Alimera Sciences Inc. (ALIM) intends to resubmit its New Drug Application for ILUVIEN for the treatment of diabetic macular edema to the FDA by the end of March. Diabetic macular edema, or DME, is the most common cause of visual loss in diabetic patients.
ILUVIEN has received complete response letter twice - in December 2010 and in November 2011.
ALIM closed Thursday's trading at $2.91, up 0.69%.
KYTHERA Biopharmaceuticals Inc. (KYTH) expects to report topline results from its pivotal U.S. and Canadian phase III clinical trials of ATX-101, an investigational injectable drug for the reduction of unwanted submental fat, commonly known as double chin, in mid-2013.
KYTH closed Thursday's trading at $23.88, down 0.54%.
MusclePharm Corp. (MSLP.OB), a nutritional supplement company, on Thursday said it has signed a multi-year endorsement deal with the NFL San Francisco 49ers Super Bowl quarterback Colin Kaepernick. As part of the deal, Kaepernick will represent MusclePharm in a series of advertisements, radio and television appearances, and social media outlets. The company completed a $12.0 million registered direct offering of its Series D Convertible Preferred Stock at $8.00 per share last month.
MSLP.OB has thus far hit a 52-week low of $3.90 and a 52-week high of $8.50. The stock closed Thursday's trading 4.46% higher at 8.20.
Titan Pharmaceuticals Inc.'s (TTNP.OB) investigational Probuphine implant for the treatment of adult patients with opioid dependence has won the backing of FDA panel members. The panel members voted 10-5 in favor of the effectiveness, and 12-2 in favor of safety of Probuphine.
The FDA's decision date is set for April 30, 2013. The FDA usually follows the recommendations of its panels although it is not mandatory.
Titan Pharma has a license deal in place with Braeburn Pharmaceuticals for the commercialization of Probuphine in the United States and Canada that was signed last December.
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