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March 31, 2014
13:41 EDTNVS, MRKNovartis rises after committee recommends early closure of study
Shares of drug maker Novartis (NVS) are climbing after the Data Monitoring Committee of its PARADIGM-HF study, which tested LCZ696 in comparison to patients who received standard care with enalapril, unanimously recommended early closure of the trial due to the drug's efficacy. WHAT'S NEW: Novartis announced that the committee unanimously recommended early closure of the study, indicating patients with chronic heart failure with reduced ejection fraction who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril. Based on the compelling efficacy and primary endpoint having been met, the trial was closed early. This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable. One of the two principal investigators, Dr. Milton Packer, said, "The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure." The company said the results of PARADIGM-HF will be submitted to a major medical conference for presentation and Novartis will now initiate discussions with global health authorities regarding approval for marketing. WHAT'S NOTABLE: Novartis said that the PARADIGM-HF study was initiated in December 2009 and currently is the largest clinical trial in heart failure ever undertaken. LCZ696 is a medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms. LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover. LCZ696 is the second treatment being developed by Novartis for patients with heart failure, along with RLX030 for acute heart failure. The standard ACE-inhibitor enalapril has been marketed as VASOTEC in the U.S. by Merck (MRK). Several companies sell generic enalapril under the name enalapril maleate tablets. PRICE ACTION: During afternoon trading, shares of Novartis were up by $3.31 or 4%, to $84.90.
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January 23, 2015
18:37 EDTNVSNovartis confirms FDA approval of Bexsero
Novartis announced that the US FDA has granted accelerated approval of Bexsero for active immunization to prevent invasive meningococcal disease caused by serogroup B in adolescents and young adults from 10 years through 25 years of age. Bexsero is the only meningitis B vaccine approved in the US with a two-dose regimen and a flexible dosing schedule. As part of the accelerated approval process, Novartis will complete its ongoing studies to confirm the effectiveness of Bexsero against diverse serogroup B strains.
16:21 EDTNVSFDA approves Novartis vaccine Bexsero
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12:33 EDTNVSOn The Fly: Midday Wrap
Stocks on Wall Street were mixed at midday, with the Nasdaq leading and the Dow lagging. The futures dipped this morning after UPS (UPS) pre-announced that its quarterly earnings would miss Street estimates. The earnings miss dragged other transportation names lower. ECONOMIC EVENTS: In the U.S., Markit's preliminary January manufacturing PMI fell to 53.7 from 53.9 previously, versus expectations for a reading of 54.0. Existing home sales rebounded 2.4% to a 5.04M rate in December, which was below the consensus forecast for a 3% increase. The leading indicators rose 0.5% to 121.1 in December, topping expectations for a rise of 0.4%. COMPANY NEWS: Shares of UPS plunged over 9% after the shipping giant warned that its Q4 adjusted EPS is now expected to be $1.25, below the consensus forecast of $1.47. "UPS invested heavily to ensure we would provide excellent service during peak when deliveries more than double. Though customers enjoyed high quality service, it came at a cost to UPS. Going forward, we will reduce operating costs and implement new pricing strategies during peak season,” said CEO David Abney. Subsequently, its peer, FedEx (FDX), reaffirmed its FY15 EPS forecast of $8.50-$9.00. The outlook compares to a consensus forecast of $8.97. FedEx shares, which were briefly halted for the announcement, are down 2% afterward... Shares of McDonald’s (MCD) slid about 1% near noon after its earnings miss, though the world’s largest restaurant chain's same-store sales declined less than analysts expected. Same-store sales in the company's fiscal fourth quarter declined 0.9%, versus the Consensus Metrix analysts' estimate for a 1.5% drop. Of note, McDonald’s U.S. same-store sales had their first monthly gain in more than a year in December, having risen 0.4%. MAJOR MOVERS: Among the notable gainers was Starbucks (SBUX), which rose 6.5% and had several research firms issue upbeat notes after the company reported in-line results last night. At least three firms responded to the report by raising their price targets on the shares. Also higher was Array BioPharma (ARRY), which jumped 38% after announcing that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. Among the noteworthy losers was Avon Products (AVP), which dropped 11% after Wells Fargo downgraded the stock to Market Perform from Outperform after shares rallied yesterday over 14% following a report that the company has held talks with TPG Capital about a possible deal. Wells says it leveraged buyout math suggests a takeout of the entire company is unlikely. Also lower was DreamWorks Animation (DWA), which fell 9% after announcing a new strategic plan that will see it cut its feature production from three films per year down to two and cut about 500 jobs. INDEXES: Near midday, the Dow was down 42.58, or 0.24%, to 17,771.40, the Nasdaq was up 9.68, or 0.2%, to 4,760.08, and the S&P 500 was down 3.40, or 0.16%, to 2,059.75.
08:52 EDTNVSArray BioPharma to hold a conference call
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08:10 EDTNVSArray agrees to acquire rights to encorafenib
Array BioPharma (ARRY) announced that it has reached a definitive agreement with Novartis (NVS) to acquire worldwide rights to encorafenib, a BRAF inhibitor currently in Phase 3 development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline (GSK) on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals. Array previously announced a definitive agreement with Novartis to regain global rights to the Phase 3 MEK inhibitor binimetinib, the material terms of which remain in place following this agreement. In order to address competition concerns raised by the European Commission, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. The European Commission is expected to issue a decision regarding the Novartis-GSK transaction on January 28, 2015. Upon satisfaction of all conditions and closing of the deal, Array will acquire global rights to encorafenib. Other than a de minimis payment due to Novartis from Array, there are no milestone payments or royalties payable under this agreement by either party. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array all patent and other intellectual property rights Novartis owns to the extent relating to encorafenib. As part of the transaction, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Novartis will conduct and fund the COLUMBUS trial through the earlier of June 30, 2016 or completion of last patient first visit. At that time, Array will assume responsibility for the trial, while Novartis will reimburse Array for out-of-pocket costs along with 50% of Array's full time equivalent costs in connection with completing the COLUMBUS trial. Novartis is responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50% of Array's FTE costs in connection with completing the trials. Novartis will supply encorafenib for clinical and commercial use for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib. The effectiveness of the agreement is subject to the receipt of regulatory approvals and to the consummation of the Novartis-GSK transaction. In addition, Array agreed to undertake to obtain certain third party consents or waivers necessary for Array to consummate the transactions under the Novartis Agreement.
07:36 EDTNVSIncyte earns $25M milestone payment from Novartis for Jakavi
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07:25 EDTNVSNovartis drug Jakavi recommended by CHMP for EU approval
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06:39 EDTMRKNIH, GlaxoSmithKline, Merck launch joint Ebola vaccine test in Liberia, WSJ says
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January 21, 2015
12:35 EDTNVSNovartis confirms FDA approval for Cosentyx
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12:33 EDTNVSFDA approves Novartis psoriasis drug Cosentyx
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10:26 EDTNVSHigh option volume stocks
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10:16 EDTMRKLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
08:02 EDTMRKMerck completes tender offer to acquire Cubist
Merck (MRK) announced the successful completion of the tender offer for all of the outstanding shares of common stock of Cubist Pharmaceuticals (CBST) at a purchase price of $102.00 per share. As of the tender offer expiration yesterday, 58,039,667 shares of common stock of Cubist were validly tendered and not properly withdrawn from the tender offer, representing approximately 75.7% of the outstanding common stock of Cubist on a fully diluted basis. All of such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck expects to promptly pay for all such shares. Following consummation of the tender offer, Merck expects to complete the acquisition of Cubist later today through a merger of Merck’s wholly owned subsidiary with and into Cubist without stockholder approval. Upon completion of the merger, all outstanding shares of common stock of Cubist, other than shares held by Cubist in treasury or shares held by Cubist’s stockholders who are entitled to and properly exercise appraisal rights under Delaware law, will be canceled and converted into the right to receive cash equal to the $102.00 offer price per share without interest, less any applicable withholding taxes. In addition, upon completion of the merger, Cubist will become a wholly owned subsidiary of Merck and the common stock of Cubist will cease to be traded on the NASDAQ Stock Market.
January 20, 2015
17:18 EDTMRKDana Holding to replace Cubist in S&P 400 as of 1/22 close
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07:23 EDTMRKMerck funding testing of lower dosages of Zilmax, Reuters reports
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January 16, 2015
08:31 EDTNVSGlaxoSmithKline CEO says more IPOs like ViiV could happen, Retuers says
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January 15, 2015
11:20 EDTMRKGoldman cuts J&J to sell citing competitive pressures
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07:59 EDTMRKAmerican Society of Clinical Oncology to hold a symposium
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January 14, 2015
11:45 EDTNVSImmunoGen discloses triggering of $5M milestone payment from Novartis
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08:34 EDTMRKMerck and Practice Fusion's health vaccine initiative shows positive results
Merck and Practice Fusion announced the results of a recent collaboration designed to improve public health outcomes through a Population Health Management program for adult vaccines. Launched in April, the program contributed to a statistically significant relative increase in recorded vaccinations among eligible patients on Practice Fusion's EHR platform. During the four-month test period, Practice Fusion observed a 73% relative increase in recorded vaccinations in test versus control patients.
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