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Stock Market & Financial Investment News

News Breaks
April 29, 2014
07:59 EDTAZN, SNY, ABBV, PFE, AMGNAnalyst sees Amgen, AbbVie as alternate Astra partners, Bloomberg says
Citigroup analyst Andrew Baum contended yesterday that AstraZeneca (AZN) could seek a merger of equals with Amgen (AMGN) or AbbVie (ABBV) as an alternative to the deal proposed by Pfizer (PFE), or that others like Sanofi (SNY) could make rival unsolicited bids, reported Bloomberg. Note that a later Bloomberg report claimed that Amgen is not interested in making a bid for AstraZeneca. Reference Link
News For AMGN;ABBV;AZN;PFE;SNY From The Last 14 Days
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July 24, 2015
07:55 EDTABBVAbbVie reports Q2 Global Humira sales up 16.4% to $3.54B
Strong U.S. HUMIRA growth continued, driven by double-digit growth across all three major market categories, rheumatology, dermatology and gastroenterology. Reported international HUMIRA sales growth in the quarter was reduced by nearly 18 percent due to unfavorable foreign exchange. First-half 2015 international HUMIRA sales grew nearly 9 percent on an operational basis, consistent with planning expectations and the full year forecast for international HUMIRA sales growth of 9 to 10 percent on an operational basis. As noted last quarter, the first-quarter international operational growth rate of nearly 15 percent was favorably impacted by the timing of shipments in select markets. Consequently, sales growth in the second quarter was negatively impacted by shipment timing.
07:54 EDTABBVAbbVie backs FY15 adjusted EPS $4.10-$4.30, consensus $4.24
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07:54 EDTABBVAbbVie reports Q2 adjusted EPS $1.08, consensus $1.06
Reports Q2 revenue $5.48B, consensus $5.62B
07:21 EDTSNYRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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July 23, 2015
15:05 EDTABBVNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's open, with earnings consensus, include AbbVie (ABBV), consensus $1.06... Biogen (BIIB), consensus $4.10... Simon Property Group (SPG), consensus $2.36... State Street (STT), consensus $1.37... V.F. Corp. (VFC), consensus 36c... Johnson Controls (JCI), consensus 91c... American Airlines (AAL), consensus $2.60... Rockwell Collins (COL), consensus $1.30... Cabot Oil & Gas (COG), consensus 4c... Lear (LEA), consensus $2.48... Encana (ECA), consensus (15c).
14:55 EDTABBVAbbVie technical comments before earnings news
The stock is trading close to its life high at $71.60 ahead of earnings news. On a 2-year chart basis recent high price and the near-matching high from December of last year indicates shares are at major resistance. If the news is a bearish surprise, these two peaks in price could be construed as potential double top. Next supports below $70 would be at $68.50, $66.52, and $64.81. If the news is a bullish surprise, the life high could easily be taken out. An extension of the current bullish price channel in time yields a potential target at $75. Without overhead resistance, that level could be exceeded depending on the nature of the news.
13:56 EDTABBVEarnings Watch: AbbVie sees Q2 EPS $1.04-$1.06
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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 22, 2015
13:58 EDTAZNPiper cuts Array target by only 50c after failed trial
Piper Jaffray analyst Edward Tenthoff says selumetinib for Uveal Melanoma is a small indication and represented only a small part of his valuation for Array BioPharma (ARRY). As such, after partner AstraZeneca (AZN) announced that selumetinib failed in the Phase III trial, the analyst cut his price target for Array by only 50c to $14.50. The primary drivers for Array remain binimetinib and encorafenib in NRAS and BRAF melanoma and low-grade serous ovarian cancer, the analyst tells investors in a research note. He keeps an Overweight rating on the stock.
10:01 EDTABBVOn The Fly: Analyst Initiation Summary
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09:07 EDTAZNOn The Fly: Pre-market Movers
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08:32 EDTPFEPfizer expands lease agreement with MIT subsidiary
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07:04 EDTABBVAbbVie initiated with a Buy at SunTrust
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05:12 EDTAZNAstraZeneca says Phase 3 study of selumetinib did not meet primary endpoint
AstraZeneca (AZN) announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing. Selumetinib is a MEK inhibitor in late-stage development, with a primary Phase 3 program in second-line KRAS-mutant advanced non-small cell lung cancer in combination with docetaxel. Selumetinib is also being investigated in a Phase 3 study in differentiated thyroid cancer and in a Phase 2 registration study in patients with neurofibromatosis Type 1. Selumetinib is an oral small molecule MEK inhibitor invented by Array BioPharma (ARRY) and licensed to AstraZeneca in 2003.
July 21, 2015
12:47 EDTSNY, AMGNPiper 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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08:04 EDTPFEPfizer launches Caltrate Bone & Joint Health supplement
Pfizer Consumer Healthcare announced the launch of Caltrate Bone & Joint Health, a 3-in-1, triple action product that delivers UC-II, an exclusive form of collagen, to support healthy cartilage and promote joint flexibility, calcium and vitamin D3, to nourish strong and healthy bones, and vitamin C and minerals to support collagen production for healthy bones and skin.
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.
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