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ICPT –16% on Ocaliva safety warning: #msg-134545079.
That blogger is as bearish on ICPT as I am, LOL.
These results are awesome ...
Prurit is present for all branches of dose's OCA
Increase of LDL
14 patients have disapeared from the study
1 patient died ...
Everybody know the side effect of Statins, it means, that, most of patient using already Statins, will have to increase their doses of statins to fight the side effect of OCA LOL
Do not forget, that FDA has recommended to ICPT to reduce dose of OCA for PBC, because of side effects .
Because of side effect of statins, I guess, patient will take an other workaround ...
Small phase-2 shows adding statins to Ocaliva neutralizes LDL increase, but this is hardly surprising—nor does it make OCA a better drug for treating NASH, IMO:
#msg-133432507
It's to the point now I can't defend this stock anymore it really is a useless pile of shit and ocliva is a total bust !!
You're preaching to the choir vis-á-vis Ocaliva. I'm bearish on the REGENERATE trial, and have said so numerous times.
On the other hand, newer and better FXR agonists do not seem to have the side-effect baggage that comes with Ocaliva. I'm bullish on ENTA's NASH compound, EDP-305. (I'm long ENTA.)
Dont forget, that OCALIVA has received approbation from FDA only because there was not other treatment for PBC. And, the doses have been reduced.
Dont forget that OCALIVA increase bad cholesterol, it means, it can increase the risk of cardiovascular issue ...
Maybe you knew Georges Michaël ...
Anyway, when you have choice to take OCALIVA with all undesire effects, or Elafibranor, what would you to take ?
What would you prefer that your doctor give you ?
For me choice is fast ... It s not only a question of money, but public health ...
Risk of cancer, increase of bad cholesterol, prurit .. only attack the Fibrosis, and not the NASH, while Fibrosis is a consequence of NASH ...
Ok, you are saying not a big deal ... We ll see that ...
Not a big deal, IMO: #msg-129405710.
FXR agonist Cancer ? This is not good for ICPT, Gilead
http://www.journal-of-hepatology.eu/article/S0168-8278(17)30062-4/pdf
The CC slides have only the design outline of the REGENERATE trial—no details on p-value thresholds.
ICPT -8% on 4Q16 results: #msg-128940872.
Just listen and watch the slides ...
http://wsw.com/webcast/leerink28/gnft/index.aspx
I am not based in France.
But I am sure you have experience with Vomit, Prurit etc ...
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
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 ;)
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
Blah Blah Blah Go back to your hole froggy
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 !
Comments on new protocol of REGENERATE trial: #msg-128603305.
ICPT CEO sold $5.8M of stock when AGN-TBRA merger announced: #msg-125344069.
Target Price ICPT 58$
(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.
Huge convertible-debt offering: #msg-123610432.
Which FIelD , Prurit Field ? Side Effects Field ?
For sure ... ICPT is the one player !
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.
1 in 1000 women over 40 affected. Off-label potential not discussed much but extensive.
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 ...
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
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
— Andy Biotech (@AndyBiotech) October 28, 2015
Primary endpt p=0.053
No improvement in fibrosis score
Confirm high prutitus AE% pic.twitter.com/Kepcxbf5mx
Very small market ... 1.3 billion better than what genfit is doing .. Good luck with that dog
Very small market ... But enjoy ...
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.
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
How many points (up or down) is the expectation ? Approval or non approval
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 .
ICPT has had a good history with FDA thus far.
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 ...
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