In a major disappointment for Spectrum Pharmaceuticals (SPPI), the US Food and Drug Administration (FDA) last week refused to approve the company’s supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) in its current form. The company was seeking approval for the treatment of patients with advanced metastatic colorectal cancer. Following the news, the shares plummeted 18% on Friday.

Spectrum received a Complete Response Letter (CRL) from the FDA, in which the agency stated that the Fusilev data did not confirm the drug’s non-inferiority to leucovorin. Spectrum Pharmaceuticals plans to request a meeting with the agency to discuss the future course of action. The drug is currently approved by the FDA as a treatment option after high dose of methotrexate therapy in patients with osteosarcoma, a type of bone cancer.

Earlier in September, the company raised $50 million in a registered direct offering of shares and warrants priced at $7.55. We believe

...

Here are the stocks added to the Zacks #5 Rank ("strong sell") List today:

Ada-es Inc (ADES) Aircastle Ltd (AYR) Akzo Nobel NV (AKZOY) China Green Agriculture Inc (CGA) Concurrent Computer Corp (CCUR) Dun & Bradstreet Corp (DNB) Exterran Holdings Inc (EXH) Fairpoint Communications Inc (FRP) First Community Bancshares Inc (FCBC) Goldleaf Financial Solutions Inc (GFSI) Lufkin Industries Inc (LUFK) MGIC Investment Corp (MTG) Monsanto Co (MON) Net17 1 Ueps Technologies Inc (UEPS) Omnicare Inc (OCR) Otter Tail Corp (OTTR) PetSmart Inc ...

SPPI, Spectrum Pharmaceuticals, Inc.

ERIC, LM Ericsson Telephone Co.

NWMT, NewMarket Technology, Inc., NWMT.PK

PennyOmega.com Watch List!

PennyOmega.com Watch List ! for Tuesday September 8, 2009

Our Picks at PennyOmega.com for Tuesday September 8, 2009 are:

**************************************************************

SPPI, Spectrum Pharmaceuticals, Inc.

SPPI is a commercial-stage biotechnology company with a focus in oncology.

SPPI’s ZEVALIN® (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, received approval from the U.S. Food and Drug Administration (FDA) for an expanded label for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy.

**************************************************************

ERIC, LM Ericsson Telephone Co.

ERIC is the

...

 

PennyOmega.com Hot Stock News & Alerts!

________________________________________

FREE Daily Stock Alerts From PennyOmega.com

________________________________________

 

Sunday September 6, 2009

PennyOmega.com X-Tra Hot Stock Alert!

AIG, TEF, SPPI, VTR

**************************************************************

AIG, American International Group, Inc.

AIG , through its subsidiaries, provides insurance and financial services in the United States and internationally.

AIG reached a deal to sell a portion of its asset management business to Bridge Partners LP, which is owned by

...

Lockheed Martin (LMT) is making its smart grid ambitions clear, August 25, 2009 announced that it will partner with construction firm Black & Veatch to help utilities put together stimulus-worthy smart grid projects – and to protect them from cyber-attack.

Ultimate Software (Nasdaq:ULTI), a leading provider of end-to-end strategic human resources, payroll, and talent management solutions, August 25, 2009 announced that eClinicalWorks, a market leader in ambulatory clinical systems, is taking advantage of UltiPro Workplace’s employee self-service, recruiting, and human capital management (HCM) reporting capabilities to accommodate the medical software company’s rapid expansion.

BeaconEquity.com announces August 25, 2009 an investment report featuring drug maker Spectrum Pharmaceuticals Inc. (Nasdaq:SPPI - News). The report includes financial, comparative and investment analyses, and pertinent industry information you need to know to make an educated investment decision.

Graymark Healthcare Inc. (Nasdaq:GRMH) August 25, 2009 announced the acquisition of somniCare, Inc. and somniTech, Inc. (collectively, “Somni”) from Avastra USA,

...

Stock-PR Highlights The DIRECTV Group, Inc. (NASDAQ:DTV), Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), SIRIUS XM Radio (Nasdaq: SIRI) Sign up to receive FREE Stock-PR alerts from CRWENewswire.com at http://www.crwenewswire.com/?p=2546

The DIRECTV Group, Inc. (NASDAQ:DTV) today reported that second quarter 2009 revenues increased 9% to $5.22 billion, operating profit before depreciation and amortization1 (OPBDA) increased 2% to $1.38 billion while operating profit decreased 12% to $702 million compared to last year’s second quarter.

Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has acquired 100% rights to RenaZorb® (a family of compounds represented by SPI-014, also known as RZB-014), a lanthanum-based nanotechnology compound with potent and selective phosphate binding properties, for all human and non-human indications.

About RenaZorb®

RenaZorb, or SPI-014, is a non-aluminum, non-polymer, non-calcium, lanthanum-based nanotechnology with highly potent and selective phosphate binding properties, for the potential treatment via oral administration, of hyperphosphatemia, (high phosphate

...

DrStockPick.com Stock Report!

Monday August 3, 2009

**************************************************************

SouthWest Water Company (NASDAQ:SWWC), a leading provider of water, wastewater and public works services, said that it has completed an amendment to its credit facility with its banking syndicate to gain the additional time needed to file its quarterly reports on Form 10-Q for the quarters ended March 31, 2009 and June 30, 2009. The amendment grants the company until August 28, 2009 to submit its 2009 first quarter results and September 18, 2009 to submit its second quarter results.

Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial-stage biotechnology company with a focus in oncology, announced today that an overview of the Company’s business strategy will

...

PennyOmega.com Stock Report!

PennyOmega.com Hot Stock News & Alerts!

 

Monday, July 20, 2009

PennyOmega.com Stock Report!

**************************************************************

Fuel Tech, Inc. (NASDAQ: FTEK), a world leader in advanced engineering solutions for the optimization of combustion systems and emissions control in utility and industrial applications, today announced that it has received contracts related to the initiation of commercial FUEL CHEM(R) programs on two small oil-fired units at an industrial power plant in the Republic of Korea. Chemical injection for each program is scheduled to commence later this quarter.

Natus Medical Incorporated (Nasdaq:BABY) today announced that it was awarded a contract to provide its Newborn Hearing Screening Data Management Service to the California Department of Health Care Services. Natus will

...

Spectrum Pharmaceuticals Inc.’s (SPPI) share price has moved into oversold territory with a stochastic value of 8.17. The Zacks #1 Rank (“Strong Buy") stock has topped the consensus estimate in each of the last 4 quarters with an average surprise of 90.02%, or 23 cents per share. Moreover, the consensus forecast on the company’s full-year earnings has improved by 15 cents over the past 2 months to a loss of 28 cents per share."SPPI" Free Stock Analysis: Buy? Sell? Hold?Zacks Investment Research

Below are 12 extreme FDA trades for 11 companies with market caps below $200M which have pending new drug product decisions or other meetings/milestones scheduled 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 extreme FDA and Clinical Trial Calendar trades, which are highlighted in periodic articles at BioMedReports.com.

Hemispherx Biopharma [HEB: 1.36, -0.10 (-6.85%)]: Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no

...