New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
August 13, 2014
16:04 EDTAMGNAmgen says Phase 3 clinical trial FOCUS did not meet primary endpoint
Amgen and its subsidiary, Onyx Pharmaceuticals announced that the Phase 3 clinical trial FOCUS did not meet its primary endpoint of improving overall survival, OS. The 315-patient, open-label study evaluated single-agent Kyprolis® (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. Nearly all patients in the control arm received cyclophosphamide. Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rate of cardiac events observed in the Kyprolis arm was consistent with the current U.S. Kyprolis label. There was an increase in the incidence of renal adverse events of all grades observed in the Kyprolis arm compared to the active control arm and the label. "While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals.
News For AMGN From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 >>
February 5, 2016
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
Subscribe for More Information
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
Subscribe for More Information
February 2, 2016
08:53 EDTAMGNPiper Jaffray biopharma analyst holds an analyst/industry conference call
Subscribe for More Information
February 1, 2016
08:25 EDTAMGNAlder pullback Friday a buying opportunity, says Leerink
Subscribe for More Information
January 29, 2016
13:38 EDTAMGNAmgen wins right to allege willful infringement in Praluent suit, Markman says
Subscribe for More Information
January 28, 2016
16:06 EDTAMGNAmgen trades higher after hours, levels to watch
Subscribe for More Information
16:05 EDTAMGNAmgen raises FY16 EPS to $10.60-$11.00 from $10.35-$10.75, consensus $10.67
Subscribe for More Information
16:03 EDTAMGNAmgen reports Q4 EPS $2.61, consensus $2.29
Subscribe for More Information
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
Subscribe for More Information
12:49 EDTAMGNEarnings Watch: Amgen shares down almost 9% since last report
Subscribe for More Information
January 27, 2016
08:07 EDTAMGNAmgen volatility elevated into Q4 and outlook
Subscribe for More Information
January 25, 2016
17:23 EDTAMGNAmgen announces FDA acceptance of BLA for ABP 501
Subscribe for More Information
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.
January 22, 2016
05:36 EDTAMGNAmgen announces Repatha Injection approved in Japan
Subscribe for More Information
1 | 2 >>

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use