Ampio Pharmaceuticals Inc. (AMPE) has initiated a clinical trial of its investigational drug Optina in diabetic macular edema. Optina has a 505(b)(2) status, and drugs designated under this pathway can be approved on a single trial. The trial is designed to enroll a total of 450 patients who will be randomized to receive oral Optina or placebo over a period of 12 weeks.
AMPE closed Wednesday's trading at $3.92, up 3.43%.
Shares of Antares Pharma Inc. (ATRS) rose over 5% to $3.54 on Wednesday after the company announced that its New Drug Application for OTREXUP has been accepted for review by the FDA.
OTREXUP is being developed for self-administration of methotrexate to enhance the treatment of rheumatoid arthritis, poly-articular-course juvenile RA and psoriasis.
The FDA's decision date is set for October 14, 2013.
AVEO Oncology's (AVEO) New Drug Application for Tivozanib for the treatment of patients with advanced renal cell carcinoma is scheduled to be reviewed by an FDA panel on May 2, 2013.
AVEO has a deal in place with Tokyo-based Astellas Pharma Inc. to develop and commercialize Tivozanib outside of Asia for the treatment of a broad range of cancers. AVEO will lead commercialization of Tivozanib in North America and Astellas will lead commercialization of Tivozanib in the European Union.
The FDA's decision regarding the Tivozanib NDA is expected by July 28, 2013.
Cardica Inc. (CRDC) on Wednesday said that the European clinical trial to evaluate the safety of its investigational product - MicroCutter XCHANGE 30 cutting/stapling device, in a variety of surgical procedures has enrolled 109 patients. The study is designed to enroll 160 patients, and enrollment is expected to be completed in Q2 2013.
CRDC closed Wednesday's trading 4.21% higher at $1.24.
Titan Pharmaceuticals Inc.'s (TTNP.OB) New Drug Application for Probuphine for the maintenance treatment of adult patients with opioid dependence is scheduled to be reviewed by an FDA panel on March 21, 2013.
The company is seeking approval of Probuphine under 505(b)(2) regulatory pathway. The Probuphine NDA has been assigned a priority review by the FDA with a decision date set for April 30, 2013.
The FDA decision on Zogenix Inc.'s (ZGNX) New Drug Application for Zohydro ER may not be announced on March 1, 2013 as it is likely to be delayed. The company has been notified that the delay would be brief and may last only several weeks.
Zohydro ER is an oral, novel extended-release formulation of hydrocodone without acetaminophen.
The company is seeking approval of Zohydro ER for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid therapy for an extended period of time.
ZGNX closed Wednesday's trading 40.50% higher at $1.70. The stock further gained 4.71% in extended trading.
by RTT Staff Writer
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