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CYPB Analysis & Videos »
CYPB: Bull or Bear?
FDA, Clinical Trial Calendar Updates: CTIC, CYPB, FRX, MRK
CYPB
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-24.37%
in
205 days
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete r...
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Trading FDA Decisions: CYPB Soars, A Trio of Buys
CYPB
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-20.80%
in
97 days
(closed on 04/21/09)
Trading FDA Decisions: CYPB Soars, A Trio of Buys After the market close today, Cypress Bioscience (CYPB) and Forest Labs (FRX) received FDA approval for Savella (milnacipran) in the treatment of fibromyalgia, almost exactly three months after the original PDUFA date of 10/18/08. Shares of CYPB are soaring into double digits (up over 50%) while FRX is up 10% in after hours trading at just after 6 pm ET. <> Meanwhile, Schering Plough (SGP) was not as fortunate, as the company received a complete response letter for schizophrenia drug Saphris (asenapine). Howe...
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FDA Decision Date Calendar
CYPB
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+37.17%
in
1 day
(closed on 01/14/09)
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The accompanying table [click to enlarge] includes an updated calendar of expected FDA new product decisions with over 70 entries as a follow-up to my previous article on pending clinical trial results .
Click here for a link to my previous FDA calendars and the companies listed below have expected decisions within the next month or decisions which are overdue for a ruling by the agency.
1.) Schering-Plough (SGP): Saphris (asenapine) – nearly three months overdue
2.) Genzyme (GENZ): Synvis...
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My UpDown Virtual Investing Portfolio
CYPB
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+6.58%
in
12 days
(closed on 01/13/09)
<> 
Start earning real money with zero risk while improving your trading skills and strategies at the UpDown Virtual Investing website -- just click on the image above or any of the text links to the site in this article to sign up today. My stats and profile are featured in the accompanying table and on my blog site below the last posted entry. I started trading at the UpDown on 11/23/08 with a gain of 32.5% through today -- my profile name on the site is 'ETFinnovators' with a portfolio of long positions and link...
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Four Healthy Stocks Trading Above Moving Averages
CYPB
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+1.48%
in
1 hour
(closed on 01/01/09)
Amgen (AMGN), AspenBio Pharma (APPY), BioDelivery Sciences (BDSI), and Cypress Bioscience (CYPB) are four healthcare stocks that I follow which are poised to close out a rough 2008 for the overall market trading above their 50 and 200-day moving averages, in addition to having significant catalysts in 2009 which may lead to further gains. Below is a summary of the 2009 catalysts for these companies and click on the names or tickers below for a link to all of the articles on my blog for each stock: <> Amgen filed a BLA for bone drug denosumab in the following two indicatio...
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Five Healthcare Stocks for a Happy New Year
CYPB
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+5.31%
in
8 days
(closed on 12/31/08)
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The accompanying table includes a basket of five small-cap stocks chosen from the ETF Innovators [ETFI] new healthcare indexes. The five companies are trading above their 50-day moving averages with expected upside catalyst(s) in the next six months or less.
AMAG Pharma (AMAG) announced last evening that the FDA issued another complete response for its iron deficiency anemia drug ferumoxytol (Feraheme). More details are expected today at 8:30 AM [ET] when AMAG will hold a conference call , but the Company...
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UpDown Virtual Investing: Earn Real Money with Zero Risk
CYPB
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+3.23%
in
4 days
(closed on 12/23/08)
<> 
Start earning real money with zero risk while improving your trading skills and strategies at the UpDown Virtual Investing website -- just click on the image above or any of the text links to the site in this article to sign up today. My stats and profile are featured in the accompanying table and on my blog site below the last posted entry. I started trading at the UpDown 26 days ago with a gain of about 27% through today -- my profile name on the site is 'ETFinnovators' with a portfolio of long pos...
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Updated FDA Calendar: Buying Cypress Bioscience
CYPB
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+11.71%
in
7 days
(closed on 12/19/08)
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The accompanying table [click to enlarge] includes a weekly update of 71 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Decision Catalyst Index. Since my article last week , the following action has taken place at FDA:
1.) Pain Therapeutics (PTIE) & King Pharma (KG) lost 21% and 7%, respectively, today after receiving a complete response letter from the FDA for their abuse-resistant form of controlled-release oxycodone, which is designed to deter the abuse and diver...
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Trading the Trials: Cytori and Cypress Bio
CYPB
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-2.80%
in
3 days
(closed on 12/12/08)
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Cytori Therapeutics (CYTX) reported preclinical study results in large animals which demonstrated the ability of adipose-derived stem and regenerative cells [ADRCs] to repair and increase the tissue density of damaged spinal discs, which was retained at both six and 12-month follow-up assessments. The study demonstrates the potential for a patient's own ADRCs to heal injured spinal discs in a safe manner (as no inflammation was present within the disc space), with results expected to be reported in full next spring.
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A Coiled Spring: Near-Term Catalysts & Oversold Stocks
CYPB
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+10.23%
in
6 days
(closed on 12/09/08)
<> AMAG Pharma (AMAG) more than doubled on word that the FDA accepted its complete response for a NDA of iron-deficiency anemia drug ferumoxytol in patients with chronic kidney disease and will issue a final ruling before year-end. The news is a major relief for AMAG as no new clinical trials were required and the quick decision deadline before year-end is encouraging for the approval prospects of ferumoxytol.
A trio of companies expect FDA decisions for abuse-resistant pain drugs before year-end, including Pain The...
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Updated FDA Calendar of 75 Decision Dates
CYPB
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+2.17%
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12 days
(closed on 12/03/08)
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The accompanying table [click to enlarge or download] includes an updated calendar of 75 expected FDA decision dates as part of the ETF Innovators [ETFI] New Drug Regulatory Catalyst Index, which includes a full slate of expected action before year-end outlined in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX).
An FDA panel voted against Targanta's oritavancin, which has an upc...
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Stock Picks for a 'Roadhouse Blues' Market
CYPB
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-1.36%
in
2 hours
(closed on 11/21/08)
<> The fear and pessimism behind major selling pressure and stock market losses can be summarized by the late Jim Morrison in a song by The Doors called 'Roadhouse Blues' – "The future's uncertain, and the end is always near." Some stocks that I follow which are trading at less than half of the 20% decline for the S&P 500 ETF (SPY) below its 50-day moving average are highlighted below.
Earlier this week, AspenBio Pharma (APPY) reported that its key clinical trial was nearly 90% enrolled for AppyScore, which is a blood-...
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A Backlog of Decisions is Building at the FDA
CYPB
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-4.46%
in
14 days
(closed on 11/21/08)
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The accompanying table presents 70 FDA product approval decision dates along with the market caps and one year stock price change for the underlying companies. A note of caution for investors and traders is that the most common outcome from the FDA in the past year has been a delay in decisions due to understaffed conditions at the agency. However, several companies have pending decisions which are likely to occur either before year-end or early next year and will have a major impact on their stock prices.
Disco...
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Teva is on Target to Acquire Barr
CYPB
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+0.56%
in
9 days
(closed on 11/07/08)
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The accompanying table [click to enlarge image] presents an updated calendar of expected FDA decision dates, including a new NDA filing by Johnson & Johnson (JNJ) for Comfyde and recent approval for Barr Pharma's (BRL) low-dose birth control pill Lo-Seasonique. Teva Pharma (TEVA) has closed a deal with Barr's unsecured credit holders in an effort to close its proposed $7.5B acquisition by year-end, which will expand Teva's generic drug business and also add to its line-up of brand name medications through Barr's strong presenc...
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Six Healthcare Stocks on Sale
CYPB
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-3.08%
in
5 days
(closed on 10/29/08)
<> Despite the notion of investing in the healthcare sector as a safe haven, the following six companies (APPY, CMED, CYPB, DSCO, MYL, PFE) are all down sharply over the past year despite solid underlying fundamentals, which are largely unaffected by global economic conditions.
Diagnostics
China Medical (CMED) is trading near its IPO levels of August 2005 despite excellent growth prospects and a PEG ratio of 0.3X, a forward PE of 8X, and a dividend yield of 1.8%. For some perspective on the velocity of the downturn in CMED, the stock...
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