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FDA Calendar Updates: Anadys, Merck, Schering-Plough

Fri, 31 Jul 2009 01:05:36 GMT

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 289 entries as of 7/30/09. 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 respo (...)[More...]

Indices Snap Back Off Bottom of 3-Day Down-Channels

Thu, 08 Jan 2009 22:42:00 GMT

The stock market indices hit the bottom of their 3-day down-channels early in the morning and reversed, consolidated, and then rallied strongly into the close.[More...]

Biotechnology Industry - Zacks Analyst Interviews

Fri, 05 Dec 2008 12:44:00 GMT

Historically, the biotech industry was less impacted by market conditions due to its unique characteristics. In large part, biotech stocks have been event-driven. Specifically, investors are more focused on clinical development and pipeline advancement for individual biotech companies. However, current market conditions have exerted a negative impact on the valuation of individual companies in the biotech industry. We believe the different impact current market conditions have exerted is mainly due to the credit crunch. Most biotech companies are in early or middle development stages, and continuing financing is an integral part of their operations in order to advance their drug pipelines. Under current market conditions, liquidity has dried up for some companies, and raising capital has been extremely difficult in the past few months. Some companies are forced to enter into survival mode to reserve cash by restructuring. Some even have to suspend operations[More...]

Biotechnology Industry

Thu, 04 Dec 2008 20:05:00 GMT

Historically, the biotech industry has been less impacted by market conditions due to its unique characteristics. In large part, biotech stocks have been event-driven. Specifically, investors are more focused on clinical development and pipeline advancement for individual biotech companies. ? However, current market conditions have exerted a negative impact on the valuation of individual companies in the biotech industry. We believe the different impact current market conditions have exerted is mainly due to the credit crunch. Most biotech companies are in early or middle development stages, and continuing financing is an integral part of their operations in order to advance their drug pipelines. Under current market conditions, liquidity has dried up for some companies, and raising capital has been extremely difficult in the past few months. Some companies are forced to enter into survival mode to reserve cash by[More...]

Analyst Comments: Anadys Pharma, HealthSouth, Tractor Supply, State Auto Financial, ICICI Bank

Fri, 01 Aug 2008 16:28:00 GMT

Anadys Pharmaceuticals Inc. (ANDS) is currently rebuilding its pipeline after discontinuing the development of both its clinical compounds, ANA380 for hepatitis B virus (HBV) infection and ANA975 for both HBV and hepatitis C virus (HCV) infections. The company has undertaken a major restructuring program and will focus on the development of only two compounds, ANA598 for chronic HCV infection and ANA773 for certain cancers and HCV. We see a balanced risk/reward profile for the company and maintain our Hold rating. Based on encouraging preclinical results for ANA598, the company is focusing its resources on speeding up the clinical program and moving the compound into phase II trials by 2009. The increased focus on ANA598 translates into a longer development time for ANA773 and higher cash burn. We had previously expected a product launch to occur by 2009; now with both ANA975 and ANA380 gone, the latest the[More...]

Analyst Comments: Ciena Corp., Anadys, Coca-Cola, Jabil Circuit, Vertex Pharma, CRA International, Ferrellgas, Soapstone

Fri, 06 Jun 2008 20:19:19 GMT

Ciena Corp. (CIEN) reported strong margins in the first half of FY 2008, and looks poised to maintain this throughout the year. Its FlexSelect products allow carriers to transition networks to carrier grade Ethernet, one of the fastest-growing technologie[More...]

Analyst Comments: AMERCO, Baker Hughes, LoopNet, Grey Wolf, Anadys Pharmaceuticals, Kyocera, Varco, Alvarion, Alexion

Fri, 02 May 2008 14:07:27 GMT

AMERCO, Inc. (UHAL) is the parent company of U-HAUL International, the largest consumer truck rental company in the world. It is also the second largest self-storage company in N. America. Unprecedented number of calamities led to marketing opportunities.[More...]

Rhyme Nor Reason

Thu, 21 Feb 2008 13:23:12 GMT

Good morning. We start the day with a positive bias. Rallies in overseas markets, more speculation concerning worldwide bank rescues, a little M&A activity, some buying interest in technology (CSCO, RIMM, HPQ), and falling jobless claims are this morning'[More...]

Jobs Report - Jan 4 2008 10:29AM

Fri, 04 Jan 2008 14:24:00 GMT

Good morning. A weaker than expected jobs report showing only 18,000 jobs and a higher unemployment rate at 5% have set a negative tone for the market. Although expectations for a friendly Fed will likely increase, so will anticipation for recession. At 10:AM we have ISM non-manufacturing survey. [More...]

Analyst Comments: Borg Warner, Vimpel-Communications, Anadys Pharmaceuticals, Procter & Gamble, UDR Inc

Thu, 03 Jan 2008 14:31:48 GMT

An update with a major cut in the price target has come out on Borg Warner, Inc. (BWA), in which senior auto industry analyst Paul Raman, CFA maintains his cautious approach and reaffirms the Hold rating on the company. We excerpted the following details:'Borg Warner is expected to benefit from the growing demand for its strong technology-based...[More...]

Las Vegas Sands, Disney, UBS, Ford are big movers

Fri, 31 Jul 2009 22:08:00 GMT

NEW YORK - Stocks that were moving substantially or trading heavily Friday on the New York Stock Exchange and Nasdaq Stock Market.
Analysts said traffic was slowing at casinos and cited concerns about the company's capital position after it posted a quarterly loss.
Ford Motor Co., up 61 cents at $8

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SAIC, KeyCorp, Textron, UAL are big movers

Thu, 04 Jun 2009 21:47:00 GMT

NEW YORK - Stocks that moved substantially or traded heavily Thursday on the New York Stock Exchange and Nasdaq Stock Market:
Intel Corp. is buying the software maker for $884 million in cash, or $11.50 a share, to help the chip giant diversify beyond PCs.
Odyssey Marine Exploration Inc., down $1.66 at $2.21

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ANA773 Demonstrates Significant Antiviral Response in Early Clinical Trial in Hepatitis C Patients

Tue, 11 Aug 2009 11:25:00 GMT

Anadys Pharmaceuticals, Inc. today announced viral load data for the final cohort of hepatitis C patients in a Phase I clinical trial of ANA773, the Company's oral inducer of endogenous interferons that acts via the toll-like receptor 7 pathway. In patients who received 2000 mg ANA773 every other day over 10 days, the mean maximal decline in viral load was 1.3 log10, compared to a mean maximal decline of 0.3 log10 in patients who received placebo . Five of the eight patients who received 2000 mg ANA773 experienced a maximal decline of greater than 1 log, while none of the eight patients who received placebo experienced a decline of greater than 1 log . The mean end-of-treatment decline was 0.6 log10 in patients who received 2000 mg ANA773 compared to 0.1 log10 in patients who received placebo. ANA773 was well-tolerated in patients throughout the course of the study and there were no serious adverse events reported.[More...]

Anadys Pharmaceuticals Reports Second Quarter 2009 Financial Results and Program Highlights

Thu, 30 Jul 2009 20:05:00 GMT

Anadys Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C, today reported its financial results and program highlights for the second quarter ended June 30, 2009.[More...]

Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients

Thu, 30 Jul 2009 20:01:00 GMT

Anadys Pharmaceuticals, Inc. today announced finalization of the protocol for the Company's Phase II trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance of the protocol has been received from the United States Food and Drug Administration , and patient dosing is expected to commence within the next several weeks.[More...]

Anadys Pharmaceuticals to Report Second Quarter 2009 Financial Results

Thu, 23 Jul 2009 20:02:00 GMT

Anadys Pharmaceuticals, Inc. announced today that it will report second quarter 2009 financial results on Thursday, July 30, 2009, after the U.S. financial markets close.Anadys will hold a conference call and webcast on Thursday, July 30, 2009 at 5:00 p.m. Eastern Daylight Time to discuss its second quarter 2009 financial results and highlights and to provide an update on its development programs. A live webcast of the call will be available online at www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 or 617-801-6888 , passcode 85411914. The webcast and telephone replay will be available through August 13, 2009.About AnadysAnadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines. The Company is developing ANA598, a non-nucleoside polymerase inhibitor for the treatment of hepatitis C. The Company has also investigated the potential of ANA773, an oral, small-molecule inducer of endogenous interferons that acts via the Toll-like receptor 7, or TLR7, pathway in hepatitis C. Safe Harbor Statement Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to Anadys' strategy, development programs, and ability to develop novel medicines for the treatment of hepatitis C. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. For example, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 or ANA773 will not have unforeseen safety issues, will have favorable results in ongoing or future clinical trials or will receive regulatory approval. Risk factors that may cause actual results to differ are discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2008 and the Current Report on Form 8-K filed on June 4, 2009. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.[More...]

Anadys Pharmaceuticals, Inc. Announces Pricing of Common Stock and Warrant Offering

Thu, 04 Jun 2009 13:50:00 GMT

SAN DIEGO, June 4 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. announced that it has entered into definitive agreements with institutional investors to raise approximately $17.5 million in gross proceeds in a "registered direct" offering through the sale of shares of its common stock and warrants.
The shares of common stock and warrants are immediately separable and will be issued separately.
In addition, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 will not have unforeseen safety issues, will have favorable results in future clinical trials, will maintain fast track designation or will receive regulatory approval.

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Anadys Pharmaceuticals, Inc. Announces Strategic Restructuring to Focus Operations on Continuing the Advancement of ANA598

Thu, 04 Jun 2009 13:21:00 GMT

Anadys Pharmaceuticals, Inc. Announces Strategic Restructuring to Focus Operations on Continuing the Advancement of ANA598[More...]

Anadys Pharmaceuticals Reports First Quarter 2009 Financial Results and Highlights

Thu, 23 Apr 2009 20:01:00 GMT

Anadys Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology, today reported its financial results and highlights for the first quarter ended March 31, 2009.[More...]

ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients

Thu, 23 Apr 2009 15:02:00 GMT

Data Being Presented Today at 44th Annual Meeting of EASL[More...]

Anadys Pharmaceuticals to Report First Quarter 2009 Financial Results

Fri, 17 Apr 2009 22:24:00 GMT

Anadys Pharmaceuticals, Inc. announced today that it will report first quarter 2009 financial results on Thursday, April 23, 2009, after the U.S. financial markets close.[More...]

Anadys Pharmaceuticals to Present at the CanAccord Adams Hepatitis C Conference - Mar 31 2009 4:37PM

Tue, 31 Mar 2009 20:00:00 GMT

Anadys Pharmaceuticals, Inc. announced today that it will present at the CanAccord Adams Hepatitis C Conference on Tuesday, April 7, 2009 at 2:00 p.m. EDT . The conference is being held at the InterContinental The Barclay Hotel in New York City.[More...]