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Stock Market & Financial Investment News

News Breaks
February 24, 2014
07:24 EDTNLNK, FOLD, ADXS, VRTX, PLX, ISIS, CYTK, RNA, NPSP, GEVA, CNAT, XOMA, RARECanaccord to hold a conference
Orphan Drugs 1:1 Day will be held in New York on February 24.
News For ADXS;CNAT;CYTK;FOLD;GEVA;ISIS;NLNK;NPSP;PLX;RARE;RNA;VRTX;XOMA From The Last 14 Days
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May 12, 2015
16:19 EDTVRTXVertex confirms FDA panel voted 12-to-1 to recommend approval of Orkambi
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16:16 EDTVRTXVertex confirms FDA panel voted 12-to-1 to recommend approval of Orkambi
16:16 EDTVRTXPiper Jaffray remains confident in approval for Vertex
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15:43 EDTVRTXFDA panel votes 12 to 1 that data supports Orkambi approval
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15:35 EDTVRTXFDA panel votes unanimously that data support Orkambi safety
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15:32 EDTVRTXFDA panel inconclusive on if Lumacaftor contributes to Orkambi effectiveness
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12:34 EDTNLNKOn The Fly: Top stock stories at midday
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10:40 EDTNLNKNewLink Genetics weakness a buying opportunity, says Stifel
10:23 EDTVRTXVertex shares halted while FDA panel meeting takes place
10:16 EDTNLNKOptions with decreasing implied volatility
Options with decreasing implied volatility: NDLS WTW FUEL AOL LC NLNK ZU CYBR ARWR HZNP
09:20 EDTNLNKOn The Fly: Pre-market Movers
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08:04 EDTNLNKNewLink Genetics weakness not a buying opportunity, says Baird
Baird noted NewLink Genetics would continue its flagship IMPRESS trial as planned despite disclosing the FDA did not endorse management's plan to switch statistical methods midstream and the trial failed to show the required 30% OS improvement to stop early for efficacy. Baird expects the shares to open lower and would not be buyers, as they believe the chance of success of its algenpantucel-L trial has been lowered. Baird maintained its Neutral rating and $41 price target on NewLink Genetics shares.
07:58 EDTVRTXFDA Pulmonary-Allergy Drugs Advisory Committee to hold a meeting
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07:52 EDTGEVALeerink to hold a tour
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07:47 EDTRAREUltragenyx price target raised to $78 from $68 at Canaccord
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May 11, 2015
19:15 EDTNLNKOn The Fly: After Hours Movers
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16:42 EDTNLNKNewLink Genetics IMPRESS Phase 3 cancer trial with Algenpantucel-L to continue
NewLink Genetics announced the continuation without any modification or sample size adjustment for its pivotal, Phase 3 IMmunotherapy for Pancreatic RESectable cancer Study, called "IMPRESS," of algenpantucel-L for patients with surgically resected pancreatic cancer following the second planned interim data analysis. After careful consideration, including a series of communications with the FDA regarding the statistical analysis plan, the company decided to retain the benefit of the SPA and not to change the statistical analysis plan as defined in the original protocol. For the second interim analysis, the independent data safety monitoring committee, or DSMC, reviewed available patient data with the originally planned log-rank analysis and sample size recalculation, in all respects consistent with the SPA. No other statistical methods were used. The DSMC recommended the study proceed without any modifications, including sample size adjustment, to final analysis. Therefore the company believes the trial remains powered to determine efficacy upon the occurrence of 444 events.
16:26 EDTRAREUltragenyx reports Q1 EPS (63c), consensus (54c)
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07:40 EDTVRTXFocus on Vertex will shift to pricing after Orkambi FDA meeting, WSJ says
An FDA advisory committee that meets Tuesday to decide whether to recommend approval of Vertexís Orkambi will be closely watched by health insurers and pharmacy-benefit managers concerned that the experimental cystic-fibrosis drug will be high-priced, said The Wall Street Journal. Vertex hasnít announced a price, but analyst at JPMorgan predict the drug will have a wholesale price of about $287,000 annually per patient. Publicly traded PBM owners include Catamaran (CTRX), which is being acquired by UnitedHealth (UNH), CVS Health (CVS) and Express Scripts (ESRX). Reference Link
06:50 EDTXOMAXOMA management to meet with Jefferies
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