ARTICLE | Clinical News

Isis falls after mipomersen update

November 18, 2009 2:11 AM UTC

Isis Pharmaceuticals Inc. (NASDAQ:ISIS) fell $2.28 (17%) to $11.12 on Tuesday after it and partner Genzyme Inc. (NASDAQ:GENZ) reported that four patients treated with mipomersen had elevations in liver transaminases above three times the upper limit of normal in the Phase III RADICHOL 1 trial to treat homozygous familial hypercholesterolemia (hoFH). The partners also said that Genzyme now plans to submit regulatory applications in the U.S. and EU by mid-2011. Previously, Genzyme said it planned to submit an NDA in 2H10. The additional data were presented at the American Heart Association meeting in Orlando. The companies reported in May that mipomersen met the primary endpoint of significantly reducing LDL-C after 26 weeks vs. placebo in the trial (See BioCentury Extra, Wednesday, May 20, 2009). ...