Intercept Pharmaceuticals
WKN: A1J5U0 / ISIN: US45845P1084Intercept Pharmaceuticals Inc
09.01.14 14:25
#1
rokrockt
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
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
09.01.14 14:26
#2
rokrockt
:-)
Kurs steht in DE bei 52,8€ und MM bedient mich nicht
ahhaha Schade
weil Premarket ist jetzt schon über 170$ ;-))))
ahhaha Schade
weil Premarket ist jetzt schon über 170$ ;-))))
09.01.14 15:19
#5
rokrockt
MM
hat um 13:44 letztes mal BID/ASK aktualisiert
hehe das wäre ja Wahnsinn
hehe das wäre ja Wahnsinn
09.01.14 15:23
#6
einsteger
ich habe in Frankfurt angerufen:
es ist dort zur Zeit von Handel "ausgesetzt"
09.01.14 15:26
#7
rokrockt
vielicht auch gut so
ich denke die wird in weniger als 5min 100$ runter rauschen
09.01.14 15:56
#11
jonzweit
Re:
JETZT FICKEN WIR DIE GANZE COTE D´AZUR!!! BOAH....ha ha ha...das wars Mann...das ist ES! ES hat zugeschlagen...Das ES!!!
HA ha ha!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
HA ha ha!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
09.01.14 16:23
#12
Weltenbummler
Gibt es gründe für den Anstieg oder nur Zocken?
Wenn es Gründe gibt, dann bitte auf Deutsch.
10.01.14 12:10
#18
rokrockt
Intercept Pharmaceuticals Inc
Pre Market wieder 345$
Wahnsiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiin
Wahnsiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiin
10.01.14 12:19
#20
M.Minninger
Das ist Ramses IV
Der will die Bude im Alleingang hochziehen. ;-))))))
10.01.14 12:47
#24
Andrew6466
Zur Zeit ...
... bei den Biopharmaceuticals völlig normal, liegen absolut im Trend!
Ein PLUS von knapp 87 US Dollar im PRE Market zum Vorabend kann sich sehen lassen, wo soll das heute eigentlich hingehen? 1000 US Dollar? Mal sehen, ob die wirklich spinnen, die Amis!
Ein PLUS von knapp 87 US Dollar im PRE Market zum Vorabend kann sich sehen lassen, wo soll das heute eigentlich hingehen? 1000 US Dollar? Mal sehen, ob die wirklich spinnen, die Amis!
10.01.14 13:12
#25
Andrew6466
Vielleicht von allgemeinem Interesse?!
http://www.handelsblatt.com/finanzen/aktien/...0-prozent/8999088.html