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Lower Q3 Loss for Regeneron – Analyst Blog

Zacks Market Commentaries (November 9th, 2009) Writes:
Regeneron Pharmaceuticals Inc. (REGN) reported a third-quarter net loss of $1.015 million, or 1 cent per share, which was much better than the Zacks Consensus Estimate of a loss of 23 cents. The company suffered a loss of $19.084 million or 24 cents in the year-ago quarter. The narrower loss reflected the increased contract research and development revenues from its collaborations with Sanofi-Aventis (SNY) and Bayer HealthCare, coupled with a milestone payment from Bayer. Total revenues for the quarter came in at $117.45 million from $65.58 million, up 79%. Total revenues consisted of contract research and development revenues, a 2009 research progress payment, technology licensing revenues apart from net product sales. Revenues from contract research and development increased 56% to $82.48 million from $52.88 million in the year-ago quarter. Contract research and development revenues relate primarily to Regeneron’s aflibercept and antibody collaborations with Sanofi-Aventis ...

Regeneron Enrolls for Studies – Analyst Blog

Zacks Market Commentaries (September 24th, 2009) Writes:
Last week, Regeneron Pharmaceuticals, Inc. (REGN) announced the completion of enrollment in two late stage studies of its VEGF (vascular endothelial growth factor) trap-eye treatment for age-related macular degeneration (wet AMD), a leading cause of blindness in adults. Each of the randomized, double-masked trials has enrolled more than the target of 1,200 patients. The company is developing the drug in partnership with Bayer HealthCare (BAYRY.PK). The study will be a non-inferiority comparison of the VEGF trap-eye with ranibizumab (Lucentis from Genentech, Inc- now a wholly owned subsidiary of the Roche group (RHHBY.PK)), an anti-angiogenic agent approved for use in wet AMD. The company expects one-year primary endpoint data from both studies in the fourth quarter of 2010. As a reminder, Regeneron and Bayer HealthCare entered into a collaboration agreement in Oct 2006 for the development and commercialization of the VEGF trap-Eye outside ...

FDA, Clinical Trial Updates: ADLS, CLDA, GENZ, ISTA, Theratech

Bullish Bankers (June 10th, 2009) Writes:

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.

Clinical Data [CLDA: 11.83, -0.23 (-1.91%)] announced positive top-line results on 6/2/09 from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary

...

Biotech Industry – Zacks Analyst Interviews

Zacks Market Commentaries (June 1st, 2009) Writes:
OVERVIEW

The Biotech industry as a whole continues to underperform the market so far this year. As of May 26, 2009, Both the AMEX Biotech Index and the broader NASDAQ Biotech Index declined 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies), while the Dow Jones Biotech Index declined 3% (which includes 33 companies).

At the same time, both the NASDAQ Composite and S&P 500 have achieved positive returns. NASDAQ has made a gain of 11% as of 5/26/09 and the S&P 500 has gained 0.8%, while the Dow Jones Industrials reached a negative 3.5% return.

This constitutes a sharp contrast with last year when the Biotech industry as a whole achieved much better performance than the market. In 2008, all three biotech indices outperformed all three major market indices by a large margin. The three major indices declined as much as over 40% (34%, 41%

...

Biotech Industry – Industry Outlook

Zacks Market Commentaries (May 29th, 2009) Writes:
OVERVIEWThe Biotech industry as a whole continues to underperform the market so far this year. As of May 26, 2009, Both the AMEX Biotech Index and the broader NASDAQ Biotech Index declined 6.8% (AMEX Biotech has 20 biotech companies while NASDAQ Biotech Index includes over 130 component companies), while the Dow Jones Biotech Index declined 3% (which includes 33 companies).At the same time, both the NASDAQ Composite and S&P 500 have achieved positive returns. NASDAQ has made a gain of 11% as of 5/26/09 and the S&P 500 has gained 0.8%, while the Dow Jones Industrials reached a negative 3.5% return.This constitutes a sharp contrast with last year when the Biotech industry as a whole achieved much better performance than the market. In 2008, all three biotech indices outperformed all three major market indices by a large margin. The three major indices declined ...

Zacks Analyst Blog Highlights: BP, Exxon, Chevron, Ardea Biosciences, Inc. and Bayer HealthCare. – Press Releases

Zacks Market Commentaries (April 29th, 2009) Writes:
For Immediate Release

Chicago, IL - April 29, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: BP (BP), Exxon (XOM), Chevron (CVX), Ardea Biosciences, Inc. (RDEA) and Bayer HealthCare (BAYRY).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Tuesday's Analyst Blog:

BP Beats on Better Cost Controls

London-based BP's (BP) first-quarter results came in better than expected on the back of stronger cost controls. Compared to the year-earlier level, weak commodity prices offset the impact of increased oil and natural gas production and lower costs.

BP's

...

Ardea Lands Bayer Partnership – Analyst Blog

Zacks Market Commentaries (April 28th, 2009) Writes:
Ardea Biosciences' balance sheet gets boosted by Bayer partnershipEarly this morning in a news release, Ardea Biosciences, Inc. (RDEA) announced that it has entered into a global agreement with Bayer HealthCare (BAYRY) to develop Ardea's small molecule mitogen-activated ERK kinase (MEK) inhibitors for the treatment of cancer or other indications. The current focus will be on cancers.Pursuant to the agreement, Ardea will grant Bayer a worldwide, exclusive license to develop and commercialize Ardea's MEK inhibitors for all indications. The agreement is valued at $407 million, not including royalties. This amount includes an upfront cash payment to Ardea of $35 million, as well as additional cash payments upon achievement of certain development, regulatory and sales-based milestones. Ardea is also eligible to receive low double-digit royalties on sales of products under the agreement.The lead compound in this program is RDEA119, which is currently ...

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