Intercept Pharmaceuticals Inc

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09.01.14 14:25 #1 Intercept 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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91 Postings ausgeblendet.
09.08.18 20:09 #94 sehr stabil nach diesem up
da sind wohl noch viele Käufer nicht drinnen...  
11.09.18 16:21 #95 wie am schnürl
26.09.18 16:52 #96 Ich
Sag nix mehr  
07.01.19 23:51 #97 Intercept international
Nicht mal die Firma richtig geschrieben die Holzköpfe von Analysten  
19.02.19 16:38 #98 ICPT 124,69$ (+13%)
01.03.19 12:04 #99 ICPT 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 #100 ICPT 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 #101 Sell on good news...
09.05.19 15:35 #102 ICPT 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 #103 ICPT 76,00$ (-5%)
Das 52 Wochen-Tief liegt bei 71,16$.  
12.07.19 16:23 #104 ICPT 69,20$
02.08.19 17:18 #105 ICPT 61,70$
  • neues 52 Wochen-Tief
  • Zahlen für Q2/19 am 07. August
 
26.11.19 22:15 #107 Der Zug nimmt Fahrt auf. 200 Euro bis Weih.
26.02.20 10:47 #109 ICPT 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 #110 ICPT 48.34$ (-14%)
  • MK 1,59 Mrd. $
  • neues 52 WT
  • kurz- bis mittelfristige Katalysatoren
 
12.05.20 13:52 #112 genfit schon mal weg...
22.05.20 14:18 #113 Verzögerungen 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 #114 ICPT 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 #115 re #114
Danke für die "Übersetzung" .... ;-))))  
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