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 ...

Yesterday, Allos Therapeutics (ALTH) announced the closure of an underwritten public offering of 14 million shares of newly issued common stock at $7.1 per share. The company received net proceeds of $93 million after deducting issue related expenses.  We had forecasted that Allos would need to raise funds based on its cash position and requirements. The proceeds of the issue will be primarily used to support the commercialization of Folotyn (pralatrexate injection), other research and developmental activities and general corporate purposes.  Earlier, in September, Allos received accelerated approval from the US Food and Drug Administration (FDA) for Folotyn for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. Folotyn is Allos' first drug to receive FDA approval. While the drug will be available to patients in October, the commercial launch is scheduled for January 2010.  Allos is doubling its sales force from the ...

In a major breakthrough, Allos Therapeutics (ALTH) received FDA-accelerated approval for Folotyn (pralatrexate injection) last week.

The company was seeking approval of the drug for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn becomes Allos' first drug to receive FDA approval.

While the drug will be available to patients within a month, the commercial launch is scheduled for January 2010. Allos is increasing its sales force from the current level of 25 to 50, and doing the necessary preparations for its launch.

Allos has agreed to conduct additional clinical trials to further verify the benefit of Folotyn. The requirement of additional trials comes with accelerated FDA approval as the agency requires further studies after the launch to confirm the drug's benefits to patients.

Earlier this month, Folotyn received a favorable recommendation from the FDA advisory panel, which voted 10-4 in favor of the drug along with stating

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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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Monday August 10, 2009

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Bowne & Co., Inc. (NYSE: BNE), a global leader in shareholder and marketing communications services, today announced that Standard & Poor’s Ratings Service affirmed its ‘B’ corporate credit rating and revised the rating outlook to positive.

Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the Company has received notification from the U.S. Food and Drug Administration’s (FDA) that the Oncologic Drugs Advisory Committee (ODAC) will hold a meeting on September 2, 2009, to review the Company’s New Drug Application (NDA) for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Astea International Inc. (Nasdaq:

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Allos Therapeutics (ALTH) is scheduled to release its second quarter results on August 4. We expect the company to post a net loss of $16.5 million or $0.19 per share. The company does not have any marketed product; hence it does not have any revenue stream.

The current year seems to be quite crucial for Allos Therapeutics especially related to its most advanced pipeline candidate, pralatrexate. The company has submitted a new drug application (NDA) for pralatrexate to the FDA for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) in March, 2009. We expect its approval by the end of 2009 or early 2010.

Pralatrexate has an orphan drug (presently no FDA approved drug for PTCL is available) status from the FDA and European Medicines Agency (EMEA) for the treatment of patients with PTCL. This status brings with it seven years of marketing exclusivity in the US

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Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. 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 response rulings by the agency which require more information before an approval can be granted.

Allos Therapeutics [ALTH: 7.19, -0.13 (-1.78%)]: On 5/30/09 , ALTH updated data from the Company’s pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent

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