New User:

-or-
Username:
Password:
Forgot your password?

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
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | 3 | 4 | all recent news | >>
March 20, 2015
09:01 EDTRHHBYEli Lilly up 2% to $75.75 in pre-market trading
Subscribe for More Information
07:41 EDTCELGAmerican Academy of Dermatology to hold annual meeting
Subscribe for More Information
06:26 EDTCELGCelgene price target raised to $144 from $135 at Piper Jaffray
Subscribe for More Information
March 19, 2015
18:14 EDTGSKGlaxoSmithKline, Theravance announce FDA panel outcome on Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States FDA regarding the supplemental New Drug Application for Breo Ellipta as a once-daily inhaled treatment for asthma in patients aged 12 years and older. The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against). The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18 against). The Committee voted that the efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated in this sub-population. The Committee recommended that a large LABA safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on April 30.
16:14 EDTRHHBYProthena report positive results from Phase 1 study of PRX002
Subscribe for More Information
16:01 EDTGILDOptions Update; March 19, 2015
Subscribe for More Information
15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
Subscribe for More Information
09:37 EDTCELGActive equity options trading on open
Subscribe for More Information
09:08 EDTGILDNew Gilead HIV drug likely to be approved in mid-2015, says Argus
Subscribe for More Information
07:26 EDTGSKFDA to hold a joint advisory committee meeting
The Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee discuss the supplemental New Drug Application (sNDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREOŽ ELLIPTAŽ), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older in a meeting being held in Gaithersburg, Maryland on March 19 at 8 am. Webcast Link
07:10 EDTGSKTheravance announces trading in common stock halted as FDA meets on sNDA
Subscribe for More Information
07:09 EDTSNYSanofi reports top-line results for Lyxumia for cardiovascular safety
Sanofi announced top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. The results will be included in the U.S. New Drug Application of lixisenatide, which is on track to be resubmitted to the FDA in Q3. Lixisenatide is not approved in the U.S.
07:02 EDTRHHBYSigma-Aldrich signs exclusive distribution agreement with Roche
Subscribe for More Information
05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
Subscribe for More Information
March 18, 2015
17:07 EDTCELGCelgene GED-0301 Phase II data published in New England Journal of Medicine
Subscribe for More Information
12:48 EDTRHHBYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
Subscribe for More Information
09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
Subscribe for More Information
07:46 EDTRHHBYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
05:23 EDTQIHUQihoo 360 announces partnership with Microsoft
Qihu 360 (QIHU) announced a partnership with Microsoft (MSFT) to bring Windows 10, for free, to its customers in China through seamless upgrades. Qihu 360 will enable the Windows 10 upgrade with just a few clicks for their customers with accelerated download speeds. As a result, millions of Qihu 360 users will be able to upgrade to Windows 10 quickly and easily.
05:21 EDTQIHUMicrosoft announces Windows 10 to launch this Summer in 190 countries
Subscribe for More Information
1 | 2 | 3 | 4 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use