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News For MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA From The Last 14 Days
Check below for free stories on MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA the last two weeks.
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September 16, 2014
06:27 EDTAZNAstraZeneca, Eli Lilly to jointly develop, commercialize AZD3293
AstraZeneca (AZN) and Eli Lilly (LLY) announced an agreement to jointly develop and commercialize AZD3293, an oral beta secretase cleaving enzyme inhibitor currently in development as a potential treatment for Alzheimer's disease. AZD3293 has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer's patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials. Under the terms of the agreement, Lilly will pay AstraZeneca up to $500M in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50M in the 1H15. The companies will share all future costs equally for the development and commercialization of AZD3293, as well as net global revenues post-launch. AstraZeneca and Lilly aim to progress AZD3293 rapidly into a Phase II/III clinical trial in patients with early Alzheimer's disease. Lilly will lead clinical development, working with researchers from AstraZeneca's Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization of AZD3293. The agreement is subject to customary terms and conditions. It will have no impact on AstraZeneca's 2014 Core Earnings per Share.
September 15, 2014
17:09 EDTNPSPOn The Fly: Closing Wrap
Stocks on Wall Street were mixed to begin the week, as the Dow managed to register mild gains but the Nasdaq was weighed down by slides in a number of so-called "momentum stocks" like Tesla (TSLA). Investors may remain cautious in the next two sessions ahead of the Fed's much anticipated rate decision and accompanying statement, which is due Wednesday. ECONOMIC EVENTS: In the U.S., New York Fed's Empire state survey for September rose to a five-year high of 27.54. Industrial production unexpectedly dipped 0.1% in August from a downwardly revised 0.2% July gain, missing the forecast for a rise of 0.3%. Capacity utilization dropped to 78.8% last month from 79.1% previously. In China, industrial output increased 6.9% in August versus the same period a year earlier, which was its weakest advance, excluding months that fell during New Year holidays, since December 2008. Chinese retail sales growth for August came in at 11.9%, missing the consensus estimate. COMPANY NEWS: Shares of Apple (AAPL) edged down 3c, or 0.03%, to $101.63 despite the company's announcement that a record 4M iPhone 6 and iPhone 6 Plus pre-orders were placed in the first 24 hours that ordering was available. Demand for the new phones exceeds the initial pre-order supply, the company added, stating that delivery of "many" iPhone pre-orders have been pushed out to October... Microsoft (MSFT) slid 45c, or 0.97%, to $46.24 after the company confirmed an agreement to acquire Mojang, the developer for the "Minecraft" video game franchise, for $2.5B... MAJOR MOVERS: Among the notable gainers was Avanir Pharmaceuticals (AVNR), which surged $5.75, or 85.31%, to $12.49 and was upgraded to Buy from Hold at Jefferies after the company announced results from its phase II clinical trial evaluating the safety and efficacy of its treatment of agitation in patients with Alzheimer's disease. Also higher was SABMiller (SBMRY), which jumped $4.72, or 8.5%, to $60.26 after the Wall Street Journal said that ABInBev (BUD) was looking to obtain financing for an acquisition of the U.K.-based brewer and Heineken (HEINY) confirmed that it rebuffed SABMiller's approach regarding a potential transaction. The news of potential consolidation in the space also drove other beer makers highers, with Molson Coors (TAP) rising $4.20, or 5.85%, to $76.00 and Boston Beer (SAM) gaining 71c, or 0.33%, to $218.47. Among the noteworthy losers was Tesla (TSLA), which dropped $25.34, or 9.08%, to $253.86 after Morgan Stanley analyst Adam Jones wrote that he agrees with the assertion of Tesla's CEO Elon Musk that the company's stock may have gotten ahead of itself. Also lower were shares of NPS Pharmaceuticals (NPSP), which fell $5.42, or 16.56%, to $27.28 after Oppennheimer and Jefferies stated that approval of its Natpara drug for hypoparathyroidism could be delayed after concerns were raised during an FDA panel meeting, even though the advisors were in favor of approving the drug. INDEXES: The Dow rose 43.63, or 0.26%, to 17,031.14, the Nasdaq dropped 48.70, or 1.07%, to 4,518.90, and the S&P 500 declined 1.41, or 0.07%, to 1,984.13.
12:31 EDTNPSPOn The Fly: Midday Wrap
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09:25 EDTPFEJPMorgan biotech analysts hold an analyst/industry conference call
Analysts assess Pfizer's M&A options on an Analyst/Industry conference call to be held on September 15 at 10 am.
09:16 EDTNPSPOn The Fly: Pre-market Movers
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08:05 EDTNPSPNPS Pharmaceuticals expected to win Natpara approval at Leerink
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07:55 EDTALKSAlkermes shares attractive ahead of Q1 catalysts, says Leerink
Leerink says its recent meeting with Alkermes management confirmed its conviction that the company is executing on its growth strategy. Leerink believes clinical trials for ALKS 8700 in multiple sclerosis, ALKS 7106 in abuse deterrent opiate analgesic and the Phase II trial for ALKS 3831 in schizophrenia are all billion dollar market opportunities that are not reflected in the current stock price. The firm finds the stock attractively valued ahead of clinical data readouts that start in early Q1 of 2015. It reiterates an Outperform rating on Alkermes with a $66 price target.
07:51 EDTNPSPNPS Pharmaceuticals PDUFA could be delayed, says Oppenheimer
After NPS Pharmaceuticals' stock rallied 25% on briefing materials that were thought to be benign and an FDA panel voted 8-5 to recommend approval of the company's Natpara drug, Oppenheimer thinks the PDUFA date for Natpara, could be delayed. The firm also believes that the panel's commentary was not "an overwhelming victory" for the drug, but Oppenheimer predicts that it will eventually be approved and keeps a $40 price target and Outperform rating on the name.
07:45 EDTNPSPNPS Pharmaceuticals approval likely to be delayed, says Jefferies
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07:27 EDTCELG, PFEIBC Life Sciences to hold a conference
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07:27 EDTPFE, AZNPfizer acquisition could drive shares higher, says JPMorgan
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September 14, 2014
13:32 EDTPFEPfizer shares look cheap, Barron's says
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September 12, 2014
17:09 EDTNPSPFDA recommends approval of NPS Pharmaceuticals Natpara for Hypoparathyroidism
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10:32 EDTAZN, PFEPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
09:01 EDTTEVATeva to present Copaxone gene expression analysis
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08:06 EDTTEVATeva presents new clinical safety data in RRMS patients treated with Laquinimod
Teva (TEVA) and Active Biotech (ACTI) announced new follow-up data evaluating the clinical safety of laquinimod in patients with relapsing-remitting multiple sclerosis, or RRMS, who were treated with laquinimod in Phase II, Phase III and open-label extension studies for two or more years. The pooled safety analysis of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies supports findings observed in the core studies where currently identified risks were observed within the first months of laquinimod treatment. In the pooled safety analysis, rates of adverse events, or AEs, and serious AEs were lower in the open-label extensions than in the core studies and less than three percent of patients discontinued treatment due to AEs during these extensions. Additionally, shifts to potentially significant laboratory values were considerably lower in patients exposed to at least two years of laquinimod.
08:03 EDTTEVATeva, Active Biotech present laquinimod follow-up data
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07:47 EDTNPSPNPS Pharmaceuticals to host conference call
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07:17 EDTNPSPFDA Endocrinologic and Metabolic Drugs Advisory Committee to hold a meeting
The Committee discusses NPSP Pharmaceuticals' Biologics License Application (BLA) 125511, proposed trade name, NATPARA, (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH), for the proposed indication of replacement for parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism will be held in Hyattsville, Maryland on September 12 at 8 am. Webcast Link
07:09 EDTNPSPNPS Pharma stock trading halted, FDA to review Natpara BLA
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