VVUS - Vivus Inc - Page 6

Vivus Diet Drug Denied

http://blogs.forbes.com/matthewherpe...rtner=yahootix

hmmm... like that article above points out, this isnt a terrible CRL.. Yea, the pps is going down, but could be a nice time to get in.. either for a quick bounce or waiting a few months leading to a second shot at approval

Up 33% pre market

It looks like JP Morgan upgraded their price target to 13$. That's pretty interesting. I bet they are trying to unload.

So since the FDA wants more safety data from an already finished clinical trial, I wonder what they are looking at as far as a time-line for resubmitting? The CRL looks like it's about as good as they could expect.

lol...did not expect that...

Heavy selling pressure since this price target and the jump to 8$. I think many of these institutions are putting out exaggerated targets on AVNR, VVUS ect, so they can unload before a market pullback.

A sell off in the broader market takes these types of stocks down with it most of the time and those without immediate near term catalysts are usually hit the hardest.

Running hard on OREX approval.

It wasn't approval it was a Panel vote

Which means approval to follow 99.99% of the time. Approval set for Jan 31st.

By Thomas Gryta
Of DOW JONES NEWSWIRES

NEW YORK (Dow Jones)--Vivus Inc. (VVUS) was dealt a setback in getting weight-loss drug Qnexa to the market after the Food and Drug Administration asked whether prior data may shed light on the risk of birth defects from the drug.
The FDA has asked Vivus to assess the feasibility of analyzing prior databases to determine whether topiramate, an ingredient in the drug, causes birth defects. Vivus said it will determine the timeline for resubmitting its application for Qnexa to the FDA after it finishes the feasibility assessment.
Based on talks with the FDA, Vivus believes the new request stems from published reports derived from pregnancy registries that show defects from topiramate use in two children born in the U.K. and four in North America. Vivus said there were no reports of any fetal malformations in the 15 births from women exposed to Qnexa or topiramate in the initial Qnexa clinical studies.
Vivus is one of three companies trying to get a new obesity treatment approved in the U.S. Vivus and Arena Pharmaceuticals Inc. (ARNA) both had their diet drugs rejected by FDA panels and ultimately by the agency itself. Orexigen Therapeutics Inc.'s (OREX) weight-loss drug Contrave got a positive recommendation from a panel in December and is expecting an FDA decision later this month.
Shares of Vivus dropped 16.1% to $8.75 on Friday afternoon, while Orexigen fell 3.2% to $8.75 and Arena shares lost 2.5% to $1.92.
Qnexa is a combination of stimulant phentermine and antiseizure drug topiramate, sold as Topamax by Johnson & Johnson (JNJ). The two drugs work together to reduce appetite and make the user feel more satisfied.
The requested investigation of health-care records would determine the incidence of oral clefts in children born to women using topiramate for preventing migraines. The dosage used in Qnexa is closer to that used for migraines than the higher amounts used in treating epilepsy.
The FDA initially rejected Qnexa in October, asking for an assessment of Qnexa's potential to cause birth defects and evidence that the product doesn't increase the risk for major adverse cardiovascular events.
Vivus didn't mention the cardiovascular concerns in its statement Friday, and a spokesman said the company isn't commenting beyond what is included in the press release.
Canaccord Genuity analyst Adam Cutler believes the birth defect concerns can be addressed with a risk management program and aren't an impediment to approval.
"We are optimistic about the probability of approval in 2011 and recommend buying on weakness," Cutler said in a note to client. He has a $15 price target on Vivus shares.
Lazard Capital Market analyst William Tanner is less optimistic about the uncertainty surrounding the drug and the possible findings of birth defect risk.
"Unless and until there is clarity regarding the timing of resubmission and the likelihood that topiramate will not be viewed as of concern by physicians and patients, we see no reason to own VVUS shares," he said.

reaction to the set back news...

that .01% is a killer tho

Or not

Tell me someone banked here?

 

Vivus, Inc.-FDA Advisory Committee Recommends Approval Of Qnexa

 

http://www.reuters.com/finance/stocks/VVUS.O/key-developments

 

Pre-market: 20.86 +10.31 (97.73%)

 

i was thinking the same thing

So I took profits today - bought an island and I'm on the tarmat at Teterboro right now, was good knowing you guys.  

 

Oh well, there's always the next 100% FDA panel mover!