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Acorda Therapeutics, Corp. Executive Board, Amazon.com, Pearson Plc and John Wiley & Sons – Press Releases

Zacks Market Commentaries (May 7th, 2009) Writes:
For Immediate Release

Chicago, IL - May 7, 2009 - Zacks Equity Research picks Acorda Therapeutics, Inc. (ACOR) as Bull of the Day and The Corporate Executive Board (EXBD) as Bear of the Day. In addition, the analysts at Zacks Equity Research discuss the latest on Amazon.com (AMZN), Pearson Plc (PSO) and John Wiley & Sons (JW.A).

Full analysis of all these stocks is available at: http://at.zacks.com/?id=2678

Bull of the Day

Acorda Therapeutics, Inc. (ACOR) received some very good news on May 6, 2009 when the U.S. FDA informed the company that the new drug application (NDA) for Fampridine-SR was accepted. The news comes only two weeks after the re-filing of the NDA on April 23, 2009.

However, the biggest surprise with the acceptance off the NDA was that the FDA also granted Acorda a priority review for the application. We note this was an independent decision by

...

Acorda Therapeutics (ACOR) – Bull of the Day

Zacks Market Commentaries (May 7th, 2009) Writes:
Acorda Therapeutics, Inc. (ACOR) received some very good news on May 6, 2009 when the U.S. FDA informed the company that the new drug application (NDA) for Fampridine-SR was accepted. The news comes only two weeks after the re-filing of the NDA on April 23, 2009.

However, the biggest surprise with the acceptance off the NDA was that the FDA also granted Acorda a priority review for the application. We note this was an independent decision by the FDA, as Acorda did not specifically ask for a priority review.

Clearly this is another very good sign and proves that the FDA views MS walking disability as a significant unmet medical need, with Fampridine-SR as potentially a breakthrough product for its treatment. The PDUFA action date has been set for October 22, 2009. Zacks Investment Research

Zacks Analyst Blog Highlights: The Coca-Cola Company, Acorda Therapeutics, Inc., Royal Caribbean, United Parcel Service, Inc. and Robert Half International Inc. – Press Releases

Zacks Market Commentaries (April 24th, 2009) Writes:
For Immediate Release

Chicago, IL - April 24, 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: The Coca-Cola Company (KO), Acorda Therapeutics, Inc. (ACOR), Royal Caribbean (RCL), United Parcel Service, Inc. (UPS) and Robert Half International Inc. (RHI).

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 Thursday's Analyst Blog:

Coca-Cola Gets Innocent

The Coca-Cola Company (KO) is investing £30 million ($44 million) for a minority stake of between 10% and 20% in Innocent Drinks, a U.K.-based maker of fruit smoothies. Innocent sells about 2 million smoothies a

...

Buy-Rated ACOR Resubmits NDA – Analyst Blog

Zacks Market Commentaries (April 23rd, 2009) Writes:
Buy Rated Acorda Resubmits Fampridine-SR NDAThis morning, Acorda Therapeutics, Inc. (ACOR) announced it had resubmitted a New Drug Application (NDA) for Fampridine-SR to the U.S. FDA. Fampridine-SR is a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS).We remind investors that Acorda received a Refuse to File (RTF) letter for the Fampridine-SR NDA on March 30, 2009, which cited the need to correct "format issues" and requested additional supporting information on a fed/fasting study before the NDA could be accepted for review. Acorda management held subsequent discussions with the FDA, and now believes the filing this morning addresses all the outstanding issues with the RTF letter.Acorda's stock was punished hard in late March 2009 on the news that the NDA was rejected with an RTF letter. At that time, we advised investors to use the significant sell-off ...

Take Advantage of Acorda Sell-Off – Analyst Blog

Zacks Market Commentaries (April 1st, 2009) Writes:
On March 31, 2009, Acorda Therapeutics Inc. (ACOR) received a "refuse to file" (RTF) letter from the U.S. FDA regarding its new drug application (NDA) for Fampridine-SR, the company's novel therapy designed to improve walking ability in people with multiple sclerosis (MS).According to management, the FDA raised three issues in the RTF letter. The first issue raised by the FDA notes a "format issue" regarding the electronic common technical document (eCTD) submission, and requested that some of the data in the filing be reformatted.The FDA also asked Acorda for additional data relating to a fed/fasting study and some analytical information from the clinical program on Fampridine-SR. Our best guess is that management can compile the necessary fed/fast and analytical data and re-file the NDA in six months. Management plans to meet with the FDA sometime in the next 30 days to discuss the RTF ...

Acorda Down on FDA Delay – Analyst Blog

Zacks Market Commentaries (March 31st, 2009) Writes:
This morning, Acorda Therapeutics (ACOR) received a "refuse to file" (RTF) letter from the U.S. FDA regarding its new drug application (NDA) for Fampridine-SR, the company's novel therapy designed to improve walking ability in people with multiple sclerosis (MS).According to management on the conference call this morning, the FDA raised 3 issues in the RTF letter. The first issue raised by the FDA notes a "format issue" regarding the electronic common technical document (eCTD) submission and requested that some of the data in the filing be reformatted.This could be as simple as font or margin issues to as tedious as re-working a data presentation. On the conference call, CEO Ron Cohen noted the issue pertained to only a part of the filing.The FDA also asked Acorda for additional data relating to a fed/fasting study and some analytical information from the clinical program ...

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