Ardea Biosciences Inc. (RDEA) reported third quarter net loss of $2.47 million, or 13 cents per share, which was significantly lower than the Zacks Consensus Estimate of 47 cents. The company reported a net loss of $14.2 million or 95 cents in the year-ago period. The lower loss was attributable to the higher revenues coupled with lower operating expenses recorded in the quarter.  Revenues came in at $9.17 million as against none in the year-ago quarter. The revenues resulted from the recognition of a portion of the upfront payment of $35 million under the global agreement, with Bayer HealthCare focused on the development of MEK inhibitors for the treatment of cancer.  Operating expenses for the quarter decreased 21.4% to $11.4 million primarily due to reduced research and clinical development expenditures. Research and development expenses decreased to $9 million from $11.5 million in the third quarter of ...

Ardea Biosciences Inc. (RDEA) recently announced additional positive results from the completed first cohort of an ongoing mid-stage, proof-of-concept (POC) study of RDEA594, for the treatment of hyperuricemia (abnormally elevated uric acid levels) and gout. Data from the study were presented at a medical meeting in Philadelphia, Pennsylvania.  Results showed that RDEA594 significantly lowered serum uric acid levels in gout patients and was well tolerated with no serious adverse events and no premature discontinuations. Approximately 90% of the gout patient population consists of patients who excrete less than normal amounts of uric acid and are the primary target for treatment with RDEA594. At the same time, results also revealed that the drug is not more effective than current medication − allopurinol − a cheap generic.  Ardea is aiming to develop RDEA594 as an add-on or alternative for patients who do not benefit from the existing medications ...

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Xerox Corporation (NYSE: XRX) and Affiliated Computer Services, Inc. (NYSE: ACS) today announced a definitive agreement for Xerox to acquire ACS in a cash and stock transaction valued at $63.11 per share or $6.4 billion as of the closing price of Xerox stock on Sept. 25. This acquisition will transform Xerox into the leading global enterprise for document and business process management, and will accelerate its growth in an expanding market.

Cover-All Technologies Inc. (OTC Bulletin Board: COVR),

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On Friday, Ardea Biosciences Inc. (RDEA) posted a second-quarter net loss of $8 million, or 44 cents per share, which was significantly lower than the Zacks Consensus Estimate of 60 cents per share. The company had reported a net loss of $15.7 million, or $1.10 per share in the year-ago period.

The narrower quarterly loss was attributable to the licensing payment from Bayer and lower expenses. Revenue of $5.5 million came from recognition of a part of the $35 million upfront payment under the Bayer agreement on development of MEK inhibitors for treatment of cancer and other indications. Ardea had registered no sales in the year-ago quarter.

Operating expenses for the quarter fell 19% to $13.2 million primarily on lower costs for discovery research since Ardea is concentrating its resources on development of its gout candidate, RDEA594, which is in mid-stage study. The decrease was partially offset by

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Ardea Biosciences' Gout Drug Shows Promising Results  Positive results from phase II a and phase I trialsRDEA594 is Ardea Biosciences' (RDEA) lead drug candidate for the treatment of gout. The company recently announced positive interim results from an ongoing phase IIa, proof-of-concept study of RDEA594 for the treatment of hyperuricemia and gout, as well as additional positive results from completed phase I studies of RDEA594 in normal, healthy volunteers.In late April 2009, the company initiated a placebo- and active-controlled, proof-of-concept study of RDEA594 in gout patients with hyperuricemia (uric acid = 8 mg/dL). This study is now fully enrolled and the majority of the 20 patients have completed the first week of dosing. Patients received RDEA594 200 mg once daily (QD) for the first week, followed by 400 ...

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. 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 pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 12.06, -0.40 (-3.21%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for

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Shares of Savient Inc. (SVNT) jumped the most in eight months on Friday after US health regulators said the company's gout treatment appears to be effective.

Since it began reviewing the company's application last December, the Food and Drug Administration has already delayed a verdict regarding approval of the drug, Krystexxa, once. In its briefing memo before a panel meeting on Tuesday, the FDA said although it "does not dispute the efficacy" of the drug, it would focus its attention on safety issues.

Clinical trials of the drug have shown potential for deadly side effects like heart problems and allergic reactions. But FDA's Dr. Bob Rappaport said, "Because most of the patients developing the serious cardiovascular adverse events had other cardiovascular risk factors... there was uncertainty concerning whether the cardiovascular adverse events represent a genuine safety signal."

The FDA will now ask its advisory panel whether benefits

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Highlights include Ardea Biosciences (RDEA), Takeda Pharma (TKPHY) and Savient Pharma (SVNT). Ardea Biosciences gets positive results for RDEA594 for goutYesterday, at its annual investor and analyst event held in New York, biotech company Ardea Biosciences, Inc. (RDEA) announced positive results from a phase I study in normal, healthy volunteers of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, and a pilot phase IIa proof-of-concept study in gout patients of RDEA594's prodrug, RDEA806. RDEA594 is an inhibitor of URAT1, a transporter in the kidney that regulates uric acid excretion. RDEA806 is a prodrug of RDEA594 which is converted to RDEA594 in the body. Further data will be presented at an upcoming scientific conference.According to the company, a reduction of 45% from baseline (corrected for placebo) was observed after 10 days at the ...

Highlighted stocks include Regeneron Pharmaceuticals, Inc. (REGN), Sanofi-Aventis SA (SNY), AstraZeneca plc (AZN), Bayer AG (BAYRY) and Astellas Pharma Inc. (ALPMY).Fundamentals Remain StrongRegeneron reported 4th quarter financial results on Februay 26, 2009. Although total revenue and net loss fell short of our expectations due to fluctuations in R&D revenue quarter by quarter, Arcalyst sales in 4Q08 were in line with our estimate. The company's guidance of Arcalyst for 2009 is also in line with our expectation. Also, the company's balance sheet remains strong.Total revenues decreased to $55.8 million in the 4th quarter of 2008 from $64.7 million in the same quarter of 2007, and increased to $238.5 million for the full year 2008 from $125.0 million for the same period of 2007. The company's revenue was comprised of contract research and development revenue, technology licensing revenue, and net product sales.The Company shipped $10.7 million of Arcalyst ...

Ardea Biosciences, Inc.’s (RDEA) lead drug candidate is RDEA806 which is under phase II studies for HIV and phase I for gout. Another candidate is RDEA119 under phase I studies for cancer indications. We are concerned about the weak pipeline and early stage of development. Competition in the HIV and cancer markets, combined with the cash burn concern make us believe Ardea’s risk/reward is balanced. We maintain a Hold rating on the stock.

Ardea is still a development stage company. The company has been incurring operational losses since its inception. There is no product revenue currently, and the company depends on equity and debt financing to fund its drug research and development activities. We expect Ardea to continue to incur operating losses and not to receive any product revenue in the foreseeable future, other than milestone payments from Valeant research projects currently underway.

The management anticipates 2008 net cash usage

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