Intercept Pharmaceuticals (ICPT)

[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

[harry12]

I bet. MS has a large short position. Pure manipulation from a bunch of crooks

[sorkin]

Morgan Stanley thinks it is Snake Oil!
Downgraded with PT 80

[sorkin]

Congratulations

[IPO$]

FALSE. Your comment was also wrong with respect to snake oil. FDA cleared the go ahead for APPROVAL!!!!!!!!!!!!!!!!!! To the moon for this stock!!

[sorkin]

Nope, not going well at the meeting

[IPO$]

ICPT halted, pending FDA news!!!

[IPO$]

$161 and climbing!

[IPO$]

I might short on the news on Friday

[3kidsplus1]

Also heavy buying still in this range.

[3kidsplus1]

Looks like that's more likely then 80. But even the 200dma 172 seems like a no brainer.

[IPO$]

*Could hit 200 but that would be a 52 week high

[3kidsplus1]

Well the chart looks bullish.

[3kidsplus1]

lol 300 maybe...someone knows it's going there from at least 2-3 months

[3kidsplus1]

Could get a close around $170+

[3kidsplus1]

$250 coming.

[IPO$]

Yes, but NO news after that until 2018.

[venturecapp]

Advisory Review Marks a Big Week for Intercept Pharmaceuticals

http://marketexclusive.com/advisory-review-marks-big-week-intercept-pharmaceuticals-inc-nasdaqicpt/5167/

[osaffer]

Conclusion
The applicant’s model was informed by plasma concentrations of OCA and conjugates
observed in subjects with varying degrees of hepatic impairment (relatively rich model
development dataset) and was able to generally capture OCA exposure observed in subjects
with normal hepatic function and with hepatic impairment (verification datasets). The applicant
also predicted plasma and liver exposures of CDCA in subjects with normal hepatic function
and in subjects with severe hepatic impairment (cholestasis and non-cholestasis). Despite
several limitations recognized for modeling of both OCA and CDCA and the lack of
predictability of PBPK for hepatic impairment [13], the applicant’s prediction of liver OCA
exposures using PBPK is considered useful in supporting dosing recommendations of OCA in
patients with hepatic impairment.
Although the magnitude of elevation in liver OCA concentrations in subjects with severe
hepatic impairment was predicted to be less than that in plasma concentrations, there were
significantly higher plasma OCA exposures in subjects with moderate and severe hepatic
impairment compared to patients with normal liver function. With the evidence of doseresponse
relationship for pruritus (and related discontinuations, see main text of Question Based
Review) and unknown relationship of plasma/liver exposures to pruritus, a conservative
approach of adjustment of starting dose in subjects with severe hepatic impairment to match
plasma exposures to those subjects with normal hepatic function, followed by subsequent uptitrations
of dose and dosing frequency, appears reasonable.

[IPO$]

Puts and calls have lost their heavy premiums as of this AM

[IPO$]

Thanks for the document!

[DewDiligence]

FDA briefing docs for PBC advisory committee:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/UCM494108.pdf

[IPO$]

I was thinking about selling the puts at that level. Do you think the announcement on Friday is going to be bad?

[sorkin]

Buy Puts, $80 strike

[sorkin]

Snake oil for Fatty liver\ NASH

[IPO$]

Up $13 in the premarket today

[IPO$]

There area ton of calls this morning on ICPT but 341 puts at $100 is a sign of someone betting for lower Friday open.

[IPO$]

Market is pricing in a favorable FDA press release Thursday after the market close based upon company press releases to this point.,

[IPO$]

There's a new sheriff in town. ME LOL

[osaffer]

Markets | Thu Mar 31, 2016 8:00am EDT Related: MARKETS, HEALTHCARE
Genfit plans to test its drug in second liver disease
French drugmaker Genfit SA on Thursday said it would begin a midstage trial this year of its experimental drug elafibranor to treat primary biliary cholangitis, a chronic disease in which bile ducts in the liver are gradually destroyed.

The company is already enrolling a 2,000-patient Phase III trial of elafibranor for the fast-growing fatty liver disease nonalcoholic steatohepatitis, or NASH, which is driven by obesity, diabetes and over-indulgent lifestyles and can lead to cirrhosis, liver failure and cancer.

Genfit expects the late-stage trial for NASH to be completed by mid-2018 with possible approval a year later in a market some analysts have said could grow to as much as $40 billion, with effective drugs racking up annual sales of $10 billion each.

"We think we can take 50 percent of the (NASH) market," Genfit Chief Executive Jean-Francois Mouney told Reuters.

Mouney said Genfit decided to also go after the far smaller primary biliary cholangitis (PBC) market because it believes its drug offers advantages over treatments from likely competitors, such as Intercept Pharmaceuticals Inc, and because most patients are not helped by current treatments.

The damage from PBC can inhibit the liver's ability to rid the body of toxins, and can lead to scarring of liver tissue known as cirrhosis.

In earlier trials, the Genfit drug led to reductions in "bad" LDL cholesterol, triglycerides and blood sugar. Some potential rival drugs have caused LDL increases in clinical trials.

A panel of advisers to the U.S. Food and Drug Administration is scheduled next week to decide whether to recommend approval of Intercept's drug for PBC.

The Genfit PBC trial will test its one pill, once-a-day drug in patients who do not tolerate or do not respond sufficiently to the current standard treatment with ursodeoxycholic acid. That can be as many as 70 percent of PBC patients, Genfit said.

After discussions with experts in the field, we have decided "that PBC is the next logical target in our development plan," Mouney said in a statement.

The company made the announcement at a meeting in New York to discuss its research and development plans.

Genfit said it will work with regulatory agencies to determine the study goals and design in the coming months, with the aim of beginning the trial before the end of the year. (Reporting by Bill Berkrot; Editing by Bernard Orr)

[osaffer]

Genfit will start Phase 2 for PBC this year

Genfit will need only 1 year to recruit 1000 patients for Phase 3 of Elafibranor

[IPO$]

Per Market Exclusive: The FDA has set a PDUFA date for Intercept’s priority review, breakthrough designation lead development candidate, obeticholic acid in a primary biliary cirrhosis indication, of May 29, 2016, and an upcoming advisory panel meeting should offer insight into the likelihood of approval."

[IPO$]

BIG FDA meeting on April 7th.

Do you know how previous FDA meetings have turned out and how the stock price reacted to such news? The FDA meeting on April 7th is supposed to be big and there is a lot of premium on the call and put options expiring on April 8th.

[IPO$]

Does anyone know how previous FDA meetings have turned out and how the stock price reacted to such news? The FDA meeting on April 7th is supposed to be big and there is a lot of premium on the call and put options expiring on April 8th.

[IPO$]

Q. Do you know how previous FDA meetings have turned out and how the stock price reacted to such news? The FDA meeting on April 7th is supposed to be big and there is a lot of premium on the call and put options expiring on April 8th.

[IPO$]

Do you know how previous FDA meetings have turned out and how the stock price reacted to such news? The FDA meeting on April 7th is supposed to be big and there is a lot of premium on the call and put options expiring on April 8th.

[osaffer]

NASH

[IPO$]

$110 puts expiring next Friday have a big spread at $.65 by $2.70 now after the stock went up $1. makes no sense.

[IPO$]

$110 puts expiring next Friday have a big spread at $.40 by $2.65.

[Anthropoid]

today news - digestive microbiota treat liver diseases.

next , syn bio microbiota drug delivery .

[osaffer]

Look at this:
http://www.globenewswire.com/news-release/2016/02/25/814196/0/en/New-Emergence-of-Potential-Tx-Dx-Options-could-transform-the-35-Billion-Landscape-for-Liver-Diseases-NASH.html

GFT505 is efficient ... and they have the biomarkers

[osaffer]

ICPT is game over, dont deny that

Genfit is number one in the Nash, the publication in Gastroenterology demonstrates the efficiency of Genfit against Nash.

ICPT has NOT yet started the recruitment of patient for Phase 3, during Conference call, CEO was not able to give a date, and so, ICPT has received the green light for Phase 3 a long time before Genfit ... While for Genfit is totally different .

If I were you, I will buy Genfit while the price is still so low.

Most of Analyst decrease the conscensus of ICPT, when the US Analyst will enforce their projection on Genfit, the price will rise rapidly ...

Fundamentals are strong with Genfit, no doubt on that, publication is there, with all experts of Nash ...

Even Adam Feuerstein, big, defender of ICPT cannot attack Genfit anymore ...

Things are changing ... take the good train ...

[osaffer]

http://www.sfgate.com/business/article/Intercept-Pharmaceuticals-sale-carries-big-risk-6834997.php?cmpid=twitter-desktop

[nyctraydr]

Movers and Shakers in Biotech: The Week so Far - article discusses Intercept
http://marketexclusive.com/2957-2/2957/

[harry crumb]

great post with that info. we read it prior, very interesting an gild could be the one

[harry crumb]

we own a few so this could make some serious cash

[north40000]

ICPT: The link:

http://www.reuters.com/article/us-intercept-m-a-exclusive-idUSKCN0VL1ZC

Reference to it was in my TDA mobile news. WSJ short link also there.

GILD on the other side? See its incoming CEO Milligan's comments in Q&A during 4th Qtr earnings call re interest/focus on aspects of liver disease:

"... We're very interested in liver diseases, so that's a very important area for us, and we'll continue to try to bolster those to make sure that the company has the assets necessary to have the progress for the future."

[harry crumb]

yes yes yes, had a hunch a sale could happen with this. not a large position, but some nice green here. gl everybody, sell or wait for 130's