Savient Pharmaceuticals, Inc. (SVNT)

SVNT has a too high valuation compared to its sales potential. It is also loss making at least until 2011.

HT BB

check out news on their new drug for gout --

I believe their gout treatment drug Krystexxa will receive approval with some level of monitoring. I do not think it is a coincidence that Savient recently hired one of Wyeth's vice presidents. I will keep my eyes open for a possible tender after FDA approval.

ZZ jumped out of his red thumb like a magician and back in again after the pop this week. Having your pulse on the bios/meds FDA regime is difficult, full of risk and full of reward. Unlike ZZ, (who knows much better than I), I think Savient has a chance with the FDA. Stock buyers had little idea how to play the review boards analysis. Effective, but safety concerns. Clearly affectivity is good and the hard part is behind Savient on thier Krystexxa for gout. The safety concerns, however, (heart) are usually enough to send most drugs down the drain or back to the back lab to try to alter doseage or formulary to offset the risk. In this case, the FDA does add some weight when considering risk to the benefits. There are no other drugs that meet Krystexxa's results for gout. Risk/reward? I'm leaning toward approval. Again, ZZ has me by years and brains on these type of issues, but no guts, no points. I also tend to prefer to root on the side of science. The occasional reward helps to heal the losses on the majority of disapprovals.

A very curious development today in Savient, which requires familiarity with FDA approval procedures as well as the history of this particularly interesting baby biotech to understand. I was at one point very confused about the approval process after NDA submission, and now I watch others suffer from the same misconceptions and misinterpretations.

The FDA occasionally chooses to have NDA's reviewed by an independent advisory panel of expert scientists. It is unclear whether the decision to have an advisory panel review affects the eventual probability of approval. The panel votes on safety and efficacy issues and the FDA will often, but not always follow their recommendation. A few days before the panel meeting, the FDA will release position papers outlining their official impressions. The panel will often go against these position papers creating substantial confusion and controversy in advance of the eventual approval decision. Last year's adventures with Ligand are an excellent example.

The development today was the release of the FDA documents (which I have not read) which seem to indicate that the FDA sees Krystexxa (barf) as an effective treatment for gout. The documents reiterated some previously described cardiovascular safety concerns. The share price subsequently shot up by 50%. However, those with a passing familiarity with Savient's recent history would not see this FDA position as a reason to celebrate. Savient's share price soared last year after positive phase III efficacy data, only to crash resoundingly many months later after the belated release of data indicating a significantly increased risk of dangerous cardiovascular complications. Efficacy has not been the concern about Krystexxa. Savient stock now has two ways to fall - with a weakly positive or a negative advisory panel vote on Krystexxa safety on June 16, or with a Complete Response letter from the FDA on or about July 30. While one might get lucky and clear both those bars with a resultant triple, historical odds suggest a more conservative FDA approach which will likely knock the price back down below 5, or even further. The 50% jump today swings the risk/reward ratio negative.

If I'm wrong on this call, I've decided to name my first-born daughter Krystexxa.

closed the gap, should go back down

I bought this one last week for 5.80 and sold the calls 7.50 June. Its a quick hitter. If you buy now, you might consider to sell the 10 calls - 10% return on the call and 30% if it gets called out. Won't be a bad investment for less than 3 weeks...

http://seekingalpha.com/article/136379-fda-clinical-trial-calendar-updates-wye-svnt-amrn-isis-slxp-somx?source=feed

Drug safety issues will kill this company.

After a major gap down on false rumors, the gap is likely to fill in the coming months, especially in view of the expected positive news flow in December-January.

Time to buy, pharmaceuticals are needed every day, always be a market for them today, tomorrow so on and so on ....

Puricase serves a clear need in treatment-failure gout. The product treats a highly symptomatic disease whose sufferers are traditionally affluent and have healthcare willing to accept higher than Wall Street estimate prices for drugs treating smaller, well-defined patient populations in distress. Motivated patients already being treated (unsuccessfully) in a high prescriber environment will find new drugs, especially if that drug is physicians’ first new treatment option in 40 years.

SVNT expects to receive approval from the FDA for Puricase, a Gout treatment, later this year. They passed Phase 3 trials meeting all their endpoints. All indications point to a major pharma company acquiring SVNT later this year or early next year to add Puricase to their pipeline. The treatment has huge potential.

Lots of downside not much upside. I see negative numbers how bout you?

Should continue to show strength in niche markets.

fast tracked for new gout med great clinical trial results

The gout drug will be a big winner.

Will be over 30!