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DJ Intercept Announces Advanz Pharma To Acquire Ocaliva In PBC In Markets Outside The U.S. For Up To $450MM, Including $405MM Upfront And An Additional $45MM In Contingent Payments >ICPT
$ICPT: The day it popped from $75 to $480/sh
I remember this day very very veryyyyyyyyyyyyyy well.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=94008675
Now at $14.90
I'm here !
GO $ICPT
NASH doubletalk from ICPT:
https://www.globenewswire.com/news-release/2021/07/29/2271107/23024/en/Intercept-Pharmaceuticals-Reports-Second-Quarter-2021-Financial-Results-and-Provides-Business-Update.html
“We continue to make progress on our development program in NASH fibrosis… Since the beginning of 2021, we have had frequent exchanges with FDA to gain alignment and feedback on safety, biopsy methodology and efficacy data. We have now gained enough insight from FDA in these critical areas to move forward on our plan, and with the right team in place, we have begun to generate what will ultimately be the largest data package ever produced in the NASH field. We will be evaluating available data internally to inform decision-making and expect that process to continue into the early part of next year, with a goal of holding our pre-submission meeting to review the data with FDA during the first half of 2022.”
ICPT shakes off new contraindication in Ocaliva label:
https://finance.yahoo.com/news/intercept-announces-updated-ocaliva-obeticholic-203000633.html
However, my “dead money” prediction at the start of the calendar year (#msg-160656464) looks pretty safe; as I’m typing, ICPT is -31% YTD.
With a product selling not badly, it is sad the price is so awful.
ICPT is dead money. It's headed to $9, not $90.
Share price is awful ! When can it goes back to $90?
Anyone who had attended the meeting on 19 May? Any update from there?
Now it's at 20...Good move
How's your list today?
Had about a million shares purchased and or covered in the last 15 minutes of trading. Definitely on my list.
I highly doubt that. Looks like a delayed reaction to an insider buy that was filed two weeks ago but was written up on Yahoo today (https://finance.yahoo.com/news/strong-insider-buying-could-indicate-014759282.html ).
Yet another ICPT executive departs—the CFO:
https://www.globenewswire.com/news-release/2021/03/10/2190409/0/en/Intercept-Announces-Departure-of-Chief-Financial-Officer.html
Here we goooooo$$$$$
its a sort squeez play now,,im loading,,time is here n now,,tweet it out $$$$$$
ICPT’s President, U.S. Commercial &Strategic Marketing, quits:
https://www.sec.gov/ix?doc=/Archives/edgar/data/1270073/000110465921005851/tm213669d1_8k.htm
He knows the stock is dead money.
ICPT +14% on “productive meeting with FDA” about the possibility of resubmitting the rejected NDA for Ocaliva in NASH sometime in 2021:
https://finance.yahoo.com/news/intercept-pharmaceuticals-reports-third-quarter-120000280.html
Caveat emptor.
FDA identifies new Ocaliva safety signal:
(scan up)$ICPT —This language about a new safety signal is "hidden" insofar as it was inserted in the middle of a paragraph that addresses an unrelated subject (the 2018 black-box warning in the PBC label). My view of Ocaliva continues to be as tweeted in Dec 2019: https://t.co/7WUUuQDrxT
— Roy Friedman (@DewDiligence) October 6, 2020
breaking $43 pivot,,$45 on par mhop $$$$
loading zone,,mhop $80 soon
ICPT cuts workforce 25%—170 jobs—as a result of CRL:
https://www.sec.gov/ix?doc=/Archives/edgar/data/1270073/000110465920101204/tm2029969d1_8k.htm
ICPT receives CRL for Ocaliva NDA in NASH:
https://www.globenewswire.com/news-release/2020/06/29/2054576/0/en/Intercept-Receives-Complete-Response-Letter-from-FDA-for-Obeticholic-Acid-for-the-Treatment-of-Fibrosis-Due-to-NASH.html
The CRL indicated that, based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH. The FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue.
Sorry. You are correct.
The PDUFA delay was announced a month ago (https://finance.yahoo.com/news/intercept-provides-regulatory-120010620.html ), although no new date was cited.
Is there something more recent?
ICPT—(-14%/PM)—FDA postpones 6/9/20 advisory panel—extends 6/26/20 PDUFA for NASH NDA to unspecified date:
https://finance.yahoo.com/news/intercept-provides-regulatory-120010620.html
The postponement will accommodate the review of additional data requested by the FDA that the company intends to submit within the next week. The FDA has indicated that it will reach out to Intercept in the near future with a new proposed AdCom date.
Dew- Gilead CEO expresses interest in NASH and cancer assets, Dealreporter says When pressed by an analyst during its Q3 earnings call, Gilead Sciences' (GILD) CEO Daniel O'Day said the company is looking carefully in the areas of nonalcoholic steatohepatitis and in oncology, said Dealreporter, according to contacts. If Gilead "is serious about wading into NASH, which would build on its liver franchise-building expertise in HCV, Intercept Pharmaceuticals (ICPT) could be a name to watch," the deal-focused publication stated, according to contacts.
Read more at:
https://thefly.com/landingPageNews.php?id=2981475
Also:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=137563501
My point, both AMRN & ICPT are key to GILD NASH success.
BB
PDUFA date for NASH NDA—>6/26/20 (instead of 3/26/20); this was expected after the FDA convened an advisory panel meeting for 4/22/20 (later than the original PDUFA date):
https://www.sec.gov/ix?doc=/Archives/edgar/data/1270073/000110465920004918/tm203659d1_8k.htm
See #msg-152827890 for related info.
ICPT—The intense focus of today’s webcast’s on discrediting liver biopsy as a NASH diagnostic was a form of lobbying directed at members of the upcoming FDA advisory panel, IMO.
Ocaliva’s sales prospects in NASH will be substantially diminished if the FDA label mandates a pre-treatment biopsy to establish a threshold fibrosis level, and this is the kind of issue where the FDA will likely seek guidance from the advisory panel.
ICPT is well capitalized and doesn’t stand to gain anything from pumping the share price. The real target audience for today’s 3.5-hour “investor” webcast was not investors!
CC slides from ICPT’s ‘NASH Commercial Day’:
http://ir.interceptpharma.com/static-files/076ed33d-3f9a-4605-a5ca-ed39c1695beb
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
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