Intercept Pharmaceuticals Inc
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rokrockt : Intercept Pharmaceuticals Inc
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
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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."
Ice-Nine coming : Verzögerungen AdCom und PDUFA
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.
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moggemeis : Bessere Ansätze
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.