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Stock Market & Financial Investment News

News Breaks
July 14, 2014
11:20 EDTEXEL, RHHBYExelixis seen as potential target for Roche, TheStreet says
David Miller thinks Roche (RHHBY) will likely acquire Exelixis (EXEL) after the partners announced a phase III study of coBRIM in melanoma met its primary endpoint, reported TheStreet's Adam Feuerstein. Shares of Exelixis are up nearly 8% following this morning report on the trial. Reference Link
News For EXEL;RHHBY From The Last 14 Days
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February 8, 2016
06:28 EDTRHHBYPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space 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). Reference Link
February 3, 2016
14:32 EDTRHHBYPacific Biosciences deal with Roche may take time to get done, says Cantor
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February 2, 2016
16:23 EDTRHHBYOn The Fly: Top stock stories for Tuesday
Stocks began the session in negative territory and remained there throughout the entire session. The early weakness was attributed to oil prices, which were down early and never recovered during the day. The losses of more than 5% brings the loss over the past two days to more than 10%, pushing WTI crude back below $30 a barrel and squashing equities in the process. Any hope that oil prices would de-couple from stock prices will have to wait another day as the two continue to move in lockstep with each other. Even a solid earnings report from tech bellwether Alphabet (GOOG) could not help the market. ECONOMIC EVENTS: In the U.S., the economic calendar was quiet. In Europe, statistics agency Eurostat reported that unemployment across the eurozone decreased by 49,000 to a total of 16.75M in December dropping the unemployment rate to its lowest since September 2011 at 10.4%. In central bank news, the Reserve Bank of Australia and Reserve Bank of India both held their benchmark interest rates steady, as expected. COMPANY NEWS: Class A shares of Alphabet (GOOGL) advanced 1.3% to $780.91 after its better than expected quarterly results were followed by analysts around Wall Street hiking their price targets for shares, including Deutsche Bank analyst Ross Sandler, who raised his target on the parent of Google to $1,080 from $900... Exxon Mobil (XOM) reported better than expected revenue and profits in the fourth quarter, but its shares slid 2.2% to $74.61 amid the renewed weakness in oil prices. Shares of fellow oil major BP (BP) plunged 8.5% to $29.02 in New York trading after reporting a steep quarterly loss, largely due to $2.6B in charges related to impairments of Upstream assets as well as restructuring... Ford (F) shares fell 4.6% after the company reporting that its U.S. sales declined 3% last month versus a year ago. Peer General Motors (GM) slid 1.5% after reporting that its U.S. sales grew 0.5% in January... Dow Chemical (DOW) jumped 5.75% to $45.03 after posting better than expected earnings and revenue. Of note, Dow CEO Andrew Liveris said he plans to transition out of the company when it completes its planned merger with DuPont (DD). MAJOR MOVERS: Among the notable gainers were Michael Kors (KORS) and Mattel (MAT), which rose nearly 24% and almost 14%, respectively, following their earnings reports. Also higher was Pacific Biosciences (PACB), which jumped 24% to $12.67 after Reuters said Roche (RHHBY) has recently approached the company to discuss a potential acquisition. Among the noteworthy losers following earnings were Integrated Device (IDTI), which fell 26.8%, ADT (ADT), which dropped 15.7%, and Royal Caribbean (RCL), which declined 15.2%. INDEXES: The Dow fell 295.64, or 1.8%, to 16,153.54, the Nasdaq lost 103.42, or 2.24%, to 4,516.95, and the S&P 500 declined 36.35, or 1.87%, to 1,903.03.
15:12 EDTRHHBYRoche approached Pacific Biosciences about possible acquisition, Reuters says
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15:10 EDTRHHBYRoche approached Pacific Biosciences about possible acquisition, Reuters says
08:36 EDTRHHBYPiper Jaffray biopharma analyst holds an analyst/industry conference call
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February 1, 2016
11:02 EDTRHHBYRoche: Updated cervical cancer screening guidelines support use of cobas test
Roche announced that recently updated cervical cancer screening guidelines from the American College of Obstetricians and Gynecologists support the use of its cobas HPV Test for primary cervical cancer screening as an alternative to current cytology-based cancer screening methods in women 25 and older. The College's revised Practice Bulletin 157, published in the January issue of Obstetrics & Gynecology, reinforces similar guidance issued in 2015 by the Society for Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. The cobas HPV Test was approved by the FDA in 2011 for use in screening women 21 and older with unclear Pap test results and for co-testing with a Pap test in women 30 and older. The FDA approved it for first-line primary cervical cancer screening for women 25 and older in April 2014 following a unanimous recommendation from the independent Microbiology Devices Panel of the FDA's Medical Devices Advisory Committee. Currently utilized by more than 250 labs in the U.S., the cobas HPV Test is the only test approved in the U.S. for all three HPV testing options now supported by three major medical societies.
08:07 EDTEXELExelixis announces positive overall survival results from Meteor trial
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January 31, 2016
16:13 EDTRHHBYGenentech receives orphan designation for Avastin in mesothelioma
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January 28, 2016
16:17 EDTEXELExelixis announces EMA acceptance of MAA for cabozantinib
Exelixis announced the European Medicines Agency, or EMA, has accepted for review the Marketing Authorization Application, or MAA, for cabozantinib as a treatment for patients with advanced renal cell carcinoma, or RCC, who have received one prior therapy. The completion of the MAA validation process confirms that the submission is sufficient to permit a substantive review for marketing authorization in the European Union. The EMA's Committee for Medicinal Products for Human Use, or CHMP, previously granted accelerated assessment to cabozantinib for advanced RCC. As a result, the MAA will be eligible for a 150-day review, versus the standard 210 days.
09:19 EDTEXELOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Facebook (FB), up 13.9%... Under Armour (UA), up 14.6%... MicroStrategy (MSTR), up 8.9%... Harley-Davidson (HOG), up 8%... Paypal (PYPL), up 6%... Mellanox (MLNX), up 7.9%... Cirrus Logic (CRUS), up 6.2%... Alibaba (BABA), up 4.5%. ALSO HIGHER: Neos Therapeutics (NEOS), up 61.4% after the FDA approved Adzenys XR-ODT for the treatment of ADHD... Exelixis (EXEL), up 4.7% after the U.S. FDA determined the company's New Drug Application for cabozantinib is sufficiently complete... Kinder Morgan (KMI), up 6.7% after being upgraded at Credit Suisse and Stifel. DOWN AFTER EARNINGS: OSI Systems (OSIS), down 21.3%... ServiceNow (NOW), down 22.3%... eBay (EBAY), down 11.5%... InvenSense (INVN), down 10.5%... Juniper Networks (JNPR), down 9.3%... Hologic (HOLX), down 4.4%... Abbott Laboratories (ABT), down 3.6%... Potash (POT), down 2.1%... Qualcomm (QCOM), down 3.6%.
08:03 EDTEXELExelixis: FDA deems NDA for cabozantinib as 'sufficiently complete'
Exelixis announced that the U.S. FDA has determined the company's New Drug Application for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016. "With FDA granting Priority Review to our application, Exelixis is one step closer to offering physicians cabozantinib as an important new therapeutic option for their patients with advanced renal cell carcinoma," said Michael M. Morrissey, Ph.D., president and CEO of Exelixis. "While we work closely with the FDA during the review process, Exelixis will continue to execute on our commercial plans, including our commitment to be ready for a potential launch by April 1st of this year." A Priority Review designation is granted by the FDA for drugs that, if approved, would be significant improvements in the treatment, prevention or diagnosis of a disease. Previously, the FDA granted cabozantinib Breakthrough Therapy designation and Fast Track designation for the compound's proposed RCC indication. The NDA is based on the results of METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis announced top-line results demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. These data were later presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine.
05:48 EDTRHHBYRoche expects 2016 sales to grow low- to mid-single digit
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05:48 EDTRHHBYRoche board recommends dividend increase to CHF 8.10 per share
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05:47 EDTRHHBYRoche reports FY15 core EPS CHF 13.49 vs. CHF 14.29 last year
05:46 EDTRHHBYRoche reports FY15 Group sales CHF 44.15B vs. CHF 47.46B last year
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05:37 EDTRHHBYAbbVie announces venetoclax granted Breakthrough Therapy Designation by FDA
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January 27, 2016
12:19 EDTRHHBYPiper Jaffray biopharma analyst holds an analyst/industry conference call
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09:02 EDTRHHBYEli Lilly and Roche to collaborate on Alzheimer's diagnostic tool
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