Canaccord Genuity Maintains a 'Hold' on ISIS Pharmaceuticals (ISIS); Adjusting Estimates After Top & Bottom Line Beat
May 9, 2012 9:52 AM EDT
Canaccord Genuity maintains a 'Hold' on ISIS Pharmaceuticals (NASDAQ: ISIS) price target of $9.00.
Analyst, Salveen Richter, said, "ISIS reported a Q1 top- and bottom-line beat and provided a detailed update on the pipeline. The focus remains on Kynamro ahead of a CHMP opinion on E.U. approval (HoFH and severe HeFH) expected in mid-’12. In addition, given a 10-month standard review (Jan 29, 2013 PDUFA), we expect a likely FDA panel in late-Q3/early Q4 (shared with AEGR’s lomitapide). Management stated that a pre-approval inspection of the manufacturing facility for E.U. approval went well. We continue to be encouraged by ISIS' vast and diverse pipeline – APOCIII (high triglycerides) entered P2, TTR (TTR amyloidosis, partnered with GSK) is slated to enter a P2/3 in H2/12, FXI (clotting in total knee replacement) and SMN (spinal muscular atrophy, partnered with BIIB) are expected to advance into P2 studies in H2/12 and YE12, respectively – as well as by the company's ability to attract lucrative partnerships. However, we recognize that the pipeline is highly leveraged to the regulatory success of Kynamro."
"...we are lowering our FY12 GAAP EPS estimate to ($0.79) from ($0.69), but increasing our FY13+ estimates due to lower SG&A expense."
For an analyst ratings summary and ratings history on ISIS Pharmaceuticals click here. For more ratings news on ISIS Pharmaceuticals click here.
Shares of ISIS Pharmaceuticals closed at $8.32 yesterday, with a 52 week range of $6.25-$9.37.
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Genzyme, Isis submit NDA for Kynamro in HoFH, Isis gets $25M milestone payment Genzyme, a Sanofi company (SNY), and Isis Pharmaceuticals (ISIS) announced that Genzyme has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for Kynamro for the treatment of patients with homozygous familial hypercholesterolemia, or HoFH. Isis will receive a $25M milestone payment from Genzyme following FDA acceptance of the NDA submission. Provided the necessary approvals are granted, mipomersen would be marketed under the brand name KYNAMRO, the name that has been submitted to health authorities for the investigational agent. The FDA has granted mipomersen Orphan Drug designation for the treatment of patients with HoFH. :theflyonthewall.com --------
analysts at Piper Jaffray (NYSE: PJC) upgraded shares of ISIS Pharmaceuticals from a “neutral” rating to an “overweight” rating in a research note to investors on Tuesday, May 1st. They now have a $15.00 price target on the stock, up previously from $10.00.