Gilead, Abbott, Isis, United Therapeutics Face Key Events in October

By Brett Chase  OCT 01, 2012 9:30 AM

There are a slew of FDA approval decisions scheduled for October. Also watch hepatitis C drug stocks as study updates are released.


MINYANVILLE ORIGINAL There are a number of drug approval decisions scheduled in October. The US Food and Drug Administration is expected to make several rulings on whether experimental treatments can be sold. It’s also a big month for hepatitis C drug developers ahead of a major medical conference in November.

Here are some of the key dates for drug and biotech companies in October. Some dates are subject to change.

October 1
Scientific abstracts for the 2012 Liver Meeting, the annual conference of the American Association for the Study of Liver Diseases, will be released at 10 a.m. ET. However, high-profile, “late-breaking” study abstracts aren’t expected out until October 15, says Leerink Swann analyst Howard Liang.

The November Liver Meeting held in Boston is a major medical conference that will draw even more attention this year as a number of companies race to develop the next-generation of hepatitis C treatments. Among the highlights: study data from Gilead Sciences (NASDAQ:GILD) and Abbott Laboratories (NYSE:ABT). Other hepatitis C stocks include Vertex Pharmaceuticals (NASDAQ:VRTX), Idenix Pharmaceuticals (NASDAQ:IDIX), and Achillion Pharmaceuticals (ACHN).

October 12
Celegene (NASDAQ:CELG) expects word from the FDA on potential expanded use of the drug Abraxane to treat lung cancer. The drug is currently approved for breast cancer.

October 16
NPS Pharmaceuticals
(NASDAQ:NPSP) faces a panel of government advisers as it tries to win approval for its drug Gattex to treat adult short bowel syndrome. The disabling condition affects as many 15,000 people in the US who can’t absorb nutrients or fluids, according to NPS. October 17
Aegerion Pharmaceuticals (NASDAQ:AEGR) will present to another FDA panel for the experimental drug lomitapide for treatment of homozygous familial hypercholesterolemia, a rare genetic disease characterized by high levels of bad cholesterol. The disease can cause heart attacks at a young age. This is the first of back-to-back panels discussing experimental treatments for the same disease.

October 18
Isis Pharmaceuticals (NASDAQ:ISIS) and partner Sanofi (NYSE:SNY) go before the same advisory panel as Aegerion to make a case for their drug, mipomersen, to treat homozygous familial hypercholesterolemia.

October 19
Supernus Pharmaceuticals (NASDAQ:SUPN) awaits a decision by the FDA on possible approval of the company’s experimental drug for epilepsy. Supernus shares have doubled this year.

October 21
Impax Laboratories
(IPXL) should get a ruling from the FDA on its application to sell the drug Rytary for Parkinson’s disease.

October 27
United Therapeutics
(NASDAQ:UTHR) is scheduled to hear from the FDA about approval of its treprostinil diethanolamine sustained release tablets for pulmonary arterial hypertension.

October 29
The FDA is scheduled to decide on possible approval of Cornerstone Therapeutics’ (NASDAQ:CRTX) treatment for hyponatremia, a metabolic condition that leaves the body short of salt.

Twitter: @brettchase

No positions in stocks mentioned.

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