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April 4, 2014
09:02 EDTAMGNAmgen announces analysis results of Phase 3 trial of talimogene laherparepvec
Amgen announced top-line results from the primary overall survival analysis of a Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor. Results showed that, while the primary end point of durable response rate was met, the secondary endpoint of OS was not met, although there was a strong trend in favor of talimogene laherparepvec. The estimated OS hazard ratio and improvement in median OS were similar to what was previously reported at the interim OS analysis. The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.
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October 27, 2014
16:54 EDTAMGNAmgen sees $150M in restructuring charges in Q4
Restructuring charges in the quarter were $376M. In July, the company announced a restructuring plan to invest in continuing innovation and the launch of its new pipeline molecules while improving its cost structure which will result in estimated pre-tax accounting charges in the range of $835M-$885M. The company estimates the fourth quarter of 2014 will have related charges of up to $150M.
16:06 EDTAMGNAmgen raises FY14 EPS view to $8.45-$8.55 from $8.20-$8.40, consensus $8.42
Raises FY14 revenue view to $19.8B-$20B from prior view $19.5B-$19.7B, consensus $19.73B.
16:04 EDTAMGNAmgen reports Q3 EPS $2.30, consensus $2.11
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15:34 EDTAMGNNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Amgen (AMGN), consensus $2.11; General Growth Properties (GGP), consensus 31c; Avalonbay (AVB), consensus $2.00; Hartford Financial (HIG), consensus 83c; Universal Health Services (UHS), consensus $1.36; XL Group (XL), consensus 63c; Masco (MAS), consensus 32c; Plum Creek Timber (PCL), consensus 30c; T-Mobile US (TMUS), consensus 2c; Cliffs Natural (CLF), consensus (3c); Twitter (TWTR), consensus 1c; American Capital Agency (AGNC), consensus 73c; DDR Corp. (DDR), consensus 30c; PartnerRe (PRE), consensus $3.66; Owens & Minor (OMI), consensus 47c; Manitowoc (MTW), consensus 42c; Compass Minerals (CMP), consensus 78c; Allison Transmission (ALSN), consensus 30c; Regal Entertainment (RGC), consensus 17c.
14:49 EDTAMGNEarnings Preview: Amgen Q3 results may be driven by Enbrel, Kyprolis, Prolia
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10:09 EDTAMGNAmgen volatility elevated into Q3 and outlook
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06:36 EDTAMGNAmgen price target raised to $170 from $150 at Piper Jaffray
Piper Jaffray raised its price target for Amgen shares to $170 citing confidence in the company's pipeline and its commitment to shareholders. Piper believes splitting up Amgen would be "value destructive" since investors tend to undervalue later stage programs. It keeps an Overweight rating on the stock.
October 24, 2014
11:00 EDTAMGNAmgen unlikely to split, dealReporter says citing sources
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08:07 EDTAMGNAmgen to hold business review meeting
Business Review Meeting is being held in New York on October 28 at 8 am. Webcast Link
October 23, 2014
08:28 EDTAMGNAmgen may be positioned to split as urged by Loeb, Reuters says
It is not rare for mature pharmaceutical companies to consider, or be called on, to split into "cash" and "growth" companies, but such break-ups rarely happen, according to Reuters' "Breakingviews" columnist Robert Cyran, who contends "Amgen may be the exception" and that activist Dan Loeb "has picked the right target." Reference Link
October 22, 2014
09:03 EDTAMGNAmgen treatment of ovarian cancer designated for orphan drug status
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07:35 EDTAMGNCardiometabolic Health Congress to hold annual meeting
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October 21, 2014
15:42 EDTAMGNAmgen issues statement regarding Third Point Investment
Amgen issued the following statement with respect to media inquiries concerning Third Point LLC's equity position in Amgen: "Amgen maintains an active, engaged dialogue with all shareholders. Amgen has always appreciated the perspectives of all of its shareholders, including Third Point, and welcomes constructive input toward our common goal of enhancing shareholder value. Amgen's Board of Directors frequently receives input from shareholders, including ideas like those offered by Third Point. The Board and management continually assess Amgen's strategic priorities and, when appropriate, take action to set the best path forward to increase shareholder value. Amgen's Board of Directors and management remain focused on addressing significant unmet medical needs for serious illnesses and driving value for all shareholders. We look forward to further updating our shareholders on Amgen's strategic priorities and update on our restructuring plans at our business review on October 28th."
14:25 EDTAMGNAmgen urged by Third Point to split up
In its Q3 investor letter, Dan Loeb's Third Point said it is now one of Amgen's (AMGN) largest shareholders. Amgen's first steps to target its "inflated cost structure" should be applauded, but Third Point believes "much more can and should be done," the firm wrote. Immediate action Amgen can take to create shareholder value include focusing its R&D efforts, providing long-term margin guidance demonstrating a commitment to reducing costs and creating clarity on additional shareholder returns, Third Point also said. Additionally, Third Point said it believes that Amgen could benefit from a separation and should seriously consider breaking up into a "MatureCo" and a "GrowthCo." Shares of Amgen are up 4% to $143.12 in afternoon trading following the circulation of Third Point's Q3 investor letter.
14:09 EDTAMGNThird Point discloses new positions in eBay, Alibaba, exit from Sony
In its Q3 investor letter, Third Point says it established a "significant" position in eBay (EBAY). Dan Loeb's hedge fund also revealed it has established a significant direct investment in Alibaba (BABA) shares now that the company is public. Third Point also said it is now one of Amgen's (AMGN) largest shareholders. During the quarter, Third Point exited its position in Sony (SNE) and reduced or exited other positions, including AIG (AIG), Hertz (HTZ) and Softbank (SFTBF), the firm stated in its letter. PRICE ACTION: Following the disclosures in the Third Point letter, Amgen is up 4%, eBay is up 2.3% and Alibaba is up 3.8%, while Sony shares trading in New York are down nearly 1%.
13:56 EDTAMGNDan Loeb discloses position in Amgen at Robin Hood Conference, CNBC reports
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07:15 EDTAMGNFDA to hold workshop on breast cancer drug development
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October 20, 2014
07:19 EDTAMGNIBC Life Sciences to hold a conference
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October 19, 2014
15:56 EDTAMGNAmgen to aid in production method for Ebola drug ZMapp, Bloomberg says
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October 17, 2014
09:06 EDTAMGNAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
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