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News Breaks
December 17, 2010
10:55 EDTAMGN, AMGNLeerink's biotech analyst holds a conference call
Biotech Analyst Schimmer reviews Amgen's Xgeva survey results and discusses Leerink's rating upgrade for Amgen to Outperform on an Analyst/Industry conference call being held on December 17 at 11 am hosted by Leerink.
News For AMGN From The Last 14 Days
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May 5, 2015
09:07 EDTAMGNUBS healthcare and biotech analysts hold an analyst/industry conference call
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May 4, 2015
06:42 EDTAMGNAmgen added to SUSTAIN Focus List at Goldman
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April 30, 2015
16:19 EDTAMGNCytokinetics sees initiating phase 3 tirasemtiv program in Q2
Cytokinetics (CYTK) expects to initiate a phase III clinical development program for tirasemtiv in patients with ALS in Q2. Cytokinetics expects to initiate a phase II trial of CK-2127107 in patients with SMA in 2H. Cytokinetics expects results from COSMIC-HF to be available in 2H. Cytokinetics expects to continue joint development activities in collaboration with Amgen (AMGN) directed to the potential advancement of omecamtiv mecarbil to phase III clinical development.
07:50 EDTAMGNAlder Biopharmaceuticals price target raised to $40 from $31 at Leerink
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April 29, 2015
09:18 EDTAMGNAmgen announces FDA advisory committee meeting to review Repatha
Amgen announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA will review data supporting the company's Biologics License Application for RepathaTM for the treatment of high cholesterol at a meeting on June 10, 2015. 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, or "bad" cholesterol, from the blood. The EMDAC will review results from clinical trials in support of the BLA for Repatha, which is based on data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol in 10 Phase 3 trials. The Phase 3 studies evaluated the safety and efficacy of Repatha in patients with elevated cholesterol, including patients on statins with or without other lipid-lowering therapies; patients who cannot tolerate statins; patients with heterozygous familial hypercholesterolemia and patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder.2 The FDA has set a Prescription Drug User Fee Act target action date of Aug. 27, 2015, for the Repatha BLA.
08:17 EDTAMGNAmgen to present positive data of melanoma candidate to FDA committee
Amgen will discuss the data supporting the Biologics License Application for talimogene laherparepvec monotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma at today's joint meeting of the FDA Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee. Amgen will present the results of the pivotal Phase 3 OPTiM study, which showed that talimogene laherparepvec monotherapy is the first oncolytic immunotherapy to demonstrate therapeutic benefit in a Phase 3 pivotal trial for patients with metastatic melanoma. Amgen has in place a comprehensive clinical development program for talimogene laherparepvec in metastatic melanoma. Additionally, based on its clinical profile, talimogene laherparepvec has the potential to be studied in a variety of solid tumor types.
07:28 EDTAMGNFDA to hold a joint advisory committee meeting
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April 28, 2015
10:54 EDTAMGNUBS biotech analyst holds an analyst/industry conference call
Biotech Analyst Roden and Healthcare Technology Analyst Valiquette, along with Dr. Weinstein, an expert in nephrology, discuss the mechanics of biosimilar reimbursement in a clinical setting, with a focus on Amgen's biosimilar, Epogen, on an Analyst/Industry conference call to be held on April 28 at 1 pm.
05:53 EDTAMGNStocks with implied volatility movement; AMGN CELG
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April 27, 2015
08:07 EDTAMGNBenefit of Amgen melanoma treatment questioned ahead of FDA meeting
In advisory committee documents ahead of a meeting scheduled for April 29 to discuss the biologics license application submitted by Amgen for talimogene laherparepvec for the treatment of injectable regionally or distantly metastatic melanoma, FDA staff wrote that "uncertainty regarding the clinical meaningfulness of the study 005/05 primary endpoint results, in the absence of a clear effect on overall survival, raises concern regarding both the existence and the magnitude of an overall benefit of talimogene laherparepvec." The PDUFA date for an FDA decision on approval is October 27. Reference Link
April 22, 2015
15:19 EDTAMGNAmgen management to meet with Piper Jaffray
Group luncheon to be held in Boston on April 27 hosted by Piper Jaffray.
09:22 EDTAMGNOn The Fly: Pre-market Movers
UP AFTER EARNINGS: CalAmp (CAMP), up 12.7%... Angie's List (ANGI), up 17.4%... Broadcom (BRCM), up 6.3%... Owens Corning (OC), up 3.8%... Yum! Brands (YUM), up 3.3%... Dolby Laboratories (DLB), up 3.6%... Infinera (INFN), up 2.4%... AutoNation (AN), up 2.5%... Amgen (AMGN), up 3.1%... Coca-Cola (KO), up 2%. ALSO HIGHER: Procera Networks (PKT) up 10.4% after being acquired by Francisco Partners in deal valued at $240M... Organovo (ONVO), up 19.2% after entering into a collaboration agreement with Merck Sharp and Dohme... Vical (VICL), up 5.8% after being awarded $4M contract to manufacture HIV vaccines for clinical evaluation... CTI BioPharma (CTIC), up 4.9% after announcing that Phase 3 pacritinib data will be highlighted in a late-breaking oral presentation at ASCO meeting. DOWN AFTER EARNINGS: Chipotle Mexican Grill (CMG), down 5.2%... iRobot (IRBT), down 3.6%... Cree (CREE), down 3.5%... United Rentals (URI), down 4%... Super Micro Computer (SMC), down 2.3%... Thermo Fisher (TMO), down 2.6%. ALSO LOWER: Natural Resource Partners (NRP), down 14% after reducing quarterly distribution 75% to 9c per unit... Trinity Industries (TRN), down 3.5% following a Bloomberg report that the Justice Department has initiated a criminal investigation into Trinity guardrails.
07:59 EDTAMGNAmgen price target raised to $189 from $164 at Cowen
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07:29 EDTAMGNAmgen estimates and price target raised at UBS
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06:03 EDTAMGNAmgen price target raised to $192 from $187 at Piper Jaffray
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