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DSCO Analysis & Videos »
DSCO: Bull or Bear?
Discovery Laboratories Inc.
DSCO
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-32.41%
in
181 days
Discovery Labs (NASDAQ:DSCO): On 5/11/09, DSCO announced that it has received written notice from the FDA that an end-of-review meeting has been scheduled for 6/2/09 to determine the resolution of the remaining primary issue necessary for the Company to gain U.S. marketing approval of Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Following the meeting and receipt of formal written minutes from the FDA, DSCO plans to provide an update, including the expected timeline for the potential approval of Surfaxin. On 4/17/09, DSCO Discove...
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FDA Calendar Stocks on the Move: DSCO, VION, NFLD
DSCO
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-6.74%
in
1 day
(closed on 04/17/09)
<> 1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). The NDA was filed 2/17/09, accepted by FDA for standard, 10-month review on 4/17/09 with a PDUFA decision dat...
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A Dozen Extreme FDA Trades on New Product Decisions
DSCO
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+8.43%
in
7 days
(closed on 04/16/09)
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 ...
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Trading FDA Decisions: 14 Extreme Trades
DSCO
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+50.73%
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...
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FDA Decision Calendar: 16 Extreme Trades
DSCO
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-16.84%
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<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>...
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Buyout Binge Begins for Bio-Pharma, Diagnostics
DSCO
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+21.37%
in
25 days
(closed on 02/04/09)
<> 
<>
<> With news late Friday that Roche (RHHBY) is prepared to up its bid for complete control of Genentech (DNA) to $95 from a previous offer of $89 per share and a $41M ($1.50 per share) all-stock takeover offer by Sequenom (SQNM) for EXACT Sciences (EXAS); 2009 is off to a strong start for M&A activity in the bio-pharma and diagnostic space.
Larger and well funded bio-pharma and diagnostic companies are opportunistically looking to expand their product offerings, pipeline prospects, patent portfolios, ...
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Healthcare Catalyst Stocks for 1H09
DSCO
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-2.50%
in
3 days
(closed on 01/10/09)
<> Below are four companies I have not written about recently with expected catalysts in the first half of 2009 in the form of FDA decisions or clinical trial results.
FDA Calendar of New Product Decisions
Last Fall, Discovery Labs (DSCO) received word from the FDA that its complete response for Surfaxin was accepted, but the six-month Class II review designation means that the decision date is pushed out to mid-April. DSCO presents a model trade on a pending FDA decision at this time since it will likely enjoy a run-up in ...
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Updated FDA Calendar of Decision Dates
DSCO
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-26.79%
in
19 days
(closed on 12/02/08)
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The accompanying table of FDA decision dates is updated to include the following: 1) XenoPort (XNPT) withdrew its NDA for restless leg syndrome drug Solzira for what appears to be a minor, administrative delay to reformat some trial data at the agency's request which will also delay $23M in milestone payments from partner GlaxoSmithKline (GSK); 2) Discovery Labs (DSCO) Surfaxin NDA will undergo a Class II review with a decision deadline pushed out to 4/17/09; 3) Genentech (DNA) filed for accelerated approval of Avastin as a s...
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A Backlog of Decisions is Building at the FDA
DSCO
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-37.78%
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6 days
(closed on 11/13/08)
<> 
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
DSCO
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-8.16%
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
DSCO
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+20.10%
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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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FDA Action Heats Up Before Year-End
DSCO
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-5.66%
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3 days
(closed on 10/24/08)
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The accompanying table presents an updated calendar of expected FDA decision dates and advisory committee [FDAC] meetings expected to impact the price of underlying biotech and pharma stocks. Genzyme (GENZ) faces a FDAC tomorrow (10/21) for its pending BLA for Myozyme manufactured at the 2,000L bioreactor scale. Also, Discovery Labs (DSCO) submitted its complete response to the FDA last Friday to address an approvable ruling for Surfaxin back in May and insiders continue to buy the stock. DSCO expects the FDA to rule on Surfaxin...
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Discover a small fortune.
DSCO
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-58.52%
in
400 days
This stock has been a bit iffy to say the least. I'm seeing an upward trend that could sustain itself if the NAYsAYers would keep their damn mouths shut and let people calm their pocket pinchen.
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FDA Calendar: Near-Term Movers
DSCO
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+30.08%
in
11 days
(closed on 10/21/08)
<> 
Some likely near-term movers on the FDA's decision date calendar for 70 different items (click to enlarge, left) include Cypress Bioscience ( CYPB ) + partner Forest Labs ( FRX ) with a pending decision on milnacipran in the treatment of fibromyalgia slated for the end of October in addition to results from a Phase 3 trial for the drug some time before year end.
Also, Discovery Labs ( DSCO ) is not listed on the calendar, but expects to file a complete response to a May 1st FDA approvab...
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Discovery Labs: The Next Biotech Winner?
DSCO
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-21.76%
in
4 days
(closed on 10/10/08)
<> I think the recent decline in Discovery Labs (DSCO) since the Company announced a minor delay in submitting a complete response to the FDA for an approvable ruling on Surfaxin represents a buying opportunity and bought some shares on Friday at $1.74 per share. Insider buying over the past two months (including a 75,000 share buy from the CEO at $1.87) demonstrates management's confidence in already meeting the FDA's requirements and the plan to submit a complete response to FDA for Surfaxin, which should now occur by about the third ...
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