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Stock Market & Financial Investment News

News Breaks
March 7, 2014
13:10 EDTREGN, SNYRegeneron, Sanofi advised by FDA of adverse events in PCSK9 inhibitor class
In a filing with the SEC earlier today, Sanofi (SNY) disclosed that the company and Regeneron (REGN) have been advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class. Neither company knows the circumstances under which the FDA became aware of these adverse events or whether these adverse events were observed with a drug candidate tested as monotherapy or in combination with a statin or other cholesterol-lowering agent. The FDA has requested that Sanofi and Regeneron make an assessment of potential neurocognitive adverse events across the global development program for alirocumab, especially in the longer-term studies. While neither company is aware of any neurocognitive adverse event signal relating to alirocumab, if this or another adverse event signal is detected, the further development of alirocumab may be delayed or fail, or its commercial value diminished, which could severely harm future prospects.
News For REGN;SNY From The Last 14 Days
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July 31, 2014
05:56 EDTSNYSanofi reports Q2 business net income up 13% to EUR 1.54B
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July 30, 2014
16:31 EDTSNY, REGNRegeneron, Sanofi announce plan to use priority review voucher for alirocumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the companies intend to use a FDA rare pediatric disease priority review voucher in connection with the Biologics License Application, or BLA, submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review. Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, purchased the voucher from BioMarin GALNS, a direct, wholly-owned subsidiary of BioMarin Pharmaceutical (BMRN), which had received it through the FDA's rare pediatric disease priority review voucher program. Sanofi and Regeneron will equally share the purchase price of $67.5M. Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end.
16:24 EDTREGNBioMarin sells priority review voucher for $67.5M to Regeneron
BioMarin Pharmaceutical (BMRN) announced that it has sold the Rare Pediatric Disease Priority Review Voucher it obtained in February of this year. The company received the voucher under an FDA program intended to encourage the development of treatments for rare pediatric diseases. BioMarin was awarded the voucher when it received approval of VIMIZIM, a new biological product for patients with Mucopolysaccharidosis type IVA, also known as Morquio A syndrome. BioMarin received $67.5M from Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals (REGN), in exchange for the voucher. "Leveraging the sale of the Priority Review Voucher to reinvest in products to treat rare and ultra-rare diseases makes the most sense for BioMarin given our stage of growth," said Jean-Jacques Bienaimé, CEO of BioMarin.
12:33 EDTREGN, SNYRegeneron, Sanofi likely to file alirocumab BLA this year, says Piper Jaffray
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12:27 EDTREGNOn The Fly: Midday Wrap
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08:08 EDTREGN, SNYSanofi and Regeneron report positive Phase 2 results of alirocumab
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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.
July 28, 2014
09:02 EDTSNYSanofi, InnerWorkings sign global marketing partnership
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July 21, 2014
10:02 EDTREGNOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Adeptus Health (ADPT) initiated with a Buy at Dougherty... Amphastar (AMPH) initiated with a Buy at Jefferies... Eclipse Resources (ECR) initiated with a Neutral at SunTrust... Fidelity National (FNF) initiated with a Buy at SunTrust... First American (FAF) initiated with a Buy at SunTrust... GoPro (GPRO) initiated with a Hold at Stifel... Imprivata (IMPR) initiated with an Outperform at Wells Fargo... Lifetime Brands (LCUT) initiated with a Buy at Sidoti... Materialise (MTLS) initiated with a Buy at BB&T... Regeneron (REGN) initiated with a Buy at Argus... STAG Industrial (STAG) initiated with a Buy at Sandler O'Neill... Signature Group (SGGH) initiated with a Buy at B. Riley... TCP International (TCPI) initiated with a Buy at Canaccord... Tessera (TSRA) initiated with a Buy at Craig-Hallum... Xunlei (XNET) initiated with a Perform at Oppenheimer.
07:42 EDTREGNRegeneron initiated with a Buy at Argus
Target $375.
07:11 EDTSNYInternational Society of DNA Vaccines to hold a conference
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July 18, 2014
06:10 EDTREGNRegeneron announces results from Phase 3 VIVID-DME trial of EYLEA
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