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December 19, 2012
16:12 EDTGSK, FOLDAmicus Theraputics and GlaxoSmithKline report results from Phase 3 Fabry study
Amicus Therapeutics (FOLD) and GlaxoSmithKline (GSK) announced the 6-month primary treatment period results from the first Phase 3 global registration study of investigational oral migalastat HCl monotherapy in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay. The pre-designated primary endpoint was the number of patients who demonstrated a 50% or greater reduction in kidney interstitial capillary globotriaosylceramide-3 after 6 months of treatment with migalastat HCl compared to placebo. 13/32 (41%) in the migalastat HCl treatment group achieved the endpoint versus 9/32 (28%) in the placebo group. This difference did not achieve statistical significance. A pre-specified secondary analysis assessing the absolute percent change in kidney interstitial capillary GL-3 from baseline to month 6 showed a median reduction of 41% in the migalastat HCl group versus a median reduction of 6% in the placebo group. To date, no drug-related serious adverse events have been observed.
News For FOLD;GSK From The Last 14 Days
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December 18, 2014
09:21 EDTGSKOn The Fly: Pre-market Movers
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07:15 EDTGSKAgenus reports GSK ZOE-50 Phase 3 study met primary endpoint
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December 11, 2014
07:32 EDTFOLDAmicus Therapeutics to submit EU MAA for migalastat HCl
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December 9, 2014
10:23 EDTGSKOn The Fly: Analyst Downgrade Summary
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09:10 EDTGSKARIAD takeover rumors rekindled, Independent says
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07:44 EDTGSKAmerican Association for Cancer Research to hold a symposium
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05:37 EDTGSKGlaxoSmithKline downgraded to Underperform from Neutral at BofA/Merrill
BofA/Merrill downgraded GlaxoSmithKline to Underperform citing a lack of pipeline catalysts and its belief the European pharma sector is close to fair value.
December 8, 2014
13:32 EDTGSKEpizyme announces results for PRMT5 inhibitor
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