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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. 

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Results for icpt
Kristina Duering
23 May 15 00:52:40
RT @GeryDIVRY: $ICPT $GNFT any coherent explanation on that ? http://t.co/0FAKXrf29Z
Breaking News Now
23 May 15 00:28:02
$GILD $ICPT: Will This Drug Beat Gilead to Market in NASH?: http://t.co/HmXflKeaPA
Invest | Donate
23 May 15 00:11:40
@clayton_dd: XLE Energy Select Sector SPDR Open http://t.co/poMBBQVrk6 $XLE $ICPT $HLF $XLV #XLE #share #invest
TooTiX
22 May 15 23:49:43
RT @insider_filings: $ICPT: WILLIAMS NICOLE sold a net $243,618 in INTERCEPT PHARMACEUTICALS INC. http://t.co/j2rTwAWalY
clayton
22 May 15 23:48:35
XLE Energy Select Sector SPDR Open http://t.co/IbGssCMMkL $XLE $ICPT $HLF $XLV #XLE #share #invest
Stock Forums
22 May 15 23:41:08
LQDT Liquidity Services Inc. Dividend http://t.co/vbPDqu4heb $LQDT $BB.TO $ICPT $ALXN #LQDT #finance #nasdaq
IH NASDAQ OMX
22 May 15 23:40:09
ICPT Intercept Pharmaceuticals, Inc. Yield http://t.co/9NYQnDnmLd $ICPT $GDX $DANG $CBON #ICPT #investing #investing
nasdaqfan
22 May 15 23:39:37
IBB Biotech iShares Exchange http://t.co/9m0oc5zYpQ $IBB $BTG $BABA $ICPT #IBB #tradeideas #tradeideas
IH NASDAQ OMX
22 May 15 23:35:10
CORI Corium International, Inc. Shares http://t.co/vPJMJcImEG $CORI $SSO $XLV $ICPT #CORI #stockmarket #finance
True about ...
22 May 15 23:33:54
RT @insider_filings: $ICPT: WILLIAMS NICOLE sold a net $243,618 in INTERCEPT PHARMACEUTICALS INC. http://t.co/j2rTwAWalY
DennyT
22 May 15 23:32:04
ASHR db X-Trackers Harvest CSI 300 China A-Shares Fund Exchange http://t.co/ctB33H1ZER $ASHR $ICPT $C $QID #ASHR #investing #nasdaq
Okim59
22 May 15 21:40:04
RT @insider_filings: $ICPT: WILLIAMS NICOLE sold a net $243,618 in INTERCEPT PHARMACEUTICALS INC. http://t.co/j2rTwAWalY
CashRocket
22 May 15 20:09:07
RT @BioBreakout: RT @BioDueDiligence Biotech Tweets of the Week http://t.co/EjUbaoIaQV $BLUE $EBIO $ACHN $ICPT $KITE $SRPT $PBYI $OTIC $ONT…
Eternity101
22 May 15 20:07:02
$ICPT based on FRI May 22 close 261.46 Breakout = 290.84 R2 = 273.59 R1 = 267.52 Pivot = 261.93 S1 = 255.86 S2 = 250.27 Breakdown = 232.54
Finance Magnates
22 May 15 20:03:07
Why did shares of Intercept Pharmaceuticals Inc slide 10%? $ICPT http://t.co/sbOucrMNOw
BioBreakout
22 May 15 20:02:42
RT @BioDueDiligence Biotech Tweets of the Week http://t.co/EjUbaoIaQV $BLUE $EBIO $ACHN $ICPT $KITE $SRPT $PBYI $OTIC $ONTY etc c/o @23aloha
biotechtwt
22 May 15 19:54:07
RT @jamesdeyonker: $BLUE $ICPT $OCAT pursuing the same Reg strategy.Already Pivotal in EU (w/ AMTP) and seeking SPA and BT in US.Coordinati…
ProVesting
22 May 15 18:50:03
$ICPT: What after Nicole Williams's Insider Sale of Intercept ...: http://t.co/D1R5jKbmnn
ProTradersNews
22 May 15 18:16:02
$ICPT: Insider Selling at Intercept Pharmaceuticals Inc (ICPT) : Nicole ...: http://t.co/iPZ0t24TmF
Insider Filings
22 May 15 18:03:27
$ICPT: WILLIAMS NICOLE sold a net $243,618 in INTERCEPT PHARMACEUTICALS INC. http://t.co/j2rTwAWalY
ProVesting
22 May 15 18:03:12
$ICPT: New Insider Transaction on ICPT by Director: http://t.co/tEEEYUPgTV
Insider Alerts
22 May 15 18:03:06
NEW insider transaction on $ICPT reported a moment ago: http://t.co/YxserRVTxA
Biotech Beat
22 May 15 17:54:12
RT @LifeSciVC: ICYMI: From The Trenches- @KapellerRosana covers NASH race $ICPT $GNFT Nimbus' ACC & others http://t.co/JAoyH7TMgP http://…
Bleecker
22 May 15 15:46:19
#InsiderTrading @adamfeuerstein $ICPT insiders sells did not occurred just before news. News occurred after sales. See difference?!
Varun kumar
22 May 15 15:20:19
RT @LifeSciVC: ICYMI: From The Trenches- @KapellerRosana covers NASH race $ICPT $GNFT Nimbus' ACC & others http://t.co/JAoyH7TMgP http://…
ethan
22 May 15 15:11:44
RT @R4inb0w_: $ICPT Lipid abnormalities... "the court found that the allegations in the complaint were sufficient" http://t.co/D63QB7XI39
Subramania Kaushik
22 May 15 15:05:53
RT @R4inb0w_: $ICPT Lipid abnormalities... "the court found that the allegations in the complaint were sufficient" http://t.co/D63QB7XI39
KSS, MD, PhD
22 May 15 14:57:59
RT @R4inb0w_: $ICPT Lipid abnormalities... "the court found that the allegations in the complaint were sufficient" http://t.co/D63QB7XI39
Luke Timmerman
22 May 15 13:58:34
RT @LifeSciVC: ICYMI: From The Trenches- @KapellerRosana covers NASH race $ICPT $GNFT Nimbus' ACC & others http://t.co/JAoyH7TMgP http://…
I'm Genfit ($GNFT)
22 May 15 13:51:44
RT @R4inb0w_: $ICPT Lipid abnormalities... "the court found that the allegations in the complaint were sufficient" http://t.co/D63QB7XI39
Mark Punyanitya
22 May 15 12:22:11
RT @LifeSciVC: ICYMI: From The Trenches- @KapellerRosana covers NASH race $ICPT $GNFT Nimbus' ACC & others http://t.co/JAoyH7TMgP http://…
Joe Librescu
22 May 15 11:39:02
$vtae goes after $gild .. $cala after $agio ... $ormp after $mnkd ... $glmd after $icpt and $xene .. after $rdus ?
HORIZON-GENFIT
22 May 15 11:37:12
RT @R4inb0w_: $ICPT Lipid abnormalities... "the court found that the allegations in the complaint were sufficient" http://t.co/D63QB7XI39
Seb El Rey
22 May 15 11:23:43
RT @R4inb0w_: $ICPT Lipid abnormalities... "the court found that the allegations in the complaint were sufficient" http://t.co/D63QB7XI39
shear
22 May 15 11:10:29
RT @R4inb0w_: $ICPT Lipid abnormalities... "the court found that the allegations in the complaint were sufficient" http://t.co/D63QB7XI39
Bibi
22 May 15 10:53:53
RT @nlaurent191: $icpt #Intercept still in trouble with its class action https://t.co/kpB20lnD2g
PatAubagne
22 May 15 10:08:35
Yes you can (be nervous)!! $ICPT #NASH https://t.co/MJwldAc9pZ
Kristina Duering
22 May 15 10:08:20
RT @PatAubagne13: Not for $ICPT but perhaps for $GNFTF $GNFT!! http://t.co/ScKBkqRTtD https://t.co/vS5p4ic0sL
PatAubagne
22 May 15 10:07:06
Not for $ICPT but perhaps for $GNFTF $GNFT!! http://t.co/ScKBkqRTtD https://t.co/vS5p4ic0sL
Farouk
22 May 15 09:39:38
@codytrades do you think $GILD would offer a fair price for my left kidney or perhaps $ICPT would be fairer? ;)
PatAubagne
22 May 15 09:38:36
RT @adamfeuerstein: . @DewDiligence My POS higher than 20%. I’ll say 60% for shits & giggles. The ph 3 endpoints aren’t that different from…
PatAubagne
22 May 15 09:37:54
RT @DewDiligence: .@masterlongevity I give $ICPT's REGENERATE a 20% chance 2succeed.
PatAubagne
22 May 15 09:37:29
RT @masterlongevity: $ICPT what do you think of the design? obviously market doesnt like it $ICPT http://t.co/zPSZGbm2hf
PatAubagne
22 May 15 09:23:05
RT @GeryDIVRY: $ICPT $GNFT regarding the last studies from 150 000 to 700 000 Us Patients would die from NASH in the US .. it is an emergen…
PatAubagne
22 May 15 09:22:56
RT @nlaurent191: Again???? $icpt they sure believe in their future at #Intercept .... https://t.co/Tg3XgIt3be
PatAubagne
22 May 15 09:22:18
RT @Tootix: Statin use and nonalcoholic steatohepatitis in at risk individuals - Journal of Hepatology http://t.co/y6mrpV6AXG $ICPT $GNFT …
PatAubagne
22 May 15 09:21:34
RT @Giua_Celestri: $icpt phase 3 pour NASH type 1 à 3! C'est une blague?l'étude #golden a prouvé qu'un régime suffisait... $gnft seul sur …
PatAubagne
22 May 15 09:18:48
RT @DOGE4321: $ICPT a finalement perdu 16.08% sur la seule séance d'hier. #jackytouch
PatAubagne
22 May 15 09:18:03
RT @VERBEECK_A: $ICPT $GNFT Et quelle serait l'opinion de ODDO sur Intercept :-D ... Probablement aussi Neutre... https://t.co/kB1GAHSiGw
PatAubagne
22 May 15 09:17:55
RT @R4inb0w_: GENFIT : L'action de son principal concurrent encore en baisse - via http://t.co/QfJ79oKMqa $GNFT $ICPT http://t.co/82BJlDnI…
				
				
By  +Follow January 9, 2014 9:39AM
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