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Stock Market & Financial Investment News

News Breaks
August 25, 2014
12:19 EDTANN, SNY, ITMN, GILD, LTM, RGDO, THI, QIHU, GSK, RHHBY, BKW, CELGOn The Fly: Midday Wrap
Stocks on Wall Street continued their recent run higher, pushing the S&P 500 above 2,000 for the first time ever. The benchmark index hit the record level despite a report that showed new home sales unexpectedly declined in July. At the lunch hour, the averages were just off their best levels and the S&P had dipped back just below the 2K milestone. ECONOMIC EVENTS: In the U.S., the Chicago Fed's National Activity index jumped to 0.39 in July from an upwardly revised 0.21 in June. Markit's preliminary August services PMI came in at 58.5, which was down from a prior reading of 60.8 but above the 58.0 consensus projection. New home sales dropped 2.4% to a 412K rate in July, missing expectations for them to have risen to a 430K annualized rate. COMPANY NEWS: Shares of InterMune (ITMN) surged 35.5% to trade just below $73 per share near noon after the company agreed to be acquired by Roche (RHHBY) for $74.00 per share in an all-cash transaction. The deal announcement comes less than two weeks after Bloomberg reported that Roche, along with big pharmaceutical peers Sanofi (SNY) and GlaxoSmithKline (GSK), had made takeover bids for the smaller drugmaker. A number of other biotech companies gained following the deal announcement, including Gilead (GILD), which rose about 3%, and Celgene (CELG), which advanced 2%... Burger King (BKW) shares rose 19% after the company confirmed it is in talks regarding a potential strategic transaction with Canadian donut chain Tim Hortons (THI). The new publicly-listed company, which would be headquartered in Canada, would be the world's third-largest quick service restaurant company with about $22B in system sales and over 18,000 restaurants. Shares of Tim Horton's trading in New York also gained 20% following the confirmation of news reported by The Wall Street Journal over the weekend. MAJOR MOVERS: Among the notable gainers was Life Time Fitness (LTM), which rose 10% after confirming the company has initiated a process to explore a potential conversion of its real estate assets into a Real Estate Investment Trust, or REIT. Also higher was Ann Inc. (ANN), which gained 4.5% after Engine Capital and Red Alder, who collectively own over 1% of the company's outstanding shares, urged the company to explore value creating opportunities, including a potential sale. Among the noteworthy losers was Regado Biosciences (RGDO), which plunged 60% and was downgraded at Deutsche Bank and Jefferies after the company announced the permanent termination of enrollment in its REGULATE-PCI phase 3 trial for its lead program. Also lower after its earnings report was Chinese Internet services provider Qihoo 360 (QIHU), which dropped 8%. INDEXES: Near midday, the Dow was up 96.27, or 0.57%, to 17,097.49, the Nasdaq was up 21.29, or 0.47%, to 4,559.85, and the S&P 500 was up 11.14, or 0.56%, to 1,999.54.
News For BKW;THI;ITMN;RHHBY;RGDO;SNY;GSK;LTM;ANN;QIHU;GILD;CELG From The Last 14 Days
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November 18, 2014
12:16 EDTSNYSanofi to host seminar on New Medicines
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11:22 EDTRHHBYTeva patent victory over Warner Chilcott, Roche affirmed
The U.S. Court of Appeals for the Federal Circuit ruled that a district court was correct to grant summary judgment to Teva (TEVA) in a patent dispute with Warner Chilcott and Roche (RHHBY) over patents related to osteoporosis drug risedronate.
10:08 EDTGILDGilead granted European Commission marketing authorization for Harvoni
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07:34 EDTCELGCelgene presents long-term OTEZLA data at ACR/ARHP meeting
Celgene announced that results from long-term efficacy and safety analyses of OTEZLA from the open-label phase of two PALACE phase III clinical trials were presented at the 2014 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in Boston. OTEZLA is the Company’s oral, selective inhibitor of phosphodiesterase 4, approved by the U.S. FDA for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In PALACE 1, 84 percent of patients who completed one year of 30 mg twice daily therapy continued to receive OTEZLA at two years. Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving OTEZLA 30 mg twice daily, the ACR20 response rate was 65.3 percent. ACR50 and 70 response rates were 34.0 percent and 19.6 percent, respectively, at week 104. Similar findings were observed in PALACE 4. In this trial, nearly 84 percent of DMARD-naïve patients who completed one year of OTEZLA 30 mg twice daily monotherapy continued to receive OTEZLA at two years. At week 104, among patients treated with OTEZLA 30 mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4 percent, 40.7 percent and 19.2 percent of patients, respectively. In both PALACE 1 and PALACE 4, changes in other efficacy measures—including the HAQ-DI, which assesses improvements in physical function, and swollen and tender joint counts—were also generally sustained between weeks 52 and 104 with continued OTEZLA treatment. In PALACE 4, treatment with OTEZLA in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.
07:20 EDTGSKEuro Organization for Research & Treatment of Cancer co-hosts a symposium
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November 17, 2014
17:02 EDTGSKClovis in oncology clinical trial collaboration with GlaxoSmithKline
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16:00 EDTGILDOptions Update; November 17, 2014
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11:06 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
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09:36 EDTGILDActive equity options trading
Active equity options trading according to Track Data: AAPL PBR BHI GILD MU HD AMZN TSLA YHOO FB TWTR
07:16 EDTCELG, SNYMilken Institute--Faster Cures to hold a conference
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05:32 EDTGSKMedidata announces collaboration with GlaxoSmithKline
Medidata (MDSO) announced the completion of a method development project conducted in partnership with GlaxoSmithKline (GSK) to evaluate the impact of unifying mobile health, or mHealth, devices with cloud-based technologies in a clinical trial setting. The joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs. The collaborative project, which took place at GSK’s Human Performance Lab, demonstrated that mHealth technologies have the power to comprehensively collect large volumes of objective data that is reliable, secure and analysis-ready, and provides real-time, continuous insight into the well being of patients. All of the data collected was audited and is compliant with FDA regulations. Additionally, the effort indicated that mobile devices can support the long-term goal of lessening the burden on patients participating in studies by streamlining routine procedures, eliminating unnecessary ones and reducing visits to clinical trial sites.
05:30 EDTRHHBYInovio, Roche terminate collaboration for INO-5150
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November 16, 2014
14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
17:07 EDTCELGSoros Fund Management gives quarterly update on stakes
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14:53 EDTGILD, RHHBY, GSK, SNYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
13:27 EDTRHHBYRoche reports FDA nod for Avastin in platinum-resistant recurrent ovarian cancer
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11:48 EDTGILDStocks with call strike movement; GILD BBY
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09:38 EDTGILDActive equity options trading
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07:14 EDTCELG, GSKAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
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