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 ARCA biopharma Inc.  (ABIO) Trade Now »     Rate ABIO  -  Discuss ABIO  -  Add to Watch List         Graphic_subscribe

  
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ABIO: Bull or Bear?

FDA, Clinical Trial News: $ABIO, $GENZ, $KV-A, $SLXP Graphic_rating_buy ABIO
Mikerun
73%
 +0.13%
in 0 minute
(closed on 03/26/10)
<> <font> Shares of ARCA biopharma (NASDAQ:ABIO) are soaring today on news of an issued patent that includes the methods of treating heart failure patients with Gencaro (bucindolol) based on genetic testing. ABIO also reported that it has submitted a revised pivotal study protocol to the FDA on 3/25/10 under the SPA process and could begin the study in approximately one year, contingent upon the FDA response and adequate funding. </font> <> <font> Shares of Genzyme (NASDAQ:GENZ) are rebounding today following a drop of approximately 10% for the week on news earlier this week that the FDA w...
By  Mike Havrilla   (+1.04%  risk: moderate)  03/26/10 7 comments


BioMed News Bytes: Transcept, ProUroCare, SciClone, ABIO Graphic_rating_sell ABIO
Mikerun
73%
 -81.02%
in 123 days
(closed on 03/26/10)
On 11/23/09, Transcept Pharma (NASDAQ: TSPT) announced that it is scheduled to meet with the FDA on 1/20/10 to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). As previously announced, the CRL, received by TSPT on 10/28/09, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
 
<> The FDA indicated that t...
By  Mike Havrilla   (+1.04%  risk: moderate)  11/23/09 14 comments


13 Extreme FDA Trades: BioMedReports.com 6/1/09 Update Graphic_rating_buy ABIO
Mikerun
73%
 -15.79%
in 175 days
(closed on 11/23/09)
Below are 13 companies with market caps below $200M which have pending new drug product decisions with the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in <font> Extreme FDA and Clinical Trial Calendar Trades </font> , which are highlighted in periodic articles at BioMedReports.com .
 
<> <> ...
By  Mike Havrilla   (+1.04%  risk: moderate)  06/01/09 7 comments


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ARCA biopharma Inc. Graphic_rating_buy ABIO
Foto
62%
 -94.90%
in 1105 days
Arca biopharma (NASDAQ:ABIO): Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09 (please note this date is a Sunday so Monday 6/1 is the more likely date for an announcement or update on the FDA decision). ABIO also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ABIO has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment ou...
By  Marian Filo   (-24.55%  risk: aggressive)  05/26/09 6 comments


Encouraging Phase 3 Results for ARCA Biopharma Graphic_rating_buy ABIO
Mikerun
73%
 -58.84%
in 20 days
(closed on 06/01/09)
 
Heart failure has always been one of the predominant fatal human conditions, today I focus on a company which has developed a treatment with encouraging results against this, often fatal, disease.
 
Key Facts : Heart failure becomes more common with increasing age. About 1 in 35 people aged 65-74 years have heart failure. This increases to about 1 in 15 of people aged 75-84 years, and to just over 1 in 7 people aged 85 years and above. It is uncommon in younger people.
 
<> It is difficult to give an outlook (prognosis) for an individual. In general, th...
By  Mike Havrilla   (+1.04%  risk: moderate)  05/12/09 2 comments


A Dozen Extreme FDA Trades on New Product Decisions Graphic_rating_buy ABIO
Mikerun
73%
 +114.18%
in 33 days
(closed on 05/12/09)
Below are 12 companies with market caps below $200M which have pending new drug product decisions at the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.
 
BioMedReports.com FDA Calendar:
 
<> 1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA (filed with the FDA on 2/17/09) with priority review request as a single agent for remission induction ...
By  Mike Havrilla   (+1.04%  risk: moderate)  04/09/09 2 comments


Trading FDA Decisions: 14 Extreme Trades Graphic_rating_buy ABIO
Mikerun
73%
 +41.26%
in 29 days
(closed on 04/09/09)

Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent.

http://biomedreports.com/blog/Trading-FDA-Decisions-14-Extrem...

<> <> Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary a...
By  Mike Havrilla   (+1.04%  risk: moderate)  03/11/09 2 comments


FDA Decision Calendar: 16 Extreme Trades Graphic_rating_buy ABIO
Mikerun
73%
 -32.46%
in 35 days
(closed on 03/11/09)
FDA Decision Calendar: 16 Extreme Trades
 
By Mike Havrilla on 2/4/09
ETF Innovators
 
Click here for a link to my previous FDA calendars and the list below highlights 16 companies with pending new product decisions at the agency + market caps below $150M, making them ideal candidates for extreme stock price volatility trades.
 
 
<> BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company raised $6M in cash from partner Med<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>...
By  Mike Havrilla   (+1.04%  risk: moderate)  02/04/09 3 comments


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Updated Clinical Trial and FDA Calendar Graphic_rating_buy ABIO
Mikerun
73%
 +41.86%
in 7 days
(closed on 02/04/09)
Updated Clinical Trial and FDA Calendar
 
The tables at my website link below feature an updated calendar of 78 expected FDA new product decisions and 92 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars and below is a summary of FDA and clinical trial news since my last article.
 
 
<> 1.) Watson Pharma (WPI): WPI received FDA approval for Gelnique, which represents the ...
By  Mike Havrilla   (+1.04%  risk: moderate)  01/28/09 3 comments





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A FREE report on the approval of a new Gout Drug - FDA Panel to review this Biotech company's stress agent drug on July 28th. If they get a favorable backing by the panel, the chances of approval by th...
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