Key Developments: Aegerion Pharmaceuticals Inc (AEGR.O)
60.09USD
24 May 2013
$-0.87 (-1.43%)
$60.96
$60.61
$61.33
$59.09
278,464
635,045
$63.72
$12.86
Latest Key Developments (Source: Significant Developments)
Aegerion Pharmaceuticals Inc Reaffirms FY 2013 Revenue Guidance
Aegerion Pharmaceuticals Inc reaffirmed fiscal 2013 guidance and expects global net revenues of $15 million to $25 million for fiscal 2013 with 250 to 300 patients on JUXTAPID therapy globally by year-end 2013. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $24.5 million for fiscal 2013. Full Article
Aegerion Pharmaceuticals Inc Reaffirms FY 2013 Global Net Revenues Guidance
Aegerion Pharmaceuticals Inc confirmed the previously stated financial guidance and expects global net revenues of $15 million to $25 million for fiscal 2013 with 250 to 300 patients on JUXTAPID therapy globally by year-end 2013. In the second half of 2014, the Company expects to generate global net revenue at a $100 million annualized run rate; and achieve cash flow breakeven from operations. Full Article
Aegerion Pharmaceuticals Inc Announces Pricing Of Underwritten Public Offering
Aegerion Pharmaceuticals Inc announced the pricing of an underwritten public offering of 2,704,739 shares of common stock at a price to the public of $26.64 per share. The net proceeds to Aegerion from this offering are expected to be approximately $67.9 million, after deducting underwriting discounts and commissions. The offering is expected to close on January 16, 2013. Jefferies & Company, Inc. and J.P. Morgan Securities LLC are acting as joint book-running managers in the offering. Leerink Swann LLC, Canaccord Genuity Inc., and Cowen and Company, LLC are acting as co-managers for the offering. Aegerion has granted the underwriters a 30-day option to purchase up to an aggregate of 405,710 additional shares of common stock. Aegerion anticipates using the net proceeds from the offering to fund activities directed at commercial launch of JUXTAPID™ (lomitapide) Capsules in the United States; pursuing approval of Marketing Authorization Application submission with the European Medicines Agency for lomitapide, and, if it is approved, commercial activities in the European Union; expansion of operations in certain countries to pursue regulatory approval of lomitapide and to conduct sales on a named-patient-sales basis, where permitted; advancement of the clinical development of lomitapide; and business development activities; with any remainder to fund working capital, capital expenditures and for general corporate purposes. Full Article
Aegerion Pharmaceuticals Inc Announces Sale Common Stock
Aegerion Pharmaceuticals Inc announced that it intends to offer for sale its common stock in an underwritten public offering. All shares in the offering are being sold by Aegerion. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Jefferies & Company, Inc. and J.P. Morgan Securities LLC are acting as joint book-running managers in the offering. Full Article
FDA Approves Aegerion Pharmaceuticals Inc's JUXTAPID Capsules for Homozygous Familial Hypercholesterolemia
Aegerion Pharmaceuticals Inc announced that the U.S. Food & Drug Administration (FDA) has approved JUXTAPID (lomitapide) capsules as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non- high-density-lipoprotein cholesterol (non-HDL) in patients with homozygous familial hypercholesterolemia (HoFH). 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. The study was a multinational, single-arm, open-label, 78 week trial that was recently published in the November 2, 2012 online version of the Lancet. 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. Full Article
Aegerion Pharmaceuticals Inc Announces Issuance Of Patent By European Patent Office-DJ
Dow Jones reported that Aegerion Pharmaceuticals Inc announced the issuance by the European Patent Office of Patent No. EP1725234 for a method of treating hyperlipidemia or hypercholesterolemia, including severe hypercholesterolemia, using step-wise, increasing doses of lomitapide. The patent, entitled "Methods for Treating Disorders or Diseases Associated with Hyperlipidemia and Hypercholesterolemia While Minimizing Side Effects," describes the method of treating hyperlipidemia or hypercholesterolemia, including severe hypercholesterolemia, by gradually titrating the doses of lomitapide to increase the drug's desired activity, while managing the tolerability profile for the patient. Such dosing regimens are an important component of Aegerion's development of lomitapide as a potential treatment of HoFH. The patent expires in 2025. Full Article
FDA Reviewers Positive On Aegerion Pharmaceuticals Inc's Lipid Drug-Reuters
Reuters reported that U.S. drug reviewers were positive on Aegerion Pharmaceuticals Inc's experimental drug for lipid disorder and said it showed a greater reduction in bad cholesterol as compared with statins, according to documents posted by the Food and Drug Administration on its website on October15, 2012. The FDA said an approval of the drug would require a risk evaluation and mitigation strategy to ensure that the benefits of lomitapide outweigh the risk of serious liver injury. The reviewers said additional safety data, collected through post-marketing studies, would be needed before deciding on whether the extent of hepatic steatosis, or excessive fat deposits in the liver, is sufficiently worrisome to discontinue the drug. The FDA review of Aegerion's lomitapide comes ahead of an advisory meeting of independent experts on Wednesday to discuss the drug. The FDA, which will consider the panel's recommendations, will take a final decision on the drug later. Full Article
Aegerion Pharmaceuticals Inc Prices Public Offering Of Common Stock
Aegerion Pharmaceuticals Inc announced the pricing of an underwritten public offering of 3,400,000 shares of common stock at a price to the public of $14.75 per share. The net proceeds to Aegerion from this offering are expected to be approximately $47.3 million, after deducting underwriting discounts and commissions. The offering is expected to close on June 19, 2012. Jefferies & Company, Inc. and J.P. Morgan Securities LLC are acting as joint book-running managers in the offering. Leerink Swann LLC, Canaccord Genuity Inc., and Needham & Company, LLC are acting as co-managers for the offering. Aegerion anticipates using the net proceeds from the offering to fund activities directed at gaining approval of New Drug Application submission with U.S. Food and Drug Administration and Marketing Authorization Application submission with European Medicines Agency for lomitapide as a potential treatment for homozygous familial hypercholesteremia (HoFH), pre-commercial and commercial activities related to launching lomitapide in United States, European Union, in each case, in any other countries where lomitapide is approved as a treatment for HoFH, expansion of operations in certain countries, and advancement of the clinical development of lomitapide as a potential treatment for pediatric and adolescent patients with HoFH and of adult patients with familial chylomicronemia, with any remainder to fund working capital, capital expenditures, to be used for general corporate purposes. Full Article
Aegerion Pharmaceuticals Inc Proposes Public Offering Of Common Stock
Aegerion Pharmaceuticals Inc announced that it intends to offer for sale its common stock in an underwritten public offering. All shares in the offering are being sold by Aegerion. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Jefferies & Company, Inc. and J.P. Morgan Securities LLC are acting as joint book-running managers in the offering. Leerink Swann LLC, Canaccord Genuity Inc., and Needham & Company, LLC are acting as co-managers for the offering. Full Article
Aegerion Pharmaceuticals Inc Announces FDA Acceptance Of New Drug Application For Review
Aegerion Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has accepted New Drug Application (NDA) for lomitapide, a once-daily, oral treatment for Homozygous Familial Hypercholesterolemia (HoFH), for review. Aegerion is seeking authorization to market lomitapide as an adjunct to a low-fat diet and other lipid-lowering therapies to reduce cholesterol in patients with HoFH. As previously disclosed, the FDA has classified the submission as a standard review with a 10-month Prescription Drug User Fee Act (PDUFA) timetable. Full Article
FDA approves Aegerion's cholesterol drug with strongest warning
- Aegerion Pharmaceuticals Inc said the U.S. health regulator approved its drug as an alternative treatment for patients who have a genetic predisposition to high cholesterol.
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