Key Developments: Isis Pharmaceuticals Inc (ISIS.O)
20.39USD
22 May 2013
$-0.42 (-2.02%)
$20.81
$20.84
$21.48
$20.25
1,415,123
1,613,396
$23.03
$7.55
Latest Key Developments (Source: Significant Developments)
Isis Pharmaceuticals Inc Prices Public Offering Of Common Stock
Isis Pharmaceuticals Inc announced the pricing of an underwritten public offering of 9,000,000 shares of common stock, offered at a price to the public of $19.00 per share. The gross proceeds to Isis from this offering are expected to be $171.0 million, before deducting the underwriting discount and other estimated offering expenses payable by Isis. The offering is expected to close on or about May 14, 2013. In addition, Isis has granted the underwriters a 30-day option to purchase at the public offering price up to an aggregate of 1,350,000 additional shares of common stock. Isis anticipates using the net proceeds from the offering to increase drug development activities, develop select drugs in pipeline to later stages of development prior to partnering, and for general corporate and working capital purposes. Goldman, Sachs & Co. and J. P. Morgan Securities LLC are acting as joint book-running managers in the offering. Stifel is acting as lead manager. BMO Capital Markets, Cowen and Company, LLC and Needham & Company are acting as co-managers. Full Article
Isis Pharmaceuticals Inc Announces Proposed Public Offering Of Common Stock
Isis Pharmaceuticals Inc announced that it intends to offer for sale 9 million shares of its common stock in an underwritten public offering. In connection with this offering, Isis intends to grant the underwriters an option to purchase an additional 1.35 million shares of its common stock. All shares in the offering are being offered by Isis. 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. Goldman, Sachs & Co. and J. P. Morgan Securities LLC are acting as joint book-running managers in the offering. Stifel is acting as lead manager. BMO Capital Markets, Cowen and Company, LLC and Needham & Company are acting as co-managers. Full Article
Isis Pharmaceuticals Inc Initiates Clinical Study of ISIS-SMN Rx in Infants With Spinal Muscular Atrophy
Isis Pharmaceuticals Inc announced the initiation of a Phase 2 study of ISIS-SMNRx in infants with spinal muscular atrophy (SMA). SMA is a severe and rare genetic neuromuscular disease characterized by muscle atrophy and weakness and is the most common genetic cause of infant mortality. The study, which will begin enrolling patients soon, is a Phase 2 study in eight patients with infantile-onset SMA. The study, which initiates the Phase 2/3 program for ISIS-SMNRx in infants, is designed to provide data to allow Isis to define the optimal dose for the larger planned Phase 2/3 study in infants and to provide safety and tolerability data. Isis will earn a $3.5 million milestone payment from Biogen Idec when the first infant is dosed in the study, which is projected for May 2013. Full Article
Roche Holding AG and Isis Pharmaceuticals Inc Form Alliance For Huntington's Disease
Roche Holding AG and Isis Pharmaceuticals Inc announced that they have formed an alliance to develop treatments for Huntington's disease (HD) based on Isis' antisense oligonucleotide (ASO) technology. This alliance combines Isis' antisense expertise with Roche's scientific expertise in developing neurodegenerative therapeutics. In addition, Isis and Roche will be collaborating to combine Isis' ASOs and Roche's brain shuttle program with the objective of increasing the brain penetration of ASOs with systemic administrationUnder the terms of the agreement, Roche will make an upfront payment of $30 million to Isis, with total payments related to license fee and pre- and post-licensing milestone payments reaching potentially $362 million, including up to $80 million in potential commercial milestone payments. In addition, Isis will receive tiered royalties on sales of the drugs. Roche has the option to license the drugs from Isis through the completion of the first Phase 1 trial. Prior to option exercise, Isis is responsible for the discovery and development of an antisense drug targeting HTT protein. Roche and Isis will work collaboratively on the discovery of an antisense drug utilizing Roche's brain shuttle program. If Roche exercises its option, it will be responsible for global development, regulatory and commercialization activities for all drugs arising out of the collaboration. Full Article
Isis Pharmaceuticals Inc Publishes Data Demonstrating Antisense Targeting Of ApoC-III Significantly Reduces ApoC-III And Triglycerides
Isis Pharmaceuticals Inc announced publication of new data in journal Circulation Research [doi:10.1161/CIRCRESAHA.111.300367] demonstrating that antisense targeting of apolipoprotein C-III (apoC-III) resulted in reductions in apoC-III and triglycerides, each an independent risk factor for cardiovascular disease. Hypertriglyceridemia is a serious medical condition associated with premature coronary artery disease and an increased risk for pancreatitis. Isis is developing antisense apoC-III inhibitor, ISIS-APOCIIIRx, for the treatment of patients with severe hypertriglyceridemia and plans to report top-line data in the middle of this year. Treatment with an antisense compound targeting apoC-III produced a variety of potential cardio-protective effects including dose-dependent reductions of apoC-III and triglycerides in all models and species, including man. In addition, treatment with an antisense compound targeting apoC-III resulted in enhanced triglyceride clearance from blood following a high-fat meal, reduction of VLDL particles and a slight increase in HDL-C levels. In all models and in the Phase 1 study, antisense inhibition of apoC-III was well tolerated. These data were consistent across multiple preclinical models and species and in a Phase 1 study in healthy volunteers demonstrating that Isis' antisense technology was able to produce predictable and consistent responses among different animal models that translate into corresponding activity in man. Full Article
Isis Pharmaceuticals Inc Announces Data From ISIS-SMN Rx Phase 1 Study In Children With Spinal Muscular Atrophy
Isis Pharmaceuticals Inc announced that data from the Phase 1 study of ISIS-SMNRx in children with spinal muscular atrophy (SMA) were presented at the 65th American Academy of Neurology (AAN) Annual Meeting by Dr. Claudia Chiriboga, from Columbia University Medical Center. In the presentation, Dr. Chiriboga reported that, in this single-dose, open-label study, ISIS-SMNRx was well tolerated in children with SMA at all dose levels tested and that improvements were observed in Hammersmith scores, a measure of muscle function, in a number of the children. ISIS-SMNRx is an antisense drug designed to treat all types of SMA. The Phase 1 study of ISIS-SMNRx was an open-label, single-dose, dose-escalation study designed to assess the safety, tolerability and pharmacokinetic profile of ISIS-SMNRx in medically stable children from age 2-14. In this study, 28 children, including 15 with Type II SMA and 13 with Type III SMA, received ISIS-SMNRx as a single dose of 1, 3, 6, or 9 mg administered intrathecally. ISIS-SMNRx concentrations in plasma and cerebral spinal fluid were measured to provide information on the dose concentration and frequency for future studies. In addition, exploratory analyses of changes in motor function were conducted. Gross motor movements were measured in all children throughout the study using the Hammersmith Motor Function Scale-Expanded (HFMSE), a modified version of the Hammersmith Functional Motor Scale. Full Article
Isis Pharmaceuticals Inc Issues FY 2013 Earnings Guidance Above Analysts' Estimates
Isis Pharmaceuticals Inc announced that for fiscal 2013, it expects pro forma net operating loss (NOL) in the mid $60 million range. According to I/B/E/S estimates, analysts were expecting the Company to report EBIT of (86.94) million for fiscal 2013. Full Article
Bernstein Liebhard LLP Announces Only Six Days Remain To File Motion For Lead Plaintiff In Class Action Against Isis Pharmaceuticals Inc
Bernstein Liebhard LLP announced that only six days remain - until February 26, 2013 - to file a motion for lead plaintiff in a class action against Isis Pharmaceuticals Inc. (Isis or the Company). The action against Isis was recently commenced in the United States District Court for the Southern District of California on behalf of a class (the Class) of purchasers of Isis securities between March 29, 2012 and October 15, 2012 inclusive (the Class Period). The Complaint alleges that throughout the Class Period, the Company conditioned investors to believe that Kynamro (mipomersen sodium), one of the drugs in its pipeline, would receive approval from the U.S. Food and Drug Administration (FDA) through a host of materially false and misleading statements regarding the safety and efficacy of the drug, as well as reportedly positive results from Kynamro's phase three clinical trial. As a result of the foregoing, the Company's statements were materially false and misleading at all relevant times. Full Article
Sanofi SA's Genzyme And Isis Pharmaceuticals Inc Announce FDA Approval Of KYNAMRO (Mipomersen Sodium) Injection For Treatment Of Homozygous Familial Hypercholesterolemia
Genzyme, a Sanofi SA company and Isis Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for KYNAMROTM (mipomersen sodium) injection. KYNAMRO, given as a 200 mg weekly subcutaneous injection, has been approved as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH). The FDA approval triggers a $25 million payment to Isis from Genzyme. The FDA approval for KYNAMRO is supported by the clinical trial conducted to-date in the HoFH patient population. The randomized, double-blind, placebo-controlled, multi-center trial enrolled 51 patients age 12 to 53 years, including seven patients age 12 to 16 years, who were maintaining a regimen of maximally-tolerated lipid lowering medications. Treatment with KYNAMRO further reduced LDL-C levels by an average of 113 mg/dL, or 25%, from a treated baseline of 439 mg/dL, and further reduced all measured endpoints for atherogenic particles. KYNAMRO is an antisense drug and is metabolized without affecting the CYP450 pathways used in commonly prescribed drugs, and thus has potential for no drug-drug interactions. No clinically relevant pharmacokinetic interactions were reported between KYNAMRO and warfarin, or between KYNAMRO and simvastatin or ezetimibe. Full Article
Law Offices Of Howard G. Smith Announces Class Action Lawsuit Isis Pharmaceuticals Inc
Law Offices Of Howard G. Smith announced that a class action lawsuit has been filed in the United States District Court for the Southern District of California on behalf of all purchasers of the common stock of ISIS Pharmaceuticals, Inc. (ISIS or the Company) between March 29, 2012 and October 15, 2012, inclusive (the Class Period). The Complaint alleges that throughout the Class Period the Company and certain of its executive officers issued materially false and misleading statements regarding the safety and efficacy of the Company`s flagship product, Kynamro (mipomersen sodium), for the treatment of patients with Homozygous Familial Hypercholesterolaemia. Specifically, the Complaint alleges that defendants, through a series of materially false and misleading statements regarding the safety and efficacy of the product, and reportedly positive results from Kynamro`s clinical trials, conditioned investors to believe that Kynamro would receive approval from the U.S. Food and Drug Administration (FDA). Full Article
Roche to use Isis's technology to develop brain disorder drug
- Isis Pharmaceuticals Inc said it will form an alliance with Swiss drugmaker Roche Holding AG to develop treatments for Huntington's disease, a genetic brain disorder, based on the U.S. company's technology.
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