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SPPI Analysis & Videos »
SPPI: Bull or Bear?
Neutral on SPPI ...
SPPI
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+0.68%
in
5 days
(closed on 10/21/09)
News of SPPI's drug delay is digesting. The stock should begin to increase again soon. A third of three catalysts is up for revue in the coming months and sales from the first should start to help the bottom line. All shareholders waist 2 in for the FDA outcome for catalyst 2 in the coming months.
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RECENT NEWS
SPPI
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-31.51%
in
62 days
spectrum Pharma tgt raised to $10 at Rodman & Renshaw following FDA approval for the expanded label of Zevalin Rodman & Renshaw raise their SPPI tgt to $10 from $8 following the FDA approval for an expanded label of Zevalin, which treats the previously untreated follicular non-Hodgkin's Lymphoma. With the label expansion, the treatable population expands from 6,000 to potentially 43,000 patients annually, in the firm's opinion.
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BioMedReports FDA Calendar: Swine Flu Trial Set to Begin
SPPI
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-24.13%
in
113 days
<> Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of 265 entries as of 7/21/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com <> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinica...
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FDA Calendar Updates: DDSS, HGSI, OREX, SPPI, TRIB
SPPI
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+13.23%
in
1 day
(closed on 07/21/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 263 entries as of 7/20/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pendin...
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Spectrum Pharmaceuticals (Nasdaq: SPPI): Betsy de Parry’s Story, A Must-See Video, and More
SPPI
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-9.91%
in
116 days
Investors should find the resources in this article helpful to their research efforts on Spectrum Pharmaceuticals (Nasdaq: SPPI) regarding Zevalin®. <o:p> </o:p> <o:p> </o:p> <> As of March 16, 2009 , Zevalin® is now manufactured and sold in the <st1:country-region> <st1:place> US </st1:place> </st1:country-region> <> by Spectrum Pharmaceuticals (Nasdaq: SPPI ). Zevalin® is currently approved as a last resort treatment for refractory NHL. SPPI is seeking approval for Zevalin® as a first-line consolidation therapy for NHL. A FDA...
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SPPI is Hot > 20% next six months
SPPI
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+23.06%
in
26 days
(closed on 08/13/09)
Spectrum Pharmaceuticals , Inc., a commercial-stage biotechnology company with a focus on oncology, develops and commercializes a portfolio of drug products. Its marketed products include ZEVALIN, a form of cancer therapy called radioimmunotherapy for the treatment of non-Hodgkin's Lymphoma (NHL); and FUSILEV, which is indicated after high-dose methotrexate therapy in patients with osteosarcoma. The company is also developing apaziquone for the treatment of non-muscle invasive bladder cancer. Its phase II products include Ozarelix, a drug being investigated for benign prostatic hypertroph...
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Access Pharma (OTC:ACCP): Deep Pipeline, Shallow Valuation
SPPI
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+16.40%
in
6 days
(closed on 07/20/09)
<> Access Pharma (OTC:ACCP)(ACCP.OB) is an emerging bio-pharmaceutical company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to a treatment for a common side effect of some cancer treatments known as mucositis (painful sores in the mouth and GI mucosal lining) which has already received FDA 510(k) marketing clearance and European CE Mark approval. On 7/13/09, Access announced that it would be among the LifeTech Capital Group companies presenting at Jesup & Lamont’s 2009 Growth Stock & National Sales Conference to be held at the Waldorf Astoria<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>...
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BioMedReports: FDA Calendar Updates
SPPI
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-7.24%
in
8 days
(closed on 07/14/09)
<> <font> Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 240 entries as of 7/6/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results...
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Lixte Biotech (OTC:LIXT): Key 2H09 Catalysts Await
SPPI
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+2.86%
in
13 days
(closed on 07/06/09)
<> Since I first wrote about Lixte Biotech (OTC:LIXT) at <font> BioMedReports.com in early April </font> , the Company has provided an update on its development-stage cancer drug discovery operations as part of a SEC 10Q filing in mid-May for 1Q09. LIXT.OB was originally founded as a diagnostics company in 2005 evaluating biomarkers (indicators of disease at the molecular level), but has shifted its focus to cancer drug discovery research that is primarily focused on the development of compounds for malignancies with few effective treatment options – such as certain types of brain cancer<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>...
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Bullish on SPPI ...
SPPI
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-0.20%
in
169 days
Spectrum Pharma (NASDAQ:SPPI): SPPI is a dual extreme trade with two pending decisions at the FDA. Zevalin sBLA (priority review) to expand the approved label to include consolidation therapy for follicular B-cell non-Hodgkin's lymphoma if a first-line treatment response is achieved with an expected PDUFA decision date of 7/2/09. SPPI also has a pending sNDA for Fusilev (levoleucovorin) for Injection to expand use of the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The PDUFA decision date for the sNDA is 10/8/09.
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New Index of Cancer Diagnostic and Therapeutic Stocks
SPPI
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+130.15%
in
70 days
(closed on 06/21/09)
By Mike Havrilla on 4/12/09 at BioMedReports.com The table at the link below includes statistics for the 40 companies in the ETF Innovators Emerging Cancer Diagnostic and Therapeutic Stock Index, which is featured at BioMedReports.com in the health indexes section of the site. The index will track the performance of stocks with market caps below $200M at the inception date of 4/12/09 from a starting value of 2,632. <> A World Health Organization report released last year es...
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A Dozen Extreme FDA Trades on New Product Decisions
SPPI
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+2.75%
in
3 days
(closed on 04/12/09)
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 ...
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A Resurgence in Cell Therapeutics
SPPI
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+26.24%
in
7 days
(closed on 04/09/09)
Since I profiled Cell Therapeutics (CTIC) two months ago as a cancer biotech that was down, but not out; the stock price has more than quadrupled from 8 cents to 36 cents during intraday trading today. CTIC continues to reduce operating expenses and sold its remaining stake in a joint venture to market cancer drug Zevalin to Spectrum Pharma (SPPI) for $16.5M last month (in addition to receiving $15M last December from SPPI for the initial 50% stake). <> CTIC reduced operating expenses in 2008 by 33% and prov...
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FDA and Clinical Trial Calendar Updates
SPPI
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-0.00%
in
6 days
(closed on 04/02/09)
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 106 entries through 3/27/09. The FDA Calendar includes the following information: company name...
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