As futures for the Dow Jones industrial average, the S&P 500 and the Nasdaq 100 are all pointing to a higher opening on Monday, it's important to note that we are starting a busy week of earnings, and that could be a mixed bag for traders and investors. Last week, the five day trading stretch ended with some drops in stock prices among some familiar names.
Let's begin with Acorda Therapeutics (NASDAQ:ACOR) whose shares dropped -21.36%, after the U.S. Food and Drug Administration (FDA) posted on its website briefing documents for the Peripheral and Central Nervous System Drugs Advisory Committee meeting to review Acorda’s New Drug Application (NDA) for Fampridine-SR for the proposed indication of improvement of walking ability in people with multiple sclerosis (MS).
As subscribers to the FDA Calendar know, the Prescription Drug User Fee Act (PDUFA) action date for the Fampridine-SR NDA is October 22, 2009 and some analysts weighed in on Friday about the company:
Lazard Capital expects the FDA panel to recommend approval of Acorda's Fampridine- SR and would be a buyer of the stock ahead of meeting. The firm believes the company is well prepared for the safety questions and the firm has reiterated a "Buy" rating on the stock. Analysts at Leerink Swann believe that the "hate selling" has happened as expected, but the firm said its confidence in Acorda is "waning" although it is maintaining an Outperform rating on the stock. Analysts at Deutsche Bank, the FDA documents appear to be positive and the firm noted that the FDA does not appear to be worried about Amaya leading to an MS relapse. The firm maintains it's "Buy" rating on Acorda.
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Shares of Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) tumbled -18% after the company said the FDA wants more information and to meet with the company about its request to approve its Fusilev drug for additional patients.That news took most investors and analysts by surprise. It will be interesting to see if share prices have hit bottom of if a downward slide will continue.
The FDA stated in the Complete Response letter that the submission did not demonstrate that FUSILEV is non-inferior to leucovorin; and recommended that the Company meet with them to discuss options for continuing to seek approval of FUSILEV in advanced metastatic colorectal cancer.
The Company plans to promptly request such meeting to discuss options for FUSILEV in this indication.
Cytori Therapeutics Inc. (NASDAQ:CYTX), a company, engaged in the development and commercialization of some very promising stem and regenerative cell therapies for the treatment of cardiovascular disease, and reconstructive surgery had shares close at $3.58-0.16 (-4.28%). We are seeing a recent pullback in stem cell stocks is testing the 2009 uptrend's support. Late last month, some of the leaders in stem cell research met in Baltimore for the 2009 World Stem Cell Summit, but despite three days of presentations and panel discussions, no one had any news or developments that has investors excited about stem cell stocks.
Until the FDA starts approving some of these Stem Cell technologies, the sector may be flat with the exception of companies who are not just draining cash from investors- like the stem cell sector's profit leader, Cryo-Cell International, Inc. (OTC: CCEL). That company- profiled in my article here- keeps striking very positive development and partnership deals and is busy expanding their market reach into places like China. Best of all, their share float is very low.
Shares of Novavax, Inc. (NASDAQ:NVAX) finally closed up at $4.02 +0.51 (14.53%) after a long losing streak. Some investors attributed the spike on Friday to news out of New Delhi that "Animal trials for the H1N1 vaccine have started." Rajeev M Dhere, Senior Director, Serum Institute of India, told the press in that country: "We hope to finish the animal trials by November end or December first week and begin human trials thereafter." All clinical trials for the vaccine are expected to end by February, he said. Although he did not mention the names of the companies behind the vaccines, India is rumored to be one country interested in Novavax's flu vaccine technology platform.
At the same time, other swine flu stocks may begin to rise here at home after the CDC issued an update on the status of the flu season here in the USA, saying "During the week of Sept 27 - Oct 3, 2009, a review of the key indictors found that influenza activity increased in the US. Visits to doctors for influenza-like illness continued to increase in the US, and overall, are higher than levels expected for this time of the year. More on that story, including video from the CDC's press conference can be found at BioMedReports.
Here is a look at the rest of the winners and losers in last week's healthcare sector:
|Gainers (% price change)
|Sunrise Senior Living
|K-V Pharmaceutical Co.
Losers (% price change)
|Acorda Therapeutics Inc.
|Cantel Medical Corp.
|Cytori Therapeutics Inc
|NPS Pharmaceuticals, Inc.
Most Actives (dollar volume)
|Johnson & Johnson
|Merck & Co., Inc.
Disclosure: Long SPPI
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