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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. 

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Results for icpt
27 Mar 15 08:36:31
$gnft $icpt "its long-term benefits & safety need further clarification" (lancet). Spot on indeed (2/2)
27 Mar 15 08:33:42
$gnft $icpt "OCA improved the histological features of NASH but..." (1/2)
27 Mar 15 08:27:36
Top stocks bull trade ideas: $RHT $FIVE $NVO $ROVI $LULU $HOT $NSR $SIG $ICPT $ACN more http://t.co/afLVqGEPgY
Abhishek Shetty
27 Mar 15 08:22:19
27 Mar 15 08:14:47
UP over 10k profit for the day with $BMRN, $BIIB, $ICPT, $JUNO, $CLVS, and $IBB!!
27 Mar 15 08:14:30
$AFFX $AKRX $ESPR $ICPT $JUNO $KEG $NBIX $NG $ZIOP autocharts @ http://t.co/cLiki3R0GR
27 Mar 15 08:03:35
5-star analyst Ian Somaiya from Nomura Holdings reiterated a BUY on $ICPT. Ian has a 75% success rate http://t.co/oDWYs7FpaF #NASDAQ #stocks
27 Mar 15 07:51:38
RT @Sachakin: Deutsche Bank Key Points following $GNFT results on GFT505 - vs $ICPT http://t.co/TlvrgWzfq4
Mr Connected
27 Mar 15 07:44:05
$icpt DB note $ibb http://t.co/4QVY6Wzefj
27 Mar 15 07:40:03
$ICPT: Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) announced new ...: http://t.co/GivJNXCKrA
27 Mar 15 07:33:14
@arnaudtraderbio Don't loose your soul chasing that $GNFT pot of gold… American $ICPT is a beast and it will dominate the NASH market!!
Dror Ozeri
27 Mar 15 07:27:33
RT @AndyBiotech: $GNFT Smart take on GFT505 data by Baird's Brian Skorney: "Saying the results are ambiguous is being generous". $ICPT http…
Don Nicholson
27 Mar 15 07:27:05
RT @BentheFidler: East Coast Biotech Roundup: #Hemophilia, Levin, Vertex, Semma & More http://t.co/DtQd9TB2Fn $BPMC $IMGN $VRTX $CELG $ICP…
27 Mar 15 07:19:46
RT @BioBreakout: $GNFTF $ICPT Genfit Tortures Fatty Liver Drug to Extract Positive Results From Failed Study http://t.co/lzl8ZovK36 via @Th…
Alex Munns
27 Mar 15 07:18:52
RT @AndyBiotech: $GNFT Smart take on GFT505 data by Baird's Brian Skorney: "Saying the results are ambiguous is being generous". $ICPT http…
Scott Smith
27 Mar 15 07:10:17
$IBB Feeling the oomph on bio stocks like $JUNO $ICPT $CLDX (follow through) Chart posted on ST yesterday. http://t.co/cAYu3ivEe9
27 Mar 15 07:06:34
#Genfit $gnft on notera que $icpt ne transforme pas l'essai. !!!
Arthur Jeannerot
27 Mar 15 07:01:54
RT @R4inb0w_: CM-CIC GENFIT : "Focusing on patients with NAS score>= 4, the results were similar in magnitude to those obtained by Intercep…
27 Mar 15 07:00:47
5-star analyst Liana Moussatos from Wedbush reiterated a BUY on $ICPT. Liana has a 66% success rate http://t.co/oDWYs7FpaF #NASDAQ #stocks
Christopher Angus
27 Mar 15 07:00:03
Premarket most advanced stocks: $CONN, $OREX, $BMRN, $ABGB, $MVIS, $BBRY, $ICPT, $INFN, $ESPR, $FINL
27 Mar 15 06:59:58
#sentishiftup $ALE $T $CSCO $MSFT $C $GDX $INVT $UWTI $GS $ICPT #sentiquant 20150327 10:00:05:474
Ani Anirudhan
27 Mar 15 06:59:25
$ICPT long on gap fill https://t.co/yjBlUSbBXJ via http://t.co/11Wpw9y7t1
27 Mar 15 06:59:22
$kite $cldx $sgyp $amrn good buys yesterday. All up as biotech stocks recovering. $icpt was a good buy, glad sold $gnftf w small loss
27 Mar 15 06:58:54
$GNFTF $ICPT Genfit Tortures Fatty Liver Drug to Extract Positive Results From Failed Study http://t.co/lzl8ZovK36 via @TheStreet
Ben Fidler
27 Mar 15 06:58:23
East Coast Biotech Roundup: #Hemophilia, Levin, Vertex, Semma & More http://t.co/DtQd9TB2Fn $BPMC $IMGN $VRTX $CELG $ICPT $PRTO $OVAS $JNJ
V.S. Schulz
27 Mar 15 06:57:21
Our #NASH basket approach worked out really well btw. $GNFT $ICPT $CNAT $GILD ... #zzporte
27 Mar 15 06:56:37
$ICPT did the same thing as $BMRN yesterday..gaped up today and poof..sold
Mvldar Bearded
27 Mar 15 06:55:24
out 30 $ICPT @ 292 for a break-even, still have 20 shares left.
V.S. Schulz
27 Mar 15 06:54:53
Tempted to buy back a few #Genfit shs. $ICPT / $GNFT MC ≈ $6.4/0.9B appears to be a little overdone. 45/100 ICPT/GNFT shs in #zzporte.
Douglas Allan
27 Mar 15 06:41:53
Leerink: $GNFT $GNFT seen in "similar position to $ICPT for phase 3, May be possible for both companies to enter market around same time
Dr. Duru
27 Mar 15 06:38:05
Wow => "@DUB_C: $ICPT when a Co has this type of backing and below 500mrk cap....you BUY! CLDN http://t.co/r9JItwUSW2"
27 Mar 15 06:34:08
$ICPT getting a nice upgrade w/ $400 PT
27 Mar 15 06:30:23
RT @theflynews: Intercept price target raised to $400 from $300 at Deutsche Bank $ICPT $GNFTF: Full Story http://t.co/UteiEgosDi
Dr. Duru
27 Mar 15 06:30:04
Correction. DB raised $ICPT target $300 to $400 this morning. So still don't know what re-awoke stock unless early start on analyst rating?
Dan O'Connell
27 Mar 15 06:29:29
Picked up some $ICPT yesterday. Waiting for a run then sell some calls
27 Mar 15 06:27:51
RT @BioStocks: $ICPT PT $300 >>> $400 at Deutsche Bank
finances et culture
27 Mar 15 06:27:50
RT @R4inb0w_: CM-CIC GENFIT : "Focusing on patients with NAS score>= 4, the results were similar in magnitude to those obtained by Intercep…
Dr. Duru
27 Mar 15 06:26:03
On $ICPT pop yest I missed DB target from $300 to $400. Today, news director sold 205K shares at $272-275.18 worth ~$56.26M.
27 Mar 15 06:24:57
#sentishiftup $ALE $CSCO $MSFT $UWTI $C $ICPT $INVT $GS $IBM $JPM #sentiquant 20150327 09:25:04:417
John Connor
27 Mar 15 06:24:42
@AndyBiotech @biotech19598 Q: Is $GNFT news that + for $ICPT? Doesn’t NAS>4 only account for 15% of NASH pats? So now market much smaller?
27 Mar 15 06:22:00
Bio's bounce back toady and a well needed correction. Watch out for big moves in $ICPT, $BMRN, $RCPT, and $JUNO.
Will T.
27 Mar 15 06:18:25
RT @BioStocks: $ICPT PT $300 >>> $400 at Deutsche Bank
Daniel De Oliveira
27 Mar 15 06:16:40
RT @R4inb0w_: CM-CIC GENFIT : "Focusing on patients with NAS score>= 4, the results were similar in magnitude to those obtained by Intercep…
Kristina Duering
27 Mar 15 06:16:34
RT @GeryDIVRY: $GNFT for sure with a efficient drug on NaSH safer than competitors one and cardioprotective .. 110€ is a minimum despite…
Bio Stocks™
27 Mar 15 06:15:32
$ICPT PT $300 >>> $400 at Deutsche Bank
Kristina Duering
27 Mar 15 06:13:52
RT @zbiotech: good times leerink...'despite p2 missing the primary endpt, $GNFT could design a p3 study similar to $ICPT that could very li…
Paul Johnson
27 Mar 15 06:12:57
Analyst notes: $AMZN, $FB, $LULU, $RH, $BMRN, $ICPT, $LYB targets raised; $JAZZ, $ESPR started with buys.
27 Mar 15 06:11:45
@JFinDallas they do sometimes fail, but sometimes succeed. news on $GNTF made $ICPT go up. Bios expensive, but can be dangerous shorts.
Kristina Duering
27 Mar 15 06:10:45
RT @R4inb0w_: CM-CIC GENFIT : "Focusing on patients with NAS score>= 4, the results were similar in magnitude to those obtained by Intercep…
27 Mar 15 06:09:16
RT @R4inb0w_: CM-CIC GENFIT : "Focusing on patients with NAS score>= 4, the results were similar in magnitude to those obtained by Intercep…
By  +Follow January 9, 2014 9:39AM



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