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.

Four Closely Watched Drug Decisions Loom in February


The month also features a big gathering of biotech CEOs in New York and a cancer research meeting in Florida.

Mark these dates on your calendars before you slog through the frigid month of February. There are a number of important catalysts for drug and biotech investors in the month.

There aren't a lot of expected drug approval decisions in February, but there are some high-profile treatments facing key dates. There's also a big gathering of biotech CEOs in New York and a cancer research meeting in Florida. Expect news from both events.

Below are some of the highlights for drug and biotech investment events in the month of February. As always, some dates are subject to change.

February 2
Hemispherx BioPharma (NYSEAMEX:HEB) is scheduled to hear from the Food and Drug Administration on potential market clearance for Ampligen, a treatment for chronic fatigue syndrome. A panel of expert advisers to the FDA voted last month that Ampligen should not be approved because the company hadn't clearly demonstrated the drug works. That panel was preceded by a harsh report from FDA staffers who rapped Hemispherx for its clinical data. (See also: Hemispherx Chronic Fatigue Drug Scrutinized Ahead of Panel Review.) Note that the decision date is Saturday. Be on the lookout for news Friday, February 1.

February 10
Celgene (NASDAQ:CELG) expects to hear from the FDA on the possible approval of Pomalyst (pomalidomide) to treat multiple myeloma. CEO Robert Hugin predicts the drug will be a blockbuster product for the big biotech company. (See also: Celgene Rises After CEO Hugin Touts New Drugs, Sales Growth.)

February 11
The BIO CEO & Investor Conference takes place in New York through February 12. The event features presentations by dozens of companies. CEOs from several companies will be in the spotlight during public interviews with industry analysts. They include Celgene's Hugin as well as chiefs from Eli Lilly (NYSE:LLY), Onyx Pharmaceuticals (NASDAQ:ONXX), Gilead Sciences (NASDAQ:GILD), and BioMarin Pharmaceutical (NASDAQ:BMRN).

February 14
The Genitourinary Cancers Symposium runs through February 16 in Orlando, Florida. Treatments for prostate, kidney, bladder, and other cancers will be highlighted at this conference of the American Society of Clinical Oncology. Medivation (NASDAQ:MDVN) and partner Astellas Pharma will attract considerable attention with updated study data on the prostate cancer drug Xtandi. The research findings on Xtandi in early stage prostate cancer patients will be particularly important.

February 24
Dynavax Technologies (NASDAQ:DVAX) is scheduled to hear from the FDA on an application to sell Heplisav, an adult vaccine for hepatitis B. Shares of the company plummeted in November after a government panel review raised questions about the product's safety. (See also: Dynavax Technologies' Stock Plunges on Vaccine Safety Concern.) Dynavax has said the market for a hepatitis B vaccine is $700 million per year. Merck (NYSE:MRK) and GlaxoSmithKline (NYSE:GSK) currently have products on the market.

February 26
ImmunoGen (NASDAQ:IMGN) and Roche (PINK:RHHBY) expect a decision from the FDA on the breast cancer treatment trastuzumab emtansine, T-DM1. The drug combines ImmunoGen's chemotherapy with Roche's Herceptin. While Wall Street analysts expect the treatment to be approved, some investors were miffed that ImmunoGen didn't sign a better agreement with Roche. (See also: ImmunoGen Shares Drop on Roche Drug Royalty Payments.)

Other potential events to watch in February:
Diet pill maker Arena Pharmaceuticals (NASDAQ:ARNA) is still awaiting word from the Drug Enforcement Administration for scheduling of the drug Belviq. The DEA needs to classify the drug because of risk for abuse.

Biogen Idec (NASDAQ:BIIB) is scheduled to hear from the FDA by late March on approval of its multiple sclerosis pill, Tecfidera. But the agency may make a decision earlier given that it's already delayed a ruling on the drug once. One complication: Rival Teva Pharmaceutical Industries (NYSE:TEVA) is trying to convince the agency to reject the Biogen drug. (See also: Teva Aims to Derail Approval of Biogen Idec's MS Pill.)

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