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Intercept Pharmaceuticals Inc

Intercept Pharmaceuticals Inc (ICPT)

19.00
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(0.00%)
Closed December 08 4:00PM
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ICPT News

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ICPT Discussion

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DewDiligence DewDiligence 1 year ago
The $19/sh buyout price is only 4% of the all-time high reached in Jan 2014!
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seko19822 seko19822 1 year ago
good day today. i think LIFW ist the next..
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TheFinalCD TheFinalCD 1 year ago
Italy's Alfasigma to buy drugmaker Intercept for nearly $800 mln
https://finance.yahoo.com/news/italys-alfasigma-buy-drugmaker-intercept-120843745.html

https://dilutiontracker.com/app/search/ICPT?a=dbb88c
https://finviz.com/quote.ashx?t=ICPT&ty=c&ta=1&p=d
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DewDiligence DewDiligence 1 year ago
ICPT announces cost-cutting maneuvers from termination of NASH program:

https://www.globenewswire.com/news-release/2023/06/23/2693568/23024/en/Intercept-Announces-Restructuring-to-Strengthen-Focus-on-Rare-and-Serious-Liver-Diseases-and-Significantly-Reduce-Operating-Expenses.html Company lowers 2023 non-GAAP adjusted operating expense guidance to $350–$370 million, inclusive of restructuring costs; reiterates 2023 Ocaliva net sales guidance of $310–$340 million I wish them luck is pursuing profitability with only the PBC indication.
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DewDiligence DewDiligence 1 year ago
The demise of ICPT’s NASH program is_hardly_a_surprise; from 2019:
https://twitter.com/DewDiligence/status/1203029268441292800 Ocaliva was never going to be a suitable drug for NASH, no matter how much data re-analysis the company may have attempted.
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DewDiligence DewDiligence 1 year ago
Ocaliva gets another CRL for NASH—program discontinued:

https://finance.yahoo.com/news/intercept-receives-complete-response-letter-214500569.html
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Zilla Zilla 2 years ago
And yet another biotech that likes to pop and drop. lol
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DewDiligence DewDiligence 2 years ago
Did you type what you meant? Ocaliva has been approved only for PBC (not for NASH).
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sunspotter sunspotter 2 years ago
Ocaliva is the classic example of a drug that was approved on the basis of its effects on (alleged) surrogate endpoints while in reality its primary effect was to exacerbate the symptoms of the underlying disease.

Add that to management that is incompetent at best and dishonest at worst and here we are today.
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DewDiligence DewDiligence 2 years ago
FDA_advisory_panel_votes 15-1 against accelerated approval_for Ocaliva in NASH:
https://twitter.com/FDApanels/status/1659659649862213655
In a separate question for the panelists asking if the benefits of Ocaliva outweigh the risks in F2/F3 NASH, the vote was 12-2 against with 2 abstentions.

I’ve posted many times that Ocaliva is simply a bad drug for NASH that should not be approved for this indication—e.g. #msg-169362197 and #msg-170082971.

After today’s vote, I’m skeptical that ICPT will continue its clinical trial to the final analysis for measurement for hard clinical outcomes.

p.s. The stock is currently halted.
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Zilla Zilla 2 years ago
Was adding today early am and last week. Looking good but plan to flip for freebies. Thought it might go into 11's but added some 15 calls that are juicy now and some Jan super POP flippers just in case NASH actually happens. Doubt it but never know. =)
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harry crumb harry crumb 2 years ago
Is it time to go long
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harry crumb harry crumb 2 years ago
Shorting this is money!
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harry crumb harry crumb 2 years ago
Great job
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Zilla Zilla 2 years ago
I jumped in Monday on the DIP and bought Jan calls 10/12.5/15 made over 100% on the first two and broke even on the 15's
Would have kept the 10's but I have losses in my account overall so taking a 2100 profit after two days was too good to pass up. I thought it'd hit 14 tomorrow but these markets MOVE quickly one way or another and options are tricky sometimes. lol So Merry Christmas
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sunspotter sunspotter 2 years ago
Truth be told, a drug that works on surrogate endpoints but exacerbates the actual symptoms of actual patients without improving the underlying pathology was probably never going to be a winner.

Combine that with operational incompetence on an eye-watering scale and you’ve got ICPT.

So thanks, but no thanks.

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harry crumb harry crumb 2 years ago
Anyone else trying this play?
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harry crumb harry crumb 2 years ago
This was 80$ stock not long ago
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crudeoil24 crudeoil24 3 years ago
MORRISTOWN, N.J., May 05, 2022 (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 it has entered into an agreement to sell to Advanz Pharma, a pharmaceutical company with a strategic focus on specialty and hospital pharmaceuticals in Europe, certain foreign subsidiaries and rights regarding Intercept's international operations, including a license to commercialize Ocaliva(R) (obeticholic acid) outside of the U.S.

"This agreement marks an important step forward for Intercept as the value it brings to our company allows us to significantly strengthen our balance sheet while providing us with greater strategic optionality during this transformational year and beyond," said Jerry Durso, President and Chief Executive Officer of Intercept. "We are committed to investing in our core focus areas in the U.S., including our PBC business, potential future activities in NASH, and our advancing and expanding pipeline. At the same time, we are confident that the strong international team will continue to build on our successful PBC business as they transition to Advanz Pharma."

Upon closing of the transaction:

-- Intercept will receive consideration in the amount of $405 million
upfront, subject to customary working capital and other adjustments. The
company will receive an additional $45 million from Advanz Pharma
contingent upon receipt of an extension of pediatric orphan exclusivity
in Europe.

-- Intercept will receive royalties on any future net sales of obeticholic
acid in NASH outside of the U.S., should Advanz Pharma pursue marketing
authorization for this indication in ex-U.S. regions.

-- Intercept will continue to be responsible for the manufacturing and
supply of obeticholic acid globally and Advanz Pharma will be responsible
for packaging, distribution and commercialization of the therapy in all
markets outside of the U.S.

-- The majority of Intercept employees outside of the U.S. will transfer to
Advanz Pharma. The remaining international employees will continue to
work for Intercept.

-- Intercept will maintain an office in the UK to manage its global supply
chain, support its quality organization, and support its global clinical
trials.
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crudeoil24 crudeoil24 3 years ago
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
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makinezmoney makinezmoney 3 years ago
$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
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DewDiligence DewDiligence 3 years ago
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.” Right.
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DewDiligence DewDiligence 4 years ago
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.
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Patrickwan1 Patrickwan1 4 years ago
With a product selling not badly, it is sad the price is so awful.
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OverDraught OverDraught 4 years ago
ICPT is dead money. It's headed to $9, not $90.
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Patrickwan1 Patrickwan1 4 years ago
Share price is awful ! When can it goes back to $90?
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Patrickwan1 Patrickwan1 4 years ago
Anyone who had attended the meeting on 19 May? Any update from there?
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Zilla Zilla 4 years ago
Now it's at 20...Good move
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DewDiligence DewDiligence 4 years ago
How's your list today?
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Izzybell Izzybell 4 years ago
Had about a million shares purchased and or covered in the last 15 minutes of trading. Definitely on my list.
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DewDiligence DewDiligence 4 years ago
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 ).
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Izzybell Izzybell 4 years ago
Looks like it's getting ready for liftoff
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DewDiligence DewDiligence 4 years ago
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
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kingsransome kingsransome 4 years ago
Here we goooooo$$$$$
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kingsransome kingsransome 4 years ago
its a sort squeez play now,,im loading,,time is here n now,,tweet it out $$$$$$
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DewDiligence DewDiligence 4 years ago
ICPT’s CMO resigns:

https://www.sec.gov/ix?doc=/Archives/edgar/data/1270073/000110465921026191/tm217506d1_8k.htm
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DewDiligence DewDiligence 4 years ago
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.
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DewDiligence DewDiligence 4 years ago
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.
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DewDiligence DewDiligence 4 years ago
FDA identifies new Ocaliva safety signal:

https://twitter.com/DewDiligence/status/1313587027498196995 (scan up)
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kingsransome kingsransome 4 years ago
breaking $43 pivot,,$45 on par mhop $$$$
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kingsransome kingsransome 4 years ago
loading zone,,mhop $80 soon
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DewDiligence DewDiligence 4 years ago
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
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DewDiligence DewDiligence 4 years ago
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. As regular readers of this board know, I’ve long been bearish on Ocaliva for NASH (e.g. #msg-152659994), so today’s CRL is hardly surprising, IMO.
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Phoenix300 Phoenix300 4 years ago
Sorry. You are correct.
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DewDiligence DewDiligence 4 years ago
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?
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Phoenix300 Phoenix300 4 years ago
Delayed.
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DewDiligence DewDiligence 5 years ago
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. The PDUFA date for this NDA had already been postponed once when the original advisory panel was scheduled on 4/22/20 (#msg-152773679). I remain negative on the outcome (#msg-152659994).
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DewDiligence DewDiligence 5 years ago
ICPT 4Q19 results/2020 guidance:

https://www.globenewswire.com/news-release/2020/02/25/1989894/0/en/Intercept-Pharmaceuticals-Reports-Fourth-Quarter-and-Full-Year-2019-Financial-Results-Issues-2020-Operating-Expense-Guidance-and-Provides-Business-Update.html
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Biobillionair Biobillionair 5 years ago
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
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DewDiligence DewDiligence 5 years ago
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.
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