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News Breaks
April 23, 2014
07:30 EDTSYNSynthetic reports preclinical data to support clinical development of mAb
Synthetic Biologics announced positive preclinical research findings for SYN-005, the company's proprietary monoclonal antibody, or mAb, combination therapy for treating Pertussis. In the second pertussis study in particular, SYN-005 was associated with favorable decreases in white blood cell counts within two days and the achievement of nearly normal levels within one week. Based on positive non-human primate and murine model findings, Synthetic Biologics has filed an additional patent application around pertussis antibodies, intends to move into cGMP manufacturing of SYN-005, and intends to file an Investigational New Drug application to support a Phase I clinical trial expected to initiate during the first half of 2015. The Company also intends to request an Orphan Drug designation for SYN-005 for the treatment of Pertussis.
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August 28, 2014
08:55 EDTSYNOn The Fly: Pre-market Movers
HIGHER: Digital Ally (DGLY), up 16% after announcing order from Michigan State Police for over $1.1M... EnteroMedics (ETRM), up 12.4% after reporting three-year data from Maestro RC system... Repros (RPRX), up 0.8% after Androxal achieves superiority in both co-primary endpoints in a study... Synthetic Biologics (SYN), up 2.7% after Pfizer (PFE) was granted FDA Fast Track designation for its investigational Clostridium difficile vaccine candidate. Synthetic Biologics announced earlier this week that SYN-004, the company's lead anti-infective product candidate for the prevention of the effects of C. difficile, will be presented in October... Signet (SIG), up 3.9% after Q2 revenue tops consensus. DOWN AFTER EARNINGS: Abercrombie & Fitch (ANF), down 5.7%... Guess (GES), down 8.3%... Frontline (FRO), down 7%. ALSO LOWER: Williams-Sonoma (WSM), down 10.9% after downgraded at Morgan Stanley following the company's Q2 earnings report... GT Advanced (GTAT), down 2% after downgraded at Raymond James... Sungy Mobile (GOMO), down 20.1% following earnings report, CFO resignation, downgrade of stock at Oppenheimer... Genesco (GCO), down 7.7% after cutting fiscal year forecast.
07:03 EDTSYNSynthetic Biologics and Fuji Photo Film improve manufacturing of SYN-004 enzyme
Synthetic Biologics (SYN) and Fuji Photo Film (FUJIY) Diosynth Biotechnologies UK Limited confirmed exceptional results from the initial phase of cGMP manufacturing of SYN-004, Synthetic Biologics' proprietary oral beta-lactamase enzyme for the prevention of Clostridium difficile infections. The initial 750-liter cGMP production run on Fujifilm's pAVEway platform yielded an unprecedented 5.5 kilograms of >95% pure SYN-004 active pharmaceutical ingredient drug substance, which will be used to support Synthetic Biologics' planned Phase I and II clinical trials, and continued research and development studies. SYN-004 is believed to be the first and only therapy designed to neutralize intravenous antibiotics in the gut.
August 26, 2014
07:07 EDTSYNSynthetic Biologics on schedule to initiate SYN-004 Phase Ia/Ib trials
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