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orexigen competition that is
ARNA will be the first to market and last i looked theirs plenty of customers for the product....ARNA has another 50-60% upside......strong buy.......rareF
orexigen is no compensation at this point whatsoever period.
and vvus at the stage theyre at, is at a disadvantage in several ways
no manufacturing set up....the risks with the drug are numerous combined with detox requirements after 90 days
I could go on
VVU# had a breakaway gap and so will ARNA imo
I am very new to active trading and this board but thankfully have made a good profit on ARNA thanks mostly to the board. In pre-trading why are the lots so small. I would have thought institutional and high net worth investors would be trading large blocks.
31 Estimated Trading days left, If FDA doesn't approve earlier.
Arena and Orexigen Compete to Bring First Weight Loss Drug to Market in Nearly 13 Years
Biotech companies are looking to cash in on the anti-obesity drug market. The race to bring the first weight-loss pill to the market is heating up as Arena Pharmaceuticals weight-loss pill (Lorcaserin) recently gained the backing of an FDA advisory panel. The Paragon Report examines investing opportunities in the Biotech Industry and provides equity research on Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Orexigen Therapeutics, Inc. (NASDAQ: OREX).
Access to the full company reports can be found at:
www.ParagonReport.com/ARNA
www.ParagonReport.com/OREX
Arena is currently competing with Vivus and Orexigen Therapeutics to bring the first anti-obesity drug to the market in nearly 13 years. All three of the companies' drugs were previously turned down by the FDA. FDA advisers last week voted 18-4 that the benefits of Arena's Lorcaserin outweigh the health risks.
According to recent numbers from the Center for Disease Control and Prevention over 78 million adults in the U.S. are obese. Obesity significantly raises the risks for health problems such as diabetes, heart attacks, and strokes. It is estimated that obesity costs the U.S. economy $147 billion a year in medicals costs and lost productivity.
Paragon Report releases regular market updates on the Biotech Industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.ParagonReport.com and get exclusive access to our numerous stock reports and industry newsletters.
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. The FDA is scheduled to decide on Arena Pharmaceuticals' anti-obesity drug, Lorcaserin by June 27.
Orexigen Therapeutics, a biopharmaceutical company focused on the treatment of obesity, recently announced financial results for the first quarter of 2012. For the three months ended March 31, 2012, Orexigen reported a net loss of $10.4 million compared to a net loss of $11.6 million for the first quarter of 2011. Orexigen's anti-obesity drug, Contrave, was rejected by the FDA at the start of 2011. The company reported in February that they have received a Special Protocol Assessment (SPA) from the FDA.
Paragon Report provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Paragon Report has not been compensated by any of the above-mentioned companies. We act as independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at:
Arena Pharmaceuticals: FDA Approval Is Just The Beginning
http://seekingalpha.com/article/584821-arena-pharmaceuticals-fda-approval-is-just-the-beginning?source=yahoo
I think it will be interesting :) especially for those of us that held through ADCOM :)))
Lets hope with all the publicity, the engines are revved up ready !!!
Morning guys - nice pre market
we got us another gapper this morning......6.72
Call the Transfer Agent and make sure the company is not diluting on you.
The otcmarkets shows the following:
Shares Outstanding 182,500,778 May 01, 2012
Also, the transfer agent is:
Computershare Trust Company Inc.
Transfer Agent
3200 Cherry Creek Drive South
Denver, CO, 80209
303-262-0600
I'll save you a seat on the bus HDS. Know YOU want some.
ARNA going higher!
ARNA candlestick looks bad IMHO.
To many alerts.......
We have alerts that say it is gonna go up up up !
We have people alerting that it is gonna go down down down !
You name it we have alerted it.....
Come on Monday......
LOL........
My wife says nope
do you have ED ??
Just keep an eye for an 8k the day off or the morning of approval.
ARNA Yes, It's great Arena is getting recognized, Bull!
My "hunch" is an upward move Monday. Friday was for profit takers (I took 25% off @ 7.05 avg from 3.38, having chump traded the 2's, lol)). Monday should see the entry of weekend armchair retail readers who'll want to get in.
On one hand I'm sorry to see the continuing prevalence of mis-information regarding cancer and heart (non) issues. It seems the media is lazy and to a large extent copy what the other reported. Well, that's giving us a little more time to see what bills we might put off in order to get "just a thousand more", lol.
Certainly enjoy your informative and candid posts, Bull, as well as those of everyone here.
I'm totally pleased and thank God.
MG
Is there ever gonna be an end to all this NEWS !!!! LOL
Gotta Love it !
I have walked everywhere with nothing but a smile on.......hahahaha
Stocks to watch Monday:
BY MarketWatch— 7:01 AM ET 05/12/2012
CHICAGO (MarketWatch) -- J.P. Morgan Chase & Co., Arena Pharmaceuticals Inc. (ARNA) and InterOil Corp. (IOC) are among the stocks that could see active trading on Monday.
J.P. Morgan Chase shares could remain under pressure after Fitch Ratings downgraded the bank's credit ratings. The stock slumped 9.3% Friday after it disclosed it took an unusual $2 billion trading loss.
Drug stocks Arena Pharmaceuticals Inc. (ARNA) and Orexigen Therapeutics Inc. (OREX) could be on the move again. Arena zoomed 74% higher after the U.S. Food and Drug Administration recommended approval of its diet pill Lorcaserin. Orexigen picked up 19% a day after the diet-drug developer said it is on track to begin a clinical trial for its Contrave offering and that it has finished Phase 2 clinical trials designed to assess another weight-loss drug, Emphatic.
InterOil Corp. (IOC)is expected to report a first-quarter profit of 5 cents a share on revenue of $310.8 million, according to a poll taken by FactSet Research.
really???
bottom end not ambitious at all
top end??? maybe a tad or not at all
when you add in all of Europe .. South America and Canada
it doesnt take an incredible amount of neural matter to see where this is headed...
meanwhile, small traders, can ride this like a gnat on a elephants azz.
Lorcaserin published in NEJM:worlds' most prestigious clinical journal
By far the most prestigious clinical publication in the world is NEJM (impact factor 53.5) vs the distant second Lancet (impact factor 33.6). One has to ask why the authors behind Qnexa would choose Lancet to publish over NEJM as Arena did.
The only logical conclusion is that Qnexa (CONQUER trial) would have been rejected by NEJM. Arena was always confident that lorcaserin was the best, which is why they chose the best journal to publish their landmark study.
The FDA is no fool. They are laughing at Kaul for harping on lorcaserin and blindly trying to pin the valvulopathy tail. Qnexa never conducted any signicant echocardiogram studies to evaluate what happens to their patient's heart valves after taking it for 1 year. Instead Arena has performed 80,000 echos. These echos showed a statistically non significant trend slight increase in valve stress across all 4 valves of the heart (4 chambers remember?) vs placebo. Is is entirely due to the change in body habitus of the patients who lost the most weight. Just ask any cardiologist, are echos clearer in obese or thin patients. Compare a dot matrix printer to a laser jet, or regular to HDTV.
In patients who took fen/phen the valve damage occurred in the aortic valve because this is the valve experiencing the most stress in the heart due to high flow and high pressure dynamics. Physiologically, it does not make sense for all the heart valve to become more stressed or damaged over time. This would occur congenitally before birth during the embryonic stage in utero. Therefore, to postulate that lorcaserin can produce this change after just 1 to 2 years goes against all known mechanisms of embryology, physiology, and pathology.
If ever VVUS is forced to undergo similar echo trials, the same findings will result regarding slight increase in all heart valve stress/valvulopathy. It is even reasonable that more will be found since more weight loss produces a higher definition of the heart valve images on echo.
You see, the FDA already knows which is the safer drug. The valvulopathy was never what held lorcaserin back. It was the tumor issue. Now that it was put to rest via the briefing docs, we can look forward to full early approval without the need for REMS.
The only thing I can see FDA requiring ARNA to do after the approval is to conduct a post Market surveillance which they should do for all drugs anyways. By the way Eisai will pick up 90% of the tab.
Lastly, the ad comm was notable for a couple of clowns. First is Caprisi who came totally unprepared because he was going to vote no anyways. A few panelist didn't know the difference between an echocardiogram vs electrocardiogram. It's like saying you cant tell the difference between an iPad vs a toddlers leapfrog. What a joke! Thankfully there were quite a few intelligent people invited by the FDA (who actually read the BD) and delivered an impartial scientific judgement.
Get ready for lorcaserin. It is coming to a local pharmacy and will not need a triplicate DEA Rx. There is absolutely no addictive properties to this molecule. It can treat addiction. We all need lorcaserin.
--> copied from cardiodr99 yahoo message board
That's why doctors will prescrive Lorcaserin the most and that's why ARNA will be approved by the FDA (June) and later this year in Europe.
You're absolutely right about the importance of the journal where you are allowed to publish. I think this should (and will) be read by institutional investors.
My target for Lorc: at least $20 and after the EMEA has approved it as well: $35
"selling stock at current prices should be seen as a positive, you would hope that a biotech stock you own would sell new stock at the high range of its chart"
Did you just say that you also expect arna to go down over the next few weeks (so what you just said about selling at high range of its chart makes sense)?
ARNA is not a penny stock, the company will file when it sells stock into the market. I do not remember if ARNA has a shelf offering in place, but selling stock at current prices should be seen as a positive, you would hope that a biotech stock you own would sell new stock at the high range of its chart price.
Interesting. Has anybody called the Transfer Agent on Friday at closing to ask what the O/S is? Just to make sure the company is not diluting on the FDA panel approval. The otcmarkets shows the following:
Shares Outstanding 182,500,778 May 01, 2012
Also, the transfer agent is:
Computershare Trust Company Inc.
Transfer Agent
3200 Cherry Creek Drive South
Denver, CO, 80209
303-262-0600
It would be interesting to call them and see what O/S is on Monday. Who knows????
Interesting. Has anybody called the Transfer Agent on Friday at closing to ask what the O/S is? Just to make sure the company is not diluting on the FDA panel approval. The otcmarkets shows the following:
Shares Outstanding 182,500,778 May 01, 2012
Also, the transfer agent is:
Computershare Trust Company Inc.
Transfer Agent
3200 Cherry Creek Drive South
Denver, CO, 80209
303-262-0600
It would be interesting to call them and see what O/S is on Monday. Who knows????
Actually, the full $60M isn't in the bag - from the latest SEC filing:
we will also receive a milestone payment from Eisai of $40.0 million or $60.0 million, depending on the approved drug label.
As far as possible dilution, I'd hate to see it happen, but they may pounce to raise cash for general corporate uses after approval, it's quite common, but should be limited given the much higher pps they will have. And for those who have owned ARNA for at least a month, you should have gotten a proxy vote letter or email for the 2012 Annual Meeting of Shareholders on Friday, June 15, 2012 - below is one of the proposals to increase the number of authorized shares - nobody I know of voted YES, for course! (can't post the link as it's my voting link)
For holders as of: 04/17/2012
5. TO APPROVE AN AMENDMENT TO THE COMPANY'S FIFTH AMENDED AND RESTATED CERTIFICATE OF INCORPORATION, AS AMENDED, TO INCREASE THE TOTAL NUMBER OF AUTHORIZED SHARES FROM 250.0 MILLION TO 375.0 MILLION AND THE NUMBER OF AUTHORIZED SHARES OF COMMON STOCK FROM 242.5 MILLION TO 367.5 MILLION.
So they already can dilute from the current 180M shrs to 250M if they want to, nothing we can do about it but hope they don't!
31 Trading days left before the explosion............hahahahahahaha
As i had said prior to Adcom " ARNA will make alot of peeps very Wealthy" It sure has my account up 3 Fold.
I'm really more excited about the drug sales even if it's only a small % of the overweight population, it's still a lot of money per month.
Nonsense. Authorized and issued are not the same. Please stop the FUD. You obviously know nothing about this company. A number of us have worked very hard to acquire a high level of understanding of this company, its drug pipeline, its management and its financial position. And it is really sickening to read the absolute errant nonsense that traders - many of whom have the attention span of flea IMHO - post on these boards.
Arena gets $60 mil from Eisai as soon as lorc is approved.
ARNA is not DSCO or BPAX.
The problem with letting people know about the AS increase, it will bring a hip load of naked shorters to sell ghostshares and cover with the shares when arna dump on the market. SEC can make a regular short cover, but naked shorters can very stubborn when it comes to cover. This will be a flip stock.
I remember DSCO, what a disappointment.....
Thanks good explanation. You are correct the mile stone payment will happen when Lorc is delivered......
Bull: If lorcaserin is approved they won't need to do a secondary ($60 million from Eisai and then product sales will keep them nicely in the green). If lorc is not approved, well, I think we are toast (Arena might be able to sell the rights to lorc or agree to a cheap buy-out).
An increase in the AS does not always mean that a company has a secondary in mind. They did a SEDA agreement not long ago to cover them if they need cash (but I don't think they will use that SEDA if lorc is approved). They may need more shares available for a variety of reasons; they need to be able to issue them if warrants are exercised, in order to offer incentive pay; and it is always wise to have an excess of authorized over issued just in case.
I just flat out don't believe that Arena will do a secondary. If lorc is approved they will have plenty of cash. I am certain that shareholders will ask them questions about the requested increase in the AS, and I would listen very carefully to the answer.
clawmann, are you sure ? I did see in the notes for investors meeting coming up soon. that apparently they will be voting on increasing the Authorized shares, which would allow them to sell more on the open market or give them out for bonuses or salaries until ARNA becomes profitable.
Do you know how much cash ARNA has ?
and their debt ?
I just hope they don't even think about this year that would stifle the rise of foam on this jug of beer.......LOL
My calculation was leading to a big gap filler high 4s, but after seeing ARNA all over every news channel and print media, this mofo may crate a new gap above $9.00 soon. The buying pressure coming from all the free awareness by the media is wow!
Thanks so much! I just looked at FDA website and it said the ADCOMM meeting notes would be posted online. I'll read them when they come out so I don't have to keep asking you all for more information. Thanks for listening in and giving us updates.
FDA spoke in defense on many issues for Lorcaserine. i.e.. safety, efficacy, tumors etc....just about everything.
The approval process is already in motion, first came a meeting that held the FDA, and Dr's from ARNA, and DR's on a separate panel that held different degrees. The FDA and ARNA since their last meeting discussed issues front he CRL from 2010. ARNA , THE FDA has laid all their cards on the table. Now the decision is up to the FDA. They will go over what was just done Thurs. and see if they are going to decide to approve or disapprove the drug Lorcaserine and if any REMS or not, labeling etc......
This can come 6-27 which is the current date set, or it can come earlier, or it may be delayed if the FDA needs more info or time ?
We all are hoping for one of the first two choices.....glty
Hi Clawmann, question regarding scheduling and to what Jack wants to submit to the F.D.A..If you don't mind, can you elaborate on the scheduling as to what you said and this person mentions.
Thanks
You mentioned this in your post:
<Right now the FDA has lorcaserin on Schedule IV, and - if that does not change - ARNA will have to go through a DEA licensing process that could take 4-6 months>
_________________________________________________________________
The other post says:
Additionally, the FDA stated in the CRL that it would recommend placement of lorcaserin in Schedule IV of the Controlled Substance Act based on its review of the materials submitted in the NDA. The CRL provided the opportunity to complete preclinical studies that may lead to a different recommendation
what Jack said is that the FDA had recommended placement of lorc in Schedule IV which would require a DEA review of 4 to 6 months. But then he stated very clearly that Arena is in discussions with the FDA to have this changed.Arena submitted additional abuse liability study data and other data to the FDA as part of their CRL response. This was not an issue for the panel to address. This is an issue that as Jack again stated will be discussed with the FDA.
I read earlier from those who listened to ADCOMM that the FDA representatives at the meeting spoke up in defense of ARNA repeatedly. Will you please elaborate?
Also, I don't really understand the approval process and am curious re: how many of the deciding FDA members are present at the ADCOMM of a drug.
It is also my understanding that the FDA can approve or reject ARNA before 6/27, that 6/27 is merely a deadline...not a guaranteed date of response. Is that correct?
Again, thanks to all of you who have been doing so much due diligence and who have been so generous in sharing their knowledge. I believe strongly that "what comes around go around" and you all deserve abundant blessings for your many kindnesses.
I think, with the new agreement just signed, the number is now $60 mil.
If you notice in that video, the projected OS is 160 million shares now and for the next 5 years. Does not indicate a secondary. There will be no secondary. If lorcaserin is approved,the company will never have to do a secondary. If it is not approved, the company tanks. Pretty simple.
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ARENA PHARMACEUTICALS, Inc. (ARNA)
http://www.arenapharm.com/
http://finance.yahoo.com/q/h?s=ARNA
http://www.secform4.com/insider-trading/1080709.htm
Arena Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, focuses on the discovery, development, and commercialization of oral drugs for cardiovascular, central nervous system, inflammatory, and metabolic diseases. It is developing a pipeline of compounds targeting orphan G protein-coupled receptors using its drug discovery technologies, including constitutively activated receptor technology and Melanophore technology. The company?s drug candidate, lorcaserin hydrochloride, is in Phase 3 clinical trial program for the treatment of obesity. Its other lead development programs include APD125, a 5-HT2a serotonin receptor inverse agonist, which is in Phase 2 clinical trail for the treatment of insomnia; APD791, an anti-thrombotic drug candidate, which is in preclinical development stage for the treatment of arterial thromboembolic diseases, such as acute coronary syndrome. The company has collaboration agreements with Ortho-McNeil Pharmaceutical, Inc. for developing APD668, an orally administered drug candidate, which is under clinical development for the treatment of type 2 diabetes and other disorders; and with Merck & Co., Inc. for the development of MK-0354 for atherosclerosis and related disorders. Arena Pharmaceuticals was incorporated in 1997 and is based in San Diego, California.
http://finviz.com/quote.ashx?t=arna
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