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News Breaks
July 25, 2014
05:35 EDTBAYRY, AMGNBayer, Onyx reports NEXAVAR Phase 3 trial did not meet primary endpoint
Bayer HealthCare (BAYRY) and Onyx Pharmaceuticals, an Amgen subsidiary (AMGN), announced that an investigational Phase 3 trial of NEXAVAR tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival. The study, called RESILIENCE, evaluated the efficacy and safety of sorafenib in combination with capecitabine, an oral chemotherapeutic agent, compared to placebo plus capecitabine, in patients with HER2-negative breast cancer who are resistant to or have failed prior taxane therapy, and resistant to or failed anthracycline or for whom further anthracycline therapy is not indicated. Based on initial review of the data, the types of adverse events observed were generally comparable with those known for either sorafenib or capecitabine. Data from this study are expected to be presented at an upcoming scientific congress.
News For BAYRY;AMGN From The Last 14 Days
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September 1, 2015
16:05 EDTAMGNAmgen announces Phase 3 study of romosozumab met primary endpoint
Amgen and UCB announced top-line results from the STRUCTURE trial. The study met the primary endpoint, demonstrating a statistically significant difference in favor of romosozumab in the percent change of total hip bone mineral density through month 12. In the study, a total of 436 patients previously treated with bisphosphonate therapy received either subcutaneous romosozumab or subcutaneous teriparatide through to month 12. The overall subject incidence of adverse events was generally balanced between arms. Adverse events in patients treated with romosozumab were similar to those previously reported and no new safety signals were detected. Adverse events reported in the romosozumab arm in more than five percent of patients were nasopharyngitis, arthralgia, back pain, headache and fall. Further analysis of the Phase 3 STRUCTURE study results are ongoing and will be submitted to a future medical conference and for publication, the companies said.
11:40 EDTBAYRYBayer sees stock market flotation for MaterialScience unit by mid-2016 at latest
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10:05 EDTAMGNOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: 8point3 Energy (CAFD) initiated with an Equal Weight at Barclays... AMAG Pharmaceuticals (AMAG) initiated with an Outperform at Raymond James... Acadia (ACHC) initiated with an Outperform at Leerink... Acorda Therapeutics (ACOR) initiated with a Market Perform at Raymond James... Alexion (ALXN) initiated with a Strong Buy at Raymond James... Amedisys (AMED) initiated with an Outperform at Wells Fargo... Amgen (AMGN) initiated with a Market Perform at Raymond James... Amplify Snack Brands (BETR) initiated with a Neutral at Credit Suisse... BioMarin (BMRN) initiated with an Outperform at Raymond James... Biogen (BIIB) initiated with a Strong Buy at Raymond James... Celgene (CELG) initiated with a Strong Buy at Raymond James... CoreLogic (CLGX) initiated with a Neutral at SunTrust... Digi International (DGII) initiated with an Overweight at Stephens... First Solar (FSLR) initiated with an Overweight at Barclays... LHC Group (LHCG) initiated with an Outperform at Wells Fargo... Lancaster Colony (LANC) initiated with a Buy at BB&T... McCormick (MKC) initiated with a Buy at BB&T... NephroGenex (NRX) initiated with a Buy at H.C. Wainwright... Omega Protein (OME) initiated with a Hold at BB&T... Preferred Apartment (APTS) initiated with an Outperform at FBR Capital... Qorvo (QRVO) initiated with an Outperform at CLSA... Regeneron (REGN) initiated with an Outperform at Raymond James... Skyworks (SWKS) initiated with an Outperform at CLSA... SunPower (SPWR) initiated with an Equal Weight at Barclays... TESARO (TSRO) initiated with a Strong Buy at Raymond James... Ultragenyx (RARE) initiated with an Outperform at Raymond James... VEREIT (VER) initiated with a Buy at Goldman... Westmoreland (WLB) initiated with an Outperform at BMO Capital.
10:03 EDTBAYRYBayer announces capacity expansion at facilities producing weed control system
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August 31, 2015
19:23 EDTAMGNAmgen initiated with a Market Perform at Raymond James
06:35 EDTAMGNAlnylam price target raised to $184 from $180 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for Alnylam Pharmaceuticals (ALNY) to $184 saying the company over the weekend reported positive Phase I data on ALN-PCS showing LDL-cholesterol lowering comparable to Amgen (AMGN) and Sanofi/Regeneron's (REGN) anti-PCSK9 antibodies, but with only quarterly or potentially every 6-month injections. Tenthoff recommends using the recent pullback in shares of Alnylam as a buying opportunity and keeps an Overweight rating on the name.
August 30, 2015
15:50 EDTAMGNAlnylam, The Medicines Co. say ALN-PCSsc reduces LDL cholesterol as much as 83%
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August 28, 2015
13:53 EDTAMGNAnthem has not made coverage decision about Amgen's Repatha, Bloomberg reports
Bloomberg cites an emailed statement from Anthem (ANTM) regarding Amgen's (AMGN) Repatha injection, which was approved last night by the FDA as an option for some patients who are unable to get their low-density lipoprotein cholesterol under control with current treatment options.
08:01 EDTAMGNAmgen pricing for Repatha competitive with Praluent, says Piper Jaffray
After the FDA announced last night that it has approved Amgen's (AMGN) Repatha injection, Piper Jaffray analyst Joshua Schimmer said that the drug's indications seem "generally in line" with those for Praluent from Regeneron (REGN) and Sanofi (SNY). Amgen disclosed an annual WAC of $14,100 for Repatha, which the analyst notes is about $500 per year below Praluent, but Schimmer said that the actual recognized price for each will ultimately be determined by discounting. Schimmer also noted that Amgen said it is working with payers and other purchasers on "innovative pricing programs," though he is uncertain if that means the company is working on a kind of "pay per performance" scheme. The analyst, who believes the market will prove large enough for both treatments, keeps a $200 price target and Overweight rating on Amgen shares.
August 27, 2015
19:14 EDTAMGNExpress Scripts to cover both Repatha, Praluent for now, Bloomberg says
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18:52 EDTAMGNOn The Fly: After Hours Movers
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17:58 EDTAMGNEsperion up 1.9% after FDA approves Amgen cholesterol drug Repatha
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17:55 EDTAMGNAmgen confirms FDA approval of Repatha cholesterol-lowering medication
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17:24 EDTAMGNFDA approves Repatha
The U.S. Food and Drug Administration approved Repatha injection for some patients who are unable to get their low-density lipoprotein cholesterol under control with current treatment options. Repatha is marketed by Amgen Inc., of Thousand Oaks, Calif. Reference Link
08:06 EDTAMGNFDA PDUFA Date for Amgen's Repatha is August 27, 2015
August 26, 2015
06:02 EDTAMGNAmgen implied volatility of 41 at upper end of index
August 25, 2015
10:14 EDTBAYRYForward signs supplier agreement extension with Bayer Healthcare
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09:16 EDTAMGNAmgen to present Repatha data analysis at ESC Congress 2015
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09:02 EDTAMGNAmgen submits NDA for hyperparathyroidism treatment
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August 24, 2015
13:36 EDTAMGNBiotech correction presents some opportunities, says RBC Capital
RBC Capital analyst Michael Yee said he won't try to pick the short-term bottom in biotech, but contends that any macro weakness in China shouldn't have any major impact to financials or fundamentals for the sector given their minimal exposure there. If the market continues to be volatile, Yee recommends a focus on names with defensive characteristics, such as higher margins and free cash flow yield, naming Amgen (AMGN), Celgene (CELG) and Gilead (GILD) as some examples. The analyst adds that he likes Vertex (VRTX) on the pullback for "more aggressive" growth investors. Yee has Outperform ratings on all of the stocks mentioned above.
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