MINYANVILLE ORIGINAL There’s plenty to keep biotechnology and drug company investors busy this holiday season: New study data, potential marketing approvals, panel reviews, and maybe even a quarterly dividend increase from the big gorilla of biotech.
Below are a number of highlights for the month of December. As always, some dates are subject to change.
The San Antonio Breast Cancer Symposium
is held through December 8. The latest treatment, diagnosis, and prevention of breast cancer is the focus of this annual event. Roche
(NASDAQ:GERN), Puma Biotechnology
(NASDAQ:PBYI), and Galena Biopharma
(NASDAQ:GALE) are among companies presenting study data.
(NASDAQ:ZGNX) faces a panel
of Food and Drug Administration expert advisers who will make a recommendation regarding possible approval of Zohydro ER, an extended-release treatment for chronic pain. The FDA is expected to make a decision on market clearance of the drug by March 1.
The American Society of Hematology
meets through December 11 in Atlanta. This big medical meeting focused on blood diseases will feature study data from many companies, including Pfizer
(NASDAQ:CELG), Seattle Genetics
(NASDAQ:SGEN), Gilead Sciences
(NASDAQ:IMGN), Infinity Pharmaceuticals
(NASDAQ:INFI), and Ariad
(NASDAQ:ARIA). There will be a great deal of investor focus on Celgene’s study data for pomalidomide as a treatment for multiple myeloma.
(NYSE:GSK) expects a US approval decision on raxibacumab for the treatment of inhaled anthrax. The drug was developed by Human Genome Sciences, which Glaxo acquired earlier this year.
(HEB) faces an advisory committee
of the FDA that will review the drug Ampligen for chronic fatigue syndrome.
(NASDAQ:ALXA) awaits word from the FDA on possible approval of Adasuve for agitation in patients with schizophrenia or bipolar disorder. In May, the FDA rejected the drug, citing manufacturing problems at a plant. The drug was first rejected by the agency in 2010. The stock has had a bumpy ride and is down by about half over the past 12 months.
(NASDAQ:NPSP) is scheduled to hear from FDA on its market application for Gattex, a treatment for short bowel syndrome. In October, FDA advisers voted to recommend approval. The drug aims to treat a condition that robs people of their ability to absorb nutrients or fluids.
Also in December:
Johnson & Johnson
(NYSE:JNJ) should find out middle of the month whether its drug Zytiga will be cleared for use
in prostate cancer patients who have not been treated with chemotherapy. The drug already is approved for patients in later stages of the disease. J&J’s news will also be important to rival Medivation
(NASDAQ:MDVN) and its partner Astellas and their prostate cancer drug Xtandi.
RBC Capital Markets analyst Michael Yee says he expect the board of Amgen
(NASDAQ:AMGN), the world’s largest biotech drug maker, to raise the company’s quarterly dividend around the middle of the month. Look for at least a 30% increase from the current 36 cents a share, Yee says.
(NASDAQ:VRTX) is expected to disclose mid-stage study data for its experimental flu drug.
(NASDAQ:BIIB) should disclose in December (or January) late-stage study data for the company’s experimental treatment for Lou Gehrig’s Disease.
There should be news from Amarin
(NASDAQ:AMRN) in the first half of the month on whether it will sell its newly approved heart drug Vascepa alone or with a partner. The company also awaits word from the FDA on market exclusivity of its product, a pure fish-oil treatment.
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.