Intercept Pharmaceuticals (ICPT)

[DewDiligence]

The $19/sh buyout price is only 4% of the all-time high reached in Jan 2014!

[seko19822]

good day today. i think LIFW ist the next..

[TheFinalCD]

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

[DewDiligence]

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.

[DewDiligence]

The demise of ICPT’s NASH program is_hardly_a_surprise; from 2019:

$ICPT's Ocaliva is going nowhere in NASH: https://t.co/4Lv9RUUbrW

— Roy Friedman (@DewDiligence) December 6, 2019

Ocaliva was never going to be a suitable drug for NASH, no matter how much data re-analysis the company may have attempted.

[DewDiligence]

Ocaliva gets another CRL for NASH—program discontinued:

https://finance.yahoo.com/news/intercept-receives-complete-response-letter-214500569.html

[Zilla]

And yet another biotech that likes to pop and drop. lol

[DewDiligence]

Did you type what you meant? Ocaliva has been approved only for PBC (not for NASH).

[sunspotter]

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.

[DewDiligence]

FDA_advisory_panel_votes 15-1 against accelerated approval_for Ocaliva in NASH:

$ICPT VOTE on Q4
1-a
15-b pic.twitter.com/H4nkmYydmQ

— FDAadcomms (@FDAadcomms) May 19, 2023

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.

[Zilla]

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. =)

[harry crumb]

Is it time to go long

[harry crumb]

Shorting this is money!

[harry crumb]

Great job

[Zilla]

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

[sunspotter]

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.

[harry crumb]

Anyone else trying this play?

[harry crumb]

This was 80$ stock not long ago

[crudeoil24]

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.

[crudeoil24]

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

[makinezmoney]

$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

[DewDiligence]

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.

[DewDiligence]

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.

[Patrickwan1]

With a product selling not badly, it is sad the price is so awful.

[OverDraught]

ICPT is dead money. It's headed to $9, not $90.

[Patrickwan1]

Share price is awful ! When can it goes back to $90?

[Patrickwan1]

Anyone who had attended the meeting on 19 May? Any update from there?

[Zilla]

Now it's at 20...Good move

[DewDiligence]

How's your list today?

[Izzybell]

Had about a million shares purchased and or covered in the last 15 minutes of trading. Definitely on my list.

[DewDiligence]

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 ).

[Izzybell]

Looks like it's getting ready for liftoff

[DewDiligence]

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

[kingsransome]

Here we goooooo$$$$$

[kingsransome]

its a sort squeez play now,,im loading,,time is here n now,,tweet it out $$$$$$

[DewDiligence]

ICPT’s CMO resigns:

https://www.sec.gov/ix?doc=/Archives/edgar/data/1270073/000110465921026191/tm217506d1_8k.htm

[DewDiligence]

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.

[DewDiligence]

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.

[DewDiligence]

FDA identifies new Ocaliva safety signal:

$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

(scan up)

[kingsransome]

breaking $43 pivot,,$45 on par mhop $$$$

[kingsransome]

loading zone,,mhop $80 soon

[DewDiligence]

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

[DewDiligence]

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.

[Phoenix300]

Sorry. You are correct.

[DewDiligence]

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?

[Phoenix300]

Delayed.

[DewDiligence]

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).

[DewDiligence]

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

[Biobillionair]

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

[DewDiligence]

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.