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.

Vivus Awaits Decisions on Two Drug Approvals in April


Also expect an FDA rejection for Amgen, hepatitis C study data and watch those cancer drug stocks this month.

April is a big month for biotech company Vivus (VVUS), which expects market approval decisions on two separate drugs -- one for obesity and another for erectile dysfunction.

Elsewhere, medical conferences will give investors a window into the progress of clinical-stage treatments. The list below highlights some significant events this month for drug and biotech companies. In certain cases, the dates are subject to change.

April 4
Scientific abstracts for a major liver disease conference in Europe will be released. Investors in Gilead Sciences (GILD), Vertex Pharmaceuticals (VRTX), Bristol-Myers Squibb (BMY), Merck (MRK), Idenix Pharmaceuticals (IDIX), and other hepatitis C drug developers will want to pay attention to this data. The conference is the International Liver Congress sponsored by the European Association for the Study of the Liver.

April 14
The annual meeting of the American Association of Neurological Surgeons takes place in Miami. Brain cancer treatments will be featured among the scientific presentations. Shares of Agenus (AGEN) are rising Monday after the company said it will present data for study of its vaccine for a type of brain cancer.

April 17
Vivus is expected to hear word from the Food and Drug Administration on possible approval of the diet drug Qnexa. This is a second try for Vivus and the company's drug was backed by a panel of FDA expert advisers in February. Shares of the company more than doubled since that positive endorsement. Still, this decision will depend on the FDA's comfort level with safety concerns. Diet pills are a sensitive issue because there is a history of undesirable side effects for these types of products. This is one of the most closely watched FDA decisions this year as there has been no new diet pill approved in the US in more than a decade. Two other companies, Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (OREX) also are trying to win approval for new diet drugs.

April 25
Furiex Pharmaceuticals (FURX) and partner Takeda (TKPYY.PK) await an FDA decision on possible approval of the treatment combination of alogliptin/metformin for diabetes. The treatment was rejected in 2009. Shares of Furiex jumped by about two thirds over the past six months.

April 26
Amgen (AMGN) should get news from the FDA on additional use for its drug Xgeva. Amgen is seeking approval to market the drug for patients with advanced prostate cancer. In February, FDA advisers voted against the expanded use. Xgeva already is approved to treat bone fractures and pain in cancer patients.

April 27
Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) expect a decision from the FDA on approval of its drug Relistor for the expanded use of treating patients with constipation caused by the use of opioids.

April 29
Vivus should hear from the FDA on possible approval of erectile dysfunction drug Avanafil.

Also this month, expect some small cancer drug stocks to get a pop from the so-called ASCO effect when news begins to trickle out about upcoming presentations at a huge oncology conference in June. ASCO stands for the American Society of Clinical Oncology and the group's meeting is a significant catalyst for cancer drug companies, which can double on expectations leading up to the annual conference.

"If you're a cancer-focused biotech, you're probably going to get some play," says industry consultant Michael Becker.

Companies big and small -- from Johnson & Johnson (JNJ) to Aveo Pharmaceuticals (AVEO) -- will present at the conference. ASCO will publish a list of scientific abstract titles on its website toward the end of the month, says a spokeswoman. The abstracts will be released May 16, an important date for investors interested in developers of cancer treatments.

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