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February 4, 2013
16:02 EDTGEVASynageva announces publication of sebelipase alfa study
Synageva BioPharma announced publication of the 12-week Phase I/II extension study data of sebelipase alfa in adults with lysosomal acid lipase deficiency in the online version and an upcoming print edition of Hepatology. Nine adults with LAL Deficiency were enrolled in the Phase I/II trial. After completing the initial portion of the Phase I/II trial, patients were allowed to continue treatment with sebelipase alfa as part of a long-term, open-label extension study. In the extension study, patients received four once-weekly infusions of sebelipase alfa and then transitioned to every other week infusions of sebelipase alfa. Eight of nine patients enrolled in the extension study. Data published in Hepatology were derived from the seven patients who completed the first 12 weeks of dosing in the extension study. Sebelipase alfa was well tolerated throughout the initial 12 weeks of the extension study, the company said.
News For GEVA From The Last 14 Days
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October 23, 2014
16:32 EDTGEVASynageva reports sebelipase alfa data at NASPGHAN meeting
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October 21, 2014
16:19 EDTGEVASynageva announces submission of BLA to the FDA for sebelipase
Synageva BioPharma announced the start of a rolling submission of a Biologics License Application, or BLA, to the FDA for sebelipase alfa as a treatment for patients with lysosomal acid lipase deficiency, a rare genetic disease with significant morbidity and early mortality. A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. The company anticipates completing the rolling submission of the BLA to the FDA and submitting the Marketing Authorization Application to the European Medicines Agency) by the end of January 2015.
09:48 EDTGEVAShire could target BioMarin, TheStreet's Feuerstein says
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October 16, 2014
10:01 EDTGEVAOn The Fly: Analyst Initiation Summary
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07:53 EDTGEVASynageva initiated with a Buy at SunTrust
Target $117.

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