
STEM, StemCells, Inc.
** STEM reported that the FDA has authorized the initiation of a Phase I/II clinical trial of the Company’s proprietary HuCNS-SC product candidate (purified human neural stem cells) in dry age-related macular degeneration (AMD), the most common form of AMD. AMD is the leading cause of vision loss and blindness in people over 55 years of age, and approximately 30 million people worldwide are afflicted with the disease. There are no approved treatments for dry AMD.
According to STEM, preclinical data submitted as part of itsInvestigative New Drug application demonstrated that HuCNS-SC cells protect host photoreceptors and preserve vision in a well-established animal model of retinal disease that is relevant to dry AMD. HuCNS-SC transplants significantly protect against the degeneration of photoreceptors, the key cells of the eye involved in vision.
STEM is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery.
More about STEM at www.stemcellsinc.com.
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DSCO, Discovery Laboratories, Inc.
** DSCO reported that AFECTAIR is now registered with the FDA and is cleared to be marketed in the United States.
AFECTAIR originates from the AEROSURF development program and is a proprietary disposable ventilator circuit/patient interface connector that simplifies the delivery of aerosolized medications to critical-care patients requiring ventilatory support from either intermittent mechanical ventilation or continuous positive airway pressure.
DSCO is also pursuing a European Conformity (CE) marking for commercialization of the initial AFECTAIR products in the European Union (EU) and believes that it may be in a position to initiate the commercial introduction of the initial AFECTAIR products in EU in late 2012.
More about DSCO at www.discoverylabs.com.
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GMCR, Green Mountain Coffee Roasters, Inc.
** GMCR reported its first quarter fiscal 2012 results, posting net sales of $1,158.2 million, up 102% over net sales of $574.1 million in the year-ago quarter
- GAAP EPS of $0.66 compared to first quarter fiscal year 2011 GAAP EPS of $0.02; non-GAAP EPS of $0.60 increases 233% over $0.18 in the year-ago quarter
- GAAP operating income of $145.8 million compared to first quarter fiscal year 2011 GAAP operating income of $23.3 million; non-GAAP operating income of $158.0 million improves 258% over the year-ago quarter
- GAAP net income of $104.4 million compared to first quarter fiscal year 2011 GAAP net income of $2.4 million; non-GAAP net income of $96.0 million increases 264% over the year-ago quarter
As a leader in specialty coffee and coffee makers, GMCR is recognized for its award-winning coffees, innovative Keurig Single Cup brewing technology, and socially responsible business practices.
More about GMCR at www.greenmountaincoffee.com
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Tags: Discovery Laboratories, DSCO, GMCR, Green Mountain Coffee, Nasdaq:DSCO, NASDAQ:GMCR, NASDAQ:STEM, STEM, StemCells
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