Sorry!! The article you are trying to read is not available now.
Thank you very much;
you're only a step away from
downloading your reports.

Exelixis, Celgene, Gilead Sciences, Dynavax See Key Dates in November


FDA panels and a first look at data from a blood disease conference should move stocks during the month. An approval decision on Exelixis' cancer drug is expected by the end of the month.

MINYANVILLE ORIGINAL Pharma and biotech investors can expect a number of stock catalysts in November, including Food and Drug Administration advisory panels and a first peak at scientific abstracts for a major medical meeting in December.

The following is a list of some highlights for the month. As always, a number of dates are subject to change.

November 1
Hurricane Sandy prompted some companies, including Pfizer (NYSE:PFE), Onyx Pharmaceuticals (NASDAQ:ONXX), and Vertex Pharmaceuticals (NASDAQ:VRTX) to delay reporting quarterly results until Thursday. Vertex and Onyx plan to release results after markets while Pfizer is expected to report in the morning.

Also, Medivation (NASDAQ:MDVN) partner Astellas reports earnings, which should give investors a sense of how prostate cancer drug Xtandi is selling after its recent launch.

November 2
GlaxoSmithKline (NYSE:GSK) is scheduled to go before an FDA advisory committee that will consider the company's market application for raxibacumab, a treatment for inhaled anthrax. The therapy was developed by Human Genome Sciences, which Glaxo acquired earlier this year. Click here for the meeting's briefing documents.

Dendreon (NASDAQ:DNDN), maker of the prostate cancer vaccine Provenge, rescheduled its quarterly results release to Friday due to the storm.

November 5
Scientific abstracts for the December meeting of the American Society of Hematology will be posted online. Among the companies presenting data for their blood disease treatments at the annual meeting are Celgene (NASDAQ:CELG), Gilead Sciences (NASDAQ:GILD), ImmunoGen (NASDAQ:IMGN), and Seattle Genetics (NASDAQ:SGEN). Other stocks to watch, according to RBC Capital Markets analysts: Pharmacyclics (NASDAQ:PCYC), Infinity Pharmaceuticals (NASDAQ:INFI), and Spectrum Pharmaceuticals (NASDAQ:SPPI).

November 8
Novo Nordisk (NYSE:NVO) faces an FDA panel as it tries to win US approval for a pair of insulin products for the treatment of diabetes. Investors were spooked last week after the FDA disclosed that the meeting would focus on the cardiovascular risk of the products. The US shares of the Denmark company dropped last Thursday.

November 15
Dynavax Technologies (NASDAQ:DVAX) faces an advisory committee of the FDA that will review Heplisav for hepatitis B. Heplisav is a vaccine and Dynavax says the market for such vaccines is $700 million a year. Merck (MRK) and Glaxo already have approved vaccines. Dynavax shares are up 25% this year.

November 28
Johnson & Johnson (NYSE:JNJ) will go before an FDA advisory panel as it tries to win approval for the drug bedaquiline for tuberculosis. The FDA granted the drug application a priority review. The medicine aims to treat multi-drug resistant pulmonary tuberculosis.

November 29
Theravance (NASDAQ:THRX) will present before a panel of FDA advisers reviewing Vibativ for treatment of pneumonia contracted by hospital patients.

Exelixis (NASDAQ:EXEL) expects word from the FDA on possible approval of cabozantinib for treatment of thyroid cancer. The experimental therapy was granted a priority review from the US agency. The company is testing the drug for a number of cancers, including prostate, which is where much of the investor interest lies.

Twitter: @brettchase

Follow the markets all day every day with a FREE 14 day trial to Buzz & Banter. Over 30 professional traders share their ideas in real-time. Learn more.
< Previous
  • 1
Next >
No positions in stocks mentioned.
The information on this website solely reflects the analysis of or opinion about the performance of securities and financial markets by the writers whose articles appear on the site. The views expressed by the writers are not necessarily the views of Minyanville Media, Inc. or members of its management. Nothing contained on the website is intended to constitute a recommendation or advice addressed to an individual investor or category of investors to purchase, sell or hold any security, or to take any action with respect to the prospective movement of the securities markets or to solicit the purchase or sale of any security. Any investment decisions must be made by the reader either individually or in consultation with his or her investment professional. Minyanville writers and staff may trade or hold positions in securities that are discussed in articles appearing on the website. Writers of articles are required to disclose whether they have a position in any stock or fund discussed in an article, but are not permitted to disclose the size or direction of the position. Nothing on this website is intended to solicit business of any kind for a writer's business or fund. Minyanville management and staff as well as contributing writers will not respond to emails or other communications requesting investment advice.

Copyright 2011 Minyanville Media, Inc. All Rights Reserved.
Featured Videos