Isis Pharmaceuticals Inc. (ISIS) reported a net loss of 7 cents per share in the third quarter, which was wider than the Zacks Consensus Estimate of a net loss of 5 cents. The company had reported a net income of 2 cents in the year ago period. The wider-than-expected loss was due to lower revenues and higher operating expenses.  Revenues declined 9.1% to $26.8 million. Revenues include license fees, milestone-related payments and other payments. Revenues declined during the reported quarter as the company finished amortizing the revenue associated with the $50 million upfront payment received from Johnson & Johnson’s (JNJ) Ortho-McNeil-Janssen in 2007.  The company reported higher expenses during the quarter mainly due to the expansion of its clinical development programs, including additional expenses associated with the phase III clinical program for mipomersen, expenses for Regulus as it builds its core team and expenses related ...

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Genzyme [GENZ: 59.12, +0.75 (+1.28%)] and Isis Pharma [ISIS: 13.66, +0.53 (+4.04%)] announced on 5/20/09 that the Phase 3 clinical trial of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25% reduction in LDL

...

We are keeping our Buy rating and $22 price target on Isis Pharmaceuticals (ISIS). We are big fans of antisense technology and believe that the number of potential therapeutic applications is enormous. Antisense drugs may have significant potential to treat a number of diseases where small molecule and biologic compounds have failed.Although still early-stage, antisense technology as a platform for developing drugs reminds us greatly of the promise of biologic drugs over a decade ago. Potential mechanisms such as siRNA, RNAi, alternate splicing and micro RNA have the potential to change how we treat disease in the years to come.Isis is pioneering the effort into antisense research. The company has already commercialized the first antisense drug in 1998 with Vitravene. Isis has several proprietary compounds in clinical development as well as partnered programs with large pharmaceutical companies such as Glaxo (GSK), Bristol-Myers (...