Also, what do you guys think of HGSI? Same type of play as before, watch for volume on the breakout.
Quote from: kuepper on June 30, 2005, 10:31:34 PM
Also, what do you guys think of HGSI? Same type of play as before, watch for volume on the breakout.
I like it. Applause for posting the chart and comments.
What I also like about it, is the up trendline off the April 29 reaction low, after the big rally from March 30 to April 11. Connect the April 29 low with the June 15 low, and extend it on out.
On the morning of June 24, that up trendline came in at 10.70. HGSI opened right at 10.70, validating that trendline (it ticked lower by only a penny), then it took off to the upside, putting in a bullish engulfing pattern on triple the volume of the prior day, and on the best volume day since the initial thrust off the March 30 low. Nice action. :)
I'd use a close below that validated April 29 up trendline for a stop. It's a little lower than your steeper up trendline, but I think that the pattern is deserving of a little more room.
Using the "mini" Ascending Triangle off the April 29 low, a breakout above 11.70 would put Target: 13.48 IN PLAY. That would be a 15% gain from the breakout.
Figuring the target:
Pattern high (June 1) of 11.70 - 9.92 (April 29 low) = 1.78 points
1.78 points added to the breakout at 11.70 is 1.78 + 11.70 = Target: 13.48
The January 10, 2005 was 13.40, so a return to that high looks about right, on a breakout. Could go higher, using your larger Ascending Triangle.
Broke out above the Ascending Triangle, printing 11.71.
my 3 years experience with HGSI says it will stay in a tight range. Lot of promise but little money
Quote from: maris on July 01, 2005, 03:57:26 PM
my 3 years experience with HGSI says it will stay in a tight range. Lot of promise but little money
If HGSI can break out of this small Ascending Triangle (Kuepper drew the larger one), I think it can rally 10-15% by mid-September. HGSI is up 6 days in a row, so it might need to take a rest before it breaks out on a closing basis (if it does).
I especially like how ASTM has acted over the past two months. It's up 74%. I'll post that chart in the ASTM file, in case you'd like to look at it.
Broken... but needs a close above...
Quote from: kuepper on July 05, 2005, 03:16:52 PM
Broken... but needs a close above...
There's your close above the Ascending Triangle...and WELL above it. Applause!
HGSI closed at 12.00, the high of the day. Volume could have been better, but there was so some good buying interest late in the day, and at the close.
1200 shares at 12.00.....2881 shares at 12.00...7347 shares at 12.00...1100 shares at 12.00...they were willing to pay the high tick at the end of the day. I like that.
13.48 is IN PLAY as long as we remain above the top of the Ascending Triangle. I think that the target will be MADE by mid-Septermber. Mid-October, at the latest. We'll monitor it along the way.
http://ts-lc.sc8.finance.lycos.com/1120593263359?User=demo&Pswd=demo&DataType=GIF&Symbol=NASDAQ:HGSI&Interval=D&Permission=1000&Ht=400&Wd=600&Display=2&Study=&Param1=&Param2=&Param3=&FontSize=10&LocaleID=0x0409
HGSI is up (currently $0.20) this morning on news:
Updated: 08:15 AM EDT
Human Genome: GlaxoSmithKline Exercises Joint Devt Option
ROCKVILLE, Md. -(Dow Jones)- Human Genome Sciences Inc. (HGSI) said GlaxoSmithKline plc (GSK) exercised an option to jointly develop and commercialize Human Genome's rheumatoid arthritis and systemic lupus erythematosus, or SLE, treatment LymphoStat-B.
Under the terms of a June 1996 agreement, the companies will share development costs, as well as sales and marketing expenses. The companies also agreed to share equally in profits of any product commercialized under the agreement.
In April, Human Genome disclosed that results from a phase 2 trial demonstrated that LymphoStat-B was safe, well tolerated, biologically active, and reduced the signs and symptoms of rheumatoid arthritis.
In a press release Thursday, Human Genome noted results of a separate phase 2 clinical trial in patients with SLE are expected in the fall.
Human Genome said it remains confident that GlaxoSmithKline's decision to exercise its option on LymphoStat-B will greatly facilitate its commercialization.
Company Web site: http://www.hgsi.com
http://ts-lc.sc8.finance.lycos.com/1120593263359?User=demo&Pswd=demo&DataType=GIF&Symbol=NASDAQ:HGSI&Interval=D&Permission=1000&Ht=400&Wd=600&Display=2&Study=&Param1=&Param2=&Param3=&FontSize=10&LocaleID=0x0409
HGSI closed yesterday at 12.18. Bank of America started it as a buy this morning. HGSI is indicated at 12.61 ASK..12.63 BID.
Quote from: Melf Elf on July 08, 2005, 09:28:42 AM
HGSI closed yesterday at 12.18. Bank of America started it as a buy this morning. HGSI is indicated at 12.61 ASK..12.63 BID.
I bought the 11.71 Ascending Triangle breakout last Friday. Sold it here at 12.90. That's a big gap opening this morning that might get filled later. I took the 10% gain.
http://ts-lc.sc8.finance.lycos.com/1120593263359?User=demo&Pswd=demo&DataType=GIF&Symbol=NASDAQ:HGSI&Interval=D&Permission=1000&Ht=400&Wd=600&Display=2&Study=&Param1=&Param2=&Param3=&FontSize=10&LocaleID=0x0409
HGSI printed 13.41 this afternoon, almost at the 13.48 target on my Metastock chart (above) that I expected by mid-September I sold it this morning at 12.90, expecting a pullback.
Expect the unexpected :(
HGSI, with the double pattern breakout, turned out to be a Stock on Fire. It blew past the Little Ascending Triangle target of $13.48, and got to within $0.32 of the Big Ascending Triangle target of 14.38 in only four days from the breakout. :o
I sold it for 12.90 on some Friday profit-taking, figuring I could get back in on a gap fill (of a breakaway gap!). Let me see if I can find the "embarrassed" face on the toolbar >> :-[
Bought back HGSI at 13.40. Stop is a close or obvious tank below 12.75. Risk: a loss of 5%
HGSI is up $0.36, to $13.95 on news. I'd like to see it close today above last week's high of $13.95. I'd like a close above $14.05, the high of the Symmetrical Triangle in the chart above, even better.
Human Genome wins anthrax treatment supply contract
NEW YORK, Oct 3 (Reuters) - Human Genome Sciences Inc. on Monday said it has won a contract to supply ABthrax, its treatment of anthrax disease, to the U.S. government.
The company said it will supply 10 grams of ABthrax to the U.S. Department of Health and Human Services for testing in the first phase of the contract for about $1.8 million.
The U.S. has the option to place an order within one year for up to 100,000 doses of ABthrax for its Strategic National Stockpile, the company said in a statement.
10/03/05 09:27 ET
Quote from: Melf Elf on October 03, 2005, 02:55:00 PM
HGSI is up $0.36, to $13.95 on news. I'd like to see it close today above last week's high of $13.95. I'd like a close above $14.05, the high of the Symmetrical Triangle in the chart above, even better.
HGSI closed at 14.06, but the high of the pattern also was 14.06, not 14.05. ::)
Although yesterday's candle has the look of a Bearish Hangman, I view it as bullish that HGSI went down and filled the opening gap, went into the red by nine cents, then came roaring back to close near the high of the day.
We'll see what the market has to say about that. ;D
Hey Melf Elf,
you seem to be on your own on this thread, but nice play, applaud ;)
I had a look at it the other day when you posted last, but am all in right now on some of our others.
Nice gap fill today, always makes the chart look better ;D
Hope it continues well for you tomorrow matey
the Scotsman 8)
Thanks, Scotsman! Hey, take a look at this chart from late March to the breakout in early July.
Remind you of anything? Like...EGHT? :D
Both Ascending Triangle targets were achieved in about two weeks after the breakout. Sure would be nice if we could get that on EGHT, eh? ;D
Melf, all i gotta say is, your the man. I love your TA (applause)
I enjoy getting verified by you on my TA, as well as learning from you every day as im still a newbie in this field of work only at 21 and starting my research just about 4 months ago.
You wanna learn TA? read books, And become a member of this site.
-fousc
Quote from: fousc on October 05, 2005, 05:01:58 AM
im still a newbie in this field of work only at 21 and starting my research just about 4 months ago.
-fousc
fousc,
You're only 21?????????? :o
Wow, you sure do a nice job for having studied such a short time. Applause! Applause! What wonderful success you are going to enjoy in the stock market if you continue to work as hard as you do, and if you have a plan and use discipline, as you are doing. That's wonderful!
HGSI is trading down $3.07 to $10.90 in pre-market on bad news. I'm long from $13.40.
Ouch! Ouch! Ouch!
In this kind of situation, I sell at the open AT THE MARKET, no questions asked. That's a terrible break, and I don't sit around hoping that the stock will rally from the open and let me out at a better price.
I take the hit (looks like it will be about a 19% loss) and SELL.
7:27am 10/05/05
Human Genome Sci: LymphoStat-B didn't meet key endpoints (HGSI, GSK) By Sarah Turner
LONDON (MarketWatch) -- Human Genome Sciences Inc. (HGSI) said that a Phase 2 clinical trial showed that LymphoStat-B (belimumab) did not meet overall primary efficacy endpoints of reducing the signs and symptoms of systemic lupus erythematosus (SLE) at week 24 or increasing the time to first SLE flare over 52 weeks. The drug was safe, well tolerated, and showed signs of clinical effect in patients with SLE, the company said. In addition, the company's LymphoStat-B collaborator, GlaxoSmithKline (GSK) (UK:GSK) , has exercised its option to jointly develop and commercialize LymphoStat-B. The companies will share equally in Phase 3/4 development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized under the agreement.
Sold at $9.91. Loss: 26%.
Ouch!
That is a tough break Melf Elf, let's hope its not too similar to EGHT after all :P
But until then the breakout, consolidation and breakout of the symmetrical triangle looked excellent.
This seems to be the major problem with biotechs. They can run amazingly, but news like this can also wipe them out in a second. A reminder that if you want to play this field, you've got tto understand and be willing to take the risks :-\
Hope your other trades go better today ;)
Quote from: ScottishTrader on October 05, 2005, 10:39:50 AM
Ouch!
No kidding, Scotsman! That wasn't any fun at all. :-\
I had a 10% gain in this one this summer, so that takes a little bit of the sting out of it, but still...
Ouch! >:(
QuoteThis seems to be the major problem with biotechs. They can run amazingly, but news like this can also wipe them out in a second. A reminder that if you want to play this field, you've got tto understand and be willing to take the risks :-\
Yes, that's a good point. You can get blind-sided by news in any stock, but I agree that the biotechs are more vulnerable to getting whacked than the average stock. Particularly when they are working on only a couple/few projects, and when they have a problem with trials, like HGSI did.
Quotelet's hope its not too similar to EGHT after all
We'll forget that I ever mentioned that, won't we? Let me look up at the toobar and find that Embarrassed Face >>>> :-[
QuoteHope your other trades go better today ;)
You're a pal. Thanks! ;D
Hgsi coverage initiated by Citigroup.Chart looks good.Breaking out of a trading range.
HGSI has made it into the gap and in time likley to fill
http://tinyurl.com/a8jpl
Is HGSI good buy at this leave? thanks
Trending Up.....
Looks like this one was all forgot about !
The "Golden Cross" has occurred.
On this 6 month chart formed a Falling Wedge (reversal) Pattern,with a ver mean
breakout from the pattern.
Falling Wedge (Reversal)
The falling wedge is a bullish pattern that begins wide at the top and contracts as prices move lower. This price action forms a cone that slopes down as the reaction highs and reaction lows converge. In contrast to symmetrical triangles, which have no definitive slope and no bias, falling wedges definitely slope down and have a bullish bias. However, this bullish bias cannot be realized until a resistance breakout.
The falling wedge can also fit into the continuation category. As a continuation pattern, the falling wedge will still slope down, but the slope will be against the prevailing uptrend. As a reversal pattern, the falling wedge slopes down and with the prevailing trend. Regardless of the type (reversal or continuation), falling wedges are regarded as bullish patterns.
As with rising wedges, the falling wedge can be one of the most difficult chart patterns to accurately recognize and trade. When lower highs and lower lows form, as in a falling wedge, a security remains in a downtrend. The falling wedge is designed to spot a decrease in downside momentum and alert technicians to a potential trend reversal. Even though selling pressure may be diminishing, demand does not win out until resistance is broken. As with most patterns, it is important to wait for a breakout and combine other aspects of technical analysis to confirm signals.
MACD is Bullish
Stochastic is Bullish
Support @ $12.55...12.07...11.39
52wk Range: 7.63 - 13.97
Volume: 1,859,676
Avg Vol (3m): 2,351,760
Technicals
Last Price Quote is:
7.23%above 13-day MA
14.84%above 50-day MA
RS Rating: 92
Fundamentals
Key Data:
Market Cap (M): $1,502.05
P/E Ratio: NA
PEG Ratio: -0.44
Next Earnings: 10/24/2006
Last Analyst Rating: Buy
AP
Human Genome delivering anthrax drug to US
Monday February 2, 1:03 pm ET
Human Genome Sciences starts delivery of anthrax treatment to US national stockpile
NEW YORK (AP) -- Human Genome Sciences Inc. said Monday it will begin delivering doses of its anthrax treatment ABthrax to the U.S. Strategic National Stockpile.
Shares of Rockville, Md.-based Human Genome rose 36 cents, or 20 percent, to $2.18 in afternoon trading. The stock has traded between $1.20 and $8 over the last 52 weeks.
In 2006, the company made a deal with the federal government to deliver 20,000 doses of the drug for a national stockpile of medicines meant for use in the event of a public health emergency. The company said it expects a payment of $150 million after the delivery is complete, with the deal's total value reaching $165 million.
HGSI's Anti-Anthrax Convertible
Bill Feingold Feb 02, 2009 1:15 pm
The fatal anthrax mail attacks in the aftermath of 9/11 turned out, apparently, to be the efforts of a troubled Maryland researcher. That doesn't mean the deadly bacteria might not be attractive to various terrorists and troublemakers.
A little company called Human Genome Sciences (HGSI) -- whose main business once seemed to be the steady production of new convertible bonds -- is trying to protect us from any further anthrax damage. The company announced this morning that it has begun delivery of its ABthrax drug for treating inhalation of anthrax. HGSI is expecting a $150-million infusion from the government from its first ABthrax deliveries.
While HGSI's equity-market capitalization of less than $300 million makes the stock an interesting speculative play, investors also might want to take a look at the 2 convertible bonds HGSI has outstanding. Both of them carry modest 2.25% coupons, but since they're trading between $0.30 and $0.40 on the dollar, the current income they generate is significantly higher.
Still, you wouldn't be buying these bonds for current income, rather, in the hopes that the company's Anthrax drug and its other pipeline products will enable it to make good on these 2 bonds - 1 of which matures in 2 years, the other in 3 years. The debt adds up to face value of just over $500 million. The company's cash has been running low (it's been burning about $40 million per quarter), so the coming infusion will be more than welcome. But refinancing is a major risk. That's why, after all, the bonds are trading in the 30s - depressed levels even in today's market.
One of the attractions to beaten-down convertibles in general -- and particularly those of micro-cap biotech companies -- is the "poison put" feature. I've written about this in the past, and it's worth noting in the case of HGSI.
The stock is currently trading around $2. If a major pharmaceutical company buys HGSI for cash -- a distinct possibility -- it's required to pay off the convertibles at 100. So even if the company were to be taken out at no premium (or even a discount) to the current market price, the convertibles would roughly triple in value.
The HGSI convertibles maturing in 2011 are, naturally, the higher priced bonds and are identifiable by CUSIP #444903AK4. The 2012 bonds carry the CUSIP #444903AM0.
I always believed in this company, drugs should be coming to market.
See their drug pipeline becoming the future. Think you will start seeing some real results.
Buy and be patient.
[video] HGSI's New Anthrax Drug
at CNBC(Mon 11:42am)
http://www.cnbc.com/id/15840232?play=1&video=1019667893&__source=yahoo%7Cheadline%7Cquote%7Cvideo%7C&par=yahoo
52wk Range: 1.20 - 8.00
Volume: 11,384,806
Avg Vol (3m): 2,065,030
Technicals
Most Actives
Percentage Gainer
Last Price Quote is:
16.63%above 13-day MA
6.89%above 50-day MA
RS Rating: N/A
Fundamentals
Key Data:
Market Cap (M): $245.28
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 02/23/2009
Last Analyst Rating: Sell
I'm liking the stock here, but of course I am long, and biased... lol...
Had bought 45K shares at 0.53, sold at 0.89, and now bought back 55K shares at 0.84...
nice cup and handle, imo, this coming week should be interesting.
http://www.hotstockmarket.com/forums/showthread.php?t=58135&page=7
g
•Human Genome Sciences reports 1Q profit
4:08PM Human Genome beats by $0.31, beats on revs (HGSI) 1.39 +0.06 : Reports Q1 (Mar) earnings of $0.85 per share, $0.31 better than the First Call consensus of $0.54; revenues rose 1341.5% year/year to $177.3 mln vs the $150.4 mln consensus. 2008. Revenues included $153.8 million recognized upon the sale and delivery of ABthrax to the U.S. Strategic National Stockpile, $9.0 million recognized from the Syncria agreement with GSK, $8.9 million recognized from the Albuferon agreement with Novartis and $1.6 million recognized from the LymphoStat-B agreement with GSK.
------------------------------------------------------------------------------------------------
Big in the after Hours.......
Human Genome Sciences, Inc.(NasdaqGM: HGSI)
After Hours: 1.76 0.37 (26.62%) 7:59PM ET
The revenue was gigantic and earnings beat was huge.
This is set up nice...
Read.......
http://www.bizjournals.com/washington/stories/2009/04/27/daily68.html
See their drug pipeline becoming the future.
Think you will start seeing some real results here.
Buy and be patient.
52wk Range: 0.45 - 8.00
Volume: 14,876,362
Avg Vol (3m): 3,218,310
Technicals
Most Actives
Gap Up
Percentage Gainer
Last Price Quote is:
74.21%above 13-day MA
65.82%above 50-day MA
RS Rating: 42
Fundamentals
Key Data:
Market Cap (M): $176.56
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 07/22/2009
Last Analyst Rating: Mkt Perform
;D
Daily
Next resistance 2.50$ when we break it we will see 3$ +++
Chart looks fantastic.
MACD cross bullish
Slow stochastic bullish.
must read:
http://www.rttnews.com/ArticleView.aspx?Id=964408 (http://www.rttnews.com/ArticleView.aspx?Id=964408)
Weekly looks also nice....
Quote from: setravis on February 02, 2009, 06:53:25 PM
I always believed in this company, drugs should be coming to market.
See their drug pipeline becoming the future. Think you will start seeing some real results.
Buy and be patient.
waxweazle Thanks for the update...Applaud !
Two main points to make on Human Genome Sciences: First, thank goodness for Abthrax; and second, this is a company that needs a big R&D win in the worst way.
Last quarter's better-than-expected profit came thanks to the government's desire to add more Abthrax, the company's anthrax vaccine, to the U.S. bioterrorism stockpile. While not recurring revenue, the Abthrax contract did allow Human Genome to improve its cash position and reduce its debt load somewhat -- both clear positives for the company. There is some talk about the government buying even more Abthrax, which of course, would be continued good news for the company.
In the near term, this leaves Lymphostat-B, the company's drug for lupus. Two phase III studies are under way, with data expected later this year. Lupus is an extremely tough disease, and the phase II data on Lymphostat-B produced mixed results. It's hard to call this anything more than a toss up.
52wk Range: 0.45 - 8.00
Volume: 6,109,637
Avg Vol (3m): 3,727,250
Technicals
Last Price Quote is:
40.59%above 13-day MA
62.43%above 50-day MA
RS Rating: 55
Fundamentals
Key Data:
Market Cap (M): $335.40
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 07/22/2009
Last Analyst Rating: Mkt Perform
Ready to Roar...
Years before, this company was a "high flyer." Back then, there were dreams of things to come and the stock price was in the clouds. Now the company is on the "eve" of receiving numerous approvals, and for the first time in their history, they are generating "real" revenues and the stock price is under $5 (Talk about an investor's dream opportunity.) It's really laughable when you think about it. I wonder how long it will stay under $5?
52wk Range: 0.45 - 8.00
Volume: 10,331,144
Avg Vol (3m): 3,889,180
Technicals
Most Actives
Percentage Gainer
Last Price Quote is:
30.51%above 13-day MA
64.13%above 50-day MA
RS Rating: 74
Fundamentals
Key Data:
Market Cap (M): $335.40
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 07/22/2009
Last Analyst Rating: Mkt Perform
Quote from: setravis on February 02, 2009, 06:53:25 PM
I always believed in this company, drugs should be coming to market.
See their drug pipeline becoming the future. Think you will start seeing some real results.
Buy and be patient.
Quote from: setravis on June 03, 2009, 09:18:37 PM
Ready to Roar...
Years before, this company was a "high flyer." Back then, there were dreams of things to come and the stock price was in the clouds. Now the company is on the "eve" of receiving numerous approvals, and for the first time in their history, they are generating "real" revenues and the stock price is under $5 (Talk about an investor's dream opportunity.) It's really laughable when you think about it. I wonder how long it will stay under $5?
Bingo!
52wk Range: 0.45 - 8.00
Volume: 121,904,287
Avg Vol (3m): 5,903,650
Technicals
Record Price High
Most Actives
Record Price Break Out
Gap Up
Percentage Gainer
Price Gainer
Last Price Quote is:
340.12%above 13-day MA
397.63%above 50-day MA
RS Rating: 99
Fundamentals
Analyst Upgrade to Buy
Earnings Expected on Jul 22
Key Data:
Market Cap (M): $450.82
P/E Ratio: NA
PEG Ratio: N/A
Next Earnings: 07/22/2009
Last Analyst Rating: Buy
Human Genome Sciences and GlaxoSmithKline Announce Positive ...
ROCKVILLE, Maryland and LONDON, July 20, 2009 /PRNewswire-FirstCall via COMTEX/ -- Human Genome Sciences, Inc. (HGSI, Trade ) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.
"The BLISS-52 results demonstrated that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Given the limited treatment options currently available, patients would benefit greatly from potential new treatments. BENLYSTA is an outstanding example of the type of treatment HGS is working to develop and bring to patients. Assuming positive results in November from our second Phase 3 trial of BENLYSTA, we and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010."
Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. No new drug for lupus has been approved by regulatory authorities in more than 50 years. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
"Lupus is a chronic, often debilitating, and sometimes fatal illness that affects an estimated five million people worldwide and can have a devastating effect on both patients living with the disease and their families," said Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK. "BENLYSTA is the first medicine being developed specifically for lupus that has reached this late stage of clinical development with positive results. We look forward to completing the pivotal studies, with the hope of bringing this potentially important therapeutic advance to patients suffering from SLE."
Key Findings from BLISS-52
"The BLISS-52 results support and extend the findings that emerged in the serologically active subgroup of SLE patients at Week 52 in our Phase 2 trial," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We are delighted to report that the efficacy of treatment with BENLYSTA plus standard of care was superior in this study to that of placebo plus standard of care, while the safety profile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a robust level of statistical significance. BENLYSTA also significantly reduced SLE disease activity versus placebo based on a number of other measures, including SELENA SLEDAI and Physician's Global Assessment. Of note, a greater percentage of patients receiving BENLYSTA achieved a clinically meaningful reduction in steroid dose. We hope to have a full presentation of BLISS-52 results at an appropriate scientific meeting later in 2009."
Topline BLISS-52 results include:
-- Based on an intention-to-treat (ITT) analysis, belimumab met its
primary efficacy endpoint of superiority versus placebo at Week 52.
A clinically and statistically significant improvement was shown in
patient response rate for belimumab plus standard of care, vs.
placebo plus standard of care: 57.6% for 10 mg/kg belimumab, 51.7%
for 1 mg/kg belimumab, and 43.6% for placebo (p=0.0006 and p=0.011
for 10 mg/kg and 1 mg/kg belimumab, respectively vs.
placebo). Patient response was defined by an improvement in
SELENA SLEDAI score of 4 points or greater, no clinically significant
BILAG worsening, and no clinically significant worsening in
Physician's Global Assessment.
Results for each individual component of the patient response rate
were consistent with the overall improvement shown for the primary
endpoint.
-- Results for prespecified major secondary efficacy endpoints were:
-- A significantly greater percentage of patients receiving
belimumab achieved a reduction in SELENA SLEDAI score of at
least 4 points by Week 52, with 58.3% for 10 mg/kg belimumab,
53.% for 1 mg/kg belimumab, and 46.0% for placebo (p=0.0024 and
p=0.019 for 10 mg/kg and 1 mg/kg belimumab, respectively vs.
placebo).
-- Improvement in Physician's Global Assessment (PGA) at Week 24
was greatest in the belimumab 10 mg/kg treatment group versus
placebo (p=0.0003 for 10 mg/kg and p=0.27 for 1 mg/kg belimumab,
respectively) with improvement observed within 4-8 weeks.
-- A higher percentage of patients in both belimumab treatment
groups, versus placebo, had their average prednisone dose
reduced by at least 25% from baseline to 7.5 mg per day or less
during the last 12 weeks of study (p=0.053 for 10 mg/kg and
p=0.025 for 1 mg/kg belimumab, respectively vs. placebo).
-- Improvement in health-related quality of life at Week 24 as
measured by the SF-36 Physical Component Summary (PCS) score was
not significantly different among treatment groups. However,
although not a major secondary endpoint, improvement in the
SF-36 PCS score at Week 52 was significantly greater in both
belimumab treatment groups (p=0.025 for 10 mg/kg and p=0.027 for
1 mg/kg belimumab, respectively vs. placebo).
-- In BLISS-52, belimumab was generally well tolerated, with rates of
overall adverse events, serious adverse events, infections and
fatalities comparable between belimumab and placebo treatment groups.
Serious infections were reported in 5.9% of patients on placebo and
6.1% of patients on belimumab. The most common adverse events were
headache, arthralgia, upper respiratory tract infections, urinary
tract infection and influenza, and were also comparable between
belimumab and placebo treatment groups. No malignancies were
reported.
Professor Sandra V. Navarra, M.D., a principal investigator and Head of Rheumatology at the University of Santo Tomas, Manila, The Philippines, said, "Given the limitations of available therapies, there is a great need for well tolerated and effective treatments for lupus. We are very encouraged by the findings of BLISS-52, and look forward to presenting these results later in the year. We also look forward to the results of BLISS-76 later this year."
About the BENLYSTA (belimumab) Phase 3 Development Program
The Phase 3 development program for belimumab includes two double-blind, placebo-controlled, multi-center Phase 3 superiority trials - BLISS-52 and BLISS-76 - to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in serologically active (i.e., autoantibody-positive) patients with SLE. This is the largest clinical trial program ever conducted in lupus patients. BLISS-52 randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76 enrolled and randomized 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe. The design of the two trials is similar, but the duration of therapy in the two studies is different - 52 weeks for BLISS-52 and 76 weeks for BLISS-76. The data from BLISS-76 will be analyzed after 52 weeks in support of a potential Biologics License Application in the United States and Marketing Authorization Application in Europe and other regions. HGS designed the Phase 3 program for belimumab in collaboration with GSK and leading international SLE experts, and the program is being conducted under a Special Protocol Assessment agreement with FDA.
The primary efficacy endpoint of BLISS-52 and BLISS-76 is the patient response rate at Week 52, as defined by: (1) a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale (which indicates a clinically important reduction in SLE disease activity); (2) no worsening of disease as measured by the Physician's Global Assessment (worsening defined as an increase of 0.30 points or more from baseline); and (3) no new BILAG A organ domain score (which indicates a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which would indicate a moderate flare of disease activity). Analysis for the primary endpoint is based on intention-to-treat (ITT) and adjusted for baseline stratification factors, including SELENA SLEDAI score, proteinuria and race.
In each of the two Phase 3 trials, patients were randomized to one of three treatment groups: 10 mg/kg belimumab (BLISS-52, n=290), 1 mg/kg belimumab (BLISS-52, n=288), or placebo (BLISS-52, n=287). Patients are dosed intravenously on Days 0, 14 and 28, then every 28 days thereafter for the duration of the study. All receive standard of care therapy in addition to the study medication. Safety is reviewed by an independent Data Monitoring Committee throughout both studies.
About BENLYSTA (belimumab)
Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS(R). BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies - antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies suggest that belimumab can reduce autoantibody levels in SLE. BLISS 52 results suggest that belimumab can reduce SLE disease activity, and a second Phase 3 trial, BLISS-76, is underway to confirm these results.
About the Collaboration with GSK
In August 2006, HGS and GSK entered into a definitive co-development and co-commercialization agreement under which HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org , the Lupus Research Institute at www.lupusresearchinstitute.org , the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov , or Lupus Europe at www.elef.rheumanet.org .
Conference Call
HGS management will hold a conference call to discuss this announcement today at 8:15 AM Eastern. Investors may listen to the call by dialing 888-632-5010 or 913-312-0402, passcode 8364417, five to 10 minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 8364417. Today's conference call also will be webcast and can be accessed at www.hgsi.com . Investors interested in listening to the live webcast should log on before the conference call begins to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com .
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer.
The Company's primary focus is rapid progress toward the commercialization of its two lead drugs, Albuferon(R) (albinterferon alfa-2b) for hepatitis C and BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) for lupus. Albuferon has now completed Phase 3 development, and the submission of global marketing applications is expected in fall 2009. BENLYSTA successfully met its primary endpoint in the first of two Phase 3 trials in systemic lupus erythematosus; results of the second BENLYSTA Phase 3 trial are expected in November 2009. Also in late-stage development is raxibacumab (ABthrax(TM)) for the treatment of inhalation anthrax (Biologics License Application currently pending with the U.S. Food and Drug Administration). In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria(R) (albiglutide), currently in Phase 3 development in patients with type 2 diabetes.
For more information about HGS, please visit the Company's web site at www.hgsi.com . Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to
[email protected] or by calling HGS at (301) 610-5790, extension 3550. HGS, Human Genome Sciences, ABthrax, Albuferon, BENLYSTA, BLyS and LymphoStat-B are trademarks of Human Genome Sciences, Inc.
HGS Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, while the Company has completed delivery of ABthrax to the U.S. Strategic National Stockpile, the Company will continue to face risks related to FDA's approval of the Company's Biologics License Application for ABthrax. If the Company is unable to meet requirements associated with the ABthrax contract, future revenues from the sale of ABthrax to the U.S. Government will not occur. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the 'Business Review' in GSK's Annual Report on Form 20-F for 2008.
SOURCE Human Genome Sciences, Inc.
http://www.hgsi.com
Reminder - Human Genome Sciences to Host Conference Call to ...
ROCKVILLE, Maryland, July 20, 2009 /PRNewswire-FirstCall via COMTEX/ -- Human Genome Sciences, Inc. (HGSI, Trade ) will host a conference call today at 8:15 AM Eastern to discuss the results from BLISS-52, the first of two pivotal Phase 3 clinical trials of BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) in systemic lupus erythematosus (SLE).
Investors may listen to the call by dialing 888-632-5010 or 913-312-0402, passcode 8364417, five to 10 minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 8364417.
This conference call also will be webcast and may be accessed at www.hgsi.com . Investors interested in listening to the live webcast should log on before the conference call begins in order to download any software required. The archive of the conference call will remain available for several days.
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
HGS, Human Genome Sciences, BENLYSTA and LymphoStat-B are trademarks of Human Genome Sciences, Inc.
[webcast]
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, while the Company has completed delivery of ABthrax to the U.S. Strategic National Stockpile, the Company will continue to face risks related to FDA's approval of the Company's Biologics License Application for ABthrax. If the Company is unable to meet requirements associated with the ABthrax contract, future revenues from the sale of ABthrax to the U.S. Government will not occur. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
SOURCE Human Genome Sciences, Inc.
http://www.hgsi.com/
30-Day % Change
410.70%
At 18.63 continuation gap up, confirms enormous buy signal in July, confirms it is not go back to fill that tremendous gap up, because of big moves already.
moving on... 8)
HGSI If You Bought Shares of Human Genome Sciences, Inc....
BOSTON, Nov. 15, 2010 /PRNewswire via COMTEX/ -- The Securities and Exchange Commission and the United States Department of Justice have filed civil and criminal complaints alleging that the defendant in those cases (Yves M. Benhamou, M.D.) gave material non-public information regarding the failure of a major clinical trial of HGSI to hedge funds which then sold approximately six million shares of HGSI during December 2007 and January 2008, while in possession of that material non-public information. On January 23, 2008, HGSI publicly disclosed the information regarding the clinical trial failure. In response to that negative news, on January 23, 2008, the price of HGSI stock dropped $4.40 per share (44%), to $5.62 per share. By selling its shares before that public announcement, those hedge funds avoided losses of at least $30 million. It has been confirmed that the hedge funds which sold those shares of HGSI while in possession of material, non-public information are hedge funds managed by FrontPoint, which is owned by Morgan Stanley.
Under the federal securities laws, if you purchased shares of HGSI around the time that the FrontPoint funds were selling shares of HGSI (December 7, 2007 through January 22, 2008) you would have a claim against the FrontPoint funds. Your claim would likely be worth approximately $4.40 per share, for each share of HGSI that you purchased from December 7, 2007 through January 22, 2008.
As reflected on our website ( www.shulaw.com ), Shapiro Haber & Urmy LLP is a highly experienced law firm specializing in prosecuting actions under the federal securities laws. If you purchased shares of HGSI during the period December 7, 2007 through January 22, 2008, we would welcome the opportunity to discuss this matter with you. Please contact by email attorney Edward Haber (
[email protected]) or attorney Michelle Blauner (
[email protected]) or by telephone (617-439-3939).
SOURCE Shapiro Haber & Urmy LLP
8 Promising Biotech Buyout Targets if Their Products Can Deliver...
The following are a few biotechs with promising products in their pipelines that have made the big boys sit up and take notice. Without further ado, the 8 promising biotechs priced for a buyout if their products can deliver:
Human Genome Sciences (HGSI): Human Genome Sciences has many late-stage products in its pipeline to potentially add to its recently approved lupus drug, Benlysta. Benlysta has great potential; the Lupus Foundation of America estimates that 1.5 million Americans suffer from lupus, and close to 200,000 suffer from moderate to severe forms of the disease. Benlysta has been very effective in treating more severe cases of lupus, and a less potent form of the drug is in Phase III development to treat milder cases. HGSI prices Benlysta at $30,000 dollars a year, and its unique method of treatment could become part of the standard in lupus treatment. This all combines to make Benlysta a potential blockbuster. Human Genome has two other major drugs in Phase III development aimed at larger markets as well: Darapladib, which treats cardiovascular disease, and Syncria, which treats Type II Diabetes. Both face stiff competition, and so proving clinical efficacy will be crucial. HGSI's robust product line-up and $5.0 billion market cap make it a takeover target. Shares currently trade at $28.43
Technicals
Last Price Quote is:
0.19%above 13-day EMA
5.17%above 50-day EMA
RS Rating: 72