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PATH Cleared, GENT On Agenda, ZMH, PCRX Hit New High, TSRX Falls, Spain Says Yes


NuPathe Inc. (PATH) rose more than 14% in after-hours trading Thursday following its migraine patch Zecuity getting FDA approval. Zecuity, which is a single-use, battery-powered patch applied to the upper arm or thigh during a migraine, becomes the first FDA-approved migraine patch.

The product is expected to be launched in the fourth quarter of this year, and the company is seriously considering commercial partnership opportunities.

Forest Laboratories Inc. (FRX) announced Thursday that its Canadian subsidiary's first product BYSTOLIC has secured approval in Canada for the treatment of hypertension. BYSTOLIC is expected to be available to Canadian patients in Q2 2013.

FRX, which is trading near its 52-week high, closed Thursday's trading 1.23% higher at $37.02.

Zimmer Holdings Inc. (ZMH) hit a new 52-week high of $73.38 on Thursday before closing the day's trading at $73, following FDA clearance to market iASSIST Knee, the Personalized Guidance System for knee replacement procedures.

According to the company, iASSIST represents a revolutionary next step in surgical guidance, providing simple, intuitive and accurate intraoperative feedback and alignment validation to surgeons during joint replacement procedures, eliminating the need for bulky capital equipment.

Trius Therapeutics Inc. (TSRX) dropped more than 6% to $4.90 in after-hours trading on Thursday following its proposed public offering of common stock. Details of the offering are awaited.

Bristol-Myers Squibb Co. (BMY) on Thursday announced the appointment of Mike Burgess to the post of senior vice president, Discovery Medicine and Clinical Pharmacology.

AVEO Pharmaceuticals Inc. (AVEO) on Thursday priced the public offering of 6,667,000 shares of its common stock at $7.50 each. The gross proceeds to AVEO from this offering are expected to be approximately $50.0 million. The offering is expected to close on or about January 23, 2013.

Pacira Pharmaceuticals Inc. (PCRX) on Thursday priced its private offering of $110 million in aggregate principal amount of its 3.25 percent Convertible Senior Notes due 2019. The stock touched a new 52-week high of $19.67 before closing at $19.43.

Discovery Laboratories Inc. (DSCO) on Thursday received a new U.S. patent for "Pulmonary Surfactant Formulations. This patent provides exclusivity till December 2028 for new formulations of KL4 surfactant, and is separate and distinct from the patent portfolios covering SURFAXIN, the company's FDA-approved product, and AEROSURF, an investigational drug-device product.

Alimera Sciences Inc. (ALIM) on Thursday announced that its diabetic macular edema drug - ILUVIEN, has received marketing authorization in Spain, which marks the sixth national approval in the EU. ILUVIEN is already approved in Austria, the United Kingdom, Portugal, France and Germany. The company intends to resubmit its NDA for ILUVIEN to the FDA during Q1, 2013.

Gentium S.p.A.'s (GENT) Marketing Authorization Application for Defibrotide will be discussed at the European Medicines Agency's Committee for Medicinal Products for Human Use meetings scheduled to be held on February 18-21, 2013. Defibrotide is being developed to treat and prevent hepatic veno-occlusive disease in adults and children undergoing haematopoietic stem cell transplantation therapy.

by RTTNews Staff Writer

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