be in huge trouble here Could pull a $PBYI $ICPT
27 Oct 14 13:49:40
$RCPT Shorts Could be in huge trouble here Could pull a $PBYI $ICPT
27 Oct 14 13:13:30
Bad news on $OTIV? No so fast it's only a matter of time! Take of like jet for iPhone legacies. $ICPT is another potential too!
27 Oct 14 12:16:28
Commented on StockTwits: Nice share! espec since SA has now made the original article only for its paid subs. $ICPT http://t.co/bpY4txmlAl
27 Oct 14 11:58:56
$ICPT On the 10 minute chart, looks ready for a pocket pivot. Will need 606k in volume. Not likely today BWTFDIK?
By  +Follow January 9, 2014 9:39AM



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