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Salix, Peregrine, Navidea Approach Key Dates In September


Drug makers Regeneron, Novartis, and Cornerstone Therapeutics also face important product approval dates.

MINYANVILLE ORIGINAL It's back to work and the catalyst calendar is filling up for drug and biotech investors. There are some key dates to circle this week and for the weeks ahead as companies seek approval for new treatments and test experimental therapies.

Here are some highlights for the month. Some dates are subject to change.

September 5
Salix Pharmaceuticals
(SLXP) expects word from the FDA on approval of the drug crofelemer to treat diarrhea associated with HIV therapies. The agency originally planned to rule on the drug in June, but extended the decision date. In July, regulators shot down Salix's bid to expand use of the drug Relistor for opioid-induced constipation. Shares of Salix are down 8% this year.

September 5
(NVS) faces a panel of expert advisers to the FDA that will consider the tobramycin inhaled drug for cystic fibrosis patients who suffer a bacteria infection. The big drug maker likely faces some tough questions on the effectiveness of the treatment following an FDA staff review released Tuesday.

September 7
Peregrine Pharmaceuticals
(PPHM) will announce data from a mid-stage study of its cancer drug bavituximab at a medical meeting. While the drug is being tested for multiple cancers, the late-breaking oral presentation will show results for a trial of the treatment as a secondary option for lung cancer. There's been a lot of speculation about the drug, leading to considerable volatility in the stock. The shares traded as low as $.40 earlier this year, but have come roaring back, trading at $2.75 each in Tuesday morning trading.

September 10
Navidea Biopharmaceuticals
(NAVB) expects to hear whether the FDA will approve Lymphoseek, a radioactive tracing agent for lymph node imaging in cancer patients. The FDA was expected to make a decision in April on the product, but needed more time to assess Navidea's application. The company said the delay didn't appear to be related to concerns about the product's safety or effectiveness. Navidea was known as Neoprobe until it changed its name in January. The company rebranded itself after selling its medical device business last year.

September 13
Cornerstone Therapeutics
(CRTX) will face an FDA panel as the company seeks approval of its drug lixivaptan for a metabolic condition that leaves patients short of salt. Cornerstone acquired the drug by taking over Cardiokine earlier this year. Cornerstone shares are up 20% this year.

September 23
Regeneron Pharmaceuticals
(REGN) expects to hear from the FDA on a possible expansion of the company's drug Eylea to treat a condition known as central retinal vein occlusion. Eylea was approved last year to treat age-related macular degeneration, a leading cause of blindness in the elderly.

Twitter: @brettchase

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