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Amgen Inc. (AMGN)

  • Wed, Oct. 28, 4:06 PM
    • Amgen (NASDAQ:AMGN): Q3 EPS of $2.72 beats by $0.34.
    • Revenue of $5.72B (+13.7% Y/Y) beats by $400M.
    • Shares +1.8%.
    • Press Release
    | Wed, Oct. 28, 4:06 PM | 14 Comments
  • Tue, Oct. 27, 10:29 AM
    • Cytokinetics (CYTK +4.9%) and collaboration partner Amgen (AMGN) announce positive top-line data from a Phase 2 clinical trial assessing omecamtiv mecarbil in patients with chronic heart failure. Study participants treated with the drug candidate showed statistically significant improvements in several measures of cardiac function at 20 weeks following randomization.
    • The study, called COSMIC-HF, was designed to evaluate an oral formulation of omecamtiv mecarbil in chronic heart failure patients with reduced ejection fraction. It consisted of two parts: a dose escalation phase and a longer expansion phase. The latter enrolled 448 subjects who were dosed for 20 weeks and followed for a total of 24 weeks. They were randomized to receive either placebo or omecamtiv mecarbil 25 mg twice daily or 25 mg escalating to 50 mg twice daily. The primary endpoints were an assessment of the maximum and pre-dose plasma concentration of omecamtiv mecarbil. Secondary endpoints included measures of cardiac function including changes from baseline in systolic ejection time, stroke volume. left ventricular end-systolic diameter and heat rate at week 20.
    • Final results will be presented at a future medical conference and for publication.
    • Omecamtiv mecarbil activates a protein in cardiac muscle cells called myosin, which is directly responsible for converting chemical energy into the mechanical energy that results in cardiac contraction.
    | Tue, Oct. 27, 10:29 AM | 8 Comments
  • Wed, Oct. 21, 1:22 PM
    • As if anyone following biotechs needs reminding, sellers are overwhelming the space. The iShares Nasdaq Biotechnology ETF (IBB -2.8%) is down 6% since Monday.
    • Key tickers: (BIB -6.5%)(BIS +6.3%)(VRX -38.5%)(AGN -5.9%)(BIIB -0.1%)(AMGN -1.7%)(GILD -1%)(CELG -2%)
    | Wed, Oct. 21, 1:22 PM | 66 Comments
  • Tue, Oct. 13, 3:49 PM
    • Getting out in front of what should be more bashing of their business models at the Democratic debate tonight, the healthcare names (XLV -1.3%) have about doubled the decline in the S&P 500. Within healthcare, it's the biotechs (IBB -3.1%) and pharmaceuticals (XPH -3.2%) leading the way south.
    • Celgene (CELG -3.3%), Biogen (BIIB -3.6%), Amgen (AMGN -3.5%), Allergan (AGN -4.1%), Mylan (MYL -3.6%)
    • The biotech heavy Russell 2000 (IWM -1.4%) is feeling the pain as well.
    | Tue, Oct. 13, 3:49 PM | 27 Comments
  • Mon, Oct. 12, 8:38 AM
    • Eli Lilly (NYSE:LLY) is down 10% premarket on robust volume in response to its announcement that it has terminated the development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease due to lack of efficacy. Its decision was based on a review by the independent data monitoring committee.
    • The move will result in a Q4 charge to R&D expense of up to $90M ($0.05 per share after tax). The company will incorporate the change in its 2015 guidance that it will provide during its earnings call on October 22.
    • SVP and President of Lilly Bio-Medicines David Ricks says, "We're obviously disappointed in this outcome, as we hoped the evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials. We remain confident in our pipeline as we prepare for launches in other therapeutics areas with significant unmet needs."
    • Related tickers and status premarket: (NASDAQ:REGN+4%; (NASDAQ:AMGN+3%; (NASDAQ:ESPR+14%; (NYSE:SNY+1%.
    | Mon, Oct. 12, 8:38 AM | 7 Comments
  • Tue, Oct. 6, 6:44 PM
    • Leading pharmacy benefits manager Express Scripts (ESRX -1%) has settled an investor debate about which pricey cholesterol drug it will cover -- by saying it will cover both of them.
    • Praluent, from Regeneron (REGN -2.9%) and Sanofi (SNY -0.7%), and Repatha, from Amgen (AMGN -1.8%), will both be included on Express Scripts' formulary. Each of the PCSK9 inhibitors is at least $14,000/year, significantly higher than the cost of now-generic statins, though more effective.
    • The drugs are injectables that dramatically lower LDL (the "bad cholesterol").
    • Express Scripts has said that the drugs won't be "budget busters," and that most prescriptions are getting rejected because patients don't meet medical criteria.
    • In after-hours action: ESRX flat; REGN +0.1%; SNY +0.8%; AMGN flat.
    | Tue, Oct. 6, 6:44 PM | 33 Comments
  • Wed, Sep. 30, 12:49 PM
    • Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
    • Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
    | Wed, Sep. 30, 12:49 PM | 26 Comments
  • Sun, Sep. 27, 8:59 AM
    • The $8B iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) fell 4.9% on Friday and 13% for the week - its worst weekly performance since the height of the financial panic seven years ago. Many biotech ETFs eat the same cooking - Gilead (NASDAQ:GILD), Amgen (NASDAQ:AMGN), Biogen (NASDAQ:BIIB), and Regeneron (NASDAQ:REGN) among the popular names - and FBT, XBI, and BBP fell in amounts similar to IBB.
    • The news flow was relatively quiet late in the week, but Hilary Clinton's promise Monday to clamp down on drug prices set things in negative motion for the momo sector.
    • Barron's Chris Dieterich reminds that a flood of biotech IPOs in recent years has filled the small cap universe with these highly speculative names, and biotech now makes up 7% of the iShares Russell 2000 Index (NYSEARCA:IWM). Indeed. The IWM fell 3.7% for the week, nearly tripling the decline of the S&P 500.
    | Sun, Sep. 27, 8:59 AM | 125 Comments
  • Fri, Sep. 25, 3:07 PM
    | Fri, Sep. 25, 3:07 PM | 134 Comments
  • Wed, Sep. 16, 9:08 AM
    • Xencor (NASDAQ:XNCR) licenses its Xmab antibody engineering technology to Amgen (NASDAQ:AMGN) for inclusion in a series of preclinical bispecific antibodies in cancer immunotherapy and inflammation. The deal also includes a preclinical bispecific T cell engager (BiTE) program directed at CD38 and CD3 in multiple myeloma, which complements Amgen's own BiTE platform, led by Blincyto (blinatumomab) and AMG-330.
    • Under the terms of the agreement, Xencor will receive an upfront payment of $45M, up to $1.7B in potential milestones and high single- to low double-digit royalties on commercial sales.
    • Bispecific technologies engineer monoclonal antibodies to bind to two unique drug targets, a difficult process characterized by molecules with poor stability and short half-lives. Xencor's approach produces stable antibodies that can be made with standard production methods.
    • XNCR is up 26% premarket on light volume.
    | Wed, Sep. 16, 9:08 AM | 1 Comment
  • Mon, Aug. 31, 7:53 AM
    • The Medicines Company (NASDAQ:MDCO) jumps 20% premarket on average volume in response to development partner Alnylam's (NASDAQ:ALNY) announcement that its investigational RNAi therapeutic, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83% with a mean maximum reduction of up to 64% (+-5%) in an early stage study, results comparable to Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent (alirocumab). The data were presented at the ESC Congress in London.
    • What's notable in this case is the difference in dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent is dosed once every two weeks and Repatha once every two weeks or once per month at a higher dose.
    • ALN-PCSsc turns off PCSK9 synthesis in the liver. This is a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood.
    • The Medicines Company will take the lead in developing ALN-PCSsc under the ORION Program. A Phase 2 study will commence by the end  of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies.
    • The companies will host a conference call this morning at 9:30 am ET to discuss the results and their development plan.
    | Mon, Aug. 31, 7:53 AM | 8 Comments
  • Tue, Aug. 25, 9:51 AM
    • Amgen (AMGN +2.3%) says it submitted a new drug application to the FDA for its intravenous treatment for secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.
    • AMGN says the treatment, if approved, would be the first of its kind that can be administered intravenously at the end of the dialysis session.
    • Secondary hyperparathyroidism affects many of the ~2M people throughout the world who receive dialysis, including 450K in the U.S., the company says.
    | Tue, Aug. 25, 9:51 AM | 2 Comments
  • Wed, Aug. 5, 7:35 AM
    • Nano cap Biocept (NASDAQ:BIOC) launches its proprietary quantitative Target Selector assay targeting KRAS mutations, a predictive biomarker in cancer. The assay is performed on a blood sample (liquid biopsy) instead of a tissue biopsy which allows physicians to more easily monitor cancer patients for response to treatment and progression of disease.
    • ~40% of colorectal cancer patients are KRAS mutation positive. KRAS is also present in high frequency in other solid tumor cancers including lung and pancreatic cancers. Patients with the mutation are much more resistant to anti-EGFR monoclonal antibodies such as Amgen's (NASDAQ:AMGNVectibix (panitumumab) and Lilly's (NYSE:LLYErbitux (cetuximab).
    • Investors should keep an eye on the uptake of this test. If robust, then it validates its value proposition of a more convenient, cheaper and much less invasive method of monitoring cancer patients. To date, investors appear to lack confidence in the company's prospects. Shares are down 76% since its IPO at $10 in February 2014.
    • Shares are up 10% premarket on light volume.
    | Wed, Aug. 5, 7:35 AM | Comment!
  • Thu, Jul. 30, 4:03 PM
    • Amgen (NASDAQ:AMGN): Q2 EPS of $2.57 beats by $0.14.
    • Revenue of $5.37B (+3.7% Y/Y) beats by $50M.
    • Shares +1.72%.
    • Press Release
    | Thu, Jul. 30, 4:03 PM | 4 Comments
  • Tue, Jun. 9, 6:51 PM
    • Regeneron (NASDAQ:REGN) has reopened for trading, up 1.1% to $532, after an FDA Ad Comm ruling in favor of its and Sanofi's Praluent (alirocumab) cholesterol-lowering drug.
    • Shares had been halted since just before 7 a.m.
    • The vote was 13-3. On Wednesday, the committee turns its attention to Amgen's (NASDAQ:AMGN) drug evolocumab.
    • Sanofi estimates that 11M Americans might qualify for the drugs, which could run up to $10K/year in cost. Amgen estimates that 8M Americans might qualify.
    | Tue, Jun. 9, 6:51 PM | 13 Comments
  • Tue, Jun. 2, 9:44 AM
    • Aveo Pharmaceuticals (AVEO +11.4%) is set for a gap up this morning stoked by positive data on its lead product candidate, tivozanib, that was presented yesterday at ASCO (abstract #4557).
    • In a Phase 3 study, TIVO-1, patients with metastatic renal cell carcinoma were randomized to receive either tivozanib or sorafenib (Bayer (OTCPK:BAYRY) and Amgen's (AMGN -1.1%) Nexavar). Progression-free survival (PFS) and overall survival (OS) in the tivozanib arm were 14.6 months and 29.0 months, respectively. For the sorafenib arm, PFS and OS were 9.7 months and 34.1 months, respectively.
    • In the 163 patients that crossed over from sorafenib to tivozanib, median PFS and median OS were 11.0 months and 21.6 months, respectively, from the start of tivozanib therapy.
    | Tue, Jun. 2, 9:44 AM | Comment!
Company Description
Amgen Inc is a biotechnology company that discovers, develops, manufactures and delivers human therapeutics. It operates in one business segment being human therapeutics.
Sector: Healthcare
Industry: Biotechnology
Country: United States