4 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.
While not many drug approval decisions are expected in February, 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. Some of the dates are subject to change as regulators delay their decisions.
Hemispherx BioPharma (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 on Minyanville: 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.
Celgene (CELG) expects to hear from the FDA on the possible approval of Pomalyst (pomalidomide) to treat multiple myeloma. CEO Robert Hugin predicted the drug will be a blockbuster product for the big biotech company. (See on Minyanville: Celgene Rises After CEO Hugin Touts New Drugs, Sales Growth.)
The BIO CEO & Investor Conference takes place in New York February 11-12. The event features presentations by dozens of pharmaceuticals and biotechs. 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 (LLY), Onyx Pharmaceuticals (ONXX), Gilead Sciences (GILD), and BioMarin Pharmaceutical (BMRN).
The Genitourinary Cancers Symposium runs February 14-16 in Orlando, Florida. This conference of the American Society of Clinical Oncology will highlight treatments for prostate, kidney, bladder and other cancers. Medivation (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.
Dynavax Technologies (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 on Minyanville: Dynavax Technologies' Stock Plunges on Vaccine Safety Concern.) Dynavax has said the market for a hepatitis B vaccine is $700 million per year. Merck (MRK) and GlaxoSmithKline (GSK) currently have products on the market.
ImmunoGen (IMGN) and Roche (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 on Minyanville: ImmunoGen Shares Drop on Roche Drug Royalty Payments.)
Other potential events to watch in February:
Diet pill maker Arena Pharmaceuticals (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 (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 (TEVA) is trying to convince the agency to reject the Biogen drug. (See on Minyanville: Teva Aims to Derail Approval of Biogen Idec's MS Pill.)
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