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News Breaks
April 9, 2014
08:08 EDTAEGRAegerion initiates Phase 3 clinical trial for lomitapide in Japan
Aegerion Pharmaceuticals announced that patient enrollment has been initiated in Japan in a clinical trial of lomitapide as an adjunct treatment to reduce low-density lipoprotein cholesterol, or LDL-C, in Japanese patients with homozygous familial hypercholesterolemia, or HoFH. Last year, Aegerion received orphan drug designation from Japan's Ministry of Health, Labour and Welfare for lomitapide. The phase three, open-label trial in Japan is similar in design to the completed Phase 3 trial conducted in the United States and other countries. Estimated enrollment is between five and 10 adult HoFH patients who are receiving concomitant lipid-lowering therapies, including, in some cases, apheresis. After a six week run-in period, patients will receive lomitapide for 26 weeks, starting at 5 mg/day and escalating to a maximum dose of 60 mg based on tolerability. After 26 weeks, patients will enter a 30 week safety phase. The primary endpoint is % change in LDL-C levels from baseline to week 26. Secondary endpoints include % change in lipid parameters, long-term safety, and changes in hepatic fat from baseline to week 56. The Japanese regulatory authorities have indicated they will allow the new drug application to be filed following completion of the 26 week efficacy phase.
News For AEGR From The Last 14 Days
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July 28, 2015
10:00 EDTAEGROn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Aegerion (AEGR) upgraded to Buy from Hold at Jefferies... Ameren (AEE) upgraded to Neutral from Sell at Goldman... AutoNation (AN) upgraded to Buy from Neutral at Sterne Agee CRT... Beacon Roofing (BECN) upgraded to Outperform at Baird... BlackBerry (BBRY) upgraded to Equal Weight from Underweight at Morgan Stanley... Bojangles (BOJA) upgraded to Buy from Neutral at SunTrust... Boyd Gaming (BYD) upgraded to Neutral from Underperform at BofA/Merrill... Columbus McKinnon (CMCO) upgraded to Buy from Neutral at Sidoti... Danaher (DHR) upgraded to Overweight from Equal Weight at Morgan Stanley... Emerald Oil (EOX) upgraded to Hold from Sell at Wunderlich... Haemonetics (HAE) upgraded Outperform from Market Perform at Barrington... Jefferies sees entry point for Aegerion (AEGR), upgrades to Buy... Philips (PHG) upgraded to Buy from Hold at Societe Generale... Plum Creek Timber (PCL) upgraded to Buy from Neutral at DA Davidson... Raytheon (RTN) upgraded to Buy from Neutral at BofA/Merrill... SandRidge Energy (SD) upgraded to Hold from Sell at Wunderlich... Telecom Argentina (TEO) upgraded to Outperform from Market Perform at Raymond James... Teva (TEVA) upgraded to Outperform from Market Perform at BMO Capital... Triumph Bancorp (TBK) upgraded to Buy from Hold at Evercore ISI... Waste Management (WM) upgraded on valuation, rebounding businesses at Argus... Wisconsin Energy (WEC) upgraded to Buy from Neutral at Goldman.
07:34 EDTAEGRJefferies sees entry point for Aegerion, upgrades to Buy
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06:10 EDTAEGRAegerion upgraded to Buy from Hold at Jefferies
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July 27, 2015
08:19 EDTAEGRAegerion sees Q2 net product sales $63M-$64M, consensus $56.94M
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08:17 EDTAEGRAegerion appoints Smith as interim CEO
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