New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 4, 2013
13:25 EDTACAD, ACAD, CYTK, CYTK, GILD, GILD, SHPG, SHPG, SNY, SNY, ACOR, ACOR, ALXN, ALXN, FURX, FURX, THLD, THLDCowen to host a conference
33rd Annual Health Care Conference is being held in Boston on March 4-6 with webcasted company presentations to begin on March 4 at 1:30 pm; not all company presentations may be webcasted. Webcast Link
News For ACAD;CYTK;GILD;SHPG;SNY;ACOR;ALXN;FURX;THLD From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | 3 | 4 | all recent news | >>
July 24, 2015
14:44 EDTSNYEsperion slides after FDA assigns indication for rival cholesterol drug
Shares of Esperion Therapeutics (ESPR), a drug company focused on LDL-cholesterol lowering therapies, are sharply lower in afternoon trading after the FDA granted approval for the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. WHAT'S NEW: This afternoon, the FDA announced the approval of Praluent injection, which is a PCSK9 drug marketed by Sanofi (SNY) and Regeneron (REGN). Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol, the FDA indicated. The drug, like Esperion's ETC-1002, seeks to lower patients' cholesterol. PRICE ACTION: In afternoon trading, Esperion shares are down 12% to $84.21. The stock spiked as low as $81.50 immediately after the FDA made its announcement regarding Praulent. Meanwhile, Sanofi shares are fractionally higher and Regeneron shares are halted.
14:20 EDTSNYSanofi drops 0.4% to $53.32 after FDA makes announcement on Praluent
Subscribe for More Information
14:20 EDTSNYFDA approves Regeneron, Sanofi cholesterol-lowering treatment
The announced the approval of Praluent injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Praluent is marketed by Sanofi-Aventis (SNY) and Regeneron (REGN). Shares of Regeneron remain halted.
07:21 EDTSNYRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
Subscribe for More Information
06:27 EDTGILDGilead price target raised to $131 from $120 at Piper Jaffray
Subscribe for More Information
July 23, 2015
14:01 EDTSHPGShire receives 'positive opinion' on Intuniv from CHMP
Shire announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv, or guanfacine hydrochloride extended release, for the treatment of attention deficit/hyperactivity disorder in children and adolescents. The positive opinion is based on results from three Phase 3 pivotal studies investigating the short- and long-term safety and efficacy of Intuniv in children and adolescents. The European Commission will now consider the CHMP positive opinion in its decision of whether to grant marketing authorisation for Intuniv in Europe, said Shire.
12:45 EDTGILDGilead July weekly volatility elevated into Q2 and outlook
Subscribe for More Information
07:25 EDTSHPGShire raises FY15 EPADS growth view to mid-to-high single digit percentage
Subscribe for More Information
07:22 EDTSHPGShire reports Q2 EPS $2.63, consensus $2.81
Subscribe for More Information
July 22, 2015
09:28 EDTALXNBiogen downgraded to Neutral at Piper Jaffray after Alzheimer's data
Subscribe for More Information
07:05 EDTACORAcorda Therapeutics awarded grant to study ACRUS technology in RDS
Subscribe for More Information
July 21, 2015
14:12 EDTGILDGilead reports study of E/C/F/TAF met primary endpoint
Gilead Sciences announced detailed 48-week data from an open-label Phase 3 study evaluating its investigational once-daily single tablet regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg, or E/C/F/TAF, among 1,436 virologically suppressed adult patients switching from tenofovir disoproxil fumarate-containing regimens. The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters. These data were presented in an oral session at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada. Among the 1,436 patients who were randomized in the study, virologic success rates at Week 48 were higher in patients taking E/C/F/TAF, 97% versus 93% for all TDF-based regimens; difference in percentages: 4.1%, 95% CI: 1.6% to 6.7%. The rates of virologic failure were similar between the two arms, with E/C/F/TAF, 1.0% and TDF-based regimen, 1.3%. General safety was similar between the two arms through 48 weeks of treatment, with similar percentages of patients in each group having any adverse events. Adverse events leading to treatment discontinuation were more common among patients treated with a TDF-based regimen.
12:47 EDTSNYPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
07:05 EDTALXNOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
Subscribe for More Information
July 20, 2015
07:33 EDTGILDInternational AIDS Society to hold a conference
Subscribe for More Information
July 17, 2015
10:21 EDTGILDCigna says 98.4% of customers treated with hep C drug Harvoni are cured
Subscribe for More Information
09:03 EDTGILDGilead granted orphan status for gastric cancer treatment
Subscribe for More Information
July 16, 2015
09:22 EDTGILDBristol-Myers says EU approves Evotaz for treatment of HIV-1 infection in adults
Subscribe for More Information
1 | 2 | 3 | 4 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use