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News Breaks
January 9, 2014
08:38 EDTBMY, VRTXVertex announces first data from initial cohorts of VX-135 Phase 2a study
Vertex Pharmaceuticals (VRTX) announced the first data from the initial cohorts of an open-label Phase 2a study of VX-135 in combination with daclatasvir, Bristol-Myers Squibb's (BMY) NS5A replication complex inhibitor. In an intent-to-treat analysis, the sustained viral response rate four weeks after the completion of treatment was 83% in treatment-naïve genotype 1 patients who received 200 mg of VX-135 in combination with daclatasvir. In this arm, one patient discontinued treatment after the first dose due to a serious adverse event of vomiting/nausea. The 11 other patients in this arm completed 12 weeks of treatment, and 91 percent (10 of 11) achieved SVR4. In the study, the majority of adverse events were mild. Vertex expects to submit data to present at a medical meeting in 2014.
News For VRTX;BMY From The Last 14 Days
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May 26, 2015
09:38 EDTBMYuniQure reports collaboration with Bristol-Myers closed, triggers $50M payment
uniQure (QURE) announced the closing of its strategic collaboration with Bristol-Myers Squibb (BMY) to develop gene therapies for cardiovascular disease. The transaction was previously announced on April 6. Under the terms of the agreement, Bristol-Myers Squibb will make near-term payments of approximately $100M, including an initial upfront payment of $50M upon closing of the transaction, a $15M payment upon selection of three collaboration targets, in addition to S100A1, to be made within three months of closing, and an initial equity investment in uniQure representing 4.9% of the total number of shares outstanding following such issuance, at a purchase price of $33.84 per share, or approximately $37M in total. The initial equity investment is expected to close on June 12. Bristol-Myers-Squibb will acquire an additional 5.0% ownership before December 31, at a 10% premium, and has been granted two warrants, each to acquire up to an additional 5% equity interest, at a premium, based on additional targets being introduced into the collaboration. The parties have also agreed to enter into a supply contract, under which uniQure will undertake manufacturing of all gene therapy products under the collaboration. uniQure will also be eligible to receive research, development and regulatory milestone payments, including up to $254M for the lead S1A001 therapeutic and up to $217M for each other gene therapy product potentially developed under the collaboration. Additionally, uniQure is eligible to receive net sales based milestone payments and tiered single to double-digit royalties on product sales.
07:37 EDTBMYBristol-Myers opportunity in renal cell over $2B, says JPMorgan
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May 22, 2015
10:52 EDTBMYJPMorgan says Actavis shares cheap compared to peers
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07:33 EDTBMYBristol-Myers receives positive CHMP opinion for Nivolumab
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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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07:37 EDTBMYPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
09:01 EDTBMYBristol-Myers receives amended breakthrough therapy designation for daclatasvir
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07:21 EDTBMYUBS to hold a conference
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May 19, 2015
08:57 EDTBMYLeerink biotech analyst holds an analyst/industry conference call
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07:56 EDTBMY, VRTXGilead for Achillion rumor not ridiculous, but highly unlikely, TheStreet says
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07:45 EDTBMYJacobs Engineering receives contract from Bristol-Myers
Jacobs Engineering (JEC) received a contract from Bristol-Myers Squibb Company (BMY) to provide construction management services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland. Jacobs is also providing architectural and engineering services for the facility, which is being built to produce multiple therapies for the company’s robust and growing portfolio of approved and investigational biologic medicines, and to increase Bristol-Myers Squibb’s biologics manufacturing capacity. The new facility is expected to include multiple large scale bioreactors, a purification area, as well as office and laboratory space. Bristol-Myers Squibb’s Board of Directors has approved initial funding that will support the first phase of the project, with the full cost of the facility expected to be finalized in the second half of 2015. The facility is estimated to be operational in 2019.
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
11:03 EDTBMYBristol-Myers treatment of progressive supranuclear palsy granted orphan status
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10:41 EDTBMYAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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09:22 EDTBMYLeerink pharma/biotech analysts hold an analyst/industry conference call
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09:09 EDTBMYBristol-Myers down 1.3% after release of ASCO abstracts
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May 13, 2015
13:12 EDTBMYSen. Sanders urges VA to break patents on Gilead hepatitis C drugs
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07:19 EDTVRTXVertex shares should have upward momentum in near-term, says JMP Securities
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