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December 24, 2012
07:45 EDTAEGRAegerion announces Boxed Warning for newly-FDA approved Juxtapid
Juxtapid contains a Boxed Warning citing the risk of hepatic toxicity. The safety and effectiveness of Juxtapid have not been established in patients with hypercholesterolemia, or HoFH, who do not have HoFH. The effect of Juxtapid on cardiovascular morbidity and mortality has not been determined. The safety and effectiveness of Juxtapid have not been established in pediatric patients. The FDA based its approval of Juxtapid on Aegerion's pivotal Phase III study, which evaluated the safety and effectiveness of the medicine to reduce LDL-C levels in 29 adult patients with HoFH. In this study, Juxtapid was initiated at 5 mg daily and gradually escalated to doses of 10 mg, 20 mg, 40 mg, up to 60 mg, based on tolerability and acceptable liver enzymes levels. The most common adverse reactions in the Phase III trial were gastrointestinal. Adverse reactions included diarrhea, nausea, vomiting, dyspepsia and abdominal pain. Other common adverse reactions included weight loss, abdominal discomfort, abdominal distension, constipation, flatulence, increased ALT, chest pain, influenza, nasopharyngitis, and fatigue. Elevations in liver enzymes and hepatic fat were also observed.
News For AEGR From The Last 14 Days
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October 22, 2014
07:35 EDTAEGRCardiometabolic Health Congress to hold annual meeting
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October 20, 2014
07:24 EDTAEGRAegerion price target lowered to $46 from $66 at Leerink
Leerink lowered its price target for Aegerion shares to $46 after its survey of 40 U.S. cardiologists implied a more bearish outlook for Juxtapid once PCSK9s emerge. The firm, however, believes new patient adds are well outpacing Juxtapid discontinuations in the near term. It keeps an Outperform rating on the stock.
October 14, 2014
16:13 EDTAEGRPoint72 Asset Management reports 5.2% passive stake in Aegerion
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