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February 13, 2014
07:37 EDTENTAEnanta Pharmaceuticals reports Q1 EPS (30c), consensus (15c)
Reports Q1 revenue $893K, consensus $1.41M. The company said, "The changes in revenue for the three-month periods are primarily related to the timing and amount of milestone and other payments from collaborations, which have varied significantly from period to period and are expected to continue to do so."
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April 22, 2014
08:56 EDTENTAEnanta announces ABT-450 NDA submission
Enanta (ENTA) announced that AbbVie (ABBV), Enanta’s collaboration partner for ABT-450, has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for an investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection. The three direct-acting antiviral regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. ABT-450 is the lead protease inhibitor developed through Enanta’s collaboration with AbbVie. The U.S. NDA filing triggers a $20M milestone payment to Enanta from AbbVie. AbbVie also plans to submit applications for regulatory approval of its regimen in the European Union in early May. Enanta is entitled to receive an additional $20M upon the first regulatory filing in the European Union for a regimen containing a collaboration compound.
April 12, 2014
19:23 EDTENTAEnanta reports detailed results from Turquoise ll study
Enanta Pharmaceuticals (ENTA) announced that detailed results from AbbVie’s (ABBV) pivotal phase 3 TURQUOISE-II study, will be presented as a late-breaking oral presentation at the International Liver Congress, ILC, which is the 49th Annual Meeting of the European Association for the Study of the Liver, EASL. Results from the TURQUOISE-II study were featured in the ILC press conference and were published on-line in the New England Journal of Medicine. The TURQUOISE-II study reports results from AbbVie’s investigational three direct-acting antiviral regimen containing ABT-450, Enanta’s lead protease inhibitor discovered through Enanta’s collaboration with AbbVie. The regimen consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. TURQUOISE-II is a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie's three direct-acting antiviral regimen with ribavirin, RBV, in adult patients with genotype 1, GT1, chronic hepatitis C virus, HCV, infection with compensated liver cirrhosis. Patients achieved sustained virologic response rates 12 weeks post-treatment, SVR12, of 91.8% and 95.9% in the 12-week and 24-week treatment arms, respectively. Patients in the study were either new to therapy or treatment-experienced, failed previous treatment with pegylated interferon and RBV.
April 11, 2014
05:27 EDTENTAEnanta announces results for partner AbbVie's HCV studies
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April 9, 2014
07:23 EDTENTAEuropean Association for the Study of the Liver to hold annual meeting
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