July 20, 2009
– Comments (26)
HGSI webcast (discussion) is currently ongoing.
HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE POSITIVE PHASE 3 STUDY RESULTS FOR BENLYSTA™
REMINDER - HUMAN GENOME SCIENCES TO HOST CONFERENCE CALL TO DISCUSS TOP-LINE PHASE 3 RESULTS FOR BENLYSTA™ (FORMERLY LYMPHOSTAT-B®) IN SYSTEMIC LUPUS ERYTHEMATOSUS
link to the webcast
HGSI is currently at ca. $11.43 in pre-market trading. Friday close was $3.32.
a guide to my blog posts can be found in the comment section to this post
(should be or should be close to the last comment)
*** WARNING ***
When I say "outperform" in my list of calls consider buying, but when I say "end outperform" maybe it is better to just ignore that. I usually end calls too early it appears ...
#145) On March 10, 2009 at 3:06 PM, portefeuille (99.98) wrote: HGSI - 0.50 - outperform
(52w low is $0.45.)
#595) On July 16, 2009 at 1:00 PM, portefeuille (99.98) wrote: HGSI - end outperform - 3.69 - no new rating
(now (July 20) $11.06 ...)
$0.50 -> $11.06 would be +2112%
HGSI in Frankfurt trading. See the ca. 200% price increase today? I drew an arrow to assist ...
> HGSI is currently at ca. $11.43 in pre-market trading. Friday close was $3.32.
unbelievable. Though this is the reason I don't invest in drug and biotechs. I don't understand them so I have no idea what chances a given company has. And you never know when this or that study will come out with what results.Too unpredictable.
conference call is over now.
currently at ca. $10.97.
I am not an expert either. I have read some stuff but never took any related classes (except for mathematics, physics, chemistry) as a student.
But this may be my best "caps" game sector.
The expert here is zzlangerhans.
Pitch by: zzlangerhans 10/13/08 3:00 PM
Human Genome stands at a 12 year low despite reasonable pipeline progress. The LymphoStat-B BLISS trials for lupus are probably the best thing the company has going right now, given the pulmonary side effects of albuferon. The negative data for HGS-ETR1 in myeloma is a bad sign, but they may have better luck in hepatocellular and NSCLC. And it's always possible the ACHIEVE trials of albuferon could have better results than expected. At this price a lot of pessimism is written in, so the upside is bigger than the downside. Hopefully they can get back into the 5 range if the market rebounds.
HGSI is currently at $10.00. May still be cheap (or again?) ...
> Human Genome stands at a 12 year low despite reasonable pipeline progress. The LymphoStat-B BLISS trials for lupus are probably the best thing the company has going right now, given the pulmonary side effects of albuferon. The negative data for HGS-ETR1 in myeloma is a bad sign, but they may have better luck in hepatocellular and NSCLC. And it's always possible the ACHIEVE trials of albuferon could have better results than expected. At this price a lot of pessimism is written in, so the upside is bigger than the downside. Hopefully they can get back into the 5 range if the market rebounds.
There is a problem right there. I udnerstand the verbs, but not nouns. lol.
Human Genome Drug Effective Against Lupus
Human Genome Sciences
Human Genome Sciences (HGSI) is racking up bullish analyst notes ahead of the open after the firm reported unexpectedly successful results from the late-stage trials of its lupus drug. Subjects who took Benlysta "achieved a clinically and statistically significant improvement in patient response rate" compared to those who took a placebo.On the heels of this news, Lazard upgraded HGSI from "sell" to "hold," while Citigroup upped the equity from "hold" to "buy." Ahead of the open, shares of the drug company are up 245% to trade above $11.Option activity ramped up on HGSI last Friday in anticipation of the Benlysta news. The day's speculation appeared to have a mildly bearish bias, with the stock trading 2.8 times its average daily put volume, compared to 2.47 times its average daily call activity.
Adam Feuerstein07/20/09 - 09:48 AM EDTUpdated with stock information
Human Genome Sciences(HGSI Quote) has beaten lupus.The Rockville, Md.-based drugmaker announced Monday that its experimental drug Benlysta achieved a clinically and statistically significant improvement in disease response compared with placebo, according to results from a pivotal phase III study of lupus patients.If confirmed in a second phase III study due later this year, Benlysta likely will become the first new drug approved to treat lupus specifically in 50 years. Human Genome is partnered with GlaxoSmithKline(GSK Quote) for Benlysta's development and marketing.The success of the Benlysta study is a signal achievement for Human Genome Sciences, placing the company on the path toward its first blockbuster product.Human Genome shares were up 218.4% to $10.57 in Monday morning trading.Study Results Should Surprise ManyThe Benlysta win is also a bit of a surprise given the intractable nature of lupus -- a complex and hard-to-treat autoimmune disease with a notorious reputation as a drug development graveyard. For this reason and others, nearly all of the analysts covering Human Genome predicted Benlysta would fail.They were wrong.Human Genome reported that 57.6% of lupus patients responded to treatment with a high dose of Benlysta compared with 43.6% of lupus patients treated with a placebo. A lower dose of Benlysta also was tested, and it too demonstrated an improvement in disease response over placebo. The results were statistically significant.The phase III study, known as BLISS-52, enrolled 852 patients with active lupus and treated them with Benlysta or a placebo for one year, making this the largest clinical trial ever conducted in lupus patients.
Odds, Analysts Against Human Genome's Lupus Drug
Adam Feuerstein07/15/09 - 10:37 AM EDT
Perhaps the biotech understatement of the year: Analysts are hating Human Genome Sciences(HGSI Quote) ahead of the company's release of results from a key lupus drug study next week.The sell-side community tends to be an optimistic lot, which is why the near-universal negativity directed at Human Genome's drug Benlysta (formerly lymphostat-B) by almost every analyst covering the company cuts against the grain.Human Genome will be releasing results from the Benlysta phase III study in lupus patients before the opening bell on Monday, July 20.A chorus of analysts says the study is going to fail."We continue to believe the probability that Lymphostat-B succeeds is extremely low, wrote an analyst at Lazard Capital Markets on Tuesday, tacking a sell rating and a $1 price target to the stock.On Monday, UBS downgraded Human Genome to neutral from buy. "We believe significant downside risk exists with the read-out of the BLISS-52 data later this month," wrote UBS. BLISS-52 is the name of the Benlysta study.Barclays Capital, from a July 6 report: "Benlysta likely to fail BLISS studies."Piper Jaffray's analyst chimed in on Monday, calling the Benlysta study "hard to call but find risk reward unfavorable."Also expressing skepticism and caution on Human Genome in recent weeks were analysts from Citibank, Sanford Bernstein and JMP Securities.The only positive view of Benlysta appears to be emanating from the analyst at Leerink Swann, who gives the drug a 60% chance for success. That's enough to rate the stock outperform. SummerStreet Research Partners, which rates Human Genome neutral, calls the odds of success for Benlysta "50/50 at best" in a report issued Wednesday.One big reason for all the skepticism is that lupus is a tough-to-treat disease and a graveyard for drug development. There hasn't been a new drug approved for the disease in 30 years, but there have been many failed attempts. Most recently, a drug from La Jolla Pharmaceuticals(LJPC Quote) and BioMarin Pharmaceuticals(BMRN Quote) failed in a phase III study of lupus patients. Rituxan, an otherwise wildly successful cancer and autoimmune drug for Roche and Biogen Idec(BIIB Quote), also came up short in a phase III lupus study last year.Lupus is a chronic disease in which the body's immune system attacks connective tissue, resulting in inflammation and tissue damage, often to the heart, joints, lungs and kidneys. Women are more often diagnosed with lupus than men, and the disease goes through periods where it flares up then goes into remission.Benlysta is a human monoclonal antibody designed to recognize and tamp down the biological activity of B-lymphocyte stimulator, or BLyS, a substance that was discovered by Human Genome.The company believes that in lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS contribute to the production of autoantibodies -- antibodies that attack and destroy the body's own healthy tissues.A phase II study of Benlysta in lupus patients produced mixed results. The primary endpoint of the phase II study was not met; however, a certain subset of lupus patients did benefit significantly from treatment with the drug.Human Genome, in consultation with the FDA, designed the phase III studies based on the positive subset data gleaned from the phase II study in hopes of increasing the odds of success.The Benlysta study results will be announced on July 20. A win for Human Genome could push the stock price to $10. A failure could cut the value of shares today -- $2.50 -- in half.
zzlangerhans and feuerstein are two of my favourite biotech information sources!
Just the right balance of information and entertainment.
Some of the best feuerstein stuff is in the "mailbag" articles.
Biotech Stock Mailbag: Geron Fans Gone Wild
Adam Feuerstein03/13/09 - 07:59 AM EDT
Welcome back to the Biotech Mailbag: The Hate Email edition.I'm feeling a bit punchy lately -- too much work, too much winter weather. Where's spring? I need a good laugh and maybe you do, too, so I decided to devote a large portion of this week's Mailbag to reproducing my hate email because, generally, it makes for fun reading.I know some of you read this column for actual biotech investing advice, so I'll start with the smart reader email first. All the hate email is tacked to the bottom of the Mailbag unedited except for "Bleeping" out the extra naughty bits. Enjoy.From Peter R., a question about Amgen(AMGN Quote):"What's your feel on Amgen? Speculation was it was a potential target of Pfizer(PFE Quote) before the Wyeth(WYE Quote) acquisition. Amgen seems quiet these days. Do you think they'll make their own large purchase this year or will they sit back and rely on their pipeline?"Amgen sold off to around $46 recently, in large part due to investors concerns about how the company, and the biotech group generally, will fare under President Obama's health care reform plans. When Amgen sank to $46 last week, I thought it was oversold, so I added the stock to the model portfolio of my Biotech Select subscription newsletter.On a price-to-earnings basis, Amgen trades below the biotech peer group. Later this year, probably in the third quarter, the company will be releasing phase III data from cancer studies of its bone-building drug denosumab. [Denosumab should also receive FDA approval in osteoporosis in the fall.] Lastly, with Roche sealing the takeover of Genentech(DNA Quote), the minority shareholders of Genentech will have about $40-50 billion in capital freed up to reinvest somewhere. My hope and bet is that a good amount of that money flows into Amgen.I don't have a prediction about Amgen's deal-making plans.Craig P. writes, "I have a question about pharmaceutical phase I and phase II studies. I see a lot of companies completely blow up (see Keryx(KERX Quote), Pharmos etc.) when their phase III studies completely failed and showed no evidence of efficacy versus placebo. Okay, so how do these studies show promising results and very good efficacy in phase I and phase II trials?Is this a case of the management teams of these companies scamming the investment and scientific community by handpicking patients that only show a response? Basically, my point is this: How is it possible that these drugs fail in phase III when they are so effective in phase II studies?"Craig asks a great question, because there isn't a biotech investor out there -- pro or amateur -- who hasn't been flummoxed when a phase III study they thought was guaranteed to succeed comes up negative instead. Sometimes, all the homework and due diligence in the world can't protect against a drug blowing up unexpectedly.With a few noteworthy exceptions, management teams don't purposefully set out to manipulate early clinical data in order to bamboozle investors. What happens more often is that phase I and phase II studies are poorly designed so that the data collected don't translate into success when pivotal phase III studies are run.The classic example of this phenomenon occurs often in cancer studies, when a company will conduct an uncontrolled or non-randomized study that purports to show some tumor response or a survival benefit. Unfortunately the study doesn't have a control arm, so there is nothing to compare the drug's effect against. More often than not, the benefit seen in the phase II study doesn't translate when a randomized, controlled phase III study is conducted.This is why data from randomized phase II studies is better, at the very least it cuts down (but doesn't eliminate) the risk of a phase III failure. [Genentech does this better than any company.]When randomized phase II data isn't available, I look for phase II data that comes from large numbers of patients in studies that are well designed with patient populations and clinical endpoints that match well with whatever may be used in phase III studies. Different endpoints or mismatched patient populations between phase II and phase III studies are often a big red neon sign, screaming "watch out!"John R. is back again with a question about Xoma(XOMA Quote):"The more I read on XOMA's 052 the more I feel like this has blockbuster written all over it. Monthly or better Diabetes care -- that's almost a cure!! Why am I the only one buying? This has to make them a prime takeover target. What do you say about them? Am I missing something?"The XOMA drug John refers to is XOMA 052 which Xoma is developing in diabetes. I wrote about XOMA 052 in a Sept. 12, 2008 Mailbag, (actually, in response to a question from him), so click here to read that.The Xoma stock chart since September looks downright ugly. A big part of that, of course, is the market meltdown. More recently, Xoma has also been under pressure because of concerns about a slowdown in royalty revenue stemming from Europe's decision to pull Genentech's psoriasis drug Raptiva off the market due to safety issues. [Xoma receives royalties on Raptiva sales, among other antibody drugs.]To get more to John's question about XOMA 052, I still think the drug shows great promise, but again, the data we have are early and preliminary. This week, Xoma said it will finish the ongoing phase I study of XOMA 052 by mid-year and start a phase II study in type 2 diabetics in the third quarter. The company also said it will seek out a partner for XOMA 052.The more positive data (hopefully) Xoma can collect, the stronger deal it can strike with a potential partner. But also understand that the psychology of this market does not lend itself to speculative investing. At this early stage, Xoma is not going to get a lot of credit for XOMA 052, even if such credit is deserved. Look at ImmunoGen(IMGN Quote), one of my favorite small-cap biotech stocks. It has a drug in phase III trials with Genentech, and it's hard to get investors interested.David M. asks, "Regarding Elan(ELN Quote), any idea when we might hear some updates/news regarding its Alzheimer's drug bapineuzumab, currently in development? I know you were not a big fan of the phase II results last summer. Any thoughts would be appreciated."Elan has submitted the bapineuzumab data from the phase II study for publication in what the company calls a major or top-tier medical journal. I'd expect to see that publication this spring or during the summer.When I met with Elan in January, CEO Kelly Martin said the company planned to schedule a meeting with the FDA to nail down the regulatory endpoints for the phase III studies. I haven't checked back with Elan to see if that FDA meeting took place yet, and if so, what the outcome was.The most important news on bapineuzumab won't come until 2010 when results are released from the phase III studies.Alright, now for the fun: a selection of recent hate emails, many of which were sent by aggrieved shareholders of Geron(GERN Quote).You'll probably have two questions after reading below, so the answers, quickly: 1) yes, this is what a good portion of my inbox looks like on a weekly basis; and 2) no, it doesn't bother me. In my line of work, you grow a very thick skin.Jack T. writes, "if craemer is your guru I understand still having some belief in this pile of crap..hundreds of millions of $$ to develop berivimat..then sell it for 7 million now that investing,,,you are now a qulaified as a BLEEP idiot..imop...or the BLEEP wipes that take your advice are,,,take your pick,,,or maybe you're just an unwitting complicit fool,,now there's a real possibility,,,or just a run of the mill part of the criminal conspiracy with the mgt ?.....fraud will come up sooner or later,,,and they'll find out...here's hoping..welll you know,,,"From Lawrence S.: "Mr. FartStain It's been awhile, I thought you were charging for your great advise? Hey Dendreon is due out by April 1st, don't forget to bash that before the results. Now you are picking on the Pinkies! I see ACTC is one on your list. Were where you when I was buying that up at .03? Sitting on a half a MILLION of free shares now. I see you are just a useless piece of BLEEP. Some things I guess will never change. Hey I also hold physical Gold & Silver along with Guns & ammo, you may want to slam that too. And lets not forget the stockpile of food I have put together."Robert M. chimes in: "Yes it's me shorty.There is a special place in Hell for you. I would read Dante's Inferno tonight before you go to bed, if you live that long. You are truly a Cretan Mr. Mensa. I am ashamed to share the same gene pool with you. "John P. writes, "WHY DONT YOU GO OVERDOSE ON SOMETHING?"Apparently, John P. felt the need to make a stronger point, so the next day sent this:"hey you bald headed BLEEP. i just turned your wothless BLEEP over the sec. tell me how much money to get from big pharm to trash little companies with competitive drugs? all of your financial records are going to be exposed."Lastly, an email from Rick B. "Are You implying that if you invest in something you believe in ,that You are Greedy ? Are You BLEEP Nuts ! or just half retarded, notice i gave you only half, when you are probably fully retarded ! go crawl back under the rock you came under from Idiot ! !!! My mother dided because she could not get another kidney that wouldn't reject .BLEEP hole !"
maybe the HGSI news lets me finally break the resistance at 12500, hehe ...
this bravobevo guy, ts ts ts ...
just a chart
NDX is the NASDAQ 100 cash index (related to QQQQ).
-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments-
What happened to some of the best "outperform" calls from my list (some of those calls have been ended (see comment #5 above!)).
ticker start now rel. change (%)
HGSI 0.50 10.67 2034.00VVTV 0.27 2.51 829.63SEH 1.49 11.00 638.26BGP 0.55 3.98 623.64CENX 1.11 6.54 489.19DNDN 4.08 23.32 471.57IFNNY.PK 0.79 4.00 406.33 BCS 4.13 20.77 402.91LVS 1.99 9.93 398.99GMK 0.93 4.61 395.70FITB 1.46 7.06 383.56NVAX 0.65 3.01 363.08STEC 7.60 32.87 332.50MIC 0.94 3.66 289.36ACAS 0.75 2.86 281.33BLC 0.55 2.08 278.18CSE 1.25 4.39 251.20FEED 1.68 5.84 247.62CRAY 2.37 8.23 247.26ING 3.42 11.47 235.38EXAS 0.86 2.79 224.42UIS 0.50 1.62 224.00BAC 4.02 12.26 204.98PMI 0.66 2.01 204.55
How Will Human Genome Evolve From Here?
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