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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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September 16, 2014
07:31 EDTREGNRegeneron's EYLEA Injection granted designation for treatment of retinopathy
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September 12, 2014
10:04 EDTSNYSanofi unit granted orphan status for treatment of Gaucher disease
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September 11, 2014
05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
07:09 EDTSNYAmericas Committee for Treatment & Research in MS to hold a meeting
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September 8, 2014
14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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07:15 EDTREGNIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
September 4, 2014
05:37 EDTREGNRegeneron submits application for Eylea injection in Japan for macular edema
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September 3, 2014
12:49 EDTSNYSanofi reports Dengue vaccine candidate achieves its phase 3 primary endpoint
Sanofi Pasteur, the vaccines division of Sanofi, announced that the final landmark phase 3 efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. Results showed an overall significant reduction of 60.8% of dengue disease cases in children and adolescents 9-16 years old after a three-dose vaccination schedule. Importantly, efficacy was observed against each of the four dengue serotypes. Additional observations of the results showed a clinically important reduction by 80.3% in the risk of hospitalization due to dengue during the study. The results also showed in the study population an efficacy against dengue haemorrhagic fever, the severe form of dengue, which is consistent with the results released from Sanofiís phase 3 dengue study in Asia. Lastly, the results suggest better protection in case of prior exposure to dengue.
September 2, 2014
20:26 EDTSNYSanofi has a conference call hosted by JPMorgan
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13:58 EDTREGN, SNYRegeneron expected to receive priority review at Piper Jaffray
Piper Jaffray expects Regeneron (REGN) and Sanofi (SNY) will receive priority review for alirocumab via the priority review voucher recently acquired from BioMarin (BMRN). Piper says potential approval of the drug is likely by mid-2015 and it reiterates an Overweight rating on Regeneron with a $382 price target.
13:48 EDTREGNRegeneron price target raised to $390 from $380 at Brean Capital
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08:35 EDTSNYIntrexon enters into ECC with Sanofi subsidiary to develop APIs
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08:04 EDTREGNRegeneron price target raised to $436 from $389 at Leerink
Leerink raised its price target for Regeneron shares to $436 after its survey of 100 physicians indicated potential blockbuster status for the company's PCSK9-inhibitor Alirocumab. The firm reiterates an Outperform rating on the stock.
07:21 EDTSNY, REGNRegeneron data positive, says RBC Capital
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07:14 EDTREGNRegeneron price target raised to $400 from $340 at Credit Suisse
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