GNLB - Sector: Healthcare ---Industry: Biotechnology & Drugs

[setravis]

Watching GNLB this morning.....check it out

[setravis]

May be getting ready to take off members.
Parked just above the 50 day.

[goformoney]

From Street.com

Genelabs Technologies (GNLB:Nasdaq - commentary - research) rose 24.4% after the company said that its Prestara drug has been granted orphan drug status by the Food and Drug Administration. The investigational drug is used for the treatment of lupus. Specifically, the FDA said that the drug qualifies for orphan status as an indication for the "prevention of loss of bone mineral density in systemic lupus erythematosus patients on glutocorticoids." Genelabs says that it has scheduled a meeting with the FDA to discuss the company's options regarding the development of the drug.

The chart sounds too.

[setravis]

after a breather,we have some action

[lojze]

But the runup doesn't want to be persistent ...

[setravis]

Active in the pre-market +10.67%

[shawFund]

Another bio company and it is in uptrend now.

Has higher lows:

$0.37 -> $0.42 -> $0.46 up 26% in two days.

Buy on pull back may be n $0.50

[setravis]

Taking another stab at it....back above the 50-day ema.
Indicators have turned north,volume up nice today.
Let's see what's cooking.

[setravis]

Press Release Source: Genelabs Technologies, Inc.


Genelabs Announces Results From Preliminary Analysis of an Open Label Study of Its Lupus Drug Prestara(TM)
Thursday August 18, 8:05 am ET


REDWOOD CITY, Calif., Aug. 18 /PRNewswire-FirstCall/ -- Genelabs Technologies, Inc. (Nasdaq: GNLB - News) today announced positive results from a preliminary analysis of an open label clinical trial, Study GL03-01, which has met its primary objective of maintaining the bone mineral density (BMD) of women with systemic lupus erythematosus (SLE or lupus) receiving glucocorticoids. This clinical trial measured the effect of Prestara(TM) on BMD for a 12-month period following completion of the company's 6-month double-blind, placebo-controlled clinical trial (Study GL02-01), the results of which were announced in October 2004.


(Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/19990728/GNLBLOGO )

The primary endpoint of Study GL03-01 was maintenance of bone mineral density at the lumbar spine for patients receiving 200 mg of Prestara per day, which has been the standard dose Genelabs has used in clinical evaluation of Prestara. All patients in Study GL03-01 received Prestara(TM), either 100 or 200 mg per day, with approximately two-thirds of the patients receiving 200 mg per day. While the trial was not designed with a placebo control, it was randomized and all of the patients' BMD scans were sent to a centralized reading site. All patients enrolled in Study GL03-01 were taking glucocorticoids, which normally cause a decrease in bone mineral density.

Preliminary results of Study GL03-01 demonstrated that patients who received 200 mg of Prestara per day increased their BMD at the lumbar spine by approximately 0.9% during the 12 months they were enrolled in Study GL03-01. Results of Study GL03-01 also demonstrated that patients who received a lower dose of Prestara, 100 mg per day, did not increase their BMD during the clinical trial, and in fact lost a measurable amount of bone mineral density at the lumbar spine over the 12-month period of Study GL03-01. The patients who had previously received 200 mg per day of Prestara in the earlier Study GL02-01 and who were then randomized to continue receiving 200 mg of Prestara in Study GL03-01 experienced an increase in BMD at the lumbar spine over each successive 6-month interval in the 18-month duration of the combined studies. In addition, the safety profile for Prestara in this study was consistent with that seen in previous clinical studies.

"The preliminary analysis of the results from this clinical trial are supportive of our belief that 200 mg per day of Prestara, the dose we have used in most of our clinical studies, improves the bone mineral density of women with lupus, and that these increases accumulate over time," stated James A.D. Smith, President and Chief Executive Officer. "The validation provided by the data from this trial is an important consideration as we evaluate the future development options for Prestara for lupus. We strongly believe in the benefits that Prestara provides to patients suffering from the debilitating effects of lupus, and this trial indicates the protective effect of 200 mg of Prestara daily on the patients' bone mineral density. However, in determining our future development plans we must weigh these benefits against the standards required by the FDA for approval of this investigational drug. Our analyses of these study results are continuing, however we expect to be able to submit them to the FDA in advance of an upcoming meeting, which we hope will provide additional clarity on what may be needed going forward."

Study GL03-01 enrolled 115 women with lupus who were randomized into one of two Prestara treatment groups. Genelabs conducted this open label trial to determine the long-term effects of Prestara on bone mineral density beyond an initial six-month period (which was measured in the company's double-blind Phase III clinical trial, Study GL02-01). While Study GL03-01 provides useful data on the positive effect of Prestara on the BMD of women with lupus, the U.S. Food and Drug Administration (FDA) normally does not consider open label studies to be sufficient to support approval of a new drug. Genelabs has scheduled a meeting with the FDA to discuss the company's options for the development of Prestara for lupus, including the results of this clinical trial.

Background of Prestara for Lupus and Bone Mineral Density

Genelabs previously completed a placebo-controlled one-year Phase III clinical trial, designated Study GL95-02, which evaluated the ability of Prestara to improve or stabilize clinical outcome and disease symptoms in women with mild to moderate lupus. Nested within this clinical trial was a separate study to assess the effect of Prestara on bone mineral density in women with lupus who were taking glucocorticoids. An analysis of the patients who had pre- and post-treatment bone mineral density measurements showed that the group of patients receiving Prestara had significantly increased bone mineral density, compared to a decrease in bone density for the group of patients on placebo. The FDA subsequently issued an approvable letter to Genelabs, which required the successful completion of an additional clinical trial providing sufficient evidence to confirm the positive effect of Prestara on the patients' bone mineral density. Genelabs conducted a double-blind Phase III clinical trial, designated Study GL02-01, which was designed to satisfy FDA's requirement if the results were positive. In October 2004 Genelabs announced that the results of Study GL02-01 were not statistically significant in favor of Prestara. Patients who completed Study GL02-01 were eligible to enroll in Study GL03-01, a one-year follow-on clinical trial which treated all patients with Prestara.

About Genelabs

Genelabs Technologies, Inc. is a biopharmaceutical company focused on the discovery and development of pharmaceutical products to improve human health. We have built drug discovery and clinical development capabilities that can support various research and development projects. Genelabs is currently concentrating its capabilities on developing a late-stage product for lupus, discovering novel compounds that selectively inhibit replication of the hepatitis C virus and advancing preclinical development of compounds from this hepatitis C virus drug discovery program. We believe that these high-risk, potentially high reward programs focus our research and development expertise in areas where we have the opportunity to generate either first-in-class or best-in-class products that will address diseases for which current therapies are inadequate. For more information, please visit www.genelabs.com.

NOTE: Genelabs® and the Genelabs logo are registered trademarks and Prestara(TM) is a trademark of Genelabs Technologies, Inc.

NOTE ON FORWARD LOOKING STATEMENTS AND RISKS: This press release contains forward-looking statements including statements regarding the future development of Prestara(TM), final analysis of the open label study, potential meetings with the FDA and the outcomes of any such meetings, possible factors that could affect a future clinical trial and prospects for our HCV program. These forward-looking statements are based on Genelabs' current expectations and are subject to uncertainties and risks that could cause actual results to differ materially from the statements made. Uncertainties and risks include, without limitation, further analysis of the data from the open label study; adverse results from the open label study or Taiwan study; an adverse response from the FDA; a determination to discontinue development of Prestara; regulatory problems or delays regarding Prestara; potential de-listing from the Nasdaq National Market; fluctuations in Genelabs' stock price; factors affecting our HCV drug discovery program; increases in expenses and Genelabs' capital requirements and history of operating losses. Please see the information appearing in the Genelabs' filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, under the captions "Risk Factors" and "Forward-Looking Statements" for more discussion regarding these uncertainties and risks and others associated with the company's research programs, early stage of development and other risks which may affect the company or cause actual results to differ from those included in the forward-looking statements. Genelabs does not undertake any obligation to update these forward-looking statements or risks to reflect events or circumstances after the date of this release.


    CONTACT:
     Matthew M. Loar
     Chief Financial Officer
     +1-650-562-1424




--------------------------------------------------------------------------------
Source: Genelabs Technologies, Inc.

[setravis]

Big white Marubozu candlestick today.
Could be back in play.
Support @ 0.60.....Resistance @ 0.69

[testosterol99]

BLOCKBUSTER NEWS ARE SCHEDULED FOR DECEMBER 12, 2005.    THIS ONE COULD GO PAST $1 AFTER THE NEWS ARE OUT
   
   
GNLB will officially present the results of its groundbreaking PHASE 2 trials for its Hepatitis E vaccine candidate on December 12 at a worldwide infectious dicease conference to be held in Washington DC. The study included 2000 subjects and was sponsored by several agencies.   
   
This will be the first commercial vaccine for Hepatatis E in the world. GlaxoSmithcline (GSK) signed an exclusive worldwide license with GNLB in November 2004 after the results of the Phase 1 trial results were shared with potential partners. GSX was selected as the partner in this venture.   
   
GSK made an initial payment of $750,000. GNLB gained 20% when the announcement was made. The agreement calls for GNLB to receive handsome royalty payments from GSK on this $400M/year drug market.   
   
Hepatitis E is a growing concern in developing countries. The mortality rate can be very high depending on the health, age, and sex of the infected individual.   
   
Here is a little primer on Hepatitis E (read the section pertaining vaccines):   
   
http://www.who.int/mediacentre/factsheets/fs280/en/   

If you really think about it, anything under 50c is dirt cheap with so much potential. Why do you think institutions are hanging on and even adding despite the pps being this low??

When the PHASE 2 results come out, GNLB will be in Pandemonium. This is the most advanced hepatitis E vaccine at Phase 2. No one esle is even near. Having giant GlaxoSmithkly by your side says a lot IMO
   
   
I don't believe GSK would make a big down payment to be part of this opportunity if the results were not excellent.   
   
GNLB has another potentially blockbuster Drug candidate in Prestara, potentially the first major drug for the treatment of Lupus (Competes with LJPC). The company received organ drug status and an "Aprovable Letter" from the FDA. A meeting with the FDA on this subject is upcoming according to a recent PR.   
   
GNLB's is also developing several vaccine candidates for Hepatitis C in association with Gilead Sciences. Gilead already made a $11M payment for GNLB to accelerate drug development. GNLB will receive royalty payments and Gilead will concentrate in the sales/marketing/commercialization end of the business.   
   
The Hepatitis C is market is estimated to be about $3 Billion now and increasing to $5 Billion plus by 2010.   
   
GNLB has $14M in cash, enough to carry the company for at least a year since it is already generating revenues from its partnership with Gilead Sciences. The company reported its best quarter ever in terms of revenues (royalties from Gilead) and losses last week.   
   
The company has been granted until mid March 2006 to regain compliance with the Nasdaq under $1 rule.   
 
GNLB could be a huge gainer in the next few weeks. This is a ground floor opportunity. Institutions have increased their stake in GNLB from the 6/30 to the 9/30 filing. Not many stocks under $1 can make that claim. The largest institutional investor is Biovail with over 8M shares followed by J.P. Morgan Chase with almost 2M shares   
   
 
I suggest that you take the time to hear the company update to institutional investors at the Rodman & Renshaw Techvest 7th Annual Healthcare Conferenc held on Monday, November 7, 2005 (link in Yahoo's site for GNLB Headlines section).   
   
   
** Do your own DD and invest at your own risk  (I did after I read this e-mail from an investment guru)**   

[fill_the_gap]

Setravis,

Any thoughts on the giant volume today ?

Roll Tide !

[setravis]

Setravis,

Any thoughts on the giant volume today ?

Roll Tide !

I don't know what's up with all that volume.
Somebody must know something....put a watchful eye on it the next market day.
StockCharts seems to be down at this time ,had to use this chart from Yahoo

Didn't roll in the last 2 games...
I got my back up USC....Go Trojans ! 
Happy Thanksgiving.

Last Trade: 0.48
Trade Time: Nov 23
Change:  0.01 (2.13%)
Prev Close: 0.47
Open: 0.48
Bid: 0.01 x 100
Ask: 9,000.00 x 100
1y Target Est: 1.00

  Day's Range: 0.47 - 0.58
52wk Range: 0.36 - 1.40
Volume: 7,368,466
Avg Vol (3m): 823,209
Market Cap: 42.66M
P/E (ttm): N/A
EPS (ttm): -0.11
Div & Yield: N/A (N/A)

[setravis]

Looks, IMO, I had better say. Taking a stab at the 50-dma.
May be forming a Rounding Bottom (reversal).
Volume: 1,056,211
Avg Volume (3m): 773,725

Technicals
Percentage Gainer

Last Price Quote is:
6.34%above 13-day EMA
0.35%above 50-day EMA
RS Rating: 11 

Fundamentals
Key Data:
Market Cap (M): $41.59 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Hold

[gambler2075]

bought 40k shares today at 0.51...

I highly suggest you listen to the conference call that they had on the 30th. It was what made me buy the stock... don't believe what the pumpers say... due your own dd.

http://www.investorcalendar.com/IC/CEPage.asp?ID=97892&CID=

nothing really that impressive for the first 18 minutes, then, WHAMMO...

Listen from minutes 18:30 to 22... I've paraphrased what they said (mostly b/c I couldn't type that fast... lol!!! but it is clear that Dec 12th is going to be a huge day.

(slide 20)

"we entered into a license with GSK to develop vaccine for Hep E... Same team that developed GSK Hep A vax is developing HEp E vaccine...

vax has been 100% effective in animal model
2 phase 1 studies showed it produced human antibodies to hep E.

2000 subject trial conducted under IND. Objective was to determine if vax candidate prevented disease... double blind, placebo controlled... based on results of this trial about a year ago, gsk paid a milestone to genelabs that was triggered under the agreement.
however, they have not publically disclosed the results of that clinical trial yet, and are planning to do that in 2 weeks at a meeting of the american society of tropical disease...on December 12th, so we are looking forward to that. ***LONG PAUSE*** <gnlb spokesperson goes on about other programs>"



good luck
Gambler