Intercept Pharmaceuticals (ICPT)

[DewDiligence]

The CC slides have only the design outline of the REGENERATE trial—no details on p-value thresholds.

[DewDiligence]

ICPT 4Q16 CC slides:

http://ir.interceptpharma.com/common/download/download.cfm?companyid=AMDA-1AUOV7&fileid=929539&filekey=8794E35F-FB92-4993-A2E4-CD0C1D68F16D&filename=4Q16_Earnings_Slides_vF2.pdf

[DewDiligence]

ICPT -8% on 4Q16 results: #msg-128940872.

[osaffer]

Just listen and watch the slides ...

http://wsw.com/webcast/leerink28/gnft/index.aspx

[osaffer]

I am not based in France.

But I am sure you have experience with Vomit, Prurit etc ...

[trendmkr]

Analyst Activity – Wedbush Reiterates Outperform on Intercept Pharmaceuticals (NASDAQ:ICPT) https://marketexclusive.com/analyst-activity-wedbush-reiterates-outperform-on-intercept-pharmaceuticals-nasdaqicpt-29/72766/?icd1

[Hanibal]

Intervention? More like nonsensical biased vomiting.

Let me guess, you're based in France? Is that why you have such a hardon for Genfit?

I think you should find Gery Divry and vomit in his mouth instead of here. He would appreciate it because he vomits just as much ;)

[osaffer]

Wow, you can only say that in response of my intervention lol

Thank you to show us your level of intelligence ...

You're a funny guy haha

[Hanibal]

Blah Blah Blah Go back to your hole froggy

[osaffer]

While ICPT has started its phase 3 several months before Genfit, ICPT has big difficulties to recruit.

Analysts are starting to think why ICPT is late in its enrollment of patient ?

We know the side effects of OCA, maybe, it must cause trouble to prescriptors to send their patients to use Ocaliva instead of Elafibranor.

Don't forget, OCA has received approbation for PBC but, it s only because there was not any treatment for PBC.

With OCA, we have prurit, increase of bad cholesterol, the increase of cardiovascular problem ...

Also, OCA is focus on Fibrosis, and neither on NASH. Fibrosis is a consequence of NASH ... When you have Fibrosis, you are already in an advanced state of NASH.

While Elafibranor attacks NASH and Fibrosis, reduce bad cholesterol etc ...

If you were sick, what treatment will you choose ?

The enrollment of Genfit seems to be very at time.

My understanding, is that ICPT has abandoned the NASH, to focus on Fibrosis, but, it s just a symptom ...

Many analysts begin to be very sceptical about ICPT... and they are right ...

The enrollment of ICPT is a failure !

[DewDiligence]

Comments on new protocol of REGENERATE trial: #msg-128603305.

[DewDiligence]

ICPT CEO sold $5.8M of stock when AGN-TBRA merger announced: #msg-125344069.

[JefftDecker]

ICPT

ICPT pre market $174.73 up $5.01
MUST BE SOMETHING ELSE IN THE WORKS, ICPT A BEAST but
a reversal looks to be underway

R5

[osaffer]

Target Price ICPT 58$

(Updated - July 6, 2016 3:11 PM EDT)

Cantor Fitzgerald initiated coverage on Intercept Pharmaceuticals (NASDAQ: ICPT) with a Sell rating and a price target of $58. Analyst Elemer Piros is cautious on the company's opportunity in NASH. At most, he thinks its Phase III trial has a 25% chance to succeed.

"While Intercept just launched Ocaliva for an orphan liver disease (market potential: $700 million), we are unenthusiastic about the drug’s future in nonalcoholic steatohepatitis (NASH). We have identified six areas of weaknesses in the previous clinical package and the design of the currently ongoing Phase III trial," said Piros.

"There are ~50 million patients suffering from NASH in the U.S. and in key European countries. Untreated, 10% of patients may progress to serious liver disease, cancer or transplant. When compared to PBC, the opportunity in NASH is orders of magnitude higher. While at first glance the data supporting Ocaliva (aka OCA) in NASH appeared exciting, as more layers of the onion were peeled off, we have become less enthusiastic about its future," continued the analyst.

Piros added, "Analysis of the two Phase IIb trials (FLINT and a Japanese study) unveils significant weaknesses. First and foremost, the primary endpoint that made the FLINT trial an apparent success is not used in the ongoing Phase III trial. Individual components of the co-primary endpoints of the Phase III trial were not significant in FLINT or in the Japanese study. To make matters worse, these endpoints are now co primary. We believe that the Phase III trial has at most a 25% chance to succeed."

For an analyst ratings summary and ratings history on Intercept Pharmaceuticals click here. For more ratings news on Intercept Pharmaceuticals click here.

Shares of Intercept Pharmaceuticals closed at $143.47 yesterday.

[DewDiligence]

Huge convertible-debt offering: #msg-123610432.

[osaffer]

Which FIelD , Prurit Field ? Side Effects Field ?

For sure ... ICPT is the one player !

[biotechhead]

ICPT is the only player on the field. Gilead acquired Phenex's FXR agonist biotech last year, which is essentially the same thing, showing that it is committed to the science that Intercept has succeeded in getting to market ahead of everyone else. This puts ICPT in a strong position to attract Gilead's competitors or conceivably to be removed from the competition by Gilead itself, despite any disgruntled criticism Gilead or others might level in an attempt to cast doubt on its value. Useful links from 2015 before this race was won by ICPT: https://lifescivc.com/2015/05/from-crawl-to-sprint-the-race-to-treat-nash/ and http://www.gilead.com/news/press-releases/2015/1/gilead-sciences-announces-acquisition-of-phenex-pharmaceuticals-development-program-for-nonalcoholic-steatohepatitis-nash-and-other-liver-diseases Liver disease kills and patients and their doctors are highly motivated. Now that ICPT's OCA can be prescribed, medications in standard usage that mitigate the side effects will be prescribed alongside it. ICPT is also well placed to take advantage of any complementary biotech that makes it to market that can help form the kind of combination treatment that Gilead is so fond of. As an overview, I would speculate that the demand - both on and off-label - for OCA is currently underestimated as a value driver by some stock analysts. Meanwhile, Gilead is trailing behind in ICPT's dust with its own FXR agonist, which began its Phase I Trial only three months ago. Please feel free to ask if you would like any of the science explaining in more easily understandable terms.

[biotechhead]

1 in 1000 women over 40 affected. Off-label potential not discussed much but extensive.

[IPO$]

Why is stock up $10 or 7% today?

[osaffer]

But the good news with the approbation of OCA, it is now an open door for Genfit and other molecule that will arrive in the market later.

The other good news, that patient will have at least a treatment, a hope ... but ...

[Spike5]

I think what we can say is we really don't know what is going and you certainly don't know what's going they are working every day to make it better but unlike Genfit they have an approved drug and I would rather be on this side of it than your side . I hope Genfit does well for you but I'm interested in intercept

[osaffer]

PBC was not targeted by Genfit, but FDA has asked to Genfit to launch a study in PBC, why ? Because knows that OCA is not efficient enough

The real market is NASH, and we can say that NASH is almost finished for OCA.

FDA recommends an use of 5 mg for PBC, while OCA seems to be a little bit efficient from 25 mg but ... with some negative effects ...

OCA with 10 mg is not really good

$ICPT Japanese Ph2 data not too hot
Primary endpt p=0.053
No improvement in fibrosis score
Confirm high prutitus AE% pic.twitter.com/Kepcxbf5mx

— Andy Biotech (@AndyBiotech) October 28, 2015

[Spike5]

Very small market ... 1.3 billion better than what genfit is doing .. Good luck with that dog

[osaffer]

Very small market ... But enjoy ...

[IPO$]

Intercept Pharmaceuticals Inc. won approval for a drug to treat an uncommon, slow-progressing liver disease called primary biliary cirrhosis, its first product to reach the U.S. market.

The Food and Drug Administration cleared Intercept’s Ocaliva, also known as obeticholic acid, according to a statement from the company on Friday. The agency approved the drug with the condition that Intercept perform further studies to show it reduces patients’ risk of liver transplant and death.

Primary biliary cirrhosis damages the ducts that carry bile, a digestive fluid, and can lead to a variety of serious complications, including liver cirrhosis and failure, according to the National Institutes of Health. The disease isn’t common, and mainly affects women between the ages of 30 and 60.


The company is also studying the same drug for patients with another liver condition called nonalcoholic steatohepatitis, or NASH, which is associated with obesity and more common than primary biliary cirrhosis. The annual worldwide market for NASH treatments may be $5 billion to $10 billion, said Michael Yee, an analyst with RBC Capital Markets Corp., in a note earlier this month.

Obeticholic acid is projected to generate $1.6 billion in sales in 2020, according to analysts’ estimates compiled by Bloomberg.

To bring the drug to market faster, Intercept initially studied whether it lowers levels of alkaline phosphatase, or ALP, a marker of liver damage. The New York-based company is now enrolling patients in a study of the drug’s effect on rates of liver failure and death that it expects to complete in 2023, according to a summary posted by the National Institutes of Health.

[cooler]

Intercept Pharma's Ocaliva Gets FDA Accelerated Approval For Patients With PBC
May 28, 2016, 12:02:00 AM EDT By RTT News

Read more: http://www.nasdaq.com/article/intercept-pharmas-ocaliva-gets-fda-accelerated-approval-for-patients-with-pbc-20160528-00001#ixzz49yOjKFVs

(RTTNews.com) - Intercept Pharmaceuticals, Inc. (ICPT), a biopharmaceutical company focused on non-viral, progressive liver diseases, announced late Friday that the U.S. Food and Drug Administration or FDA has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis or PBC.

The company noted that Ocaliva is the first new medicine for PBC in nearly 20 years.


cooler

[KING T]

How many points (up or down) is the expectation ? Approval or non approval

[KING T]

How many points (up or down) is everyone expecting ?

[osaffer]

Why is Genfit considered to be the partner of choice in offering this drug specifically?

There is another drug from the competition that has also entered phase 3. However, what is important to understand is that the main consequence of NASH is not only liver related disease, but also cardiovascular diseases. Cardiovascular events are actually the most common cause of death among NASH patients. Elafibranor, unlike its competitor, acts not only on the liver but also on the different risks factors of cardiovascular diseases. NASH is a chronic disease, which means adverse side effects can be a major issue for patients.

Elafibranor has been depicted as a first line therapy for the future by quite a few recent studies done by a variety of different institutions. We are expected to capture more than 50% of the potential market thanks to the double efficacy in prevention of cardiovascular related side effects and the treatment of NASH .

[osaffer]

Genfit CEO Interview

http://pharmaboardroom.com/interviews/interview-jean-francois-mouney-ceo-chairman-genfit-france/

[IPO$]

ICPT has had a good history with FDA thus far.

[osaffer]

Genfit Share should double soon

http://seekingalpha.com/article/3976634-genfit-shares-double?app=1&auth_para%20m=f66oc:1bju7hb:563f4a34793ad7145fb9cf21827486d4&uprof=51#alt1

[osaffer]

For me there will be some restrictions for OCA

FDA should approve OCA for PBC, but with some restrictions ...

Only because there is no other treatment at this moment ...

That would not be the first time that a bad medic will be approved ...

[IPO$]

Im short the May 27 130's

[IPO$]

5/29/16 = GOOD or BAD FDA meeting? Anyone???

[osaffer]

ICPT Class Action Suite

http://www.streetinsider.com/Corporate+News/Intercept+Pharma+(ICPT)+Announces+Settlement+of+Proposed+Class+Action+Suit/11575146.html

[sorkin]

$80 PT? Ha ha ha ha

[osaffer]

Please check FR0004163111 GNFT not GNFT on grey market.

[esedu]

Have fun navigating the $1 bid/ask spread on GNFTF.

I see all this promotion of Genfit whenever I see ICPT being discussed, and I am guessing that approximately NONE of you are actually long in GNFTF. The stock is unlisted and barely trades (volume under 2000 shares per day), and with its ridiculous spread, there's no guarantee that your money won't be held hostage.

Like the promise in Elafibranor, but not a viable investment until they uplist and get some legit volume support.

So can you all please just pipe down about it? Sheesh.

[osaffer]

Elafibranor in Cover in Gastroenterology in May 2016
ac.els-cdn.com/S0016508516300075/1-s2.0-S0016508516300075-main.pdf?_tid =d1b2f434-07b3-11e6-8add-00000aacb362&acdnat=1461238138_d725e1709fa6ba447de9 e3bc101bfd2f

Look at this !

Click on the PDF link !

Is it not awesome ?

Elafibranor is really efficient against NASH

[osaffer]

Major Actors are mainly ICPT and Genfit ...

But ICPT has already big problem to convince with PBC because of negative effects ...

Actually Genfit is in good place to be number one in NASH ...

Even FDA and authorities have asked to Genfit to go to PBC Market ...

"Elafibranor is expected to account for a major share of this market and the market for Elafibranor is expected to grow at the highest CAGR. This growth is majorly due to Elafibranor which is considered to be the most advanced drug in this category."

[osaffer]

Nonalcoholic Steatohepatitis (NASH) Therapeutics Market to Reach US$20.27 bn by 2025, Elafibranor Projected to Spur Growth: Transparency Market Research

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact [e-mail].

SOURCE Transparency Market Research

ALBANY, New York, April 18, 2016 /PRNewswire/ --

According to a new market report published by Transparency Market Research "Nonalcoholic Steatohepatitis Therapeutics Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2015 - 2025", the nonalcoholic steatohepatitis (NASH) therapeutics market is anticipated to expand at a CAGR of 10.7% from 2015 to 2025 to reach US$20.27 bn by 2025.

Download Research PDF: http://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=7691

Nonalcoholic Steatohepatitis (NASH) is a syndrome that advances in patients who are not alcoholic; it causes liver damage that is histologically indistinguishable from alcoholic hepatitis. The major feature in NASH is fat in the liver, along with inflammation and damage. Most people with NASH feel well and are not aware of their liver problem. However, NASH can be severe and can lead to cirrhosis, in which the liver is permanently damaged and no longer able to work properly. It develops most frequently in patients with at least one of the following risk factors as obesity, dyslipidemia, and glucose intolerance. Pathogenesis is not clearly understood but seems to be linked to insulin resistance. Most of the patients are asymptomatic. Laboratory outcomes include elevations in aminotransferase levels. Biopsy is essential to confirm the diagnosis. Treatment mainly focusses on elimination of causes and risk factors.

Research Report with Toc & Free Analysis: http://www.transparencymarketresearch.com/nonalcoholic-steatohepatitis-market.html

The prevalence of NASH and NAFLD is increasing across the globe but it is more in developed regions such as North America. Both NASH and NAFLD are becoming more common, perhaps because of the greater number of Americans with obesity. In the past few years, the rate of obesity has almost doubled in adults and tripled in children. Obesity also adds to diabetes and high blood cholesterol, which can further complicate the health of people suffering from NASH. Diabetes and high blood cholesterol are also becoming more common among Americans.

Currently, no specific therapies exist for NASH treatment. The most important recommendations given to persons with this disease are weight reduction (if overweight), following a balanced and healthy diet, increasing physical activity, avoiding alcohol and avoiding unnecessary medications.

Request a Custom Report: http://www.transparencymarketresearch.com/sample/sample.php?flag=CR&rep_id=7691

The NASH market is segmented based on drug type which includes potential phase III candidates such as Obeticholic acid (OCA), Aramchol, Saroglitazar and Elafibranor. Moreover, the report enlists the candidates in Phase I and Phase II clinical trials. Based on the drug type, Elafibranor is expected to account for a major share of this market and the market for Elafibranor is expected to grow at the highest CAGR. This growth is majorly due to Elafibranor which is considered to be the most advanced drug in this category.

Major players in this market are Astazeneca Plc (U.K.), Intercept Pharmaceuticals Inc. (U.S.), Galmed Pharmaceuticals Ltd. (Israel), GENFIT SA (France), Gilead Sciences, Inc. (U.S.), Zydus Cadila (India), Immuron Ltd. (Australia), Conatus Pharmaceuticals (U.S.), and Tobira Therapeutics, Inc. (U.S.).

The Nonalcoholic Steatohepatitis (NASH) Therapeutics market has been segmented as follows:

Global Nonalcoholic Steatohepatitis (NASH) Therapeutics Market, By Drug Type
Overview
Potential Drug Candidates in Phase III
Obeticholic Acid (OCA)
Aramchol (arachidyl amido cholanoic acid)
Saroglitazar
Elafibranor

[venturecapp]

Weekly Biotech Report covering – Opko Health, Intercept Pharmaceuticals, Gilead Sciences, Inc Clovis Oncology

http://marketexclusive.com/weekly-biotech-report/5369/

[IPO$]

$4 billion market cap is too over priced.

[IPO$]

Excellent point.

[DewDiligence]

Everyone expects FDA approval in PBC, so it's doubtful that there will be a significant pop when it happens.

[esedu]

When approval comes in May, all the shorting in the world won't save their asses.

[IPO$]

You're probably right. Terrible system that the big guys developed and abuse us smaller citizens.

[IPO$]

Correct. They're the bigger outfit so much weight is placed on them. The other 2 who claim $335 per share are much smaller.

[IPO$]

Stock traded FLAT today after opening DOWN