Key Developments: Aegerion Pharmaceuticals Inc (AEGR.O)

AEGR.O on Nasdaq

27.41USD
21 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Aegerion Pharmaceuticals Inc reaffirms FY 2013 revenue guidance-conference call
Thursday, 21 Nov 2013 05:00am EST 

Aegerion Pharmaceuticals Inc:Sees FY 2013 net product sales between $45 mln and $50 mln.FY 2013 revenue $49 mln -- Thomson Reuters I/B/E/S Estimates.  Full Article

Aegerion Pharmaceuticals Inc Raises FY 2013 Revenue Guidance
Wednesday, 30 Oct 2013 07:00am EDT 

Aegerion Pharmaceuticals Inc raised its fiscal 2013 revenue guidance for net product sales to $45 to $50 million, from the previous range of $30 to $35 million. The upward revision primarily reflects the Company's results and insights to date with respect to the launch of JUXTAPID in the U.S. Aegerion continues to expect total operating expenses, excluding stock-based compensation expense, to be between $75 and $85 million in 2013. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $40 million for fiscal 2013.  Full Article

Aegerion Pharmaceuticals Inc Raises FY 2013 Revenue Guidance
Tuesday, 30 Jul 2013 07:00am EDT 

Aegerion Pharmaceuticals Inc raised fiscal 2013 revenue guidance from the previous range of $15 to $25 million, to the higher range of $30 to $35 million. The upward revision reflects the results and insights to date with respect to the launch of JUXTAPID in the U.S. Aegerion continues to expect total operating expenses, excluding stock-based compensation expense, to be between $75 and $85 million in 2013. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report revenue of $32 million for fiscal 2013.  Full Article

Aegerion Pharmaceuticals Inc Receives Positive European CHMP Opinion For LOJUXTA (lomitapide) To Treat Homozygous Familial Hypercholesterolemia (HoFH)
Friday, 31 May 2013 07:17am EDT 

Aegerion Pharmaceuticals Inc announced that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion with a unanimous vote recommending a marketing authorization for LOJUXTA (lomitapide) hard capsules. If approved, LOJUXTA will be indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH). The European Commission (EC) needs to ratify the positive opinion from CHMP to grant marketing authorization for LOJUXTA in all 27 European Union member countries. A decision is expected from the European Commission in the third quarter of 2013.  Full Article

Aegerion Pharmaceuticals Inc Reaffirms FY 2013 Revenue Guidance
Tuesday, 30 Apr 2013 07:00am EDT 

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
Wednesday, 6 Mar 2013 07:00am EST 

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
Friday, 11 Jan 2013 08:57am EST 

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
Thursday, 10 Jan 2013 04:01pm EST 

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
Monday, 24 Dec 2012 07:00am EST 

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
Wednesday, 28 Nov 2012 07:01am EST 

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

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