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July 16, 2014
06:26 EDTRHHBY, MRK, BMYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
News For BMY;MRK;RHHBY From The Last 14 Days
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September 27, 2015
16:40 EDTRHHBYRoche reports results from two Phase 2 studies on atezolizumab
Genentech, a member of the Roche Group, announced results from two Phase 2 studies that evaluated the investigational cancer immunotherapy atezolizumab -- or anti-PDL1; MPDL3280A -- in people with advanced non-small cell lung cancer. In the randomized Phase 2 study POPLAR, atezolizumab met its primary endpoint and showed a statistically significant survival benefit compared to chemotherapy in people with recurrent NSCLC whose tumors expressed medium and high levels of PD-L1, which corresponded with people living 7.7 months longer than people who received docetaxel chemotherapy. A separate, single-arm Phase 2 study, BIRCH, met its primary endpoint and showed that atezolizumab shrank tumors in up to 27% of people whose disease had progressed on prior medicines and also expressed the highest levels of PD-L1. Median survival had not yet been reached. In both studies of atezolizumab, adverse events were consistent with those observed in previous studies. "We plan to submit these results to global health authorities to bring this potential new option to people as soon as possible," said Chief Medical Officer Sandra Horning.
14:58 EDTMRKMerck announces Phase 1b data on Keytruda for nasopharyngeal cancer
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September 25, 2015
18:06 EDTBMYBristol-Myers says Opdivo demonstrates superior survival in Phase 3 trial
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17:08 EDTBMYBristol-Myers' Opdivo approved by Health Canada for metastatic melanoma
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16:17 EDTBMYBristol-Myers announces FDA filing update for Opdivo+Yervoy regimen
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15:31 EDTMRKMerck volatility elevated as shares trend lower
Merck October weekly call option implied volatility is at 39, October is at 34, November is a 29; compared to its 52-week range of 15 to 34, suggesting large price movement after presidential candidate Hilary Clinton announced plans early this week to cap prescription drug prices.
08:15 EDTMRKMerck narrow Keytruda label may not matter as much as thought, says Bernstein
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08:14 EDTBMYJPMorgan reiterates Overweight on Bristol-Myers after physician survey
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08:02 EDTBMYBristol-Myers announces collaboration agreement with Moffitt Cancer Center
Bristol-Myers Squibb Company and Moffitt Cancer Center announced that they have entered into a collaboration agreement as part of Bristol-Myers Squibb's Immuno-Oncology Rare Population Malignancy program in the U.S. The I-O RPM program is a multi-institutional initiative with academic-based cancer centers focused on the clinical investigation of immuno-oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy. As part of the I-O RPM program, Bristol-Myers Squibb and Moffitt will conduct a range of early phase clinical studies, including clinical investigations by young investigators to strengthen their development as clinical research scientists.
07:42 EDTRHHBYExelixis: CHMP adopts positive opinion for cobimetinib, vemurafenib combination
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07:22 EDTBMY, RHHBYEuropean Society for Medical Oncology to hold a conference
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06:24 EDTBMYLeerink says AMAG 'extremely attractive' after McGuff label disclosure
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06:23 EDTRHHBYRoche CEO: Will see growth regardless of setbacks, Reuters reports
Roche Holding's product lineup is so good that the company will see growth regardless of setbacks, Reuters reports, citing an interview with CEO Severn Schwan with Finanz und Wirtschaft. "Roche could have six new active pharmaceutical ingredients approved within two years. We never had this before," Schwan said. Reference Link
September 24, 2015
17:04 EDTMRKMerck, Pfizer to collaborate with Agilent's Dako on Avelumab diagnostic
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16:03 EDTMRKNewLink Genetics awarded $8.1M from DTRA to advance Ebola vaccine
NewLink Genetics (NLNK) announced that the Defense Threat Reduction Agency of the Department of Defense has awarded a subsidiary of NewLink Genetics an $8.1M base contract with future options totaling $5.2M to support various development activities of the investigational rVSV-ZEBOV Ebola) vaccine candidate. NewLink has exclusively licensed research, development and manufacturing of the rVSV-ZEBOV vaccine to Merck (MRK). In late 2014, Merck, known as MSD outside the United States and Canada, licensed the vaccine from NewLink Genetics to apply Merck's vaccine expertise to help accelerate the development of this vaccine candidate. Clinical studies of the rVSV-ZEBOV are ongoing.
September 23, 2015
08:50 EDTMRKProvectus initiates Phase 1b/2 trial of PV-10 combo with Pembrolizumab
Provectus Biopharmaceuticals (PVCT) announced it has completed development of the protocol for Phase1b/2 testing of its investigational cancer drug PV-10 in combination with pembrolizumab in patients with Stage IV melanoma. Pembrolizumab, also known as Keytruda, a product of Merck (MRK), is an immune checkpoint inhibitor approved for treatment of patients with advanced or unresectable melanoma. PV-10 is Provectus's novel investigational drug for cancer that is injected into solid tumors. It is currently undergoing Phase 3 clinical testing in patients with Stage III melanoma. Clinical testing under the new Phase 1b/2 protocol is expected to commence before the end of the year. The FDA granted accelerated approval to pembrolizumab in September 2014, making it the first FDA-approved anti-PD-1 immune checkpoint inhibitor. Because pembrolizumab is already FDA-approved, Provectus can commence this study with or without assistance of a partner.
05:31 EDTBMYBristol-Myers implied volatility of 40 at upper end of index mean range
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September 22, 2015
08:09 EDTBMYBristol-Myers opportunity could be bigger than expected, says Morgan Stanley
Morgan Stanley analyst David Risinger said investors are overlooking Bristol-Myers kidney opportunity for Opdivo and believes expectations will rise. Risinger said investor perception is kidney cancer is a crowded market and question whether Opdivo can gernate significant sales. The analyst thinks upcoming data will refocus investors attention and that Opdivo can win meaningful market share in RCC. Risinger expects highly compelling survival data and bullish commentary on September 26 when CheckMate-025 details are presented at ESMO in Vienna.
07:43 EDTMRK, RHHBY, BMYDrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:19 EDTBMY, RHHBY, MRKClinton to roll out plan to rein in prescription drug costs, USA Today reports
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