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News Breaks
March 28, 2014
07:39 EDTAMGN, CYTKCytokinetics announces opening to enrollment of COSMIC-HF expansion
Cytokinetics (CYTK) announced that the expansion phase of the Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure, or COSMIC-HF, has opened to enrollment. COSMIC-HF is a Phase II double-blind, randomized, placebo-controlled, multicenter clinical trial designed to assess the pharmacokinetics and tolerability of omecamtiv mecarbil dosing orally in patients with heart failure and left ventricular systolic dysfunction. The expansion phase of COSMIC-HF will enroll approximately 450 patients randomized 1:1:1 to receive placebo, 25 mg, or 50 mg twice daily of omecamtiv mecarbil. Escalation to the 50 mg dose will depend on the plasma concentration of omecamtiv mecarbil following two weeks of oral dosing at 25 mg twice daily. The primary objective of the expansion phase of this trial is to characterize the safety, tolerability, and pharmacokinetics of omecamtiv mecarbil dosed orally during 20 weeks of treatment. The secondary objectives are to assess the changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide during 20 weeks of treatment. The expansion phase of COSMIC-HF is expected to enroll heart failure patients from approximately 100 clinical sites internationally. COSMIC-HF is being conducted by Amgen (AMGN) in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization participation rights.
News For CYTK;AMGN From The Last 14 Days
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May 22, 2015
16:24 EDTAMGNAmgen to end participation in co-development and commercialization of brodalumab
Amgen (AMGN) announced the company has commenced termination of its participation in the co-development and commercialization of brodalumab with AstraZeneca (AZN). Brodalumab, an investigational IL-17 inhibitor, is in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The decision was based on events of suicidal ideation and behavior in the brodalumab program, which Amgen believes likely would necessitate restrictive labeling. After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab. Amgen has decided to focus its efforts and resources on other key molecules that address unmet medical needs and deliver value to patients and shareholders. The Company continues to make progress against its strategic and financial commitments and does not expect any meaningful impact from this decision on its ability to meet them.
07:32 EDTAMGNAmgen receives positive CHMP opinion for use of Repatha
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the marketing authorization of Repatha recommending approval for use in certain patients with high cholesterol. Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood. The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
May 21, 2015
14:48 EDTAMGNRegeneron primary driver remains Praluent, says Piper Jaffray
Piper Jaffray noted that Regeneron (REGN) shares are at all-time highs after the company and partner Sanofi reported Phase IIb data on Dupilumab and Phase III data on Sarilumab. However, the firm believes the primary driver for Regeneron remains Praluent and firm expects launch costs to outstrip sales growth. Piper acknowledges Regeneron has "one of the richest pipelines in all of biotech," but it sees risk around Amgen's (AMGN) patent suit and keeps its Neutral rating and $484 price target on the stock.
May 20, 2015
09:52 EDTAMGNAlliance for Health Reform holds a webcast on biosimilars
"Biosimilars in the U.S.: Current & Emerging Issues" provides essential background on the U.S. and international markets for reference biologics and biosimilars, outline current policy and regulatory issues, and describe implications for the future. Speakers include Chief Scientific Officer Ramachandra from Hospira, Executive Director Eich from Amgen on the briefing being held on May 20 at 12 pm. Webcast Link
May 19, 2015
08:57 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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07:51 EDTAMGNFDA PDUFA Date for Amgen's Blinatumomab is May 19, 2015
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May 15, 2015
12:13 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Yum! Brands (YUM), NXP Semiconductors (NXPI), FedEx (FDX), McKesson (MCK), and J M Smucker (SJM). INCREASED STAKES: Actavis (ACT), Roper Technologies (ROP), Delta Air Lines (DAL), and FleetCor Technologies (FLT). DECREASED STAKES: Ally Financial (ALLY), Amgen (AMGN), Phillips 66 (PSX), eBay (EBAY), and Anheuser Busch Inbev SA (BUD). LIQUIDATED STAKES: Alibaba Group (BABA), Citigroup (C), EMC Corporation (EMC), Anglo American (AAL), and Williams Companies (WMB).
05:32 EDTAMGNAmgen presents first Phase 2 data for AMG 334
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May 14, 2015
10:41 EDTAMGNAnalysts upbeat on Amgen's Kyprolis after ASCO abstracts
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07:44 EDTAMGNInternational Headache Society to hold a conference
17th Congress of the International Headache Society is being held in Valencia, Spain on May 14-17.
May 13, 2015
17:17 EDTAMGNAmgen to present key results in solid tumor, hematologic malignancy treatments
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