Cell Therapeutics’ (CTIC) third quarter loss per share came in at 8 cents compared to a loss of $1.14 reported in the year ago period. The company does not have any marketed product at present; it derives revenues primarily in the form of license and contract revenues. Cell Therapeutics recorded revenues of $0.02 million compared to $2.6 million in the third quarter of 2009.  Revenues in the year ago period consisted of product sales of Zevalin, which the company sold to Spectrum Pharmaceuticals earlier in 2009. Operating expenses during the quarter increased 32.5% to $27 million primarily on account of more than 150% increase in SG&A expenses. Cell Therapeutics has started preparing for the launch of pixantrone in 2010 by recruiting key persons and conducting market research; which has pushed SG&A expenses higher.  As a reminder, in August, the US Food and Drug Administration (FDA) had ...

Allos Therapeutics’ (ALTH) third quarter loss per share came in at 21 cents, in line with the Zacks Consensus Estimate. However, the loss increased compared to the net loss of 16 cents reported in the year ago period. Loss increased primarily due to a 41% rise in operating expense. The huge increase in general and administrative expenses by 113% led to a rise in operating expenses.  The quarter has been quite significant for Allos. In September, the company received accelerated approval from the US Food and Drug Administration (FDA) for pralatrexate (Folotyn) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn is Allos' first drug to receive FDA approval. While the drug is available to patients since October, the commercial launch is scheduled for January 2010.  Allos is increasing its sales force from the current strength of 25 to 50 and ...

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Monday October 19, 2009

DrStockPick.com Stock Report!

PFE, PWRM, BIIB

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PWRM, Power 3 Medical Products Inc, PWRM.OB

Power3 Medical Products, Inc. is a leading bio-medical company engaged in the commercialization of neurodegenerative disease and cancer biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets. Power3’s patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and prognosis of disease, identify protein biomarkers, and drug targets. Diagnostic tests are targeted toward markets with critical unmet needs in areas including neurodegenerative disease (NuroPro) and breast cancer (BC-SeraPro). Power3 expects to complete phase

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We are awaiting the US Food and Drug Administration’s (FDA) decision regarding Allos Therapeutics’ (ALTH) lymphoma drug Folotyn. The company, which is seeking approval of Folotyn for the treatment of relapsed or refractory peripheral T-Cell lymphoma (PTCL), was assigned a Prescription Drug User Fee Act (PDUFA) date of Sept. 24.

We are optimistic about the approval of Folotyn based on the FDA advisory panel’s favorable recommendation earlier this month. The board voted 10-4 in favor of the drug and said that new treatments were required for the disease.

However, we are still wary as the studies conducted by Allos did not record robust data. The number of patients who responded to the treatment was rather low (27% of 115 patients) with the majority of them responding only partially. Moreover, effect of the treatment lasted for less than 14 weeks in more than half of these patients. The panel

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Wednesday September 23, 2009

DrStockPick.com Stock Report!

GENZ, PWRM, STEM, CTIC, PFE

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GENZ, Genzyme Corporation

GENZ is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 11,000 employees in locations spanning the globe and 2008 revenues of $4.6 billion.

GENZ provided an update on its progress to restore supplies of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) for patients worldwide and revised its 2009 revenue guidance for these products. GENZ is now approximately half-way through the anticipated shortage period

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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:

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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.

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ERIC, LM Ericsson Telephone Co.

ERIC is the

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Sunday September 6, 2009

PennyOmega.com X-Tra Hot Stock Alert!

AIG, TEF, SPPI, VTR

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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

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Yesterday, the US Food and Drug Administration’s (FDA) panel came out with a favorable recommendation regarding the approval of Allos Therapeutics’ (ALTH) lymphoma drug Folotyn (pralatrexate). The company is seeking approval of Folotyn for the treatment of relapsed or refractory peripheral T-Cell lymphoma (PTCL). Although the FDA is not required to follow the panel’s advice, it generally does so. The agency is supposed to take a final decision on the drug by Sept 24.

The FDA panel voted 10-4 in favor of the drug along with stating that new treatments are required for the disease. Studies conducted by the company did not record robust data. The number of patients who responded to the treatment was quite less (27% of 115 patients) with majority of them responding only partially. Benefit of the treatment lasted for less than 14 weeks for more than half of the responding patients. The panel voted in

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We are pleased to hear that the US Food and Drug Administration (FDA) accepted and filed for review Cell Therapeutics’ (CTIC) New Drug Application (NDA). The company is seeking FDA approval (NDA filed in June 2009) for pixantrone for the treatment of relapsed and refractory non-Hodgkin’s lymphoma (NHL). Though an action date is yet to be published, the company expects the FDA to take a final decision regarding the review status by Sept 4.

Earlier in June, Cell Therapeutics presented encouraging results from a phase III trial of pixantrone. Although the efficacy data for pixantrone were encouraging, we are concerned about its side effects. While, neutropenia was 41.2% for pixantrone versus 19.4% for comparator, leukopenia was 23.5% for pixantrone versus 4.5% for comparator.

Although the grade 3, 4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a higher incidence of serious cardiac disorders in patients

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We are awaiting the decision of the US Food and Drug Administration's (FDA) cancer advisory committee regarding approval of Allos Therapeutics’ (ALTH) Pralatrexate at a meeting scheduled for September 2, 2009. The company is seeking FDA approval for Pralatrexate for the treatment of patients with T-cell lymphoma. Although the FDA is not bound to follow the decision of the advisory panel, it generally does so. A positive recommendation from the panel increases the possibility of gaining approval for pralatrexate from the FDA. The final decision is expected by September 24th. In February this year, Allos Therapeutics came out with encouraging data from the clinical trials of pralatrexate and filed a New Drug Application (NDA) in March based on it. Pralatrexate has "orphan drug" status from the FDA and European Medicines Agency (EMEA) for the treatment of patients with T-cell lymphoma, indicating that Allos will obtain seven ...