Alright Pharma Investors, I have put together a look ahead as to what kind of news could shape this week.
Vivus (VVUS):
Expect Vivus to file an New Drug Application (NDA) for their Obesity Drug Qnexa this week. The company has stated in many filings that they expect to get the NDA filing in by the end of this year, but have yet to file. Last week competitor Arena Pharmaceuticals beat Vivus to the punch with the NDA filing for their drug lorcaserin. This shouldn’t be surprising to Vivus investors however, Arena has a lot more riding on the obesity drug space after one of their other lead developmental drugs for atherosclerosis failed to meet its preset endpoints in a clinical trial earlier in the month. Vivus on the other hand has had relative success lately and management has their hands full with moving forward with two potential blockbuster NDA filings in 2010. The company also reported slam dunk results in a Phase III clinical trial for their Erectile Dysfunction drug avanafil earlier in the month. Both of these drugs hold the potential to billions of dollars in sales, so perhaps it is best that management take its time to get the NDA’s filed appropriately. As for the Pfizer take over rumor, I’ll write a special post on that later for what I think would be a fair share price. Because lately, I’ve been seeing one-sided deals in Pfizer’s favor for takeovers.
Cephalon (CEPH):
For those that missed the news last week, Cephalon’s PDUFA date for Nuvigil has been pushed back until to March 29, 2010.
Forest Laboratories (FRX):
Expect news either this week or the next week out of the FDA in relation to Forest Laboratories’ sNDA for nebivolol tablets in treatment of chronic heart failure. The company has an advisory panel meeting set for Jan. 11, 2009. The FDA usually makes public the briefing documents the FDA uses to seek guidance from the advisory panel, in those documents the FDA outlines its concerns and questions before a panel is convened.
Biomoda (BMOD):
Biomoda has hinted routinely in press releases that they are going to start a Phase III trial for their lung cancer detection assay CyPath in January 2010. The product is in the end stages of a Phase II clinical trial and so far to date has shown a 100% accuracy rate. The trials have been funded by multiple state grants.
Sunesis (SNSS):
Expect a lot of movement from Sunesis on Monday morning. The company filed to offer up to $50 million more in securities to help fund a Phase III clinical trial of their lead AML cancer drug Voreloxin. The company recently reported stunning Phase II results at the ASH meeting in December which sent the shares flying through the roof for the month. As of late, the share price has fallen from its highs. Cont’d on next page
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