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March 31, 2014
13:41 EDTMRK, NVSNovartis 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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December 8, 2014
13:07 EDTNVSNovartis announces data from Jakavi trial
Novartis (NVS) announced data from the largest clinical trial of myelofibrosis patients treated with Jakavi, supporting the safety profile and efficacy benefit as measured in primary and secondary endpoints respectively. In an analysis of 1,144 patients treated with Jakavi to date in this ongoing expanded access study, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis. Findings from the study were presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, California. Novartis research and development efforts, in collaboration with Incyte Corporation (INCY), include early-phase and post-marketing studies in myelofibrosis and other myeloproliferative neoplasms. More than 50 abstracts on ruxolitinib are being presented at ASH, including three oral presentations exploring combinations of ruxolitinib with various investigational compounds, evaluating the possibility of simultaneously targeting multiple cancer pathways that may be involved in the pathogenesis of myelofibrosis. The JUMP study is a Phase IIIb, expanded-access trial for countries with no access to Jakavi outside of a clinical trial. The open-label, multicenter study analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary endpoint is assessment of safety and tolerability of Jakavi. Overall, the safety and efficacy profile of Jakavi was consistent with previous studies.
13:05 EDTNVSNovartis reports six-year results from Phase III ENESTnd study
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12:40 EDTMRKOn The Fly: Midday Wrap
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12:25 EDTMRKAntibiotic makers rise after Merck agrees to buy Cubist
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11:30 EDTNVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:30 EDTMRKMerck says deals with Cubist includes $250M break-up fee clause
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08:21 EDTMRKMerck says looked at all risks, including patent litgation, before Cubist deal
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08:11 EDTMRKCubist volatility elevated into Merck acquiring for $8.4B in cash
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08:08 EDTMRKMerck says about $9.5B of debt to be issued related to Cubist deal
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07:35 EDTMRKAdvaxis reports FDA acceptance of IND application for ADXS-PSA combination trial
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07:13 EDTMRKMerck to host conference call
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07:01 EDTMRKMerck to acquire Cubist for $102 per share in cash, or $9.5B
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07:00 EDTMRKMerck to acquire Cubist for $102 per share in cash
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05:42 EDTNVSSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
December 7, 2014
16:29 EDTMRKMerck in discussions to buy Cubist for $7B, Bloomberg reports
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12:58 EDTMRKMerck presents KEYTRUDA data at ASH
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December 4, 2014
12:22 EDTNVSOn The Fly: Midday Wrap
Stocks on Wall Street began the session slightly lower despite relatively in-line jobless claims data, as European markets moved down following a rate decision and accompanying commentary from ECB President Mario Draghi. Adding to the modest pressure seen in morning trading may be the fact that oil prices continue to move lower. ECONOMIC EVENTS: In the U.S., initial jobless claims fell 17K to 297K in the week ended November 29, which was nearly in-line with the expectation for 295K first-time claims. Challenger reported announced layoffs fell 15.2K in November to 35.9K. In Europe, the European Central Bank kept its key rates unchanged, as expected. ECB President Mario Draghi said in his accompanying press conference that the latest euro area macroeconomic projections indicate lower inflation, accompanied by weaker real GDP growth and subdued monetary dynamics. Additionally, he stated that early next year the Governing Council will reassess the monetary stimulus achieved, the expansion of the balance sheet and the outlook for price developments. "Should it become necessary to further address risks of too prolonged a period of low inflation, the Governing Council remains unanimous in its commitment to using additional unconventional instruments within its mandate. This would imply altering early next year the size, pace and composition of our measures," Draghi said. COMPANY NEWS: Shares of Barnes and Noble (BKS) slid about 10% after the company reported lower than expected second quarter earnings and said it continues to expect both Retail comparable bookstore sales and Retail Core comparable bookstore sales to decline in the low-single digits this fiscal year. Additionally, Barnes & Noble and Microsoft (MSFT) agreed to terminate their commercial agreement and B&N agreed to acquire Microsoft's entire preferred interest in NOOK Media in exchange for $62.4M cash and 2.74M shares of its stock. MAJOR MOVERS: Among the notable gainers was Hawaiian Electric (HE), which jumped 16% after its board approved a plan to spin off ASB Hawaii, the parent company for American Savings Bank, and establish it as an independent publicly traded company and NextEra Energy (NEE) agreed to acquire the company, excluding the banking subsidiary. Array BioPharma (ARRY) rose 15% after announcing it has reached a definitive agreement with Novartis (NVS) to regain full worldwide rights to binimetinib, a MEK inhibitor in three Phase 3 trials, which Piper Jaffray called a "big win" for the company. Among the noteworthy losers was UTi Worldwide (UTIW), which fell 11.5% after confirming that exploratory conversations have taken place with DSV, but adding those discussions never progressed beyond a preliminary stage and that no talks are currently taking place. Also lower were shares of Express (EXPR), which declined over 9% after the apparel retailer reported lower than expected Q3 revenue and gave EPS guidance that fell short of estimates. INDEXES: Near midday, the Dow was down 53.56, or 0.3%, to 17,859.06, the Nasdaq was down 2.80, or 0.06%, to 4,771.67, and the S&P 500 was down 5.49, or 0.26%, to 2,068.84.
09:15 EDTNVSArray BioPharma to host conference call
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08:45 EDTNVSAbbVie price target raised to $80 from $72 at Jefferies
Jefferies raised its price target for AbbVie shares to $80 while calling the company one of its top five global pharma picks for 2015. The firm's top U.S. pick is Pfizer (PFE) and its top Europe pick is Novartis (NVS). Bayer (BAYRY) and AstraZeneca (AZN) round out the top five. Jefferies thinks AbbVie's "strong momentum" will continue into the first half of 2015 and keeps a Buy rating on the name.
05:54 EDTNVSArray BioPharma regaining binimetinib a 'big win,' says Piper Jaffray
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