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News Breaks
June 2, 2014
07:48 EDTAMGNAmgen presents new data that support potential of talimogene laherparepvec
Amgen announced new data from two key clinical trials that support the potential of talimogene laherparepvec, a novel, investigational oncolytic immunotherapy, as both a single agent and as part of a combination regimen in patients with metastatic melanoma. Data from the 19 patients in the Phase 1b combination study showed no dose-limiting toxicities with talimogene laherparepvec in combination with ipilimumab. Additionally, tumors either shrank in size or were no longer detectable in 56 percent of patients when talimogene laherparepvec was given prior to and in combination with ipilimumab. The most common adverse events observed were chills, fevers, rash and fatigue. The pivotal Phase 3 trial met its primary endpoint showing a statistically significant improvement in durable response rate. Detailed results of the overall survival analysis, a key secondary endpoint of the pivotal Phase 3 trial evaluating talimogene laherparepvec as a single agent, were also presented. The results demonstrated a 4.4 month improvement in overall survival which closely approached statistical significance in the total patient population tested that included patients with and without visceral tumors.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.
News For AMGN From The Last 14 Days
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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.
October 14, 2014
11:23 EDTAMGNBIND Therapeutics and The Conference Forum hold a conference
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October 9, 2014
16:11 EDTAMGNAmgen blinatumomab granted priority review by FDA
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October 8, 2014
10:20 EDTAMGNAmgen biosimilar franchise underappreciated, says Piper Jaffray
After Amgen announced positive Phase 3 results for its biosimilar Humira in psoriasis, Piper Jaffray said it believes that Amgen's overall pipeline is underappreciated since the company's biosimilar franchise is generally not included in consensus estimates. The firm views Amgen as a top large cap picks and reiterate its Overweight rating on the stock.
09:16 EDTAMGNAmgen's ABP 501 for psoriasis shows positive Phase 3 results
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07:19 EDTAMGNCBI to hold a conference
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07:11 EDTAMGNEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.

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