Intercept Pharmaceuticals Inc

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09.01.14 14:25
7

5696 Postings, 2816 Tage rokrocktIntercept Pharmaceuticals Inc

Intercept Announces NASH Primary Endpoint Met: FLINT Trial Stopped Early for Efficacy Based on Highly Statistically Significa...

ntercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) today announced that the FLINT trial of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial has been met. FLINT is a multi-center, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of a 25 mg oral dose of OCA administered daily to biopsy-proven adult NASH patients over a 72-week treatment period. The trial has been sponsored and conducted by the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK), a part of the National Institutes of Health, at eight leading US academic hepatology centers comprising the NIDDK's NASH clinical research network (CRN).

The decision to stop FLINT has been based on the recommendation of the Data Safety Monitoring Board (DSMB) which reviewed liver biopsy data from before and at the end of the treatment period in approximately half of the 283 randomized patients, in accordance with a planned interim efficacy analysis. This analysis demonstrated that OCA treatment resulted in a highly statistically significant improvement (p=0.0024 on an intention-to-treat [ITT] basis) in the primary histological endpoint, defined as a decrease in the NAFLD Activity Score (NAS) of at least two points with no worsening of fibrosis, as compared to placebo. Those patients who had not yet completed the trial and therefore did not have a second biopsy were treated as non-responders in the ITT analysis. The pre-defined threshold of statistical significance for stopping FLINT was p < 0.0031.

"The unexpected early stopping of FLINT due to OCA meeting the primary endpoint with such high significance is a major milestone," said Mark Pruzanski, M.D., Chief Executive Officer of Intercept. "NASH has grown to epidemic proportions worldwide, having become a leading cause of cirrhosis and liver failure. On its current trajectory, the disease is projected to become the leading indication for liver transplant. We are deeply grateful to the NIDDK and the NASH CRN for their longstanding commitment both to improving our understanding of the disease and to sponsoring ambitious trials like FLINT in their quest to identify novel treatments for patients suffering from NASH."

Intercept will discuss NASH and the FLINT trial during the previously announced conference call and audio webcast scheduled to take place today at 4:30 p.m. ET. The live event will be available on the investor page of the Intercept website at http://ir.interceptpharma.com or by calling (855) 232-3919 (domestic) or (315) 625-6894 (international) five minutes prior to the start time. A replay of the call will be available on the Intercept website approximately two hours after the completion of the call and will be archived for two weeks

http://ih.advfn.com/p.php?pid=nmona&article=60606013  
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97 Postings ausgeblendet.

01.03.19 12:04

5757 Postings, 1147 Tage VassagoICPT 99,74$

Intercept meldet Zahlen für 2018

  • Umsatz 180 Mio. $ (vgl. 131)
    • 2019-er Umsatzprognose 225-240 Mio. $
  • Verlust 309 Mio. $ (vgl. 360)
  • Cash 436 Mio. $
  • Equity 19 Mio. $

http://ir.interceptpharma.com/news-releases/...-quarter-and-full-year

 

11.04.19 16:27

5757 Postings, 1147 Tage VassagoICPT 106,65$ (-12%)

Ich lese die Überschrift "Additional Positive Data From NASH Study" und sehe die Kursreaktion und denke mir dann so...ok...

https://www.zacks.com/stock/news/378691/...itive-data-from-nash-study  

11.04.19 23:19

192 Postings, 1196 Tage shark23Sell on good news...

09.05.19 15:35

5757 Postings, 1147 Tage VassagoICPT 82,32$ (-6%)

Intercept plant Finanzierung

  • 200 Mio. $ durch eine Kapitalerhöhung
  • 200 Mio. $ convertible senior notes due 2026

http://ir.interceptpharma.com/news-releases/...proposed-offerings-200

 

07.06.19 16:21

5757 Postings, 1147 Tage VassagoICPT 76,00$ (-5%)

Das 52 Wochen-Tief liegt bei 71,16$.  

12.07.19 16:23

5757 Postings, 1147 Tage VassagoICPT 69,20$

  • neues 52 Wochen-Tief

https://www.fool.com/investing/2019/06/30/...icals-vs-cv-science.aspx

 

02.08.19 17:18

5757 Postings, 1147 Tage VassagoICPT 61,70$

  • neues 52 Wochen-Tief
  • Zahlen für Q2/19 am 07. August
 

25.11.19 19:18

1258 Postings, 1896 Tage moggemeisEs geht stramm Richtung Zulassung....

https://seekingalpha.com/news/...olic-acid-shares-5-percent-premarket

http://ir.interceptpharma.com/news-releases/...iver-fibrosis-due-nash

 

26.11.19 22:15

192 Postings, 1196 Tage shark23Der Zug nimmt Fahrt auf. 200 Euro bis Weihnachten

20.01.20 19:51

1258 Postings, 1896 Tage moggemeisVerzögerung der Zulassung

https://seekingalpha.com/article/...liva-delayed-opportunity-presents

 

26.02.20 10:47

5757 Postings, 1147 Tage VassagoICPT 84,68$

Zahlen für 2019

  • Umsatz 252 Mio. $ (VJ 180)
  • Verlust 345 Mio. $ (VJ 309)
  • Cash 657 Mio. $
  • MK 2,77 Mrd. $

"The FDA has set a Prescription Drug User Fee Act(?PDUFA?) target action date of June 26, 2020for the completion of its review of our NDA seeking approval of OCA for liver fibrosis due to NASH.  As a result of the uncertainties relating to the launch of OCA in liver fibrosis due to NASH and their potential impact on our 2020 financial performance, we are not providing 2020 net sales guidance."

http://ir.interceptpharma.com/news-releases/...uarter-and-full-year-0

 

19.03.20 09:43

5757 Postings, 1147 Tage VassagoICPT 48.34$ (-14%)

  • MK 1,59 Mrd. $
  • neues 52 WT
  • kurz- bis mittelfristige Katalysatoren
 

08.04.20 20:37

19080 Postings, 3770 Tage Balu4ubuy rating

https://www.analystratings.com/articles/...es-a-buy-from-rbc-capital/  

12.05.20 13:52

192 Postings, 1196 Tage shark23genfit schon mal weg...

22.05.20 14:18
1

645 Postings, 1326 Tage Ice-Nine comingVerzögerungen AdCom und PDUFA

Scheint heute nicht mein Tag zu sein. Eben erst AMRN und nun hier auch. Unerwartet und unschön, aber aufgeschoben ist ja bekanntlich nicht aufgehoben. Hoffe ich mal.... ;-)))

NEW YORK, May 22, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that based on discussions earlier this week, the U.S. Food and Drug Administration (FDA) has notified Intercept that its tentatively scheduled June 9, 2020 advisory committee meeting (AdCom) relating to the company?s new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH) has been postponed. 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. Intercept now anticipates that the FDA?s review of its NDA will extend beyond the Prescription Drug User Fee Act (PDUFA) target action date of June 26, 2020.

https://finance.yahoo.com/news/...-provides-regulatory-120010620.html
 

22.05.20 16:32

5757 Postings, 1147 Tage VassagoICPT 78.23$ (-15%)

Sitzung des Beratungsausschusses wird verschoben

Die FDA hat zusätzliche Daten angefordert.

http://ir.interceptpharma.com/news-releases/...es-regulatory-update-0

 

22.05.20 16:44

645 Postings, 1326 Tage Ice-Nine comingre #114

Danke für die "Übersetzung" .... ;-))))  

25.05.20 13:30

1258 Postings, 1896 Tage moggemeisVerzögerung

https://infoviewer.infodesk.com/infodisplay/item/...p;templateId=3664

 

27.05.20 08:32

1258 Postings, 1896 Tage moggemeisInfo

https://infoviewer.infodesk.com/infodisplay/item/...p;templateId=3664  

29.06.20 13:50

645 Postings, 1326 Tage Ice-Nine comingF**k

FDA erteilt erst einmal keine Genehmigung (NASH). Grrrrr....

Vorbörslich runde 40% runter. Ein wunderbarer Start in die neue Woche..... NOT  

29.06.20 14:23
1

5757 Postings, 1147 Tage VassagoICPT 48$ (vorbörslich -38%)

CRL für OCA (in NASH)

Zum Glück hab ich das geahnt, und bin letzte Woche zu 82$ mit Gewinn raus.

https://ir.interceptpharma.com/news-releases/...-fda-obeticholic-acid

 

01.07.20 13:08

192 Postings, 1196 Tage shark23Danke an alle die Stücke abgeben

09.07.20 16:50

5757 Postings, 1147 Tage VassagoICPT 43.10$ (neues 52WT)

Kann mir gut vorstellen, dass die 40$ Marke auch noch anvisiert wird. Dort liegen vermutlich noch einige SL-Limits die man schön abfischen könnte.

https://xconomy.com/new-york/2020/06/29/...h-drug-asks-for-more-data/  

16.07.20 20:07

859 Postings, 2379 Tage usambarahört sich gut an

https://seekingalpha.com/news/...ial&utm_source=twitter_automated  

23.07.20 07:33

1258 Postings, 1896 Tage moggemeisBessere Ansätze

Ich glaube nicht, dass Obeticholsäure nach der Ablehnung durch die FDA ein Comeback feiern wird.
Es gibt weitere vielversprechende Ansätze, NAFLD zu behandeln und deren Entwicklung schreitet voran.

Nach meiner Ansicht, wird sich der Ansatz GLP-1 und/oder FGF durchsetzen.

GLP-1-Agonisten haben den Vorteil, dass die Sicherheit und Verträglichkeit bereits belegt ist und die Wirkung auf NASH offensichtlich auch sehr gut.
Zusätzlich hat ein großes Unternehmen wie NovoNordisk enorme finanzielle Mittel und kann am Markt, nach Zulassung, auch entsprechend schnell agieren.
Semaglutide befindet sich bereits im Markt und benötigt lediglich eine Zulassungserweiterung.

Was FGF21 und FGF19 angeht, ist der Weg sicher deutlich unsicherer.
Aber die bisherigen Daten sehen toll aus und auch die Verträglichkeit ist gut.
Daher favorisiere ich die genannten Ansätze.  

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