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News Breaks
May 20, 2014
16:03 EDTAMGNAmgen says journal publishes 'positive' data for asthma treatment
Amgen announced that The New England Journal of Medicine published results from a Phase 1 study adding to the growing body of "evidence that inhibiting thymic stromal lymphopoietin could be beneficial in the treatment of asthma." TSLP is a cytokine thought to be a key driver of allergic inflammation. These are the first clinical data to be reported for an anti-TSLP therapy. Results from the 31-patient study showed treatment for 12 weeks with AMG 157, a monoclonal antibody that inhibits the activity of TSLP, resulted in statistically significant reductions in early asthmatic responses and late asthmatic responses in the airways following allergen challenges in patients with allergic (atopic) asthma. The data also showed statistically significant decreases in baseline markers of inflammation in the airways. Overall, adverse events were similar across treatment and placebo groups, with no serious adverse events occurring in the stud, Amgen said.
News For AMGN From The Last 14 Days
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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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April 21, 2015
19:06 EDTAMGNOn The Fly: After Hours Movers
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17:07 EDTAMGNAmgen shares higher by 2.69% after Q1 results, guidance
16:04 EDTAMGNAmgen raises FY15 EPS view to $9.35-$9.65 from $9.05-$9.40, consensus $9.32
Narrows FY15 revenue view to $20.9B-$21.3B from $20.8B-$21.3B, consensus $20.98B.
16:02 EDTAMGNAmgen reports Q1 EPS $2.48, consensus $2.10
Reports Q1 revenue $5.03B, consensus $4.91B.
15:28 EDTAMGNNotable companies reporting after market close
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13:51 EDTAMGNEarnings Watch: Amgen's Enbrel, Neulasta sales key for Q1 results
Amgen (AMGN) is scheduled to report first quarter earnings after the market close on Tuesday, April 21 with a conference call scheduled for 5:00 pm ET. Amgen, a biotechnology medicines company, engages in the discovery, development, manufacture, and marketing of human therapeutic products in the areas of supportive cancer care, inflammation, nephrology, and bone diseases. EXPECTATIONS: Analysts are looking for earnings per share of $2.10 on revenue of $4.91B, according to First Call. The consensus range for EPS is $1.91-$2.25 on revenue of $4.62B-$5.13B. LAST QUARTER: Amgen reported fourth quarter EPS of $2.16 against estimates of $2.05 on revenue of $5.33B against estimates of $5.2B. With its Q4 report, Amgen also reiterated its fiscal year EPS view of 9.05-$9.40, on revenue of of $20.8B-$21.3B. Total product sales increased 8% for Q4 versus Q4 of 2013. The increase was driven primarily by Enbrel, Neulasta, Prolia, XGEVA and Vectibix .Growth for the quarter was due primarily to higher unit demand, and to a lesser extent, price. Product sales increased 6% for the full year driven by strong performance across the portfolio. STREET RESEARCH: On March 23, Piper Jaffray said the "positive" trial data Teva (TEVA) reported for its anti-CGRP antibody in migraines is another important validation for the class of drugs that is also being worked on by Amgen, Eli Lilly (LLY), and Alder Biopharmaceuticals (ALDR). The firm said it thinks Amgen is one of the leaders in CGRP antibody space and reiterated its Overweight rating and $187 price target on Amgen shares. On March 16, RBC Capital said it believes that data presented by Amgen on its evolocumab drug for hyperlipidemia.was "very positive." The firm expects the drug to be approved in late summer. It predicts that revenue from the drug will ramp modestly and steadily, and then accelerate after positive studies of the drug's effects are released in 2017. RBC Capital estimates that worldwide revenue from the drug will peak at $2.5B+. It keeps an Outperform rating on Amgen. PRICE ACTION: Amgen shares are higher by around 6% since its last earnings report on January 27, and are up 1.25% to to $168.06 in afternoon trading ahead of Tuesday's earnings report.

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