13.03.2014 04:57:59
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RGDO On Track, OXGN Breathes Anew, IG Gets FDA Blessing, DEPO On The Rise
(RTTNews) - Depomed Inc. (DEPO) rose more than 5 percent to $14.20 in extended trading on Wednesday as the company turned a profit in Q4, reversing a year-ago loss, on 50% increase in product sales.
Looking ahead to 2014, the company expects product sales of approximately $115 million to $125 million. This compares to product sales of $58.3 million in 2013.
IGI Laboratories Inc. (IG) touched a high of $5 on Wednesday before closing the day's trading at $4.71, following receipt of its first approval from FDA for an abbreviated new drug application.
The company's ANDA that has been approved is for lidocaine hydrochloride USP 4% topical solution, indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. IGI originally submitted this ANDA to the FDA in May, 2012.
OXiGENE Inc. (OXGN) touched a new high of $5.40 on Wednesday before closing at $4.29 as investors cheered the positive results of a phase II trial evaluating the company's experimental drug ZYBRESTAT in recurrent ovarian cancer.
According to the company, in the study, known as Gynecologic Oncology Group protocol 186I, there was a statistically significant increase in progression-free survival in the treatment arm where patients were treated with Avastin plus ZYBRESTAT compared to the group treated with Avastin alone.
Secondary endpoints in the study include safety, objective response rate (measured according to RECIST criteria) and overall survival. Though the patients treated with a combination of ZYBRESTAT and Avastin achieved a higher objective response rate, it was not statistically significant, noted the company.
Regado Biosciences Inc.'s (RGDO) expects the first interim analysis of a phase III trial evaluating its investigational antithrombotic drug system, REG1, for patients with acute coronary syndromes undergoing percutaneous coronary intervention therapy to take place during April of this year.
The trial, dubbed REGULATE-PCI study, was initiated in September 2013, and enrollment is on track.
RGDO closed Wednesday's trading 1.19% higher at $11.05.
Supernus Pharmaceuticals Inc.'s (SUPN) antiepileptic drug Trokendi XR, a novel once-daily extended-release topiramate product, has been issued a third patent, which provides protection for the product with expiration that is no earlier than 2027.
Trokendi XR is the only approved novel once-daily extended release formulation of topiramate for the treatment of epilepsy.
SUPN closed Wednesday's trading at $9.15, up 2.92%. In extended trading, the stock gained another 5.46% to $9.65.
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