ARCA Biopharma, Inc.
(Public, NASDAQ:ABIO)
Heart failure has always been one of the predominant fatal human conditions, therefore this week I will be focusing on a company which has developed a highly successful treatment.
The broad world market for this drug is truly spectacular.
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. [ source ]
It is difficult to give an outlook (prognosis) for an individual. In general, the more severe the heart failure, the worse the outlook. In many cases, the symptoms remain at a stable level for quite some time (months or years) before becomming worse. In some cases the severity and symptoms become gradually worse over time. Severe heart failure can lead to death.
In many cases, the symptoms of heart failure can be eased with treatment. Treatment not only eases symptoms but can improve prognosis and prolong life.
| Related: New test that can detect heart blockages early on, but some say there are concerns. |
About: ARCA biopharma, Inc. (ARCA), formerly Nuvelo, Inc. is a biopharmaceutical company focused on developing genetically-targeted therapies for heart failure and other cardiovascular diseases. ARCA’s lead product candidate Gencaro (bucindolol hydrochloride), a beta-blocker and mild vasodilator is under review by the United States Food and Drug Administration (FDA), for chronic heart failure (HF).
FDA News: Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09. 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 outcomes.
Gencaro Positive Phase III Results: Arca biopharma reports overall survival benefit from heart failure trial. 92% of the projected primary endpoint events available. Arca biopharma has reported data from the pivotal Phase III Best trial of Gencaro in patients with advanced chronic heart failure. The trial results demonstrated that, in a demographically diverse group of primarily US patients with New York Heart Association class III and IV heart failure, Gencaro treatment resulted in a near significant overall survival benefit and statistically significant benefits in slowing progression of heart failure, the company said.
Average follow-up shortened by 12 months, said Arca biopharma.
All eight secondary endpoints of the trial were positive and statistically significant. As pre-specified with the FDA, the composite endpoint of heart failure progression was the most important secondary endpoint, with Gencaro shown to be superior to placebo for slowing progression of heart failure (HR 0.80, p=0.00003), and for the endpoint’s components of heart failure-related mortality (HR 0.85, p=0.042), heart failure-related hospital admission (HR 0.77, p=0.00002), and heart failure-related emergency room visits (HR 0.74, p=0.024).
Zacks.com Bullish Signal: ARCA biopharma Inc’s(ABIO) MACD indicator has moved into positive territory with a reading of 0.0681, representing a bullish turn in this Zacks #1 Rank (“Strong Buy”) stock. Analysts on average see the company’s fiscal 2009 earnings improving to a loss of $10.6 per share compared to the earlier forecast of $11.9.
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right now this dsahre at 10.5
is it the right to time, what is the expected % hike, if FDA approves.
thanks in advance
right now this share is at 10.5, is it right time to buy this share?
@Murali, Yes it is a good buy in my opinion anywhere under $15. This company, as per basis on my DD and their current phase III success is one of the leading candidates to gain FDA approval. Predicting price gains post FDA approval is difficult, though I would suggest it is comparable to DNDN so $20+ PPS is not out of the question.
The broad target market most certainly also helps its case tremendeously.
Michael, thanks for inputs.
[...] points. StockShaven is a very insightful member of our group and has an alternate life over here So not my call, just letting the masses know and giving props to Stockshaven. [...]
…here’s a link to the author’s article posted on seekingalpha:
http://seekingalpha.com/article/137185-arca-biopharma-heart-disease-drug-looks-promising#comment-501855
…I STRONGLY suggest you read the “comments” section as well.
Hi Michael,
What are do you make of http://biz.yahoo.com/e/090515/abio10-q.html ? Any numbers that perk our interest?
Peter
@Peter, what interests me is the FDA approval and that it has received a very postitive light, this is what creates the buzz.
Thanks Michael.
How do you figure it is a good buy under $15? (stated in our post above)
Also Michael,
Won’t a simple stop loss prevent risky losses in these pending FDA approval biopharma type companies?
Hi Michael,
ABIO went down all the way to 8.5, is there any reason why this share went down. I didnt see any news on this.
thanks in advance.
Murali
Here’s the news that sent it down last week.
http://finance.yahoo.com/news/ARCA-Biopharma-cuts-40-jobs-apf-15328041.html?.v=1
http://www.iguanabio.com/arca-biopharma-swings-axe-40-employees-gone/
@Michael, how did you evaluate the company as a good buy under $15, I’m just curious and want to learn…
I think $10 is way too high and forget $15, the guys that bought in at $2-$4 can have this one, imo. Not gonna touch it, now.