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Author Topic: Biotech stocks in 2nd or 3rd phase trials/Positive results
invester
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Please post any stocks that have or will have positive news in there clinical trials. Buyout candidates? Partnerships?
Posts: 4381 | From: houston | Registered: Mar 2006  |  IP: Logged | Report this post to a Moderator
Happy Valley
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ISTA

http://finance.yahoo.com/news/FDA-panel-backs-Ista-drug-for-apf-4236854526.html? x=0&.v=2

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sju1973
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CYCC
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Peaser
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SVNT still has a little room to grow short term. Awaiting FDA approval around the final day of July. Just dipped nicely yesterday for swingers, recovered some today.

I'm looking for a nice climb or gap to about $18 - $20 upon approval by Aug 1st or so, by the FDA.

You've been reading my mind lately or something, pertaining to your thread title.

There was a pr a few weeks ago on yahoo that mentioned 10 stocks directly up our alley.

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Buy Low. Sell High.

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Peaser
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http://seekingalpha.com/article/145741-fda-extreme-trades-16-stocks-under-5-buck s?source=yahoo

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Buy Low. Sell High.

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jdiddy
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GNVC - $.67
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invester
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I appreciate all the information. Please post the catalyst that brings you to this summation. For one to just post a company, and no information is like posting a car for sale and no picture. Post info. Thanks fellas.
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IMAKEMONEY
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[Eek!] [Eek!] [Eek!] [Eek!] [Eek!]

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LIFE IS 10% HOW YOU MAKE IT AND 90% HOW YOU TAKE IT!

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invester
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quote:
Originally posted by Peaser:
SVNT still has a little room to grow short term. Awaiting FDA approval around the final day of July. Just dipped nicely yesterday for swingers, recovered some today.

I'm looking for a nice climb or gap to about $18 - $20 upon approval by Aug 1st or so, by the FDA.

You've been reading my mind lately or something, pertaining to your thread title.

There was a pr a few weeks ago on yahoo that mentioned 10 stocks directly up our alley.

Do you have the yahoo PR?
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delt16
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HGSI * $3.40 - Phase 3 Lupus news to be released early Monday. Analysts say that positive results could shoot the stock to over $15. Shaping up to move like DNDN did back in March after their prostate cancer drug, PROVENGE, had positive P3 results. DNDN ran from $2.60 to $23 today.
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jdizz
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DAMN GOOD CALL

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dont make yourself loose money in a stock that you had a resonable profit in

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Happy Valley
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quote:
Originally posted by Happy Valley:
ISTA

http://finance.yahoo.com/news/FDA-panel-backs-Ista-drug-for-apf-4236854526.html? x=0&.v=2

ISTA Pharmaceuticals' Bepreve(TM) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies
http://finance.yahoo.com/news/ISTA-Pharmaceuticals-prnews-3641641659.html?x=0&.v =1

$7.00 going in PM...

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oldseven
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VVUS announces positive results for 2 Phase 3 trials; Up 48% in pre-market.

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Only ONE good stock away from retirement!

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Happy Valley
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BIOD...$3.37...Nearing 52 week lows...PDUFA date end of October...Like the risk/reward here...DYODD

Final Results of Phase 3 Study of VIAject(R) vs. Regular Human Insulin in Patients with Type 2 Diabetes Presented at American Diabetes Association Annual Meeting
http://investor.biodel.com/releasedetail.cfm?ReleaseID=482736

VIAject
Treatment for Diabetes Mellitus Type I, Diabetes Mellitus Type II
FDA Accepts VIAject NDA for Review
http://www.drugs.com/nda/viaject_100301.html

http://www.sec.gov/Archives/edgar/data/315066/000031506610001464/filing.txt

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Happy Valley
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BIOD $4.10 HOD...Does not take much to move this one...

http://stockcharts.com/h-sc/ui?s=BIOD&p=D&yr=0&mn=3&dy=0&id=p89834935788&a=20479 0735&listNum=2

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Happy Valley
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BIOD...Big offer at $5.00 getting pounded right now...PDUFA date end of October fwiw...

Watch ATHX here also...Getting a bump today on over 3x adv...Not sure why yet, still digging...

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Happy Valley
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Biodel Inc.(NasdaqGM: BIOD)
Real Time: 5.39 0.40 (8.02%) 10:04AM EDT

Last Trade: 5.42
Trade Time: 9:49AM EDT
Change: 0.43 (8.62%)
Prev Close: 4.99
Open: 5.16
Bid: 5.42 x 200
Ask: 5.43 x 300
1y Target Est: 14.75
Day's Range: 5.1599 - 5.48
52wk Range: 3.22 - 6.25
Volume: 453,774
Avg Vol (3m): 390,643
Market Cap: 130.04M
P/E (ttm): N/A
EPS (ttm): -1.70
Div & Yield: N/A (N/A)


Athersys, Inc.(NasdaqCM: ATHX)
Real Time: 3.46 0.22 (6.79%) 10:00AM EDT

Last Trade: 3.37
Trade Time: 9:48AM EDT
Change: 0.12 (3.86%)
Prev Close: 3.24
Open: 3.43
Bid: 3.32 x 600
Ask: 3.37 x 700
1y Target Est: 6.75
Day's Range: 3.31 - 3.45
52wk Range: 0.97 - 6.40
Volume: 57,376
Avg Vol (3m): 78,589
Market Cap: 63.70M
P/E (ttm): N/A
EPS (ttm): -0.74
Div & Yield: N/A (N/A

Athersys Announces Groundbreaking Data Showing Neuroprotective Effects of MultiStem Therapy for Traumatic Brain Injury
http://finance.yahoo.com/news/Athersys-Announces-pz-2088842379.html?x=0&.v=1

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Happy Valley
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BIOD $5.82 HOD...
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Happy Valley
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ATHX $3.50 HOD

UPDATE 1-Athersys' stem cell therapy gets orphan drug status
http://www.reuters.com/article/idCNSGE68K0IV20100921?rpc=44

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invester
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quote:
Originally posted by Happy Valley:
Biodel Inc.(NasdaqGM: BIOD)
Real Time: 5.39 0.40 (8.02%) 10:04AM EDT

Last Trade: 5.42
Trade Time: 9:49AM EDT
Change: 0.43 (8.62%)
Prev Close: 4.99
Open: 5.16
Bid: 5.42 x 200
Ask: 5.43 x 300
1y Target Est: 14.75
Day's Range: 5.1599 - 5.48
52wk Range: 3.22 - 6.25
Volume: 453,774
Avg Vol (3m): 390,643
Market Cap: 130.04M
P/E (ttm): N/A
EPS (ttm): -1.70
Div & Yield: N/A (N/A)


Athersys, Inc.(NasdaqCM: ATHX)
Real Time: 3.46 0.22 (6.79%) 10:00AM EDT

Last Trade: 3.37
Trade Time: 9:48AM EDT
Change: 0.12 (3.86%)
Prev Close: 3.24
Open: 3.43
Bid: 3.32 x 600
Ask: 3.37 x 700
1y Target Est: 6.75
Day's Range: 3.31 - 3.45
52wk Range: 0.97 - 6.40
Volume: 57,376
Avg Vol (3m): 78,589
Market Cap: 63.70M
P/E (ttm): N/A
EPS (ttm): -0.74
Div & Yield: N/A (N/A

Athersys Announces Groundbreaking Data Showing Neuroprotective Effects of MultiStem Therapy for Traumatic Brain Injury
http://finance.yahoo.com/news/Athersys-Announces-pz-2088842379.html?x=0&.v=1

Happy, when is Biodel's drug up for approval?
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Ripler
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Old news from sept 17, but I thought Id post anyways. There are still some useful tidbits to be found.

http://seekingalpha.com/article/225830-top-5-upcoming-fda-decisions-with-bullish -options-sentiment

The following is a list of 5 FDA decisions with bullish options sentiment.

To create the list, we started with a universe of biotech stocks that have FDA decisions scheduled over the next month. We then narrowed down the list to focus on the top 5 stocks in terms of the Put/Call ratio (based on open options positions).

In other words, all of these stocks have large call option open interest relative to put option open interest, i.e. more bullish options sentiment, ahead of these FDA decisions.

FDA calendar data sourced from RTT News, options data sourced from Schaeffer's.

1. Ista Pharmaceuticals Inc (ISTA): FDA action on once-daily XiDay as a treatment for ocular inflammation and pain following cataract surgery scheduled for October 16. Call open interest at 360 contracts vs. put open interest at 26 contracts (Put/Call ratio at 0.07). ISTA expects sales from its Xibrom franchise, including XiDay, to be in the range of $95 million to $105 million.

2. Alexza Pharmaceuticals Inc. (ALXA): FDA decision on AZ-004 for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder scheduled for October 11. Call open interest at 8,855 contracts vs. put open interest at 2,158 contracts (Put/Call ratio at 0.24). AZ-004 sales could reach $272 million by 2015, according to Piper Jaffray analyst Edward Tenthoff.

3. BIODEL INC (BIOD): FDA decision on VIAject for treatment of diabetes scheduled for October 30. Call open interest at 2,321 contracts vs. put open interest at 684 contracts (Put/Call ratio at 0.29).

4. Alkermes, Inc. (ALKS): FDA decision on Vivitrol for additional indication as a treatment of opioid dependence scheduled for October 12. Call open interest at 15,997 contracts vs. put open interest at 6,770 contracts (Put/Call ratio at 0.42). The drug is already approved in the U.S. and Russia for the treatment of alcohol dependence.

5. VIVUS INC (VVUS): FDA decision on Qnexa for the treatment of obesity scheduled for October 28. Call open interest at 87,655 contracts vs. put open interest at 42,128 contracts (Put/Call ratio at 0.48). Sales could peak $1.16 billion by 2015, according to Jefferies & Co. analyst.

--------------------
Bargain Hunter

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Ripler
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BIOD only one interesting me right now in that list. Today, Call/Put ratio is about even. Share price has dropped about $2 in last 2-3 weeks; Currently sitting at 4.15.
((FDA decision on VIAject for treatment of diabetes scheduled for October 30))

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Bargain Hunter

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Happy Valley
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HGSI $28.25 AH...


UPDATE 5-U.S. advisers back Human Genome lupus drug
http://finance.yahoo.com/news/UPDATE-5-U-S-advisers-back-rc-50176075.html?x=0&.v =7

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IWISHIHAD
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I have never had much luck with the biotech's.

Hope this one is different.

GERN is an interesting play, big company in the stem cells at a reasonable price, but we will have to see how the stem cells go.

This one could go hard in either direction in a hurry with their trials going on now.

Don't think it's a play for the weak hearted.


-

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Happy Valley
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CLDX $4.31...

Celldex Therapeutics to Hold Conference Call on November 22, 2010 at 8:30 am to Review Rindopepimut ACT III Data Presented at the SNO Meeting

Companies:Celldex Therapeutics, Inc. Press Release Source: Celldex Therapeutics, Inc. On Wednesday November 17, 2010, 8:00 am EST

NEEDHAM, Mass.--(BUSINESS WIRE)-- Celldex Therapeutics, Inc. (NASDAQ:CLDX - News) will review data on Monday, November 22, 2010 from the rindopepimut (CDX-110) ACT III study that will be presented at the Annual Scientific Meeting of The Society for Neuro-Oncology (SNO) in Montreal, Quebec, Canada. Celldex executives will host a conference call at 8:30 am Eastern Time. Rose Lai, M.D., Assistant Professor of Neurology in the Division of Neuro-Oncology, Department of Neurology, Columbia University Medical Center, will join the call. Dr. Lai is a leading investigator in the ACT III, Phase 2 study of rindopepimut in patients with newly diagnosed glioblastoma multiforme (GBM).


The conference call and presentation will be webcast live over the Internet and can be accessed by logging on to the “Presentations” page of the “Investors” section of the Celldex website at www.celldextherapeutics.com. The call can also be accessed by dialing 866-730-5770 (within the United States) or 857-350-1594 (outside the United States). The passcode for participants is 76849635.


A replay of the call will be available approximately two hours after the live call concludes through December 5, 2010. To access the replay, dial 888-286-8010 (within the United States) or 617-801-6888 (outside the United States). The passcode is 70523463. The webcast will also be archived on the Company’s website.


About Celldex Therapeutics, Inc.


Celldex Therapeutics is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit http://www.celldextherapeutics.com.

http://finance.yahoo.com/news/Celldex-Therapeutics-to-Hold-bw-3073980843.html?x= 0&.v=1

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Happy Valley
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Celldex Therapeutics Reports Positive Results from Rindopepimut Phase 2 Brain Cancer Study at SNO 2010
-- Trial Met Primary Efficacy Endpoint; Randomized Phase 3 Trial to Initiate in 2011 --

-- Management to Host Conference Call on Monday, November 22, 2010, at 8:30 am --

http://finance.yahoo.com/news/Celldex-Therapeutics-Reports-bw-820470807.html?x=0 &.v=2

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