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Stock Market & Financial Investment News

News For GSK;NVS;CBST;TEVA;JAZZ;BP;CHK From The Last 14 Days
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October 21, 2014
17:13 EDTCBSTCubist sees FY14 revenue $1.19M-$1.28M, consensus $1.2B
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16:01 EDTCBSTCubist reports Q3 EPS 58c, may not compare to consensus 4c
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15:30 EDTCBSTNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Yahoo! (YHOO), consensus 30c; ACE (ACE), consensus $2.34; Discover Financial (DFS), consensus $1.34; Pinnacle Financial (PNFP), consensus 51c; Broadcom (BRCM), consensus 84c; Intuitive Surgical (ISRG), consensus $3.80; FMC Technologies (FTI), consensus 74c; Robert Half International (RHI), consensus 58c; E-Trade (ETFC), consensus 22c; Nabors Industries (NBR), consensus 36c; Waste Connections (WCN), consensus 54c; Cubist Pharmaceuticals (CBST), consensus 4c; Sonic (SONC), consensus 34c; American Campus Communities (ACC), consensus 43c; Cree (CREE), consensus 36c; Fulton Financial (FULT), consensus 20c; Costamare (CMRE), consensus 41c; Hawaiian Holdings (HA), consensus 78c; Ethan Allen (ETH), consensus 36c; Sabra Health (SBRA), consensus 55c; Rush Enterprises (RUSHA), consensus 51c.
11:04 EDTGSKGlaxoSmithKline receives orphan status for dabrafenib
The FDA granted GlaxoSmithKline orphan status for dabrafenib, its possible treatment of patients with BRAF mutation positive non-small cell lung cancer.
07:15 EDTNVSFDA to hold workshop on breast cancer drug development
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07:06 EDTGSKFierce Biotech to hold a breakfast meeting
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October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
09:22 EDTCBSTOn The Fly: Pre-market Movers
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09:09 EDTGSKEMA encourages applications for orphan designation for Ebola treatments
The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation, the regulator announced. Drug companies that are working on experimental Ebola vaccines and treatments include Tekmira (TKMR), Sarepta (SRPT), BioCryst (BCRX), Chimerix (CMRX), NewLink Genetics (NLNK) and GlaxoSmithKline (GSK).
07:32 EDTCBSTCubist names Perez CEO to succeed Bonney
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07:30 EDTCBSTCubist names Perez CEO
07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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07:19 EDTGSKIBC Life Sciences to hold a conference
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06:56 EDTCBSTShire reopens acquistion talks with NPS Pharmaceuticals, Cubist, Telegraph says
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06:28 EDTTEVAAllergan price target raised to $210 from $190 at Citigroup
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October 17, 2014
14:50 EDTNVS, GSKBARDA asks labs to ramp up Zmapp production, Reuters says
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11:17 EDTGSKGSK says Ebola vaccine too late for current epidemic, BBC reports
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07:53 EDTJAZZJazz Pharmaceuticals shares 'signifincantly undervalued,' says FBR Capital
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October 16, 2014
16:30 EDTCHKOn The Fly: Closing Wrap
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13:54 EDTBPGulf states to oppose OPEC oil production ceiling cut, WSJ says
Despite the recent turmoil in the oil market, Gulf nations including Saudi Arabia, Kuwait and the United Arab Emirates are seen as opposing OPEC oil-production ceiling cuts at next month's meeting, says the Wall Street Journal. Publicly traded companies in the space include BP (BP), Chevron (CVX), ConocoPhillips (COP), Exxon Mobil (XOM), Royal Dutch Shell (RDS.A) and Total (TOT). Reference Link
12:29 EDTCHKOn The Fly: Midday Wrap
Stocks on Wall Street were lower at midday, though well off their worst levels. The market opened sharply lower following less than stellar quarterly reports from some of the country’s largest corporations and a number of in-focus "momentum" names such as Netflix (NFLX) and eBay (EBAY). The early drop extended the market’s recent declines and put the averages close to correction territory. The market moved off its lows after a regional Fed president, who'd recently been seen as hawkish, said in an interview that the central bank should consider delaying the end of quantitative easing and that it should be more data driven than time driven. The comments were attributed as the catalyst for a reversal that brought the averages all the way back to positive territory, though the market has once again drifted back into negative ground. ECONOMIC EVENTS: In the U.S., initial jobless claims decreased by 23K to 264K last week to hit their lowest level since April 2000. Industrial production rebounded 1.0% in September, beating expectations for a rise of 0.4% and pushing capacity utilization up to 79.3% from 78.7% previously. The Philadelphia Fed manufacturing index fell 1.8 points to 20.7 in October, which was not as low as the expected 19.9 reading. The NAHB homebuilder sentiment index fell 5 points to 54 in October, versus expectations for it to hold steady at 59. Also of significant note, St. Louis Fed President James Bullard, who is not a voting FOMC member though was quoted recently saying that a rate hike might be appropriate as soon as early next year, reversed course this morning and told Bloomberg in an interview that the Fed should consider delaying an end to its quantitative easing program. COMPANY NEWS: Shares of Netflix (NFLX) plunged 22% after the company provided lower than expected Q4 profit guidance and reported lower than expected subscriber data. The move after its earnings report last night also follows Time Warner's (TWX) announcement yesterday of plans for a standalone HBO online service and Piper Jaffray saying it believes CBS (CBS) will similarly launch an over-the-top Showtime offering next year... eBay (EBAY) shares slipped nearly 6% after the company missed revenue expectations for the third quarter and lowered its outlook for fiscal 2014. Following the report, analysts at both RBC Capital and CLSA downgraded the stock. MAJOR MOVERS: Among the notable gainers was Chesapeake Energy (CHK), which rose 17% after the company announced that it sold Marcellus and Utica shale assets to Southwestern Energy (SWN) for $5.375B. Shares of the buyer Southwestern, however, fell 8% after the deal announcement. Also lower was Extreme Networks (EXTR), which dropped almost 19% after cutting its first quarter outlook citing significant delays with its North American deals as well as headwinds in Europe. INDEXES: Near midday, the Dow was down 28.46, or 0.18%, to 16,113.28, the Nasdaq was down 16.16, or 0.38%, to 4,199.16, and the S&P 500 was down 2.08, or 0.11%, to 1,860.41.
12:05 EDTCHKChesapeake rises, Southwestern Energy slips after shale asset deal
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09:23 EDTCHKOn The Fly: Pre-market Movers
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07:05 EDTCHKSouthwestern Energy acquires Marcellus and Utica assets from Chesapeake
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07:05 EDTCHKChesapeake announces sale of shale assets for $5.375B
Chesapeake (CHK) announced that it has executed a Purchase and Sale Agreement to sell assets in the Southern Marcellus Shale and a portion of the Eastern Utica Shale in West Virginia to Southwestern Energy Company (SWN) for aggregate proceeds of $5.375B. The transaction, which is subject to certain customary closing conditions, including the receipt of third-party consents, is expected to close in Q4. Chesapeake has agreed to sell approximately 413K net acres and approximately 1,500 wells in Northern West Virginia and Southern Pennsylvania, of which 435 are in the Marcellus and Utica formations, along with related property, plant and equipment. Average net daily production from these properties was approximately 56K barrels of oil equivalent during the month of September, consisting of 184K Mcf of gas, 20K barrels of natural gas liquids and 5,000 barrels of condensate. The company said, "We expect our full-year production guidance for 2015 to remain in the range of 7-10% growth from 2014 levels adjusted for asset sales. I am very proud of the efforts that our Southern Marcellus team and all of our employees have put into building and developing our assets and creating value for our company. We look forward to deploying the proceeds from this significant transaction in ways that will continue to drive even greater shareholder value.”
October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
07:44 EDTBPExxon, Shell behind rivals in lowering greenhouse gas emissions, WSJ reports
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October 14, 2014
13:09 EDTGSKGlaxoSmithKline seeks binding bids for mature drugs, Reuters reports
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11:23 EDTNVS, CBST, GSK, TEVABIND Therapeutics and The Conference Forum hold a conference
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11:19 EDTGSKNIH says several potential Ebola treatments under development
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11:19 EDTTEVATeva upgraded to Buy from Hold at Standpoint Research
10:10 EDTGSKNIH director says supporting BioCryst, Chimerix Ebola treatments
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October 13, 2014
07:12 EDTGSKOligonucleotide Therapeutics Society to hold annual meeting
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06:36 EDTBPSaudi Arabia content to let oil prices stay low, Reuters reports
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October 12, 2014
13:53 EDTBPKuwaiti Minister says OPEC unlikely to cut production, WSJ says
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13:45 EDTBPSaudis take aggressive oil measures in Europe, WSJ says
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October 10, 2014
09:05 EDTBPBP begins $1.1B North Sea project, Bloomberg says
BP CEO Bob Dudley said that the company is poised to begin a project worth close to $1.1B in the North Sea this month, which is anticipated to supply oil and gas into the next ten years, according to Bloomberg, citing comments from Dudley. Reference Link
05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.
October 9, 2014
16:11 EDTTEVAAlexza reports 32,278 Adasuve units shipped to Teva in Q3
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07:02 EDTGSKIsis Pharmaceuticals receives $18M milestone payment from GlaxoSmithKline
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October 8, 2014
11:05 EDTNVSLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses congestive heart failure and the prospects for LCZ696 in HF-PEF on an Analyst/Industry conference call to be held on October 9 at 3 pm.
08:05 EDTTEVATeva initiates NDA submission to FDA for CEP-33237
Teva Pharmaceutical announced the initiation of a rolling New Drug Application submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties CEP-33237 as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone. Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal. CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence and dizziness.
07:19 EDTNVSCBI to hold a conference
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07:18 EDTCBSTInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
06:47 EDTTEVALawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
06:11 EDTNVS, GSKNovartis says expects three executive committee members to leave
Novartis (NVS) confirmed that following completion of the transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company (LLY) in the coming months, that the three business leaders of the Novartis divisions at the center of the transaction will leave the Executive Committee of Novartis. The expected changes to the ECN are subject to the closing of the transactions announced on April 22 - Novartis expects the transaction with GSK to be completed in the first half of 2015, and the transaction with Eli Lilly for its Animal Health Business to close in the first quarter of 2015. George Gunn, currently Division Head, Novartis Animal Health, will reach his contractual retirement age in July 2015 and will retire from Novartis. Upon closing of the Animal Health transaction with Lilly he will leave the ECN. Brian McNamara, currently Division Head, Novartis OTC, will transition to GSK as Head of Americas and Europe for the consumer health businesses, reporting to the President of GSK Consumer Healthcare, effective at closing of the transaction. Andrin Oswald, currently Division Head, Novartis Vaccines, will be leaving Novartis to pursue other opportunities following closing of the transaction with GSK.
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