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News Breaks
July 10, 2014
08:26 EDTICPT, GEVALeerink reiterates caution on Intercept ahead of FLINT data
Leerink says the physicians it spoke to at its Healthcare Insights Conference who treat liver diseases were cautious on Intercept's (ICPT) obeticholic acid's clinical potential in non-alcoholic steatohepatitis due to its effect on LDL-C. Leerink remains cautious on the stock ahead of full FLINT data in the second half of 2014, as it believes there is as much if not more downside than upside due to safety concerns. The firm adds the specialists noted that they have screened and not found any patients that warrant treatment with an expensive enzyme replacement therapy, such as Synageva's (GEVA) sebelipase alfa.
News For ICPT;GEVA From The Last 14 Days
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January 30, 2015
12:45 EDTICPTOn The Fly: Midday Wrap
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09:26 EDTICPTOn The Fly: Pre-market Movers
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08:27 EDTICPTIntercept breakthrough designation a significant positive, says Summer Street
Summer Street views the breakthrough therapy designation from the FDA as a significant positive for Intercept. The firm believes the news supports its thesis that Intercept's OCA is potentially a "game changer" in the treatment of NASH. It keeps a Buy rating on the stock with a $650 price target.
January 29, 2015
19:14 EDTICPTOn The Fly: After Hours Movers
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16:31 EDTICPTIntercept gets breakthrough designation from FDA for steatohepatitis treatment
Intercept Pharmaceuticals announced that its investigational product obeticholic acid, or OCA, has received "breakthrough therapy designation" from the FDA for the treatment of patients with nonalcoholic steatohepatitis, or 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, NASH and primary sclerosing cholangitis.
January 26, 2015
07:36 EDTGEVASynageva announecs dosing of patients concerned with SBC-103 in Phase 1/2 study
Synageva announced dosing with SBC-103 in patients with mucopolysaccharidosis IIIB has begun as part of a Phase 1/2 study. In addition, the FDA recently granted SBC-103 Fast Track designation. The trial will enroll approximately nine patients, two years of age or greater but less than 12 years of age, with definitive diagnosis of MPS IIIB and developmental delay. Patients will be treated in one of three different dosing cohorts with every other week intravenous administrations of SBC-103 for 24 weeks. Patients who meet qualifying criteria may continue therapy with SBC-103 for an extended treatment period that will last up to 128 weeks. The primary endpoint of the trial is safety and tolerability of intravenous administration of SBC-103 in patients with MPS IIIB. The study will also determine the effects of dosing with SBC-103 on the onset, magnitude, and reversibility of changes in levels of total HS in cerebral spinal fluid, serum, and urine as well as measure the effects of neurocognitive and developmental function and change in brain structures as assessed by magnetic resonance imaging. Exploratory biomarkers, SBC-103 concentration in CSF, MPS IIIB disease characteristics, symptoms, and quality of life will also be measured.
January 22, 2015
07:17 EDTICPTIntercept price target lowered to $300 from $500 at Deutsche Bank
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