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News Breaks
July 29, 2014
18:38 EDTREGNRegeneron receives FDA approval for EYLEA for treatment of DME
Regeneron Pharmaceuticals announced that the FDA has approved EYLEA Injection for the treatment of Diabetic Macular Edema, or DME. The approval of EYLEA in DME was based on the one-year data from the phase 3 VISTA-DME and VIVID-DME studies of 862 patients. In Europe, the Committee for Medicinal Products for Human Use has given a positive opinion recommending approval for EYLEA in the treatment of DME. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia. A regulatory submission has been made in the U.S. and Europe for EYLEA for the treatment of Macular Edema following Branch Retinal Vein Occlusion.
News For REGN From The Last 14 Days
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October 1, 2014
07:49 EDTREGNRegeneron reinstated with a Buy at BofA/Merrill
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September 30, 2014
10:53 EDTREGNRegeneron dupilumab opportunity improved with new data, says Piper Jaffray
Piper Jaffray said it is increasingly optimistic about dupilumab's broad potential in allergic diseases following the Phase II data on chronic sinusitis with nasal polyps as well as prior data in atopic dermatitis and asthma. The firm views dupilumab as a potential blockbuster and reiterates its Overweight rating and $382 price target on Regeneron (REGN), which announced the data in partnership with Sanofi (SNY).
05:16 EDTREGNRegeneron, Sanofi announce positive Phase 2 top-line dupilumab results
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps, or CSwNP, who did not respond to intranasal corticosteroids. In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score, the primary endpoint of the study. Statistically significant improvements in all secondary efficacy endpoints were also observed, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms. In a pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control. The safety profile was consistent with previous studies. The most common AEs with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
September 29, 2014
07:26 EDTREGNInforma Business Information to hold a conference
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September 25, 2014
08:59 EDTREGNSummer Street chief scientific officer holds an analyst/industry conference call
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September 22, 2014
05:17 EDTREGNRegeneron announces EYLEA injection approved for myopic CNV treatment in Japan
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