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I took my eye off the ball due to work, checked back this morning to see a 75% loss!
Averaged down today at .92
Whats your guestimate at fair value without the approval?
Glad I did not have a lot tied up here, very harsh reaction to negative news, possibly over reaction?
Good luck
gerard
excellent timing.
upon further reading, i see you could have a loss had you not sold all.
i hope you did sell all last week
have a feeling you did
PT Barnum ran a circus, too. But he didn't let the clowns run the show.
He surely didn't let the clowns tame the lions.
On second thought, that would have been a more interesting circus.
I'll be playing a bounce, but not sure from what level. The shorts will take some off the table, but longer term VNDA is toast for now.
surf's up......crikey
Still HUGE premarket, 3.5 million with 45 minutes to go.
have seen several 50k at 1.50
a 100k at 1.50
a 200k at 1.49
an 83k at 1.48
they just keep flying by......
not that many shares out in this one, this is heavy volume for its size.....
some HUGE orders going through right now, a little over an hour before the open.....2.5 million shares....1.45 low so far that i have seen.
Vanda schizophrenia drug rejected by FDA
Monday July 28, 7:47 am ET
FDA rejects Vanda Pharmaceuticals' experimental schizophrenia drug, shares fall 50 percent
http://biz.yahoo.com/ap/080728/vanda_pharmaceuticals_fda.html?.v=1
ROCKVILLE, Md. (AP) -- Vanda Pharmaceuticals Inc. said Monday the Food and Drug Administration rejected the biotechnology company's experimental schizophrenia drug iloperidone, saying it was similar to drugs already on the market.
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Shares of Vanda lost about half their value in premarket trading on the news.
The agency wants the company to conduct additional studies on the drug, including a comparison with currently marketed treatments, such as Johnson & Johnson's Risperdal or Eli Lilly & Co.'s Zyprexa. In prior studies, the drug was more effective than placebo, but only similarly effective when compared with Pfizer Inc.'s ziprasidone.
Also, additional safety data would be needed to consider another application.
"We are disappointed by this response, but will meet with the FDA to discuss this decision further," said Vanda President and Chief Executive Dr. Mihael H. Polymeropoulos in a statement.
Vanda said all iloperidone-related activities are on hold pending further review.
Shares of Vanda dropped to $1.67 in premarket trading from a $3.36 close Friday.
At least we know why that reporter got this particular story. :^)
FDA likely to rule soon on Vanda Pharmaceuticals drug approval
Washington Business Journal - by Vandana Sinha Staff Reporter
Friday, July 25, 2008
Biotech
FDA likely to rule soon on Vanda Pharmaceuticals drug approval
Washington Business Journal - by Vandana Sinha Staff Reporter
Joanne S. Lawton
Vanda CEO Mihael Polymeropoulos hopes to find out within days if the Food and Drug Administration will allow the company to put its first drug, a schizophrenia treatment, on the market.
View Larger
Vanda Pharmaceuticals Inc. has reached a destination that few biotechs, particularly those in this area, ever see: the front door of the Food and Drug Administration’s decision-makers, who will determine whether its drug is ready for the market.
The question remains whether the Rockville biotech will make it past that make-or-break point as it seeks its first drug approval — the industry’s most elusive goal. If the FDA rejects the drug, Vanda will be hampered in its effort to raise money and push the rest of its drug pipeline forward.
An FDA decision on Vanda’s key drug, a schizophrenia treatment called Fanapta, is expected July 27, though word could come as early as July 25. A favorable decision would add Vanda to the region’s small class of biotechs with market-worthy drugs — a likely outcome, analysts said.
“I think they have a high chance of getting approved,” said Maggie Liu, equity analyst with Argus Research Co., which doesn’t own Vanda shares. “The drug has shown great promise.”
http://sanantonio.bizjournals.com/washington/stories/2008/07/28/story2.html
surf's up......crikey
I'm going to take some VNDA off the table at some point today on the strength in the stock.
surf's up......crikey
Surf - I know it's a tough number to try and estimate, but any thoughts on how high short covering could push the price by Friday?
The shorts have less to gain here, the pressure should be up through the close Friday(hopefully)
Surf, what you say makes sense.I too believe some shorts are covering today. The big question I have is, how can we be sure that none of this buying is coming from some knowledgable folks, who either know, or have strong feelings that this thing will be approved pretty soon? It seems possible to me, to believe that news, good or bad, sometimes has a way of leaking out. Florida
None what so ever, the shorts are measuring the risk and have bought some stock back. You really will not know until the FDA releases its findings. Again, my main play is the up move prior to the news release. I just hope no news comes out before this weekend.
surf's up......crikey
surf -
in your experience is a positive run up like we are seeing any indication at all of the FDA decision?
We seem to be moving pretty good. Your thougts?
starting to gain some attention, over 25% of daily volume in the 1st 45 minutes, daily high 3.78 -
the yahoo board for VNDA is crazy busy....
Guys there's not much reason to spec about what VNDA's PPS may do until the FDA verdict is out. All you need to know is that within a few trading days VNDA will be at $1.50 or $8 and measure your risk from that. It looks like it may flat line until the news, but I hope it doesn't.
surf
surf's up......crikey
Another one:
Ilo- QT impact- my research shows no impact 2-Jul-08 05:37 pm
So - I did lots of reading today at FDA website.
Per their QT Guideline doc - Ilo should not have any problems with QT prolongation.-
Per Guideline doc- QT < 20msec are inconclusive , but some of these compounds have been associated with proarrhythmic risk. Also, looking at a few other drugs with QT prolongation on FDA site- even for instances of QT>500msec.... if the occurrence of >500msec is less than 1% - Drugs still approved with QT labelling. Ilo NDA had 3000 patients... so the 2 patients identified in early studies with >500msec are fairly irrelevant as pertains to approval.... (IMO).
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_V/threadview?m=tm&bn=28025&tid=6669&mid=6669&tof=1&frt=2
Interesting post from yahoo.
There is no mention of where this was published, if it was at all. Some very good points made in this post.
Here it is:
Within six months, Vanda Pharmaceuticals VNDA will face an approval decision for lead drug candidate Iloperidone, a treatment for schizophrenia. While we're sticking with our fair value estimate for now, we'll almost certainly adjust it after the Food and Drug Administration renders its final verdict. If regulators approve Iloperidone, we'll raise our fair value estimate by as much as $8 per share; if they don't, we'll cut it by more than two thirds.
Vanda's future hinges almost entirely on Iloperidone. With its stock trading at depressed levels, the firm may not be able to raise additional capital until after the FDA makes its final decision on Iloperidone, which, coincidentally, is right around the time the firm's cash balance will run out. While Vanda has two drugs for sleep disorders in its pipeline, we're not big fans of either and think the company will have a difficult time raising funds on the promise of those candidates alone. Given the recent stock price, the market is forcing Vanda's hand: Either raise funds now and dilute shareholders but ensure access to capital whether or not Iloperidone is approved, or don't raise funds now and bet everything on an Iloperidone approval. Given its recent decision to abandon a convertible debt offering because of unattractive terms, we think Vanda is favoring the latter.
We think Iloperidone's chances for approval are high. Before Vanda acquired the compound, Novartis NVS conducted three Phase III trials for Iloperidone, to mostly mixed results. While Iloperidone improved symptoms of schizophrenia at higher doses, its benefits failed to reach statistical significance at lower doses. In addition, at these higher doses, the drug was shown to prolong the heart's QTc interval in patients, a potentially serious side effect. However, all of this was known before Vanda bought the compound, and it approached its development of the drug from an entirely different framework.
Using whole-genome association studies, Vanda found genetic mutations that correlate with patient responses to Iloperidone. As a result, through a blood test, Vanda can predict which patients will benefit most from treatment. In Vanda's Phase III trial for Iloperidone, while the overall group showed statistically significant improvement in symptoms, the benefits fell mainly to patients with the genetic markers, including a reduction in the prolongation of the QTc interval. Armed with this data, Vanda may side-step regulators' potential concerns about Iloperidone's safety by requiring a blood test for each patient. By marketing the drug to patients with specific genetic markers, Vanda could appeal to the clear need for more personalized schizophrenia medicines, since 75% of schizophrenia patients discontinue drug treatment before 18 months.
We think investors with a big appetite for risk have the right odds to call the market's all-or-nothing bet on Vanda.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_V/threadview?m=tm&bn=28025&tid=7839&mid=7839&tof=2&frt=2
nice bounce back up, just shaking out weak hands IMO
would like to see some larger volume heading into this weekend
good luck VNDA players
You can't really judge much with the low volume, everyone has placed their bets and they are waiting for the news. Again, no one really knows what will come from the FDA approval decision, but at current PPS no one seems to have any faith that it will be approved.
surf's up......crikey
Surf, does this mornings activity change your game plan in any way? I don't know what's causing this selling, although the stock has dropped 15 cents on extremely light volume. Do you think we might have a buying opportunity here? Since you seem to know this company better than most of us, it would be helpful if you would share your opinion on this situation. Thanks, Florida
Thank you for the reply and your interpretation of what is going on. It makes perfect sense and was eloquently written.
Hope it pans out positivly for those in at this sort of leval.
Good luck
Pre market ask at $3.54. I wonder how many shares they would sell at that price ???? Looks like someone is trying to scare a few folks out at the opening. If this stock has some real strength, it will bounce back up from here, and go even higher later this morning. Let's just see. Florida
Noticed someone mention Vanda on another board over the weekend, picked up a small position today. I guess now it is hope for FDA approval!
Hello Vanda fans,
good buy sell ratio today, was a bit worried we might see some selling off and the bad news from Merck and SGP -
can anyone tell me about the FDA date of 7/27 -
is this just an estimated date or will news of the drug for sure be out on this date?
From the Yahoo msg.board. Name me another biotech stock that has a book value of about 90% of its share value, no debt, and several drugs in late phases or up for FDA approval in the near future?
Re: Counter-intuitive 23 minutes ago #2 so far on monday july 21....each day things tighten....more interested in how each day closes knowing any morning the next morning can be the ONE.
Reg.why? 32 minutes ago, This stock was @ low volume in the fall of 06 and the next mourning it was up $10. It did that twice. Interesting posts, Florida
Thanks surf. If my figures are correct, that's nearly one third of this company's float. It could get really wild. Florida
surf, with approx. 26.5 million shares on the market for Vanda, which is a very tiny float for a biotech,causing these wide price fluctuations it has shown, would you have any idea just how many shares are on record as having been shorted in this stock? I agree with you, that this should be a very interesting week, and probably, with everyone guessing all over the place, a very volatile one as well. It still looks like it wants to go higher. Just how much higher, is the big question. Florida
After investing in biotechs stocks for nearly 25 years I have learned not to be a holder of a large position going into a scheduled FDA meeting. That said, if the stock has not run into the meeting I am more likely to hold some stock into that event and wait to see what the FDA outcome is. It will really depend on the price action this week on what my holdings will be come Monday morning. If the price stays current through the week($3.50) for the open on Monday, good news could see the stock open at $6.50+, the high from the last move, negative news open around $1.50, there is your possible risk. Again if we have a good short covering week we could see much of the positive news already built into the PPS. This is part of the interest in investing in these biotech events, you have to consider your risk come Monday. Again going into an FDA meeting there is no way to gauge what they will do(no way).
That said, the shorts have a nice profit in VNDA and the risk should be in their minds this coming week, it will be an interesting trading week for VNDA.
surf
surf's up......crikey
Gery, welcome to you also. Nice to be able to read a few posts on this board, no matter how long we all keep our shares. I still feel that if this stock continues to rally upward next week, it will draw more and more "new" interest. There might be a danger in selling it "too soon", as we attempt to pick an exit point, as this stock might just go a whole lot higher than we sell our shares for. I've done it several times, and try not to check a stock too much after I sell it, not wanting to see the higher prices it's trading at. But somehow, I always look at it for a while, and say to myself, "why didn't I wait just a little bit longer"??? Picking the top for a stock is just as difficult as picking a bottom. We all have to do what we feel comfortable with. Regards, Florida
I also bought a few shares on Friday, noticed this on bottom bouncers at the blue horse saloon, my whole portfolio could do with a bounce!
Hi Surf, interesting to hear your exit strategy. Are you being cautious to preserve capitol or do you get a sense that negative news may be on the way, next week? or just not willing to gamble on the chance of possible negative news, just curious.
I kind of hoped that good news a week on Monday maybe the catylist for the bounce, time will tell. I have never had much luck catching knives.....
Good luck
Gerard
My plans on my VNDA position is to hold for higher prices up into the close on Friday. I will not be holding a large position into the Monday morning PR, with the FDA you really can have no clue as to what they will do. Trading for the week should have positive pressure up to a point in the PPS, not sure what that price point will be. The risk/reward for the long vs short side for this week should favor the long side most of the week, if your short and the news is positive Monday, you could be in for days of short covering and big losses. On the long side for the upcoming week should be fairly risk-less into the Friday close. As the week and price move along I will be selling on any good upward pressure and again my plans are to have sold most of my position by the close Friday, unless VNDA has smalls gain for the week, then I would hold a small position over the weekend. Bottom line for my VNDA position this coming week is the higher the price moves, the smaller my position will become into the close on Friday.
surf
surf's up......crikey
thanks florida, actually i have been around since about a month after surf started this board, in and out a few times. not sure if i will hold through event or just the hopeful run up to it next week. seems like plenty would want to take a flyer on it.
liked the post about those that bought in at 20 must have really liked it. i almost bought in at 11 one time, but just watched it.
take care.
scstocks, welcome aboard. Three days ago there wre only two, surf and myself. We've already doubled that.If this stock keeps moving up, we should add a few more. Regards, Florida
Oops, forgot one. I added yesterday...eom
Take Care.
Moneytalks, Surf,Florida. We seem to be the "only three" that are interested in VNDA on this board. I have a feeling that a couple of more strong days will change that. Unless you know this stock from the past, most people really don't have it on their radar "yet".Hopefully this will change in the next couple of weeks. Regards to you guys that own it, and everyone else that happens to read our board on occasion. Florida
P.R.June 26th,2008 Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The company has three product candidates. Vanda's lead product candidate, iloperidone, is a compound for the treatment of schizophrenia for which Vanda submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in September 2007. The FDA accepted Vanda's iloperidone NDA for filing in November 2007 and Vanda expects a decision from the FDA on or about July 27, 2008. Vanda's second product candidate, tasimelteon (VEC-162), is a compound for the treatment of sleep and mood disorders, which is currently in Phase III for chronic primary insomnia. Vanda's third product candidate, VSF-173, is a compound for the treatment of excessive sleepiness in Phase II. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com/.
Very interesting play here.
Does anyone know when the results of the FDA review will be complete. I thought I read somewhere on July 28th.
If Iloperidone is approved this stock is going to fly, if there is hold backs looks like additional funding might be an issue.
I'm in today at $3.53 - seems to me the risk/reward factor looks too damn good..... GO VANDA!!!
Thanks for the info surf. Does the company have any date in mind to brief their shareholders on what the FDA might or might not do? The activity in this stock the past couple of days, looks like accumulation is going on. With such a small float, if anything positive is announced, it could really take off. Even yesterday, everytime some traders sold the stock off, it almost immediately attracted some slow but sure buying, and as a result finished the day up 0.16.So far it's looking stronger each day. Another up day today would be terrific, probably leading to another strong week ahead. Love your gal on the beach surf. Very relaxing. Regards, Florida
Iloperidone: A novel atypical antipsychotic for the treatment of schizophrenia
Jun 1, 2008
By: Megan J. Ehret, PharmD, BCPP, Michael A. Sopko, Jr, PharmD, Alexander Levine, PharmD
Formulary
Key Points
Iloperidone, a new-generation atypical antipsychotic, is currently under investigation for the treatment of schizophrenia.
In 4 separate phase 3 trials, iloperidone has demonstrated efficacy in treating schizophrenia, with total Positive and Negative Symptom Scale (PANSS) scores decreasing by a range of 8 to 14 points.
The most common adverse events associated with iloperidone treatment include dizziness, dry mouth, dyspepsia, sedation, orthostatic hypotension, and weight gain.
Studies have also demonstrated that iloperidone is associated with a risk of corrected QT prolongation.
The manufacturer is hoping to determine specific reliable genetic markers for predictive response to this medication.
• Abstract
Iloperidone, a new-generation atypical antipsychotic, is currently under investigation for the treatment of schizophrenia. In 4 separate phase 3 trials, iloperidone has demonstrated efficacy in treating schizophrenia, with total Positive and Negative Symptom Scale (PANSS) scores decreasing by a range of 8 to 14 points depending on the iloperidone dose. The most common adverse events associated with iloperidone treatment include dizziness, dry mouth, dyspepsia, sedation, orthostatic hypotension, and weight gain. Studies have also demonstrated that, similar to ziprasidone, iloperidone is associated with a risk of corrected QT (QTc) prolongation. Currently, iloperidone does not appear to offer any unique chemical properties that separate it from the other atypical antipsychotics. The manufacturer is hoping to determine specific reliable genetic markers for predictive response to this medication. Six polymorphisms demonstrating an association with iloperidone response have been identified. However, until genotyping patients becomes cost effective, iloperidone is not likely to drastically affect current clinical practice. (Formulary. 2008;43:190–203.)
Table 1 Phase 3 clinical trials of iloperidone
Schizophrenia, a chronic psychiatric disorder affecting approximately 1% of the US population, is characterized by positive (eg, hallucinations, delusions), negative (eg, alogia, anhedonia), and cognitive symptoms. 1 Many antipsychotic medications are currently approved by FDA for the treatment of schizophrenia, but treatment response to these agents remains highly variable. In addition, no specific markers reliably predictive of response have been identified to guide clinicians in their prescribing practices.2,3 The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) demonstrated that the currently available antipsychotic medications are associated with poor adherence, treatment discontinuation, and frequent switching attributable to lack of efficacy and intolerability in patients with chronic schizophrenia.4 More research is needed to determine the most effective medications for the treatment of schizophrenia.
Iloperidone (Vanda Pharmaceuticals) is a new-generation atypical antipsychotic that is under investigation for the treatment of schizophrenia. In October 2007, the manufacturer announced the completion of phase 3 trials, and an NDA was submitted to FDA. FDA officially accepted the NDA for iloperidone in November 2007.7
http://formularyjournal.modernmedicine.com/formulary/Feature+Articles/Iloperidone-A-novel-atypical-antipsychotic-for-the/ArticleStandard/Article/detail/520961
Surf, what is the exact date of the meeting, and when is their announcement date scheduled for??? Thanks, Florida
I'm playing the stock into the meeting and plan on adjusting my position at the end of the month prior to the final word on the drug. I am not going to try and guess what they do in that meeting and if we get a good run into it I will take most of my position off. I'd rather be able to trade back in after the release of news.
surf
Surf, interesting post on Yahoo: 17-jul-08 They spend over 500 million dollars over the years to develop this drug and at the end , Wall Street does not belive it that this management can get Illperidone approved.I put it this way, people who risked their money at the begining of this company must have seen quite a bit of potential that they invested in to it and bought the stock over $20.I am getting this baby at a 90% discount and 300%( Possible)appriciation.I think risk and reward are part of this game and my risk is too low as compared to reward.eom.
Sentiment : Strong Buy
Rating :
I'm back in VNDA now and waiting for the PDUFA event/update. I also noticed that one of their largest holders just filed and has increased its holdings:
Westfield Capital Management Company, LLC
from 2,027,400
to 2,855,600
http://secfilings.nasdaq.com/filingFrameset.asp?FileName=0001193125%2D08%2D146318%2Etxt&FilePath=%5C2008%5C07%5C03%5C&CoName=VANDA+PHARMACEUTICALS+INC%2E&FormType=SC+13G%2FA&RcvdDate=7%2F3%2F2008&pdf=
surf's up......crikey
Hello surf. I watched the opening and the steady buying in VNDA today, and picked up some shares near the close. This one just has the feel of something good happening. While it doesn't figure to reach $21 anytime soon, it certainly has room to move a lot higher than this. Very small float, and it's in the right industry. Do you still maintain a position in this company, and are you now considering buying more shares? It looks like this is a pretty quiet board right now. A few more days like today would probably change that. Regards, Florida
Buying back some VNDA soon, looking at this upcoming news update:
Expects Fanapta(TM) (iloperidone) PDUFA Action July 27, 2008; Tasimelteon (VEC-162) Phase III Trial Results Expected in June; Analyst Day Planned for May 6th in Washington, DC at the American Psychiatric Association (APA) Annual Meeting
Clears up a lot...thanks...
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http://www.vandapharma.com/
http://www.vandapharma.com/development.html
http://finance.yahoo.com/q/ks?s=VNDA
Vanda is developing important new medicines to improve the lives of patients. We use new technologies, including genetics and genomics, to inform our drug discovery, our clinical trials, and our commercial positioning of our compounds. We are working to advance the science of developing new medicines and to use novel approaches to deliver these new medicines to patients.
Our CEO, Mihael Polymeropoulos, MD, founded Vanda in 2003. Previously, he founded and ran the Novartis global Pharmacogenetics department, one of the industry leaders. Prior to that he worked for many years at the National Institute of Mental Health and the National Human Genome Research Institute, where he did pioneering work in gene mapping. He founded Vanda in partnership with Care Capital LLC, the prominent biopharmaceuticals-focused investment firm, and Bio*One Capital, an investment arm of the Singapore government with a focus on new biomedical enterprises.
Vanda has assembled an experienced team and a stable of clinical stage compounds to deliver on its vision.
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