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News Breaks
March 7, 2014
13:18 EDTSNY, REGN, AEGRRegeneron disclosed FDA contact about PCSK9 adverse events previously
Regeneron (REGN) stated in its 10-K filing on February 13 after the market close that the company its partner Sanofi (SNY) have been advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class. Similar wording was included in a regulatory filing made today by Sanofi and may be a factor in the volatility seen in shares of Regeneron this afternoon. Shares of Regeneron are off their earlier lows but remain down about 7.8% near $312 per share. Shares of Aegerion (AEGR) spiked as Regeneron shares sold off, but are off their earlier highs. Aegerion remains up about 4.5% near $52.50 in afternoon trading.
News For SNY;REGN;AEGR From The Last 14 Days
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October 29, 2014
05:28 EDTSNYSanofi downgraded to Equal Weight from Overweight at Barclays
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05:28 EDTSNYSanofi downgraded to Hold from Buy at Jefferies
Jefferies downgraded Sanofi to Hold following the company's Q3 results.
05:27 EDTSNYSanofi board removes Christopher Viehbacher as CEO
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October 28, 2014
10:53 EDTSNYSanofi sees pricing pressure, competition in diabetes sector
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09:20 EDTSNYOn The Fly: Pre-market Movers
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05:40 EDTSNYSanofi reports Q3 business EPS EUR 1.47 vs. EUR 1.36 last year
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October 27, 2014
10:52 EDTAEGRSeattle Genetics, Aegerion CEOs accused of drug use in lawsuit, TheStreet says
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07:23 EDTSNYAmerican College of Surgeons holds a conference
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07:21 EDTSNYSanofi board explains CEO development not included in meeting, Reuters says
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October 24, 2014
08:04 EDTREGNRegeneron price target raised to $460 from $350 at Canaccord
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October 22, 2014
07:35 EDTAEGR, SNYCardiometabolic Health Congress to hold annual meeting
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October 21, 2014
07:06 EDTSNYFierce Biotech to hold a breakfast meeting
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06:44 EDTSNYActavis among bidders for Omega Pharma, Bloomberg reports
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October 20, 2014
10:37 EDTSNYSanofi unit announces Aubagio gains FDA approval due to study data
Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio in the productís U.S. label. In the TOWER study, patients with relapsing MS receiving Aubagio 14 mg had a statistically significant reduction in annualized relapse rate and relative risk of sustained disability progression compared to placebo. In addition, a significant reduction in annualized relapse rate was observed in patients treated with Aubagio 7 mg compared to placebo. The TOPIC study was designed to assess whether initiation of Aubagio in patients who experienced their first neurological symptoms suggestive of MS could prevent or delay a second clinical attack. In this study, the proportion of patients free of relapse was statistically significantly greater for Aubagio 14 mg and 7 mg, compared to placebo. Results of the TOPIC study were published in The Lancet Neurology in September.
08:06 EDTSNYMerck, Sanofi unit announce pediatric hexavalent vaccine BLA
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07:24 EDTAEGRAegerion price target lowered to $46 from $66 at Leerink
Leerink lowered its price target for Aegerion shares to $46 after its survey of 40 U.S. cardiologists implied a more bearish outlook for Juxtapid once PCSK9s emerge. The firm, however, believes new patient adds are well outpacing Juxtapid discontinuations in the near term. It keeps an Outperform rating on the stock.
07:19 EDTSNYIBC Life Sciences to hold a conference
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07:16 EDTREGNAmerican Academy of Ophthalmology to hold annual meeting
AAO Annual Meeting 2014 is being held in Chicago on October 18-21.
07:10 EDTREGN, SNYAmerican Society of Human Genetics to hold annual meeting
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07:02 EDTSNY, REGNRegeneron Sanofi begins dosing in Phase 3 study of dupilumab
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the first patients have been dosed in a Phase 3 clinical study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis, or AD, that is not adequately controlled with topical AD medications. LIBERTY AD CHRONOS, the first trial in the Phase 3 clinical program for dupilumab, is a randomized, double-blind, placebo-controlled, multi-national study with the primary objective of demonstrating the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
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