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News Breaks
July 17, 2014
07:10 EDTISISIsis Pharmaceuticals begins Phase 2 study of candidate for high lipoprotein(a)
Isis Pharmaceuticals initiated a Phase 2 study evaluating ISIS-APO(a)Rx in patients with high lipoprotein(a), or Lp(a), an independent risk factor for cardiovascular disease. Isis plans to develop ISIS-APO(a)Rx to treat patients with high Lp(a) levels who are at high risk of experiencing life-threatening cardiovascular events. The Phase 2 study is a randomized, placebo-controlled, dose-titration study evaluating the safety and efficacy of ISIS-APO(a)Rx. The 12 week study will evaluate 100 mg, 200 mg and 300 mg doses of ISIS-APO(a)Rx in approximately 60 patients with Lp(a) levels of 50 mg/dL or greater.
News For ISIS From The Last 14 Days
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August 3, 2015
17:06 EDTISISIsis reports FOCUS FH Phase 3 study met primary efficacy endpoint
Isis Pharmaceuticals (ISIS) announced that the FOCUS FH phase 3 study of KYNAMRO in patients with severe heterozygous familial hypercholesterolemia met its primary efficacy endpoint, a statistically significant reduction in LDL-cholesterol after 60 weeks of treatment of once weekly injections of 200 mg of KYNAMRO compared to placebo. LDL-cholesterol reduction was similar to that observed in previous phase 3 studies. In addition, based on the data available for review, the safety profile of KYNAMRO observed in the FOCUS FH trial was similar to the safety profile reported in previous phase 3 studies. Genzyme (SNY) will provide a more in depth review of the safety and efficacy data at a future medical meeting.
05:39 EDTISISIsis Pharmaceuticals and AstraZeneca collaborate to develop antisense drugs
Isis Pharmaceuticals (ISIS) and AstraZeneca (AZN) announced a strategic collaboration to discover and develop antisense therapies for cardiovascular, metabolic and renal diseases. The new collaboration builds on a broad existing relationship between the two companies and supports AstraZeneca's strategic approach in these therapeutic areas using novel RNA-targeted treatments. It also enables Isis Pharmaceuticals to extend use of its antisense technology to diseases of the kidney. AstraZeneca will pay an upfront fee of $65M to Isis Pharmaceuticals plus development and regulatory milestones for each program that AstraZeneca advances to clinical development. Isis Pharmaceuticals is also eligible to earn tiered double-digit royalties on annual net sales for each program. This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act.
July 31, 2015
17:31 EDTISISIsis Pharmaceuticals cuts stake in Regulus to 5.57%
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July 29, 2015
17:13 EDTISISIsis announces publication of Phase 2 clinical results from volanesorsen study
Isis Pharmaceuticals and Akcea Therapeutics, its wholly owned subsidiary, announced that the New England Journal of Medicine has published positive clinical results from a Phase 2 clinical study evaluating volanesorsen, formerly ISIS-APOCIIIRx, in patients with very high to severely high triglycerides. This publication follows the December 2014 publication in the New England Journal of Medicine of the positive Phase 2 results from a clinical study of volanesorsen in patients with familial chylomicronemia syndrome. Volanesorsen is part of Isis' lipid franchise, which is being developed and commercialized by Akcea Therapeutics.
July 27, 2015
10:40 EDTISISIsis 'most obvious' Biogen takeover target, TheStreet's Feuerstein says
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07:07 EDTISISIsis Pharmaceuticals announces results from ISIS-TTRRx study
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July 22, 2015
19:26 EDTISISIsis Pharmaceuticals announces positive clinical data of ISIS-APO(a)Rx published
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July 21, 2015
07:13 EDTISISIsis Pharmaceuticals initiates Phase 1/2a clinical study of ISIS-HTT Rx
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