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The proper translation of “We don't know” in this context is Yes. I.e., US third-party payers will almost certainly require biopsies to reimburse for an estimated $20K/yr chronic, rest-of-life therapy for NASH—even if biopsies are not explicitly mandated in the FDA label (which remains to be seen).
ICPT spent most of today’s 3.5-hour webcast arguing that biopsies aren’t needed to treat NASH. This in itself ought to be a flag for investors.
From ICPT’s ‘NASH Commercial Day’ presentation today…
Q: “Will payers require a biopsy to prescribe Ocaliva?”
A: “We don’t know.”
$ICPT must see Intercept Pharmaceuticals Inc Nasdaq Icpt Short Squeeze
News: $ICPT Intercept to Host NASH Commercial Day for Investors on December 16, 2019 in New York
NEW YORK, Dec. 10, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that it will host a NASH Commercial Da...
Got this from ICPT - Intercept to Host NASH Commercial Day for Investors on December 16, 2019 in New York
News: $ICPT Here's Why Intercept Pharmaceuticals Stock Rose 48.9% in November
Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) , a biopharmaceutical company, were up 48.9% in November, according to data from S&P Global Market Intelligence . An interim analysis of the company's big non-alcoholic steatohepatitis (NASH) trial provided the lift last month. Sin...
Read the whole news ICPT - Here's Why Intercept Pharmaceuticals Stock Rose 48.9% in November
News: $ICPT FDA Accepts Intercept's NDA for OCA for the Treatment of Liver Fibrosis Due to NASH and Grants Priority Review
NEW YORK, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the U.S. Food and Drug Administra...
Read the whole news ICPT - FDA Accepts Intercept's NDA for OCA for the Treatment of Liver Fibrosis Due to NASH and Grants Priority Review
FDA Accepts Intercept’s NDA for OCA for the Treatment of Liver Fibrosis Due to NASH and Grants Priority Review
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
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
BIVI >>> Clinically de-risked development program
https://www.biovieinc.com/wp-content/uploads/2019/01/BioVie-Non-Conf-Deck_Dec_2018.pdf
Looking like re entry soon
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/
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
Please have a quick look at this :
https://www.genfit.com/wp-content/uploads/2019/01/2019.01.08-Corporate-deck-website.pdf
Sold my 700 shares for a 20+% return awaiting the next re-entry point
Shorts are trapped again. Earnings awesome!!! Fry shorts
Added another 350!shares today. Thank you for the deal
Just loaded 350 shares. We’ll oversold here. 100 will hold strong
Is this coming alive again? Sold out of this at 120+ made huge money back in the day.
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...
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
Please see the posts linked in #msg-137643821 and the reply chains to those posts.
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 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
JPM just recently filed 13G.
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
Recent changes to REGENERATE trial:
https://twitter.com/DewDiligence/status/935213189863796738
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?
Rachel McMinn is leaving the company effective 12/31/17.
ICPT stopped development of INT-767, the backup FXR agonist. It’s presumably no better than Ocaliva.
Probably needs a couple days...
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
ICPT attempt at damage control fails to lift stock: #msg-134886802.
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!
Well osaffer you got your wish I hope it makes you happy!
OCA seems to be not so yummy
ICPT –16% on Ocaliva safety warning: #msg-134545079.
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