By RTT News, October 02, 2013, 05:07:00 AM EDT
(RTTNews.com) - Anacor Pharmaceuticals' ( ANAC ) New Drug Application for Tavaborole for the topical treatment of onychomycosis has been accepted by FDA for review, and a decision date is set for July 29, 2014.
ANAC closed Tuesday's trading 1.88% higher at $10.82.
Cerus Corp. ( CERS ) touched a new high of $6.95 on Tuesday before closing at $6.79, following the submission of the first of three modules for its Premarket Approval application to the FDA for review of its INTERCEPT Blood System for platelets.
The INTERCEPT Blood System is meant to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The device is designed for three blood components namely, platelets, plasma and red blood cells.
Merrimack Pharmaceuticals Inc. ( MACK ) has completed enrollment in the second cohort of a two-cohort randomized phase II clinical trial of MM-121 in combination with Paclitaxel in the neoadjuvant setting of HER2-negative breast cancer.
The phase II study is designed to evaluate whether the combination of MM-121 with Paclitaxel is more effective than treatment with Paclitaxel alone. Final results from the second cohort are expected in 2014.
The first cohort of the study was fully enrolled in April 2013, and final results are expected in fall 2013.
MM-121 is being developed in collaboration with Sanofi.
MACK closed Tuesday's trading at $3.90, up 2.90%.
Oragenics Inc. ( OGEN ) and Intrexon Corp. ( XON ) have established an Exclusive Channel Collaboration to develop and commercialize genetically modified probiotics for the treatment of diseases of the oral cavity, throat, sinus and esophagus. The team is expected to initially focus on therapies for Behcet's disease and aphthous stomatitis.
As per the terms of the agreement, Oragenics paid Intrexon a technology access fee of $6.0 million at closing, payable in 1,348,000 shares of Oragenics' common stock at a value per share of $3.00 and a promissory note in the principal amount of $1,956,000. In addition, Oragenics will pay to Intrexon program costs, developmental milestone fees and commercial royalties.
Intrexon will provide access to its platform technologies and capabilities including the UltraVector platform, DNA and RNA MOD engineering, cell system engineering, genome engineering, and protein engineering.
OGEN closed Tuesday's trading 3.33% higher at $3.10.
Pacira Pharmaceuticals Inc.'s ( PCRX ) five-year promotion arrangement with CrossLink Bioscience LLC, an orthopedic device distributor based in Atlanta, has become effective. Under the agreement, CrossLink will act as a local agent as well as a lead partner in current collaboration with additional distributors in select markets across the United States to promote and sell EXPAREL for postsurgical pain management following orthopedic procedures.
EXPAREL net product sales for the second quarter ended June 30, 2013 totaled $15.2 million, an increase of $12.9 million from the reported $2.3 million for the corresponding period in 2012. The second quarter of 2013 marks the commencement of the second year of EXPAREL launch.
PCRX touched a new high of $52.77 on Tuesday before closing at $50.85.
The FDA is scheduled to convene an Advisory Committee on March 10-11, 2014 at which time Salix Pharmaceuticals Inc.'s ( SLXP ) Supplemental New Drug Application for Relistor injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients with chronic, non-cancer pain will be considered.
The date and agenda for the Advisory Committee will not be definitive until publication in the Federal Register.
Relistor is currently approved in 58 countries, including the U.S., for opioid-induced constipation in patients with late-stage, advanced illness like cancer, end-stage Chronic Obstructive Pulmonary Disease from emphysema, heart failure, Alzheimer's disease with dementia, HIV/AIDS or other advanced illnesses who are receiving opioids on a continuous basis to help alleviate their pain.
SLXP closed Tuesday's trading at $70.76, up 5.80%. In after hours, the stock dropped 5.48% to $66.88.
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