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.
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.
(NASDAQ:MDVN) partner Astellas reports earnings, which should give investors a sense of how prostate cancer drug Xtandi is selling after its recent launch.
(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.
(NASDAQ:DNDN), maker of the prostate cancer vaccine Provenge, rescheduled its quarterly results release to Friday due to the storm.
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: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
(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.
(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.
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.
(NASDAQ:THRX) will present before a panel of FDA advisers
reviewing Vibativ for treatment of pneumonia contracted by hospital patients.
(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.
No positions in stocks mentioned.
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