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Thanks for that info! Don't want to buy in and have it drop on an FDA approval...
insiders dumped a lot of shares back in NOV around $12
What are your sentiments here for VNDA. I plan on buying in heavy by Thursday here but not sure if the FDA decision is baked into the price already. What are your thoughts? Thanks in advance.
DMC
CLOSELY WATCH AND RADER FOR =VADA
[/bHetlioz -- PDUFA date 01/31/2014
If Vanda Pharmaceuticals' (NASDAQ: VNDA ) one-year stock chart were a roller-coaster ride at an amusement park, it might win first place for scariest attraction.
The company can attribute much of its recent success to Hetlioz (formerly tasimelteon), its non-24-hour drug designed to help totally blind people regulate their sleep habits. Whereas the majority of us use the sun as our natural meridian marker that tells us when to sleep (unless you're a vampire, of course), people who are blind have no marker to use and thus have unregulated sleeping habits. Hetlioz is expected to normalize those sleeping habits.
In mid-November the FDA's advisory panel voted overwhelmingly to recommend approval of Hetlioz as a non-24-hour drug (which would make it the first of its kind), finding that it met its primary endpoint in trials and adequately demonstrated that the drug was safe. While dapagliflozin appears to be the more exciting approval possibility, Hetlioz appears to be the drug with the best chance of obtaining approval in January with its Jan. 31 PDUFA decision date.
With peak sales estimates globally of $500 million, Hetlioz isn't going to turn Vanda into a superstar overnight, but it does have the potential to put Vanda back on the buyout radar.
[/bHetlioz -- PDUFA date 01/31/2014
If Vanda Pharmaceuticals' (NASDAQ: VNDA ) one-year stock chart were a roller-coaster ride at an amusement park, it might win first place for scariest attraction.
The company can attribute much of its recent success to Hetlioz (formerly tasimelteon), its non-24-hour drug designed to help totally blind people regulate their sleep habits. Whereas the majority of us use the sun as our natural meridian marker that tells us when to sleep (unless you're a vampire, of course), people who are blind have no marker to use and thus have unregulated sleeping habits. Hetlioz is expected to normalize those sleeping habits.
In mid-November the FDA's advisory panel voted overwhelmingly to recommend approval of Hetlioz as a non-24-hour drug (which would make it the first of its kind), finding that it met its primary endpoint in trials and adequately demonstrated that the drug was safe. While dapagliflozin appears to be the more exciting approval possibility, Hetlioz appears to be the drug with the best chance of obtaining approval in January with its Jan. 31 PDUFA decision date.
With peak sales estimates globally of $500 million, Hetlioz isn't going to turn Vanda into a superstar overnight, but it does have the potential to put Vanda back on the buyout radar.
This is the other big decision you should be following closely
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Climb should continue as we approach PDUFA date.
Very high odds for approval, IMO
Gilead, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space include Actelion Ltd. (ALIOF) and Vanda Pharmaceuticals Inc. (VNDA). Both stocks carry a Zacks Rank #1 (Strong Buy).
I hope you're right. It deserves to be priced back over 20 bucks if you look at the valuation closely. I can't believe it ever got as low as it did and wish I had bought more while it was down.
Resumed! Looks good for you!
Hope approval wasn't priced in already...seen it before...GL!
FDA panel recommends approval! Time to make some money.
There is too much momo taking this towards $21. especially with what's happening tomorrow.
Nice spike :VNDA FDA reviewer recommends approval of Vanda sleep drug for blind
08:42 EDT VNDA Vanda rallies 85% after FDA panel recommends drug for approval
The fly on the wall
"Vanda Pharma climbs as FDA panel review approaches
Vanda nearly doubles in value as date of FDA panel review for sleep disorder drug approaches
1 hour ago
NEW YORK (AP) -- Shares of Vanda Pharmaceuticals nearly doubled in value Tuesday as a group of Food and Drug Administration advisors' prepared to review the company's sleep disorder drug tasimelteon.
THE SPARK: A panel of experts will meet to discuss the drug on Thursday. Briefing documents for the meeting were posted on the agency's website Tuesday, and Wall Street found the briefing documents encouraging. A positive recommendation would improve the chances the drug will be approved.
Tasimelteon is a potential treatment for non-24-hour disorder, a rare malady that affects people who are totally blind. Patients have difficulty synchronizing their bodies with the 24-hour cycle because they can't detect light.
THE BIG PICTURE: The FDA is scheduled to make a decision on tasimelteon by Jan. 31. The drug has met its goals in two late-stage clinical trials.
Vanda Pharmaceuticals Inc. has one approved drug, the schizophrenia treatment Fanapt.
THE ANALYSIS: Piper Jaffray analyst Charles Duncan said he believes the FDA is encouraging approval of tasimelteon, and he thinks the drug will get a positive review and be approved. He rates Vanda shares "Overweight" with a price target of $21.
SHARE ACTION: Shares of Vanda Pharmaceuticals rose $6.46, or 95 percent, to $13.24 in afternoon trading. The stock more than tripled in value between January and June, but shares have slumped in the last two months."
VNDA shares jumped in recent trading after a clinical reviewer for the Food and Drug Administration recommended approval of its flagship drug.
The company has been developing tasimelteon, a potential treatment for a circadian rhythm disorder called Non-24-Hour Disorder that's most commonly found in blind individuals. Those affected don't have the ability to perceive any natural light, resulting in their internal clocks going out of sync with the outside world and causing disrupted nighttime sleep patterns and excessive daytime sleepiness and napping.
The drug has orphan-drug designation in the U.S. and Europe, which is given to novel drugs that treat rare diseases or conditions.
Ahead of an FDA advisory panel meeting on Thursday, an FDA clinical reviewer provided a positive briefing on the drug, stating the treatment had no major safety issues and was effective in treating the disorder.
There are currently no FDA-approved drugs available for the treatment of Non-24-Hour Disorder.
JMP Securities analyst Jason Butler said the briefing allayed many investo r fears on how Thursday's advisory meeting may go, noting it was rare for a medical reviewer to recommend drug approval in a briefing document.
"There's a high likelihood that Thursday is going to be a good day," he said.
After the advisory panel votes on the drug, the FDA will make a final decision on approving the drug in January, he said.
you mean "scamfraud" lol
Lol -- over on yahoo there's some crazy ass poster named 'pharmaherrrrrro' who is spamming the message board saying this is a pump-n-dump scam.
http://finance.yahoo.com/mb/VNDA/
VNDA off the table this morning.....
Good Gappage!!.Kungrat$$$ LongBulls.No chasin 4 me.Have a great Day here.
7:02AM Vanda Pharma beats by $0.03, beats on revs (VNDA) 6.45 : Reports Q3 (Sep) loss of $0.17 per share, $0.03 better than the Capital IQ Consensus Estimate of ($0.20); revenues rose 4.8% year/year to $8.7 mln vs the $8.28 mln consensus.
2013 expenses are expected to reflect lower research and development spending as compared to 2012 and an increase in commercial spending. Reflecting the recent public offering and year to date expenditures, Vanda now expects that it will end the year with between $130.0 and $135.0 million in Cash. Total 2013 operating expenses are expected to be between $50.0 and $55.0 million and decrease in Cash, excluding the impact of the recent public offering, is expected to be between $35.0 and $40.0 million.
I stopped out at 9.80
Thinking about getting back in if it only reaches a bottom.
I may wait until after ADCOM result and ride it to PDUFA date, if ADCOM is favorable?
It's on high alert on my watch list along with MSTX
Good luck
These guys are never always right or never always wrong. Just like the rest of us.
They say VNDA changed the endpoints of the study without FDA permission therefore the Advisory panel will recommend a No approval.
If you read the transcript of qtr 2 conference call when this question was asked, VNDA management said they changed the endpoints based on a recommendation from the FDA.
Do you believe them or management?
Never mind again. I saw what happened after AMRN's review meeting. OUCH!! Anyone have any thoughts on this article:
http://www.thestreet.com/story/11954365/2/vandas-sleep-disorder-drug-is-a-nightmare.html
Obviously a negative bias, but this guy was negative on AMRN also and he was right about that. Thoughts??
Never mind, I stand corrected:
http://finance.yahoo.com/news/vanda-pharmaceuticals-announces-fda-advisory-200100622.html
Looks like show time. Does anyone know what actually happens at these reviews? Could it actually be accepted/rejected during the meeting, or is it simply discussed?
Thanks
Howdy. New here (and to VNDA). I didn't think Nov. 14 was a hard date (line from PR below), but rather a tentative one. And with the government being shut down, don't you think that is likely to be pushed out? Many thanks and good luck!
The FDA has also tentatively scheduled an advisory committee meeting to discuss the tasimelteon application on November 14, 2013.
Taking a hit here the last couple of days.
5 weeks to Nov 14 catalyst
Nice move here today in a down market.
Nov 14 catalyst is in play here now
ADCOM is Nov 14
Just six weeks now. I may pick up some more cheap shares today?
This should climb into PDUFA date
Looking forward to the jump on FDA acceptance here.
8:49AM Vanda Pharma prices 4.68 mln share offering at $11.14 per share (VNDA) 11.14 :
1:51AM Vanda Pharma FDA accepts Tasimelteon New Drug Application for priority review in the treatment of non-24-hour disorder in the totally blind (VNDA) 8.05 : Co announces the FDA has accepted the filing and granted a priority review classification to Vanda's New Drug Application for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.The FDA determined the action target date under Prescription Drug User Fee Act, to be January 31, 2014. The FDA has also tentatively scheduled an advisory committee meeting to discuss the tasimelteon application on November 14, 2013.
2:05AM Vanda Pharma presents data from Phase III studies that demonstrate Tasimelteon restores daily cortisol rhythm in blind patients with non-24-hour disorder (VNDA) 11.23 : Co presents data demonstrating that tasimelteon can entrain both melatonin and cortisol rhythms. This effect further confirms tasimelteon's potential to reset the master body clock and address the circadian desynchrony which is inherent in Non-24-Hour Disorder.
In the SET study, tasimelteon achieved the primary endpoints of entrainment of the melatonin rhythm as compared to placebo and clinical response as measured by entrainment plus a score of greater than or equal to 3 on the Non-24 Clinical Response Scale. Tasimelteon also demonstrated significant improvement versus placebo across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep, as well as in the Clinical Global Impression of Change, an overall global functioning scale. In treated patients, daytime naps decreased by 46 minutes per day in the worst 25% of days in a cycle and nighttime sleep increased by 57 minutes per day during the worst 25% of nights in a cycle.
The RESET study demonstrated that continued treatment with 20mg of tasimelteon was required to maintain entrainment of melatonin and cortisol circadian rhythms in individuals with Non-24. Patients treated with tasimelteon maintained their clinical benefits while patients who received placebo showed significant deterioration in measures of nighttime sleep, daytime naps and timing of sleep. Furthermore, discontinuation of tasimelteon resulted in a rapid relapse to misaligned circadian rhythms, reinforcing the importance of chronic therapy.
VNDA in dump phase now..
VNDA in dump phase now..
3:38AM Vanda Pharma presents data from Tasimelteon Phase III studies in non-24-hour disorder (VNDA) 10.17 : Co presents additional entrainment and patient-level clinical data from its SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder) Phase III studies of tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in totally blind individuals. Non-24 is a serious, rare and chronic circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot entrain (synchronize) their master body clock to the 24-hour day. Currently there is no approved FDA treatment for Non-24.
In the SET study, tasimelteon achieved the primary endpoints of entrainment of the melatonin rhythm as compared to placebo and clinical response as measured by entrainment plus a score of greater than or equal to 3 on the Non-24 Clinical Response Scale. Tasimelteon also demonstrated significant improvement versus placebo across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep, as well as in the Clinical Global Impression of Change, an overall global functioning scale. In treated patients, daytime naps decreased by 46 minutes per day in the worst 25% of days in a cycle and nighttime sleep increased by 57 minutes per day during the worst 25% of nights in a cycle.
6:55AM Vanda Pharma announces submission to FDA of a New Drug Application for tasimelteon for the treatment of non-24-hour disorder in the totally blind (VNDA) 9.20 : Co announced the submission of a New Drug Application (NDA) to the FDA for tasimelteon, a circadian regulator. Vanda is seeking FDA approval of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. Tasimelteon was developed to address a significant unmet medical need, the treatment of Non-24, for which there are currently no FDA approved products. "The data demonstrates that tasimelteon is able to reset the master body clock and synchronize the melatonin and cortisol circadian rhythms, resulting in significant clinical benefits to patients".
Vanda Pharmaceuticals Named the 2013 Life Science Firm of the Year by the Tech Council of Maryland
Press Release: Vanda Pharmaceuticals Inc. – 14 hours ago
WASHINGTON, May 23, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (VNDA) today announced that the company has been named the 2013 Life Science Firm of the Year by the Tech Council of Maryland (TCM). Vanda was honored at the TCM's 25th Annual Tech Awards Celebration held in Bethesda, Maryland. The Tech Awards Celebration recognizes the leaders and innovators in the technology and life science communities in Maryland and the surrounding regions.
"We are deeply honored to receive this recognition from the Tech Council of Maryland," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "We are privileged to work in a region that is supportive of our efforts to develop new treatments designed to improve the lives of others."
In selecting Vanda for this award, the TCM recognized Vanda's commitment to address patient needs and the company's work to develop tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder (Non-24). Vanda recently announced positive results in the SET and RESET Phase III efficacy studies for Non-24. Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals. Currently no treatment for Non-24 has been approved by the U.S. Food and Drug Administration (FDA). Vanda is targeting a New Drug Application submission with the FDA for tasimelteon in mid-2013.
About The Tech Council of Maryland
The Tech Council of Maryland (TCM) is the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. TCM's mission is to advocate for the interests of the technology community, further the role of technology in the Maryland economy, and nurture an environment where technology companies can collaborate, grow and succeed. For more information, visit www.techcouncilmd.com.
Target raised:
May 17, 2013
07:37 EDT VNDA Vanda Pharmaceuticals price target raised to $17 from $11 at Lazard Capital
Lazard Capital raised its price target for Vanda Pharmaceuticals shares citing positive feedback on the company's sleep disorder drug tasimelteon. The firm keeps a Buy rating on the stock.
7:01AM Vanda Pharma beats by $0.10, misses on revs (VNDA) 4.90 : Reports Q1 (Mar) loss of $0.15 per share, $0.10 better than the Capital IQ Consensus Estimate of ($0.25); revenues were unchanged from the year-ago period at $8.1 mln.
Cash:
Cash decreased by $9.5 mln in the first quarter of 2013, compared to decreases of $10.6 mln in the first quarter of 2012 and $14.0 mln in the fourth quarter of 2012. Vanda's Cash as of March 31, 2013 totaled $110.9 mln.
2013 FINANCIAL GUIDANCE
2013 financial guidance assumes a mid-year NDA submission for tasimelteon for Non-24 is accepted by the FDA for Standard Review. 2013 expenses are expected to reflect lower research and development spending as compared to 2012 and an increase in commercial spending that is commensurate to progress with the tasimelteon NDA filing.
Full year 2013 decrease in Cash is expected to be between $45.0 and $50.0 mln, compared to $47.5 mln for 2012.
Total 2013 operating expenses are expected to be between $57.0 and $62.0 mln.
This includes Fanapt intangible asset amortization of $1.5 mln and $4.0-6.0 mln of non-cash stock based compensation. Total 2012 operating expenses were $61.0 mln.
2013 operating expense guidance assumes $4.3 mln in milestone payments due upon the acceptance by the FDA of a tasimelteon NDA submission and $3.0-4.0 mln in NDA filing-related expenses.
6:56AM Vanda Pharma reports successful completion of pre-NDA meeting with FDA on tasimelteon for the treatment of non-24-hour disorder in the totally blind (VNDA) 3.95 : Co announced that it held a pre-NDA meeting with the Division of Neurology Products of the FDAto discuss the regulatory path for filing a New Drug Application (NDA) for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder. At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is adequate to support filing. The NDA supporting package that includes data from clinical pharmacology, pre-clinical pharmacology program, chemistry and manufacturing was also deemed adequate to support filing. Based on this successful completion of the pre-NDA meeting, Vanda is targeting an NDA submission for tasimelteon in mid-2013.
4:09PM Vanda Pharma confirms withdrawal of marketing authorization application for Fanaptum in the European Union (VNDA) 3.80 +0.08 : This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for co to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in patients with schizophrenia. The results of this study will not be available in the timeframe allowed in the Centralised Procedure. Co intends to reassess its European regulatory strategy for Fanaptum once the results from the Relapse Prevention Study in Patients with Schizophrenia (REPRIEVE) become available.
6:56AM Vanda Pharma announces Phase IIb/III clinical study in major depressive disorder did not meet the primary endpoint (VNDA) 4.34 : Co announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD. The clinical study did not meet the primary endpoint of change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment as compared to placebo. Both tasimelteon and placebo treated patients had an approximately 40% reduction of their MDD symptoms from baseline. Tasimelteon was shown to be safe and well-tolerated, consistent with observations in prior studies. Given these current proof of concept clinical study results, Vanda has decided to discontinue all activities in this indication. Vanda has recently reported positive results in two phase III clinical studies of tasimelteon in Non-24-Hour Disorder (Non-24) and plans to submit a New Drug Application to the FDA in mid-2013.
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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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