Intercept Pharmaceuticals Inc

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09.01.14 14:25
7

5696 Postings, 2554 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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79 Postings ausgeblendet.

14.02.18 15:45

177 Postings, 934 Tage shark23Wird

Schon werden, nur geduld  

14.02.18 16:00

238 Postings, 981 Tage AndrolytAber eins ist sicher,

die Shortieshaben haben im Biotechsektor momentan die Oberhand, wird ja fast alles verdroschen..Wenn man nicht gerade auf grosse News wartet,bringt hier traden mehr als langes investieren..Also Leute demnächst  +300% oder -65% so in etwa sehe ich es
 

27.02.18 22:49

238 Postings, 981 Tage AndrolytDie aktuellen Shortzahlen:

Settlement Date Short Interest Avg Daily Share Volume Days To Cover
 2/15/2018 6,772,005 1,353,455  5.003495          §
 1/31/2018 5,528,105 1,010,514§5.470587  

28.02.18 19:15

16859 Postings, 3508 Tage Balu4uUmsätze in Deutschland gegen Null

dabei könnte man jetzt günstig einsteigen!?  

28.02.18 19:29

238 Postings, 981 Tage AndrolytAuch an der Nasdaq

lausige Umsätze..Nach oben viel wahrscheinlicher als nach unten..  

02.03.18 17:34

16859 Postings, 3508 Tage Balu4uMal was Grünes heute :)

https://www.nasdaq.com/de/symbol/icpt/real-time  

02.03.18 18:25

16859 Postings, 3508 Tage Balu4uI like it

02.03.18 20:54

16859 Postings, 3508 Tage Balu4uRockstar!

05.04.18 18:35

177 Postings, 934 Tage shark23Geht nach oben

Denke durchhalten lohnt sich  

20.04.18 09:03

4390 Postings, 885 Tage VassagoICPT 69,23$

BB Biotech hat seine Position bei Intercept in Q1/18 um 12% aufgestockt  

31.05.18 07:48

177 Postings, 934 Tage shark23Letzter halt

09.06.18 22:06

177 Postings, 934 Tage shark23Niemand mit im

07.08.18 11:05

4390 Postings, 885 Tage VassagoICPT 114,71$

https://www.fool.com/investing/2018/08/06/...tock-is-moving-high.aspx

 

09.08.18 20:09

177 Postings, 934 Tage shark23sehr stabil nach diesem up

da sind wohl noch viele Käufer nicht drinnen...  

11.09.18 16:21

177 Postings, 934 Tage shark23wie am schnürl

26.09.18 16:52

177 Postings, 934 Tage shark23Ich

Sag nix mehr  

07.01.19 23:51

177 Postings, 934 Tage shark23Intercept international

Nicht mal die Firma richtig geschrieben die Holzköpfe von Analysten  

19.02.19 16:38

4390 Postings, 885 Tage VassagoICPT 124,69$ (+13%)

NASH Phase III Studiendaten

http://ir.interceptpharma.com/news-releases/...esults-pivotal-phase-3

 

01.03.19 12:04

4390 Postings, 885 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

4390 Postings, 885 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

177 Postings, 934 Tage shark23Sell on good news...

09.05.19 15:35

4390 Postings, 885 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

4390 Postings, 885 Tage VassagoICPT 76,00$ (-5%)

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

12.07.19 16:23

4390 Postings, 885 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

4390 Postings, 885 Tage VassagoICPT 61,70$

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

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