Genfit - die Alternative zu Intercept? (Seite 29)

[hico]

Antwort auf Beitrag Nr.: 48.934.496 von question-mark am 30.01.15 14:35:04

Meinte dass man keinen engen so setzen kann wegen zu hohem spread.

[question-mark]

(CercleFinance.com) - Genfit est en pleine forme, le rush au-delà des 49E s'accélère.

Le dernier obstacle graphique a été pulvérisé via un 'gap' ouvert au-dessus des 49,45E le 26 janvier et il en résulte un gain de +25% en 4 jours avec un nouveau zénith inscrit à 59E (proche d'une résistance oblique moyen terme qui gravite vers 60E).

Le titre aligne 6 séances de hausse d'affilée pour un gain cumulé de +30%... mais aussi et surtout, Genfit gagne 54% depuis le 1er janvier: c'est pour l'instant le meilleur 'performer' de 2015.



Börsenwert immer noch "nur" ein Drittel von Intercept, aber mit 1,4 Milliarden echt üppig bewertet ...

[question-mark]

die Amis scheinen nicht nur Intercept gut zu finden, sondern kaufen jetzt fleissig genfit.

Ich muss dann auch irgendwann mal bei Intercept zuschlagen, heute ist es aber etwas teuer.

Breakthrough therapy designation müsste genfit doch auch erhalten, wenn sie mal zur FDA kommen, oder?

[question-mark]

Antwort auf Beitrag Nr.: 48.928.931 von hico am 29.01.15 23:07:21

Zitat von hico: Rucksetzer bisher ausgeblieben. Ist mMn überfällig. Wird halt auch extrem wenig gehandelt das gute stück-sl in d ist leider nix für mich.

heute sieht es wieder nicht nach Rücksetzer aus, 56 durch und weiter Kauflaune.

Was meintest du mit "sl in d ist leider nix für mich" ?

[question-mark]

http://www.streetinsider.com/Corporate+News/Intercept+Pharma…

Intercept Pharma's (ICPT) OCA Receives Breakthrough Therapy Designation in NASH


KBN: du hast wieder alles richtig gemacht - wow, gratuliere

jedenfalls geht der NASH Hype weiter, vieleicht kauf ich mir irgendwann ein Haus
in NASHville

[hico]

I frei mi.

[hico]

Off topic?

Intercept Receives Breakthrough Therapy Designation From FDA for Obeticholic Acid for Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis

Breakthrough Therapy Designation for Treatment of NASH With Liver Fibrosis Reinforces Potential for OCA to Address Unmet Medical Need in Patients With This Serious Condition


NEW YORK, Jan. 29, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), today announced that its investigational product obeticholic acid (OCA) has received "breakthrough therapy designation" from the U.S. Food and Drug Administration (FDA) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis. This indication constitutes a population of patients with a serious and life-threatening condition reflected by a higher risk of progression to cirrhosis and liver failure. OCA is currently being developed for the treatment of several chronic liver diseases, including primary biliary cirrhosis (PBC), NASH and primary sclerosing cholangitis (PSC).

"We are very pleased to have received breakthrough therapy designation for NASH with liver fibrosis, as it will enable us to work closely with FDA to finalize the design of our Phase 3 program," said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. "This designation underscores a recognition of the urgent need to bring novel treatments to NASH patients who have developed liver fibrosis, which is expected to make this serious disease the leading cause for liver transplant in just the next few years. As a first-in-class FXR agonist, we believe OCA has the potential to be an important treatment option for patients with no currently approved medicines."

Breakthrough therapy designation for OCA was based on clinical efficacy and safety data from two placebo-controlled, Phase 2 clinical trials of OCA. A Phase 2 trial in 64 patients with nonalcoholic fatty liver disease (NAFLD) assessed the impact of OCA treatment on insulin sensitivity (published in Gastroenterology in June 2013). The FLINT Phase 2 trial in 283 patients with NASH assessed the impact of OCA treatment on liver histology and fibrosis (published in The Lancet in November 2014).

The breakthrough therapy designation was created by the FDA to speed the availability of new therapies for serious or life-threatening conditions. Drugs qualifying for this designation must show credible evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy. The designation confers several benefits, including intensive FDA guidance and discussion and eligibility for submission of a rolling NDA.

About Nonalcoholic Steatohepatitis

NASH is a serious chronic liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation which leads to progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure and death. There are currently no drugs approved for the treatment of NASH. Studies have shown that 21-26% of NASH patients will develop cirrhosis over 8.2 years of follow-up and that liver-related mortality due to this disease is ten-fold that of the general population. According to recent epidemiological studies, it is estimated that more than 10% of the U.S. adult population has NASH with more than 60% of patients (potentially more than 14 million in total) believed to have liver fibrosis or cirrhosis due to progression of the disease. The proportion of liver transplants attributable to NASH has increased rapidly in past years and by 2020 the disease is projected to become the leading indication for liver transplant ahead of chronic hepatitis C and alcoholic liver disease. NASH patients with fibrosis are at greater risk of progressing to cirrhosis, liver failure and cancer.

[hico]

Rucksetzer bisher ausgeblieben. Ist mMn überfällig. Wird halt auch extrem wenig gehandelt das gute stück-sl in d ist leider nix für mich.

[Jagubert]

Leider nein. Die Firma ist mir bei einem Screen aufgefallen.

[hico]

Sieht auch interessant aus. Warst du schon vor den news gestern drin?