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March 22, 2013
14:33 EDTISISIsis Pharmaceuticals provides update on CHMP Opinion on KYNAMRO
Isis Pharmaceuticals announced that following Genzyme's request for re-examination, the Committee for Medicinal Products for Human Use of the European Medicines Agency confirmed its previous position and has maintained a negative opinion regarding the marketing authorization application for KYNAMROTM (mipomersen) as a treatment for patients with Homozygous Familial Hypercholesterolaemia. The FDA approved KYNAMRO in the United States in January for the treatment of patients with Homozygous Familial Hypercholesterolaemia.
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September 2, 2014
19:28 EDTISISIsis Pharmaceutical licensing partner Antisense reports ATL1103 phase II results
Antisense Therapeutics, or ANP, reported the primary efficacy results from its phase II clinical trial of ATL1103 in patients with the potentially life threatening growth disorder, acromegaly. The phase II trial met its primary efficacy endpoint showing a statistically significant average reduction in the serum insulin-like growth factor-I, or sIGF-1, levels of 26% from baseline at week 14 at the 400mg per week dose tested. All patients treated with 400mg per week of ATL1103 had a reduction in sIGF-I levels from baseline at week 14. Greater reductions in sIGF-I were observed in patients who had lower body weights and thereby received a relatively higher dose per kg bodyweight with the patients who received 5.5 mg/kg per week showing a 36% average reduction in their sIGF-I levels. The positive results achieved in this Phase II trial position ATL1103 to move into Phase III stage of development. Consequently, ANP will accelerate out-licencing activities to secure a pharmaceutical development partner for the drug's further development. ANP has 4 products in its development pipeline that it has in-licensed from Isis Pharmaceuticals, including ATL1103.

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