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Stock Market & Financial Investment News

News Breaks
June 27, 2014
07:17 EDTVRTXVertex receives European CHMP 'positive opinion' for KALYDECO
Vertex announced that the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending the approval of KALYDECO for people with cystic fibrosis ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator gene. The CHMP opinion is based on previously announced data from the first part of a Phase 3, two-part, randomized, double-blind, placebo-controlled, cross-over study of 39 people with CF ages 6 and older who have a non-G551D gating mutation. The first part of the study showed statistically significant improvements in lung function, sweat chloride, BMI and CFQ-R scores. Data from the second part of the study were presented at the European Cystic Fibrosis Society Conference and showed that these improvements were maintained through 24 weeks of treatment with ivacaftor. The safety profile was similar to prior Phase 3 studies of ivacaftor in people with the G551D mutation. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the E.U. The European Commission generally follows the recommendation of the CHMP and typically issues marketing approval within three to four months. The CHMP also issued a positive opinion recommending the inclusion of data from the long-term follow-up PERSIST study in the KALYDECO label
News For VRTX From The Last 14 Days
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May 21, 2015
11:04 EDTVRTXVertex has conference call hosted by JPMorgan
JPMorgan Analyst Kasimov hosts a conference call with CFO Ian Smith on May 26 at 1 pm.
10:30 EDTVRTXVertex management to meet with Maxim
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May 19, 2015
07:56 EDTVRTXGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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May 17, 2015
13:46 EDTVRTXVertex reports Orkambi data, says 'significant improvements' in primary endpoint
Vertex Pharmaceuticals announced that the New England Journal of Medicine published data from the two phase 3 studies of Orkambi, or lumacaftor/ivacaftor, a medicine designed to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. In November 2014, Vertex submitted an NDA to the FDA for the combination of lumacaftor and ivacaftor. On May 12th, the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 12-1 to recommend approval of Orkambi for people ages 12 and older with two copies of the F508del mutation. The FDA is expected to make a decision by July 5. The New England Journal reports that the studies enrolled 1108 patients who underwent randomization and received Orkambi. In both studies, there were significant improvements in the primary end point in both lumacaftor–ivacaftor dose groups. The difference between active treatment and placebo with respect to the mean absolute improvement in the percentage of predicted FEV ranged 2.6%-4%, which corresponded to a mean relative treatment difference of 4.3 to 6.7%. Pooled analyses showed that the rate of pulmonary exacerbations was 30%-39% lower than in the placebo group. The rate of events leading to hospitalization or the use of intravenous antibiotics was also lower. The incidence of adverse events was generally similar to the placebo group.
May 15, 2015
09:31 EDTVRTXAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
May 13, 2015
07:19 EDTVRTXVertex shares should have upward momentum in near-term, says JMP Securities
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May 12, 2015
17:54 EDTVRTXOn The Fly: After Hours Movers
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16:49 EDTVRTXVertex resumes after-hours trading, shares up 5.6% to $131.00
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16:20 EDTVRTXVertex to resume trading at 14:45
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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10:23 EDTVRTXVertex shares halted while FDA panel meeting takes place
07:58 EDTVRTXFDA Pulmonary-Allergy Drugs Advisory Committee to hold a meeting
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May 11, 2015
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 Vertex’s 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 hasn’t 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

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