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June 30, 2013
18:28 EDTPFE, BMYEliquis demonstrated comparable efficacy in patients with VTE
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced the results of the six month Phase 3 AMPLIFY trial of 5,395 patients with acute venous thromboembolism ,VTE, which includes symptomatic deep vein thrombosis, DVT, and/or pulmonary embolism, PE. In this trial, Eliquis as a single-agent achieved the primary efficacy endpoint of noninferiority to current standard of care (initial parenteral enoxaparin treatment overlapped with warfarin therapy) in the reduction of the composite endpoint of recurrent symptomatic VTE or VTE-related death. Eliquis also met the primary safety endpoint of superiority for major bleeding, with a 69 percent relative risk reduction, RRR, compared to current standard of care. Importantly, AMPLIFY demonstrated comparable results for the primary efficacy and safety endpoints between patients entering the study with a DVT or a PE. The findings were published online in New England Journal of Medicine and announced at the 24th Congress of the International Society on Thrombosis and Haemostasis, ISTH.
News For BMY;PFE From The Last 14 Days
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October 8, 2015
06:32 EDTBMY, PFEPiper Jaffray explains why drug prices are justifiable
Piper Jaffray's team of Biopharma analysts, led by Joshua Schimmer, explain this morning in research note to investors why they believe drug prices are justifiable. The "fairly lopsided" drug-pricing discussion "noise" has created attractive entry points for stocks in the sector, the analysts argue. They say that after adjusting for actual inflation, the growth of drug prices "does not seem particularly concerning." The current dialogue on the topic under-emphasizes the need to provide "extremely attractive incentives" for companies to embark on the "highly risky, capital-intensive, long-development cycle drug development path which is needed to bring new cures for important diseases," the analysts contend. Schimmer's top picks are Alexion (ALXN), Celgene (CELG) and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC) and Ignyta (RXDX) in the small-cap sector.
October 7, 2015
08:04 EDTBMYSeattle Genetics initiates Phase 1/2 trial of ADCETRIS
Seattle Genetics (SGEN) announced that it has initiated a phase 1/2 clinical trial of ADCETRIS in combination with Opdivo for patients with relapsed or refractory Hodgkin lymphoma, or HL, after failure of frontline treatment. The trial is being conducted under a previously announced clinical trial collaboration agreement with Bristol-Myers Squibb (BMY). ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL, which combines the targeting ability of a monoclonal antibody with a highly potent cell-killing agent. Opdivo is a human antibody that targets and inhibits the programmed death receptor-1, resulting in T-cell activation. Opdivo is part of a new class of cancer immunotherapy treatments known as checkpoint inhibitors, which are designed to harness the body's own immune system in fighting cancer by targeting distinct regulatory components of the immune system. A second trial under the collaboration is planned to begin later in 2015 for relapsed or refractory B-cell and T-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma.
07:36 EDTPFE, BMYInfectious Diseases Society of America to hold a conference
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07:05 EDTPFEPfizer, Merck KGaA say avelumab gets FDA fast track designation
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October 6, 2015
16:12 EDTPFETRACON Pharmaceuticals appoints Ronald Shazer as Chief Medical Officer
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13:32 EDTPFE, BMYBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
07:23 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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07:01 EDTBMYBristol-Myers says granted FDA priority review for Daklinza sNDAs
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October 5, 2015
11:09 EDTBMYBristol-Myers to pay $14M to settle SEC charge of FCPA violations
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10:19 EDTPFESpark trial success a positive for gene therapy sector, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer said he views the news that Spark Therapeutics (ONCE) "highly anticipated" SPK-RPE65 Phase 3 gene therapy study for congenital blindness met its primary endpoint as a positive for the ophthalmology gene therapy field as well as the broader gene therapy sector. Schimmer added that Applied Genetic Technologies' (AGTC) early clinical data in the second half of this year will be a further test of the ophthalmology gene therapy platform. The analyst noted that other companies with gene therapy programs include Avalanche (AAVL), Biogen (BIIB), bluebird bio (BLUE), BioMarin (BMRN), Cellectis (CLLS), Medgenics (MDGN), uniQure (QURE), Pfizer (PFE), Regeneron (REGN) and Sangamo (SGMO).
October 2, 2015
10:00 EDTPFEOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Alexion (ALXN) upgraded to Overweight from Equal Weight at Morgan Stanley... BlackRock (BLK) upgraded to Buy from Neutral at UBS... Dunkin' Brands (DNKN) upgraded to Outperform from Underperform at CLSA... EnPro (NPO) upgraded to Buy from Neutral at Sidoti... Finish Line (FINL) upgraded to Neutral from Sell at Goldman... FutureFuel (FF) upgraded to Buy from Neutral at Roth Capital... Google (GOOG) upgraded to Outperform from Perform at Oppenheimer... Johnson Controls (JCI) upgraded to Buy from Neutral at Nomura... Kennametal (KMT) upgraded to Neutral from Underperform at BofA/Merrill... Lufthansa (DLAKY) upgraded to Buy from Hold at HSBC... Martin Marietta (MLM) upgraded to Buy from Neutral at Longbow... Northern Trust (NTRS) upgraded to Neutral from Sell at UBS... PMC-Sierra (PMCS) upgraded to Positive from Neutral at Susquehanna... Pfizer (PFE) upgraded to Overweight from Equal Weight at Morgan Stanley... Realogy (RLGY) upgraded to Buy from Neutral at Citi... Sarepta (SRPT) upgraded to Outperform from Neutral at Wedbush... Summit Materials (SUM) upgraded to Buy from Neutral at Goldman... TreeHouse (THS) upgraded to Buy from Neutral at BofA/Merrill... Vertex (VRTX) upgraded to Overweight from Equal Weight at Morgan Stanley.
08:16 EDTPFEPfizer upgraded to Overweight from Equal Weight at Morgan Stanley
Morgan Stanley upgraded Pfizer to Overweight and raised its price target to $38 from $35. Analyst David Risinger expects revenue growth to turn positive in 2016 after years of declines and said Pfizer has a strong balance sheet to take advantage of weakness in the pharma and biotech sectors. Risinger sees share upside with limited downside risk as fundamentals improve and management takes advantage of its strong financial position.
October 1, 2015
11:04 EDTBMYBristol-Myers says Opdivo-Yervoy combo to cost about $265,000/year on average
Bloomberg reported on pricing for Bristol-Myers' Opdivo in combination with Yervoy, citing a company spokesperson.
08:04 EDTPFEPfizer completes acquisition of Nimerix, Mencevax from GSK
Pfizer (PFE) announced that it has completed the acquisition of GlaxoSmithKline's (GSK) quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax.
07:39 EDTPFE, BMYJPMorgan sees opportunities in pharma after pullback
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07:31 EDTPFE, BMYLeerink to hold a roundtable
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07:04 EDTBMYBristol-Myers' Opdivo + Yervoy regimen for melanoma approved by FDA
Bristol-Myers announced that the FDA approved Opdivo - nivolumab - in combination with Yervoy - ipilimumab -, for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. This is the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The approval is based on data from the pivotal study, CheckMate -069. Results from the trial demonstrated a statistically significant increase in confirmed objective response rate - the study's primary endpoint - in patients with BRAF wild-type melanoma treated with the Opdivo + Yervoy Regimen vs. those treated with Yervoy monotherapy. Complete responses were seen in 17% of patients. Partial responses were seen in 43% of the Regimen group and 11% of the Yervoy monotherapy group. Opdivo is associated with immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, other adverse reactions; infusion reactions; and embryofetal toxicity.
September 30, 2015
09:59 EDTPFEActive equity options trading on open
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08:37 EDTPFEPfizer lowers FY15 reported EPS view to $1.29-$1.38 from $1.38-$1.47
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08:32 EDTPFEPfizer raises FY15 adjusted EPS view to $2.04-$2.10 from $2.01-$2.07
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