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[Spinner]

And today's bolter out of the gate is....

Savient Pharmaceuticals SVNT

Up 50% on the bell.


Background from biomedreports.com

Savient Phama (NASDAQ:SVNT) announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for treatment failure gout patients, will be reviewed by an Arthritis Advisory Committee appointed by the FDA on 6/16/09. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA action date by three months to 8/1/09.

Today's spike may relate to this update (from Reuters)

* Agency: concerns over heart problems, allergies * FDA to seek advice from panel of advisers Tuesday * Savient says risks manageable with monitoring By Susan Heavey WASHINGTON, June 12 (Reuters) - Savient Pharmaceuticals Inc's (SVNT.O) proposed gout drug Krystexxa appears effective, but serious heart complications and other safety issues are a concern, U.S. health regulators said in a memo released on Friday. The Food and Drug Administration's review of two company studies raised several concerns, including a greater number of patients taking Krystexxa who suddenly died or had heart failure as well as allergic reactions, wrote Dr. Bob Rappaport, head of the FDA division that handles such rheumatology drugs. Savient is seeking U.S. approval for the drug to treat patients whom other therapies have not helped. The agency "does not dispute the efficacy" of Krystexxa at the currently proposed dose regimens of every two or four weeks, Rappaport said in the memo, which was released ahead of a public meeting on Tuesday to discuss whether to recommend approval of the drug. At the meeting, agency officials will ask the panel whether Savient has enough data to determine whether the benefits of the drug outweigh its risks. The FDA usually, but not always, follows its panel recommendations. Savient, in a separate document also released on Friday, said the drug was important for patients who have no other options and that it "can be successfully managed with careful clinical monitoring." The agency posted the memo to its website here

Cheers, Spinner

[nahoma8]

VirTra Announces First Order from Lockheed Martin

VirTra Announces First Order from Lockheed Martin
TEMPE, Ariz.--(BUSINESS WIRE)--VirTra Systems, Inc. Bob Ferris, VirTra Systems' CEO and president (Pink Sheets:VTSI), today announced that Lockheed Martin has submitted a purchase order to VirTra for an evaluation unit of its proprietary Threat-Fire™ belt system.

VirTra’s established philosophy insists that simulation training must both physically and mentally prepare trainees for the reality that hostile forces will shoot back. With that in mind, VirTra invented the patent-pending Threat-Fire™ device, which safely simulates return fire with a 30 millisecond electric stun (adjustable to 2.5 seconds). The device also has wireless activation capability and is easily rechargeable. VirTra contends that adding Threat-Fire to a simulator provides more realistic and thorough training, allowing the trainee to experience stress and apprehension on par with that of actual combat situations.

“VirTra is honored to have its technology evaluated by Lockheed Martin for possible inclusion in future Lockheed defense products,” said Bob Ferris, CEO of VirTra Systems.

[bobshishka]

How about an animal BioPharm at .0001?

I havent done much DD, just thought I would throw this out there:

PHMB
PHMB - PharmaCom BioVet Inc. - Google Finance

PharmaCom BioVet, Inc. Begins to Review the Process to Potentially Receive Minor Use/Minor Species Drug Approval From FDA

At .0001 and a 52 week high of .14, I figured why not pick up a milly or 2.

[imwbird]

I would be a little leery of this. They went from mining for gold to animal bone-marrow transplanting. Seems like quite a jump in technology.

[Kordoyn]

Stay away from PHMB it's a scam. They have a daily volume close to 1 billion and the price doesn't move. AVB gold was a scam ran out of Montreal by Dan Ryan, same person behind the resent PGYC scam.
You can't even trade this stock. I bought in 1 million shares just to see if you could day trade it. Bought at 0.0001, and even though the price has been 0.0002 for quite some time my order never goes through. They are just flooding the volume with wash shares.

[bobshishka]

Thanks for the info guys.

[schwi105]

I also posted this on the LJPC thread.


If anyone is interested, LJPC AH trading was quite attractive. They are supposedly releasing earnings on Monday, so people dropped it in anticipation of bad news. It may be a good quick pick-up on Monday depending on how bad/good the news is. Keep your head up. They have Phase III trial results later this year for their lupus drug, and they have been trading at double what they were trading at before today's AH for a while now. This may be an attractive entry point, or even lower if they report poor earnings next week.

Darin

[schwi105]

Originally Posted by schwi105 I also posted this on the LJPC thread. If anyone is interested, LJPC AH trading was quite attractive. They are supposedly releasing earnings on Monday, so people dropped it in anticipation of bad news. It may be a good quick pick-up on Monday depending on how bad/good the news is. Keep your head up. They have Phase III trial results later this year for their lupus drug, and they have been trading at double what they were trading at before today's AH for a while now. This may be an attractive entry point, or even lower if they report poor earnings next week. Darin

Nevermind. The company has some lawsuit issues. See below.

View Filing

[batya103]

6 Healthcare Stocks to Watch

6 Healthcare Stocks to Watch -- Seeking Alpha


The market experienced broad declines on Monday, hurt by weak economic data - a sharp contrast to last week when the Dow industrials rallied to turn positive for the year, increasing hopes that the economy is starting to turn around. Some key reports issued on Monday helped underscore the fact that the economy is still struggling. At mid-month, a New York state manufacturing survey (which often indicates where the country is headed) showed a decline in orders from just thirty days ago. In addition, more than half of the manufacturing respondents said that they had pared capital spending this year. Adding to the mix, the National Association of Home Builders housing-market index fell in June as higher mortgage rates damped demand. That didn't help set the table for a good week, but we'll see how things play out for the beaten bulls as the week goes on.

In the healthcare sector, Jazz Pharmaceuticals, Inc (NASDAQ:JAZZ), which had a good day last week, is off to another good start. The stock closed up +1.92 (72.73%) to $4.56 after the company's Sodium oxybate or JZP-6 demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia, according to Phase III data presented at the 2009 Associated Professional Sleep Societies meeting in Seattle, WA. The company said that these data have not been evaluated by the FDA or other regulatory authorities for use of sodium oxybate in the treatment of fibromyalgia. Assuming positive results for the second study, the company anticipates submitting a New Drug Application for sodium oxybate for the treatment of fibromyalgia to the U.S. Food and Drug Administration by the end of 2009.

AEterna Zentaris Inc. (NASDAQ:AEZS) closed up $.41 (22.78%) after the company said it will report patient follow-up results from its Phase 3 program in benign prostatic hyperplasia with cetrorelix ahead of schedule. Results will now be reported in the third quarter instead of the fourth. AEterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology.

K-V Pharmaceutical Co. (NYSE:KV.A) jumped another $.52 (22.22%) after last week's news that it has entered into a settlement agreement with privately held Purdue Pharma L.P. of Stamford, Conn., in regard to the patent infringement lawsuit between the two companies.

Purdue will grant KV Pharmaceutical certain limited non-exclusive, royalty-bearing, non-transferable rights to sell in the United States generic versions of the drug OxyContin (oxycodone HCl controlled-release) for a limited period of time. KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products

Last week's big winner, Chindex Intl, Inc. (NASDAQ:CHDX), an American healthcare company that provides healthcare services and supplies medical capital equipment, instrumentation and products to the Chinese marketplace, gave back some "buy on rumor sell on news" gains as it officially reported a net income of $3.4 million, or $0.22 per diluted share, for the fourth quarter ended March 31, 2009, compared to a net loss of $2.7 million, or $0.20 per diluted share, for the same quarter ended March 31, 2008. Shares closed at $12.88 after losing $2.32 (-15.26%). Roberta Lipson, president and CEO of Chindex, said: "During the fourth quarter and full year, we achieved our goals to make substantial progress on our KfW and US Export-Import Bank contracts, and enhanced our revenue performance in hospital services, although patient volumes were slightly less than anticipated."

Kendle International Inc. (NASDAQ:KNDL), had posted gains in the last 10 of 11 sessions. This is a stock whose investors feel has a $20+ book value, but it gapped down Monday morning and never recovered, closing at $13.89 -2.17 (-13.51%). The company is a clinical research organization, and provides clinical development services on a contract basis to the biopharmaceutical industry worldwide. It announced last week that it has opened up new offices in Malaysia, Thailand and the Philippines as part of a continued drive to access patient populations around the world.

Also on the losing side - if only for the day - was Biodel Inc. (NASDAQ:BIOD), a development-stage specialty pharmaceutical company focused on the development and commercialization of treatments for endocrine disorders, such as diabetes and osteoporosis. Shares were down 11.93%, but excited investors feel that shares may triple for this cash rich biotech firm whose product candidates are developed using VIAdel technology, which reformulates existing FDA-approved peptide drugs. Up for FDA approval soon is VIAject, a very rapid-acting form of injectable human insulin for meal-time use by patients with Type 1 or Type 2 diabetes. VIAject is comprised of commercially available recombinant human insulin and the company's own proprietary formulation of ingredients (all of which are Generally Regarded As Safe by the FDA). That same formulation delivers insulin in a form which more closely resembles the way a normal body uses insulin to help glucose enter the body's cells, providing energy that allows the body to function. Currently, insulin therapies are not delivered quickly enough to simulate the desired meal-time insulin spike. As our subscribers can see in our FDA Calendar, Biodel is now preparing its NDA submission, but if the FDA approves VIAject and sales reach only 1% of all diabetics in the US, revenue could easily surpass $250 million per year. This stock goes on my "stocks to watch" list as it closes the day at $5.24 -0.71 (-11.93%).


Gainers (% price change) Last Trade Change Mkt Cap
Jazz Pharmaceuticals, Inc JAZZ 4.56 +1.92 (72.73%) 131.90M
AEterna Zentaris Inc AEZS 2.21 +0.41 (22.78%) 117.54M
K-V Pharmaceutical Co. KV.A 2.86 +0.52 (22.22%) 142.85M
Arena Pharmaceuticals ARNA 5.47 +0.48 (9.62%) 437.77M

Losers (% price change)
Chindex Intl., Inc. CHDX 12.88 -2.32 (-15.26%) 188.23M
Kendle International Inc. KNDL 13.89 -2.17 (-13.51%) 206.25M
Biodel Inc BIOD 5.24 -0.71 (-11.93%) 124.31M
Merge Healthcare Inc. MRGE 3.48 -0.40 (-10.31%) 197.57M

Most Active (dollar volume)
Pfizer Inc. PFE 14.13 -0.63 (-4.27%) 95.35B
Johnson & Johnson JNJ 54.75 -1.31 (-2.34%) 150.87B
Wyeth WYE 43.95 -0.85 (-1.90%) 58.61B
Merck & Co., Inc. MRK 24.96 -1.12 (-4.29%) 52.63B
Abbott Laboratories ABT 44.73 -0.69 (-1.52%) 69.13B

[bobshishka]

Check this one out:

BIEL

BIEL - BioElectronics Corporation - Google Finance