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News Breaks
August 18, 2014
17:25 EDTAMGNAmgen announces AMG 416 study met its primary and all secondary endpoints
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism, SHPT, in patients with chronic kidney disease,CKD, receiving hemodialysis, met its primary and all secondary endpoints. "The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
News For AMGN From The Last 14 Days
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February 5, 2016
09:26 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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06:03 EDTAMGNAmgen resumed with a Market Perform at Leerink
Leerink analyst Geoffrey Porges resumed coverage of Amgen with a Market Perform rating and $179 price target.
February 4, 2016
19:15 EDTAMGNAmgen reinitiated with a Market Perform at Leerink
Target $179.
16:28 EDTAMGNAmgen reports BLINCYTO study met primary endpoint, stopped early for efficacy
Amgen announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study. The randomized, open-label TOWER study evaluated the efficacy of BLINCYTO versus standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The independent data monitoring committee recommended, and Amgen has accepted, that the study end early for efficacy. The BLINCYTO adverse events observed in the TOWER study were consistent with the known safety profile of BLINCYTO. Secondary endpoints are currently being evaluated.
16:02 EDTAMGNAmgen says trial of Repatha meets co-primary endpoints
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February 3, 2016
08:57 EDTAMGNPullback in biotech makes M&A more attractive, says UBS
UBS analyst Andrew Peters noted the pullback in small and mid-cap biotechs and said a consequence of the lower valuations may be an increased appetite for M&A by the larger firms. Peters noted Gilead (GILD) commented on its earnings call that "there's no question" the pullback has made M&A more attractive. UBS said with valuations so far off their highs, the question remains whether management and boards will accept deals at such depressed levels.
08:48 EDTAMGNWorkday appoints Diana McKenzie as Chief Information Officer
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February 2, 2016
08:53 EDTAMGNPiper Jaffray biopharma analyst holds an analyst/industry conference call
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February 1, 2016
08:25 EDTAMGNAlder pullback Friday a buying opportunity, says Leerink
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January 29, 2016
13:38 EDTAMGNAmgen wins right to allege willful infringement in Praluent suit, Markman says
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January 28, 2016
16:06 EDTAMGNAmgen trades higher after hours, levels to watch
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16:05 EDTAMGNAmgen raises FY16 EPS to $10.60-$11.00 from $10.35-$10.75, consensus $10.67
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16:03 EDTAMGNAmgen reports Q4 EPS $2.61, consensus $2.29
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14:36 EDTAMGNAmgen January weekly 149 straddle priced for 3.9% movement into Q4
14:29 EDTAMGNNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Microsoft (MSFT), consensus 71c... Amazon (AMZN), consensus $1.56... Amgen (AMGN), consensus $2.29... Electronic Arts (EA), consensus $1.81... Skyworks (SWKS), consensus $1.58... Western Digital (WDC), consensus $1.54... Visa (V), consensus 68c... Flextronics (FLEX), consensus 31c... NetSuite (N), consensus 4c... Fortinet (FTNT), consensus 18c... Synaptics (SYNA), consensus $1.58... Proofpoint (PFPT), consensus (11c).
14:15 EDTAMGNAmgen technical comments before earnings news
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12:49 EDTAMGNEarnings Watch: Amgen shares down almost 9% since last report
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January 27, 2016
08:07 EDTAMGNAmgen volatility elevated into Q4 and outlook
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January 25, 2016
17:23 EDTAMGNAmgen announces FDA acceptance of BLA for ABP 501
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10:55 EDTAMGNRegeneron slips after analyst says sell to avoid risk from Amgen patent suit
Shares of Regeneron Pharmaceuticals (REGN) fell in morning trading after an analyst at Chardan downgraded the stock to Sell, citing risk from a patent lawsuit in which the biopharmaceutical company is involved. CHARDAN SAYS SELL: Chardan Capital Markets analyst Gbola Amusa downgraded Regeneron to Sell from Neutral this morning, while reducing his price target on shares to $400 from $525. In a note to clients, Amusa said he believes that Regeneron is likely to face significant risks from the upcoming patent infringement case for Praluent. The suit could be a key driver of the company's share price performance in the near future, the analyst said. Regeneron, along with its partner Sanofi (SNY), launched Praluent in the U.S. last year, after the October 2014 filing of a patent infringement suit by Amgen (AMGN) relating to patents for "monoclonal antibodies that bind PCSK9," Amusa noted. The analyst believes that since Regeneron and Sanofi "likely" infringe Amgen's patents for Repatha, the Regeneron-Sanofi partnership could seek to settle the ahead of the trial by agreeing to pay 10%-20% or more of royalties to Amgen for U.S. Praluent sales. Amusa said that "such an outcome we estimate could transfer roughly $750M of operating income per year to Amgen." Further, Amusa said that catalysts surrounding the patent infringement trial are "likely to play out from late February to late March," and concedes that "both sides have good reasons to settle this case for a reasonable royalty." INCREASING COMPETITION: Amusa also noted that he sees increasing competitive risks in 2016 to Regeneron's Eylea from Novartis (NVS) and its partner Ophthotech (OPHT), which continue to progress Fovista into Phase III trials in wet AMD. WHAT'S NOTABLE: Roth Capital upgraded Regeneron to Buy from Neutral on January 19, based on valuation, as the firm said shares do not reflect the value of the company's upcoming catalysts. The firm also raised its price target to $555 from $543. The same day, Credit Suisse initiated Regeneron with a Neutral rating and $552 target. PRICE TARGET: Regeneron slipped 1.4% to $476.02 in morning trading.

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