Intercept Pharmaceuticals (ICPT)

[DewDiligence]

ICPT 3Q19 results:

http://ir.interceptpharma.com/news-releases/news-release-details/intercept-pharmaceuticals-reports-third-quarter-2019-financial

ICPT raised full-year 2019 Ocaliva sales guidance (for PBC indication only) to $245-250M (from the prior range of $235-245M).

CC slides:
http://ir.interceptpharma.com/static-files/45a2334a-a7ae-4416-bb79-052be89a326e

[Trend-Setter]

BioVie Achieves Primary Objectives in Phase 2a Clinical Trial of BIV201 in Refractory Ascites

LOS ANGELES, April 30, 2019 (GLOBE NEWSWIRE) — BioVie Inc. (OTCQB: BIVI) (“BioVie” or “Company”), a clinical-stage company developing innovative drug therapies for liver disease, today announced top-line results for its Phase 2a clinical trial of BIV201 (continuous infusion terlipressin) in six patients with refractory ascites due to advanced liver cirrhosis. The primary objectives of this initial open-label study were to assess the safety, tolerability, and steady state pharmacokinetics (PK) of terlipressin administered as a continuous infusion for 28 days to cirrhotic patients with refractory ascites.

Exploratory objectives were to assess the reduction in requirement of frequency and volume of paracentesis with continuous infusion of terlipressin.

The following results were observed:

Continuous infusion of terlipressin via portable infusion pump was maintained for 28 days in three patients with refractory ascites, and all patients remained hemodynamically stable during treatment.
The steady state plasma concentration data characterized terlipressin pharmacokinetics (PK) within the predicted PK model concentrations.
Four of the six patients treated with BIV201 experienced an increase in the number of days between paracenteses ranging from 71% to 414% compared to prior to initiating therapy.
BioVie is planning to share detailed study results with the FDA in a meeting scheduled for the first half of 2019. At that time, the Company expects to receive guidance for planning the next steps in the BIV201 clinical development plan.

“The primary study objectives were met,” stated Patrick Yeramian MD, BioVie Chief Medical Officer. “These initial findings will need to be confirmed in a larger clinical trial that is randomized and controlled.”

https://www.otcmarkets.com/stock/BIVI/news/BioVie-Achieves-Primary-Objectives-in-Phase-2a-Clinical-Trial-of-BIV201-in-Refractory-Ascites?id=226394

[Trend-Setter]

BIVI >>> Clinically de-risked development program
https://www.biovieinc.com/wp-content/uploads/2019/01/BioVie-Non-Conf-Deck_Dec_2018.pdf

[SH1TFORBRAINS]

Looking like re entry soon

[Trend-Setter]

BioVie's Coverage initiated by Tailwinds Research Group
from the article:
"In my opinion, BioVie has a relatively easy path to FDA approval. Their drug, terlipressin, has been proven effective in over 40 countries. It is commonly prescribed and has a known effect on patients with liver cirrhosis. In addition, their proprietary (in the US) delivery technology has been shown to increase effectiveness while lowering toxicity in trials".

"In the near term, BioVie has results coming from their Phase 2a safety trial. These are expected early in April. The results of this will hopefully be positive, leading to a Phase 2b trial starting in the summer. Optimistically, the FDA could move BIV201 straight into a Phase 3 trial. We will learn if this is going to happen in May, but the odds of this are not very high".

"After the Company gets their results from the Phase 2a trial, I expect them to raise the funds necessary to take them through Phase 3 and onto the market. The company requires somewhere between $10 and $15 million to accomplish this. With a positive Phase 2a trial, fundraising ultimately shouldn’t be a big issue".

"Once approved, I anticipate BioVie being acquired by a larger company with a sales force, etc. The potential price for this acquisition could be over $1B. With a phase 3 trial taking about a year until completion and FDA approval, I believe an acquisition would be a 2nd half of 2020 event at the earliest. Certainly the majority owner, Terren Peizer, is looking for a large exit and not making this investment for a small win".

"With a current market cap of $30M, BioVie is an attractive investment. They have the rights to a known drug that has been proven effective over many years. They have a novel delivery technology that increases effectiveness while reducing negative side effects. Finally, they have US patents in place and orphan drug designation that will enable them to capture a large market that is currently unaddressed. I am long BioVie and look forward to holding my shares through FDA approval and an eventual liquidity event."

"I believe the end game here is an exit through a sale of the Company. In my opinion, the most likely acquirer would be Mallinckrodt as they are active in terlipressin already. Once the drug is approved, any sale of the Company would likely return well over 5x on an investors’ money with the chance of much larger gains; typically, acquisitions of drug companies with high margins like BioVie should see can range from 10 times revenue to as high as 20 times"

For full coverage check:
.https://tailwindsresearch.com/2019/04/biovie-an-undiscovered-gem/

[Trend-Setter]

BIOVIE
Pioneering therapies for advanced liver disease
Non-confidential investor presentation | December 2018

***A new treatment option is emerging for refractory ascites
Based on investigative studies in Italy and Australia
***Terlipressin (BIV201’s active agent) is approved in 40+ countries for
treating related liver cirrhosis complications (HRS & BEV*)

***BIV201 is a new drug candidate in the US
Terlipressin is not available in the US or Japan

***Currently in US phase 2 clinical
trials; seeking to replicate
European & Australian
investigative study results

***BIV201 offers advantages in 40+ countries where
Terlipressin is already approved
Targeting improved efficacy and safety compared to IV bolus dosing

***Clinically de-risked development program
The same therapy that is currently in use in Italy and Australia

***US patent protection
through 2036
***Filed for patents in Japan,
China & Europe
***US Orphan Drug designations for
both ascites and HRS to enable 7
years of market exclusivity
***FDA Fast Track status; will seek
Breakthrough Therapy designation

https://www.biovieinc.com/wp-content/uploads/2019/01/BioVie-Non-Conf-Deck_Dec_2018.pdf

[LittleMinnow]

Just bought ICPT at 92,6

[osaffer]

Please have a quick look at this :

https://www.genfit.com/wp-content/uploads/2019/01/2019.01.08-Corporate-deck-website.pdf

[SH1TFORBRAINS]

Sold my 700 shares for a 20+% return awaiting the next re-entry point

[SH1TFORBRAINS]

Shorts are trapped again. Earnings awesome!!! Fry shorts

[SH1TFORBRAINS]

Added another 350!shares today. Thank you for the deal

[SH1TFORBRAINS]

Just loaded 350 shares. We’ll oversold here. 100 will hold strong

[jr5555]

THE BUYOUT RUMORS ARE SWIRLING ... GO ICPT

[jr5555]

THE BUYOUT RUMORS ARE SWIRLING ... GO ICPT

[harry crumb]

Is this coming alive again? Sold out of this at 120+ made huge money back in the day.

[Zilla]

Looks like the 8K came out late Friday. I thought we'd climb right back to 70 from announcment of labeling but probably just going to yoyo 50-65...

[DewDiligence]

ICPT’s partner dumps Ocaliva for Japanese/Korean markets; this was buried in ICPT’s 4Q17 PR:

https://finance.yahoo.com/news/intercept-pharmaceuticals-reports-full-fourth-120500415.html

In February, Intercept amended its exclusive license agreement with Sumitomo Dainippon to regain the rights to develop and commercialize OCA in Japan and Korea. Under the new terms of the license agreement, Intercept will forego any further milestone or royalty payments for the development and commercialization of OCA in these countries.

[DewDiligence]

Please see the posts linked in #msg-137643821 and the reply chains to those posts.

[abcd12]

The article somewhat overstates the PBC safety issues, while the larger concern for ICPT over the next few years (IMO) is the low probability of success in the phase-3 NASH trial.

I see the logic in the overstating/understating PBC safety issues. What is your reasoning in your assessment of low probability of success in the phase-3 NASH trial?

[DewDiligence]

The article somewhat overstates the PBC safety issues, while the larger concern for ICPT over the next few years (IMO) is the low probability of success in the phase-3 NASH trial.

[abcd12]

I like to see opposing view points from this article below, and comments about ICPT's phase 3 NASH trials (Regenerate and Reverse).

https://finance.yahoo.com/news/primary-reason-intercept-pharmaceuticals-inc-153200816.html

[abcd12]

JPM just recently filed 13G.

[osaffer]

ICPT ... It must be very painful no ?

[ITMS]

On Watch For Breakout In Shares Of Intercept Pharmaceuticals Inc

Shares of Intercept Pharmaceuticals Inc (NASDAQ:ICPT) are hammering on a breakout trend line at $62.50. Should the stock push through, it will likely surge to as high as $66.50, perhaps within a day or two. Definitely a chart investors should be watching.




Gareth Soloway
InTheMoneyStocks

[osaffer]

Ocaliva > < Elafibranor

Who will win ?

[DewDiligence]

Recent changes to REGENERATE trial:

https://twitter.com/DewDiligence/status/935213189863796738

[DewDiligence]

ICPT hires R&D head:

https://globenewswire.com/news-release/2017/11/27/1206216/0/en/Intercept-Pharmaceuticals-Appoints-Christian-Weyer-as-Executive-Vice-President-of-Research-Development.html

How many candidates did they have to interview, LOL?

[DewDiligence]

Rachel McMinn is leaving the company effective 12/31/17.

[DewDiligence]

ICPT stopped development of INT-767, the backup FXR agonist. It’s presumably no better than Ocaliva.

[DewDiligence]

ICPT 3Q17 PR:

https://finance.yahoo.com/news/intercept-pharmaceuticals-reports-third-quarter-110500618.html

[DewDiligence]

ICPT 3Q17 CC slides:

http://ir.interceptpharma.com/common/download/download.cfm?companyid=AMDA-1AUOV7&fileid=961913&filekey=0BDD4373-64F1-491A-9481-061364C56AFA&filename=3Q17_Earnings_Slides_vF.pdf

[fireopal]

Probably needs a couple days...

[fireopal]

Intercept Pharmaceuticals (ICPT) Worst-Case is 'Surmountable', No Change to Outlook - Baird - Intercept Pharmaceuticals (ICPT) Worst-Case is 'Surmountable', No Change to Outlook - Baird - https://www.streetinsider.com/dr/news.php?id=13324895&gfv=1

[DewDiligence]

ICPT attempt at damage control fails to lift stock: #msg-134886802.

[osaffer]

We cannot be happy when at least 26 persons died because of OCA.
I hope you have listened my advices and you have not lost too much money .
There is only one safety candidate in phase 3, it s time that USA stops
Its protectionism. Genfit is number 1 and safe!

[Spike5]

Well osaffer you got your wish I hope it makes you happy!

[Inoviorulez]

https://seekingalpha.com/article/4107001-intercepts-fall-creates-monumental-buying-opportunity

[osaffer]

Not good for ICPT
https://www.barchart.com/stocks/quotes/ICPT/news#/news/4321304/shareholder-alert-pomerantz-law-firm-investigates-claims-on-behalf-of-investors-of-intercept-pharmaceuticals-inc-icpt

[osaffer]

OCA seems to be not so yummy

[osaffer]

https://goo.gl/TbBfGV

OCA Game Over

[DewDiligence]

ICPT –16% on Ocaliva safety warning: #msg-134545079.

[osaffer]

[DewDiligence]

That blogger is as bearish on ICPT as I am, LOL.

[osaffer]

Very interesting link

http://www.nashbiotechs.com/nash-biotech-analysis/point-of-view/intercept-control-trial.html

[osaffer]

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 ...

[DewDiligence]

2Q17 CC slides:

http://ir.interceptpharma.com/common/download/download.cfm?companyid=AMDA-1AUOV7&fileid=951348&filekey=D3FB2EB0-3A1C-4874-B119-3F54E06E239E&filename=ICPT_2Q17_Earnings_Slides_vF.pdf

[DewDiligence]

2Q17 results:

https://globenewswire.com/news-release/2017/07/31/1064842/0/en/Intercept-Pharmaceuticals-Reports-Second-Quarter-2017-Financial-Results-and-Provides-Business-Update.html

[DewDiligence]

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

[Spike5]

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 !!

[DewDiligence]

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.)