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Stock Market & Financial Investment News

News Breaks
March 5, 2013
08:13 EDTVRTX, RHHBYVertex flu treatment may become large franchise, says William Blair
After Vertex (VRTX) reported data for its flu treatment, William Blair believes that the data appears promising and superior in some ways to Roche's (RHHBY) Tamiflu, a multibillion dollar franchise. The firm doesn't think the Street has assigned any value to Vertex's flu treatment, and it maintains an Outperform rating on the stock.
News For VRTX;RHHBY From The Last 14 Days
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May 18, 2015
09:23 EDTRHHBYRoche upgraded to Buy from Neutral at UBS
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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 14, 2015
09:22 EDTRHHBYLeerink pharma/biotech analysts hold an analyst/industry conference call
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May 13, 2015
18:12 EDTRHHBYGenentech alectinib shrank tumors in about half of ALK-positive NSCLC patients
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17:04 EDTRHHBYGenentech announces interim results from POPLAR study
Genentech, a member of the Roche Group announced interim results from a global, randomized Phase II study, POPLAR, in people with previously treated non-small cell lung cancer, NSCLC. The study showed the investigational cancer immunotherapy MPDL3280A doubled the likelihood of survival; hazard ratio [HR]=0.47) in people whose cancer expressed the highest levels of PD-L1 compared with docetaxel chemotherapy. An improvement in survival was also observed in people who had medium and high or any level of PD-L1 expression, as characterized by a test being developed by Roche. MPDL3280A was generally well tolerated and adverse events were consistent with what has been previously reported for MPDL3280A in NSCLC. Updated results will be presented in an oral session at the 51st Annual Meeting of the American Society of Clinical Oncology. “In our study of MPDL3280A in previously treated lung cancer, the amount of PD-L1 expressed by a person’s cancer correlated with improvement in survival,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The goal of PD-L1 as a biomarker is to identify people most likely to experience improved overall survival with MPDL3280A alone, and which people may be appropriate candidates for a combination of medicines.”
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
05:11 EDTRHHBYRoche receives FDA approval for cobas KRAS Mutation Test
Roche announced that the FDA has approved the cobas KRAS Mutation Test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer, or mCRC, patients and aid clinicians in determining a therapeutic path for them.
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