Allergan Inc.'s (AGN) experimental device JUVÉDERM VOLUMA XC, an injectable hyaluronic acid dermal filler for cheek augmentation to correct age-related volume deficit in the mid-face, on Thursday won the unanimous backing of an FDA advisory panel.
If approved, JUVÉDERM VOLUMA XC would be the first and only dermal filler in the United States with this indication. The company expects to launch the device in late 2013 upon approval.
AGN closed Thursday's trading at $101.31, up 2.68%. In extended trading, the stock rose another 2.66% to $104.
Atossa Genetics Inc. (ATOS) has signed an agreement with Millennium HealthCare Inc. for the distribution of its ForeCYTE Breast Health devices. Atossa's ForeCYTE Breast Health devices consist of the patented MASCT pump and ForeCYTE patient collection kits.
Millennium has submitted an initial order for 10,000 ForeCYTE collection kits, which it intends to market to managed-care networks, healthcare clinics and physician practices in the New York Metro Area and Northern New Jersey.
ATOS closed Thursday's trading at $7, up 0.86%.
Arena Pharmaceuticals Inc. (ARNA) is withdrawing the Marketing Authorization Application for its obesity drug Belviq in the European Union. The company said it is currently evaluating the best approach for submitting the application at a later date. Belviq was approved by the FDA last June.
ARNA closed Thursday's trading at $8.40, up 2.05%. In after-hours, the stock dropped more than 17% to $6.91.
Shares of AVEO Pharmaceuticals Inc. (AVEO) fell more than 49% to $2.65 on Thursday after an FDA panel voted 13 to 1 against recommending approval of Tivozanib for the treatment of advanced renal cell carcinoma. The FDA's decision is expected by July 28, 2013.
Gilead Sciences Inc. (GILD) is planning to initiate a third phase III trial of its investigational fixed-dose combination tablet of Sofosbuvir and Ledipasvir for the treatment of chronic hepatitis C virus infection, based on encouraging data derived from a phase II study known as LONESTAR.
The phase III study, called ION-3, will evaluate the once-daily fixed-dose combination of Sofosbuvir and Ledipasvir for eight weeks with and without ribavirin (RBV) and for 12 weeks without RBV in 600 non-cirrhotic, treatment-naïve genotype 1 HCV-infected patients.
GILD closed Thursday's trading at $52.18, up 4.07%.
Hyperion Therapeutics Inc.'s (HPTX) urea cycle disorder drug RAVICTI has qualified for orphan drug exclusivity. The orphan exclusivity is for seven years from the date of the approval on February 1, 2013.
HPTX closed Thursday's trading at $20.53, up 2.70%.
OncoGenex Pharmaceuticals Inc. (OGXI) has a couple of events lined up over the coming months for its experimental drug OGX-427 and lead drug candidate, Custirsen.
The company expects to complete patient accrual in a phase II trial of OGX-427 in combination with first-line gemcitabine and cisplatin in patients with metastatic bladder cancer in the second half of 2013.
Patient enrollment in a phase II trial of OGX-427 in combination with carboplatin and pemetrexed in patients with previously untreated, advanced, non-squamous, non-small cell lung, and in a phase II trial of OGX-427 in combination with ABRAXANE and gemcitabine in patients with previously untreated metastatic pancreatic cancer is expected to begin in mid-2013.
The company expects final results from a phase III trial of Custirsen in combination with first-line docetaxel chemotherapy in men with metastatic castrate-resistant prostate cancer, dubbed SYNERGY in the first half of 2014.
OGXI closed Thursday's trading 1.38% higher at $9.52.
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