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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
29 Jan 15 11:27:19
$CNAT 's Recent Data were so Damn Confusing - http://t.co/YMV8fuIzN7 Sometimes that's the best thing for investors. $ICPT $GILD
29 Jan 15 10:56:27
RT @Jufabref: @DOGE4321 ... Même destin que $GNFT vs. $ICPT probable...
29 Jan 15 10:45:27
Couple of watches $slxp acting strong .. $icpt needs to stay in 160s..
Hung Tran, MS, MD
29 Jan 15 09:56:43
Bio Leading the Pack: Intercept, Regeneron, MannKind, InterMune & Sanofi. http://t.co/xK20k2xKTs $SNY $MNKD $REGN $ITMN $ICPT
29 Jan 15 09:36:06
$ICPT: Intercept Pharmaceuticals PT Lowered to $375.00 (ICPT): http://t.co/HgAPhtcFFk
Sleek Money
29 Jan 15 09:34:47
Intercept Pharmaceuticals PT Lowered to $375.00 $ICPT http://t.co/e0ai0VmxVS
julien miribel
29 Jan 15 09:20:24
@DoctorTranRI360 I am sorry it's "je suis desolé" that's was your first French lesson. $GNFT #NASH $ICPT #welcome to All of you!
Dr. Duru
29 Jan 15 09:12:27
$ICPT's latest run-up ran into a major reversal move yesterday. Today's follow-on selling has finally run into buyers off the lows.
29 Jan 15 08:10:01
@DOGE4321 ... Même destin que $GNFT vs. $ICPT probable...
Agora Phile
28 Jan 15 21:26:45
RT @rypto: #Intercept à -7% ! $icpt #Genfit $gnft
28 Jan 15 21:16:03
RT @Sw1ng_Trader: http://t.co/8zZ54HvLlJ <-- *REVIEW* TIMFundamentals Part Deux $ICPT $SLV $ABX $GDXJ $JNUG $SWKS
Russell Barbour
28 Jan 15 21:07:00
http://t.co/8zZ54HvLlJ <-- *REVIEW* TIMFundamentals Part Deux $ICPT $SLV $ABX $GDXJ $JNUG $SWKS
28 Jan 15 19:02:47
@BQinvesting $PCLN $TWTR (earnings of yesteryears) $ICPT $PBYI (those 2 u put on your screen -also $BLUE) & rest mind is blank right now.lol
28 Jan 15 17:17:16
[Case Study] How A 24 yr old student Made >$0.5 Million In 8 Months With Stocks http://t.co/Hce0Z2DnDs $ILMN $MET $ICPT $VLCCF #stocks
28 Jan 15 14:59:29
$ICPT Intercept Pharma (ICPT) reiterated by Oppenheimer. Reiterated rating Outperform.
Bryon Franzen
28 Jan 15 13:44:47
$ICPT rejection at resistance http://t.co/aPX0l9ghzN
28 Jan 15 12:29:35
RT @R4inb0w_: #NASH Competitors 1Y (factor 100) : #GENFIT 1st! $GNFT +204.7% !! $GILD +30.2% $ICPT -39.7% $RPTP $CNAT $GLMD $GALT http://…
Ticker Report
28 Jan 15 11:41:50
Intercept Pharmaceuticals Price Target Lowered to $375.00 at Oppenheimer $ICPT http://t.co/7rACcvRv65
28 Jan 15 11:39:31
Updates on $DEPO, $BDSI, $ICPT http://t.co/NYRynBYA8k
28 Jan 15 11:31:04
$ICPT: Intercept Pharmaceuticals Price Target Lowered to $375.00 at ...: http://t.co/gG0Y7UzPtO
Yu Zhu
28 Jan 15 11:03:38
RT @dougheuringaria: 2014 performance across small/mid cap biotechs $TGTX $BLUE $AGIO $CELG $ACAD $RCPT $GILD $ICPT http://t.co/BnI8PJ8GW8
Daniel De Oliveira
28 Jan 15 10:59:01
#Intercept à -7% ! $icpt #Genfit $gnft
Daniel De Oliveira
28 Jan 15 10:57:56
RT @R4inb0w_: $ICPT Oppenheimer & Co (Akiva Felt) : Downgrade of PT : $375 (from $499) via Bloomberg #NASH $GNFT
Andrew Colburn
28 Jan 15 10:46:01
From what I've gathered, $ICPT is down 7x $IBB today because an analyst lowered their PT to just over double current share price. PANIC!!
28 Jan 15 10:40:18
$ICPT trading slightly outside the UBB, MACD in a uptrend as well as parabolic sars, awaiting Williams % R and increased volume on the daily
Helen Ong
28 Jan 15 10:33:21
$ICPT: Deutsche Bank Says No Big Move In FY15 - safety hurdles, mkt size uncertainty. competition, PT -40% $gild http://t.co/OxtlagsTjp
28 Jan 15 09:56:51
Receive free trade alerts via Twitter @barna_bio $ZGNX $CANF $CNAT $ICPT
28 Jan 15 09:53:57
$ICPT has 3 analyst ratings in the last 7 days and 100% are positive. Median target: $375 https://t.co/leLmr7xt8I #ICPT
V.S. Schulz
28 Jan 15 09:38:12
RT @dougheuringaria: 2014 performance across small/mid cap biotechs $TGTX $BLUE $AGIO $CELG $ACAD $RCPT $GILD $ICPT http://t.co/BnI8PJ8GW8
US Banking News
28 Jan 15 09:23:31
Oppenheimer Cuts Intercept Pharmaceuticals Price Target to $375.00 $ICPT http://t.co/yAeSY0oFYB
28 Jan 15 09:10:32
@BillyTsi good thing they never filled, failed b/o $ICPT
28 Jan 15 08:13:33
Commented on StockTwits: Some may think: whoa big dif betwn my buy, & stop limit.--but see how $ICPT rolls! If u ... http://t.co/IbCoajoEQN
Chris Carper
28 Jan 15 08:13:22
Deutsche Bank: No big move in $ICPT this year, Price target of $300 is 70% higher than current price. Oh the biotech world that we live in.
28 Jan 15 08:11:52
@sharkbiotech whats with $icpt lower pt casuing this?
28 Jan 15 08:08:01
$ICPT If you don't like the swings, get outta this name - beast!! Such a love / hate relationship w $ICPT but hopefully acquisition nt?
28 Jan 15 07:59:34
$ICPT Added at 172.55. Stop will be a close below 157. Note $IBB is down 1.7%. BioTek Sector cant win everyday! BUY when it's off.
Nicolas Lollioz
28 Jan 15 07:52:40
#NASH #GNFT benchmark ? ICPT rallye before $OCA phase 2 results last 9 january 2014 ! $ICPT http://t.co/yBpzSkZ0Bt
28 Jan 15 07:36:15
$ICPT Mkt is up, decent earnings, and $ICPT, $BIIB, $REGN unable to maintain morning highs. I blame hedgies!
28 Jan 15 07:16:25
RT @R4inb0w_: $ICPT Oppenheimer & Co (Akiva Felt) : Downgrade of PT : $375 (from $499) via Bloomberg #NASH $GNFT
28 Jan 15 07:15:14
$ICPT Oppenheimer & Co (Akiva Felt) : Downgrade of PT : $375 (from $499) via Bloomberg #NASH $GNFT
28 Jan 15 07:12:20
$ICPT I hope that was a Short deciding time to cover. Tempting opp for me to re-enter a new swing trade.
28 Jan 15 06:44:31
@peterrumble1 Is this prediction of yours based on any new information that is in the public domain? Or just 'a gut feeling'? $ICPT
28 Jan 15 06:25:06
Oppenheimer: per TipRanks, analyst A.Felt is a top 100 analyst with an average return of 40.4%! and a 63.9% success rate, PT on $ICPT =$375
28 Jan 15 06:16:31
01/28/15 PRICE TARGET CHANGED: Informatica $INFA Stifel Buy $44 > $50 Intercept Pharma $ICPT Oppenheimer Outperform $499 > $375
Hung Tran, MS, MD
28 Jan 15 05:44:36
This is a good example of biopharmaceutical catalysts investing, find out here: http://t.co/jKhpOFMXhC $ICPT
Hung Tran, MS, MD
28 Jan 15 05:43:57
To those how loves data analysis, this is your heaven right here, eats your heart out! http://t.co/GtZ0cgGu7B $ICPT
Hung Tran, MS, MD
28 Jan 15 05:43:14
Raise your hands if you think $ICPT is the wildest in the market! Remember last year? the galvanization of the bulls? http://t.co/NJE2fffwdp
Kevin Jacobs
28 Jan 15 05:32:49
RT @BioStocks: $ICPT PT lowered at Oppenheimer. $499 --> $375
Analyst Ratings
28 Jan 15 05:28:27
Oppenheimer Thinks Intercept Pharma`s Stock is Going to Recover $ICPT http://t.co/p43oaTwl6i
28 Jan 15 05:20:49
By  +Follow January 9, 2014 9:39AM



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