Vanda Pharmaceuticals, Inc. (VNDA)

[Nolerman]

Then again.....odd price action

[Nolerman]

Must be approved

[hmoney]

VNDA all over the place... Someone knows something

[Nolerman]

Nada....I keep scouring Twitter to see if it pops up. May be AH. We shall see

[KingDMC]

Still no news?

[Marvy]

Well good luck to us both.
I've seen stocks that fall after FDA approval. But I don't think this will be one of them.

[$$$eeker]

Yes , small amount.

[Marvy]

Anyone still holding?

[onkelhubert]

sold @$13.04 now. better safe than sorry.

[calidude20]

AH price=13.20 and thats just the beginning!

[onkelhubert]

haven't decided yet. holding 1k @$13.30.

[EagleD]

VNDA....who is holding through PDUFA? I bought 600 at 12.60 but Im liking the action the past two days.

[KingDMC]

Uh oh...seems like someone knows something here.

VNDA

[Nolerman]

I'm currently in March $11 puts and March $15 Calls (average .90ish on both sides)
Also added Feb $10 Puts and Feb $14 Calls slowly throughout the last two weeks.

I added puts on the runs and calls on the dips so my premiums are nice and low. I tend to be patient and methodical when adding, and always 1:1.

Either way, I don't expect an explosive run on VNDA (hence March options for slow run)...but I hope for it (hence Feb options).

CHTP on the other hand, I expect to lock in large profits very quickly in either direction (assuming no delay) as she has proved a beast with news.

Good luck all.

[Nolerman]

Very possible. $17 is my goal in the immediate/near-term. Playing a strangle for either event.

[KingDMC]

So looks like they are planning for an approval? I just don't see how much upside there will be upon approval. New 52 week high? I know it's undervalued for sure.

[Nolerman]

New 8-K filed

Item 1.01. Entry into a Material Definitive Agreement. On January 24, 2014, Vanda Pharmaceuticals Inc. (“Vanda” or the “Company”) and Patheon Pharmaceuticals Inc. (“Patheon”) entered into a Manufacturing Agreement (the “Agreement”) for the manufacture of commercial supplies of HETLIOZTM 20 mg capsules (tasimelteon capsules) at Patheon’s Cincinnati, Ohio manufacturing site. Under the Agreement, the Company is responsible for supplying the active pharmaceutical ingredient for HETLIOZTM to Patheon and has agreed to certain minimum yearly order requirements. Patheon is responsible for manufacturing the HETLIOZTM 20 mg capsules, conducting quality control and stability testing, and packaging the HETLIOZTM capsules. The Agreement has an initial term of five years and will automatically renew after the initial term for successive terms of one year each, unless either party gives notice of its intention to terminate the Agreement at least twelve months prior to the end of the then current term. Either party may terminate the Agreement under certain circumstances upon specified written notice to the other party. The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by the full text of the Agreement, a copy of which will be filed with the exhibits to Vanda’s quarterly report on Form 10-Q for the quarter ending March 31, 2014.

[Nolerman]

http://www.dailyfinance.com/2014/01/27/will-the-fda-approve-vandas-hetlioz/

[spottrader]

high risk here folks. keep your bets small.

[calidude20]

I want to sell but i think holding this sorry POS till the 31st is the smart move. Any thoughts on PDUFA price?

[$hylo]

IMO, this will break $14+ by EOW or early next week as it gets closer to approval. Huge upside moving forward.

[spottrader]

http://www.secform4.com/insider-trading/1347178.htm

[KingDMC]

Thanks for that info! Don't want to buy in and have it drop on an FDA approval...

[spottrader]

insiders dumped a lot of shares back in NOV around $12

[KingDMC]

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

[Tonyeight]

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.

[Tonyeight]

[/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
Obamacare seems complex, but it doesn't have to be. In only minutes, you can learn the critical facts you need to know in a special free report called Everything You Need to Know About Obamacare. This FREE guide contains the key information and money-making advice that every American must know. Please click here to access your free copy.

One of the world's greatest stock pickers is on a new mission -- to make YOU rich.
It all begins on Thursday, Jan. 30. That's when Motley Fool co-founder David Gardner will plunk down a sizable amount of cash on a single stock. And we'd like to share all the details with you in advance:


Privacy/Legal Information

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.

The Motley Fool owns shares of, and recommends Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

[StickyStock]

Interesting pick here

[LasNubes]

Climb should continue as we approach PDUFA date.

Very high odds for approval, IMO

[Talc Moan]

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).

[RascallyWabbit]

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.

[crudeoil24]

Excellent week!

[TheFinalCD]

very nice!!

[starbuxsux]

Resumed! Looks good for you!

[starbuxsux]

Hope approval wasn't priced in already...seen it before...GL!

[Pedro2004]

FDA panel recommends approval! Time to make some money.

[ecmoney]

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM374380.pdf

[crudeoil24]

There is too much momo taking this towards $21. especially with what's happening tomorrow.

[ClairvoyantTrader]

Shorted this 2morr!!!!

[mlkrborn]

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."

[crudeoil24]

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.

[starbuxsux]

you mean "scamfraud" lol

[Pedro2004]

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/

[surf1944]

VNDA off the table this morning.....

[~MulaGreen~]

Good Gappage!!.Kungrat$$$ LongBulls.No chasin 4 me.Have a great Day here.

[surf1944]

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.

[LasNubes]

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

[jderaney]

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?

[kaisersosze]

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??

[kaisersosze]

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