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Stock Market & Financial Investment News

News Breaks
April 25, 2014
10:40 EDTAMGN, BAYRYEMA backs expanded indication for Nexavar for thyroid cancer
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Nexavar. Nexavar is currently indicated for the treatment of patients with hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. The CHMP has now recommended an extension to the indication to include the treatment of patients with progressive, locally advanced or metastatic, differentiated thyroid carcinoma, refractory to radioactive iodine. Nexavar is marketed by Bayer (BAYRY) and Amgen's (AMGN) Onyx Pharmaceuticals.
News For AMGN;BAYRY From The Last 14 Days
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July 30, 2015
13:14 EDTAMGNAmgen technical notes ahead of earnings
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12:37 EDTAMGNAmgen July weekly 172.5 straddle priced for 3.7% movement into Q2
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12:05 EDTAMGNEarnings Watch: Amgen shares up about 1.5% since last report
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July 29, 2015
07:49 EDTAMGNAmgen July weekly volatility elevated into Q2 and outlook
Amgen July weekly call option implied volatility is at 61, August is at 32, September is at 29; compared to its 52-week range of 18 to 34, suggesting large near term price movement into the expected release of Q2 results on July 30.
05:59 EDTAMGNStocks with implied volatility movement; AMGN CLF
Stocks with implied volatility movement; Amgen (AMGN) 30, Cliffs Natural (CLF) 125 according to iVolatility.
05:47 EDTBAYRYBayer cuts FY15 sales to EUR 47B from EUR 48B- EUR 49B
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05:42 EDTBAYRYBayer reports Q2 Healthcare sales up 28% to EUR 5.91B
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05:40 EDTBAYRYBayer reports Q2 net income EUR 1.52B vs. EUR 953M last year
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July 28, 2015
07:34 EDTAMGNJefferies sees entry point for Aegerion, upgrades to Buy
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July 24, 2015
15:00 EDTAMGNBroader label for PCSK9 drug positive for Regeneron, Amgen, says Deutsche Bank
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12:44 EDTAMGNAmgen announces FDA approval of expanded Kyprolis indication
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12:27 EDTAMGNFDA approves expanded use of Kyprolis in multiple myeloma patients
The FDA announced that on July 24 the administration approved carfilzomib, or Kyprolis, marketed by Onyx Pharmaceuticals, an Amgen (AMGN) subsidiary, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The revised labeling includes new Warnings and Precautions for VTE, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. The increased safety risks, including mortality, for elderly patients is described. Detailed safety information in the prescribing information was also updated for use of carfilzomib monotherapy. Reference Link
July 23, 2015
09:10 EDTAMGNAmgen submits NDA for Kyprolis in relapsed multiple myeloma
Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy. The sNDA is based on data from the global Phase 3 ENDEAVOR trial in which relapsed multiple myeloma patients treated with Kyprolis and dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade.
July 21, 2015
12:47 EDTAMGNPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
11:49 EDTAMGNNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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07:12 EDTAMGNAmgen's Repatha granted marketing authorization by EC
Amgen announced that the European Commission, or EC, has granted marketing authorization for Repatha, or evolocumab, the first proprotein convertase subtilisin/kexin type 9, or PCSK9, inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.
July 20, 2015
10:00 EDTBAYRYOn The Fly: Analyst Downgrade Summary
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08:38 EDTBAYRYAnalyst predicts Zoetis merges with Bayer unit, not Valeant
Zoetis (ZTS) in recent months has been the subject of takeover speculation, possibly for Valeant (VRX), but a Jefferies analyst told investors today in a research note that he views a deal with a unit of healthcare giant Bayer (BAYRY) as "highly likely" for the animal medicine company. BACKGROUND: Bill Ackman of Pershing Square, who owns stakes in both Zoetis and Valeant, said in early May while speaking on CNBC that Zoetis is a "great” business on a standalone basis, but he also spoke of the company's strategic value. Ackman added, however, that he was "not sure" that Valeant was the best acquirer of Zoetis. Subsequently, in late June, The Wall Street Journal reported that Valeant made a preliminary approach regarding a potential deal to buy Zoetis. CNBC's David Faber said the next day, citing his own sources, that Valeant reached out to Zoetis as a courtesy to common shareholder Ackman and was unlikely to pursue an acquisition of the company, though he cautioned then Valeant could change its approach and pursue a deal. BAYER: Jefferies analyst Jeffrey Holford said in a note today that he views a tie-up between Zoetis and Bayer's Animal Health business in 2016 as "highly likely." He sees Mylan's (MYL) acquisition of Abbott's (ABT) non‑U.S. developed markets specialty and branded generics business as a potential proxy for how a transaction could be structured, adding that such a "spinversion" could achieve up to 36% long-term earnings accretion for Zoetis. Holford reiterated a Buy rating on Zoetis with a $60 price target, while downgrading Bayer to Hold, citing valuation following the recent outperformance of its shares. IDEXX: While being discussed as a target, some analysts have also opined on companies that Zoetis could pursue as a buyer. On June 29, Canaccord said that in investor meetings with IDEXX (IDXX) executives declined to comment on Zoetis' potential interest in scaling up its animal health diagnostics business. Canaccord added that it thought Zoetis could make a bid for IDEXX. The firm reiterated its Buy rating and $80 price target on IDEXX shares at that time. PRICE ACTION: Since June 25, the day the Journal first reported on Valeant's preliminary takeover approach to Zoetis, the animal health company's shares have dropped nearly 4%. Zoetis closed down 20c to $47.80 on Friday.
07:30 EDTBAYRYZoetis 'highly likely' to merge with Bayer unit in 2016, says Jefferies
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05:21 EDTBAYRYBayer downgraded to Hold from Buy at Jefferies
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