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Stock Market & Financial Investment News

News Breaks
May 21, 2014
11:09 EDTABBV, MRK, GILD, BMYGilead sees new pushback over price of hepatitis C drug
An insurance trade group harshly criticized Gilead (GILD) for charging too much for its hepatits C drug, while Florida has reportedly restricted the ability of Medicaid recipients to receive the drug. WHAT'S NEW: The price that Gilead is charging for its HCV treatment Sovaldi is "astronomical," America's Health Insurance Plans stated on its blog yesterday. The drug has shown "tremendous results" and is the "kind of medical innovation we need to sustain," but the price is not sustainable for consumers or society and is the result of Gilead taking "advantage of a lack of competition," according to the group, which represents the health insurance industry. Meanwhile, Florida has restricted the ability of Medicaid patients in the state to access Sovaldi, Bank of America Merrill Lynch reported in a note to investors earlier today. The firm wrote that Florida's decision supports its thesis that payers will increasingly limit access to expensive drugs. WHAT'S NOTABLE: In late March, shares of Gilead fell after three Democratic members of the House Committee on Energy and Commerce said they were concerned about the price the company is charging for Sovaldi. In a letter to Gilead's CEO, the House members stated that reports have indicated that Gilead plans to charge $84,000 per treatment for Sovaldi and that they were concerned that the drug would not be able to cure patients if it cannot be afforded. Sovaldi's costs are likely to be too high for many patients, including those with both public and private insurance, the lawmakers contended, adding that the FDA's decision to speed the approval of Sovaldi makes the high price of the drug even more problematic. They requested that the company provide more information about its methodology for determining Sovaldi's prices and they sought information about any discounts the company is providing to low income patients. Other companies that are developing HCV drugs include AbbVie (ABBV), Bristol-Myers Squibb (BMY), and Merck (MRK). PRICE ACTION: In mid-morning trading, Gilead rose 24c, or 0.3%, to $81.38. Over the last three months, Gilead shares are down about 1.5%.
News For GILD;ABBV;BMY;MRK From The Last 14 Days
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July 24, 2015
07:54 EDTABBVAbbVie backs FY15 adjusted EPS $4.10-$4.30, consensus $4.24
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07:54 EDTABBVAbbVie reports Q2 adjusted EPS $1.08, consensus $1.06
Reports Q2 revenue $5.48B, consensus $5.62B
06:27 EDTGILDGilead price target raised to $131 from $120 at Piper Jaffray
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July 23, 2015
18:21 EDTBMYOn The Fly: Top stock stories for Thursday
Stocks began the session mixed on the heels of weak earnings reports from both Caterpillar (CAT) and 3M (MMM). The Nasdaq managed to spend most of the day in positive territory but joined the other averages in negative territory by mid-afternoon. Selling picked up momentum towards late afternoon, and by day’s end each of the averages were lower by more than 0.4%, with the Dow losing nearly 0.7%. ECONOMIC EVENTS: In the U.S., initial jobless claims fell to 255,000 in the week ended July 18, below the 278,000 first-time claims that were expected. The Leading Economic Indicators advanced 0.6% in June, exceeding expectations for a 0.3% increase. In Asia, the Shanghai Composite index advanced for a sixth straight session, adding another 2.4%. In Europe, the Greek Parliament voted to accept creditor terms for a new bailout, though a decision on when to reopen Greek financial markets was deferred to next week. COMPANY NEWS: Shares of General Motors (GM) finished the session up 3.96% to $31.50 after reporting earnings per share above analyst expectations. Other notable names rising following earnings reports include SanDisk (SNDK), Under Armour (UA), Southwest (LUV)... Caterpillar, meanwhile, dropped $2.86, or 3.59%, to $76.90 after cutting its yearly guidance during this morning's earnings report, with the company noting a "relatively stagnant" global economy. Also lower following earnings were Comcast (CMCSA, CMCSK), Bristol-Myers Squibb (BMY), Dunkin Brands (DNKN), and Boston Scientific (BSX). MAJOR MOVERS: Among the notable gainers was Cigna (CI), which rose $3.29, or 2.18%, to $154.36 after the Wall Street Journal reported last night that Anthem (ANTM) is nearing a deal to acquire the company for roughly $187, representing a total transaction value of over $48B. Adding to that report, CNBC's David Faber said on Thursday morning that Anthem will announce an agreement Friday to purchase Cigna for $188 per share, at a 45% equity, 55% cash split. Also higher were shares of numerous IT security companies, with FireEye (FEYE) advancing 4.53% and Palo Alto Networks (PANW) adding 2.33% after earnings reports from security firms Fortinet (FTNT) and F5 Networks (FFIV) beat on both top and bottom lines. Fortinet and F5, meanwhile, finished Thursday's session up 10.71% and 7.75% to $46.83 and $127.68, respectively. Among the noteworthy losers following earnings was McDonald's (MCD), which edged down 0.52% to $97.10 after noting that Q2 global comparable sales fell 0.7% for the quarter, including a 2% decline in U.S. same-store sales. Also lower was Hertz (HTZ), which declined 8.53% to $16.45 following a downgrade to Underweight at Morgan Stanley, with the research firm citing increased competition from Uber and similar mobility services. INDEXES: The Dow fell 119.12, or 0.67%, to 17,731.92, the Nasdaq lost 25.36, or 0.49%, to 5,146.41, and the S&P 500 declined 12.00, or 0.57%, to 2,102.15.
15:05 EDTABBVNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's open, with earnings consensus, include AbbVie (ABBV), consensus $1.06... Biogen (BIIB), consensus $4.10... Simon Property Group (SPG), consensus $2.36... State Street (STT), consensus $1.37... V.F. Corp. (VFC), consensus 36c... Johnson Controls (JCI), consensus 91c... American Airlines (AAL), consensus $2.60... Rockwell Collins (COL), consensus $1.30... Cabot Oil & Gas (COG), consensus 4c... Lear (LEA), consensus $2.48... Encana (ECA), consensus (15c).
14:55 EDTABBVAbbVie technical comments before earnings news
The stock is trading close to its life high at $71.60 ahead of earnings news. On a 2-year chart basis recent high price and the near-matching high from December of last year indicates shares are at major resistance. If the news is a bearish surprise, these two peaks in price could be construed as potential double top. Next supports below $70 would be at $68.50, $66.52, and $64.81. If the news is a bullish surprise, the life high could easily be taken out. An extension of the current bullish price channel in time yields a potential target at $75. Without overhead resistance, that level could be exceeded depending on the nature of the news.
13:56 EDTABBVEarnings Watch: AbbVie sees Q2 EPS $1.04-$1.06
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12:45 EDTGILDGilead July weekly volatility elevated into Q2 and outlook
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11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
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07:34 EDTBMYBristol-Myers raises FY15 adjusted EPS view to $1.70-$1.80 from $1.60-$1.70
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07:31 EDTBMYBristol-Myers reports Q2 EPS 53c, consensus 36c
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06:38 EDTBMYBristol-Myers' two Opdivo applications validated by European Medicines Agency
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July 22, 2015
15:26 EDTBMYNotable companies reporting before tomorrow's open
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10:01 EDTABBVOn The Fly: Analyst Initiation Summary
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07:04 EDTABBVAbbVie initiated with a Buy at SunTrust
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07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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July 21, 2015
14:12 EDTGILDGilead reports study of E/C/F/TAF met primary endpoint
Gilead Sciences announced detailed 48-week data from an open-label Phase 3 study evaluating its investigational once-daily single tablet regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg, or E/C/F/TAF, among 1,436 virologically suppressed adult patients switching from tenofovir disoproxil fumarate-containing regimens. The study met its primary endpoint by demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens at Week 48. The study also demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL at Week 48 and statistically significant improvements in bone and renal laboratory parameters. These data were presented in an oral session at the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada. Among the 1,436 patients who were randomized in the study, virologic success rates at Week 48 were higher in patients taking E/C/F/TAF, 97% versus 93% for all TDF-based regimens; difference in percentages: 4.1%, 95% CI: 1.6% to 6.7%. The rates of virologic failure were similar between the two arms, with E/C/F/TAF, 1.0% and TDF-based regimen, 1.3%. General safety was similar between the two arms through 48 weeks of treatment, with similar percentages of patients in each group having any adverse events. Adverse events leading to treatment discontinuation were more common among patients treated with a TDF-based regimen.
14:03 EDTBMYBristol-Myers: Data from Phase IIa study support further evaluation of BMS955176
Bristol-Myers Squibb announced additional Phase IIa proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings, which are being presented in a late-breaking oral presentation at the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir and support further development of the second-generation HIV-1 maturation inhibitor. BMS-955176 is designed to inhibit one of the last steps of the HIV-1 viral lifecycle, resulting in the release of immature non-infectious HIV-1 particles. As part of a multi-part proof-of-concept study, a two-drug combination of BMS-955176 plus atazanavir had a maximum median change in HIV-1 RNA of -2.23 log10 c/mL from baseline through study discharge. The standard of care control of atazanavir 300 mg and ritonavir 100 mg plus tenofovir disoproxyl fumarate 300 mg plus emtricitabine 200 mg in a fixed dose combination had a maximum median change in HIV-1 RNA of -2.39 log10 c/mL from baseline through study discharge. In addition, a lower dose of BMS-955176 plus atazanavir and ritonavir had a similar maximum median change in HIV-1 RNA of -2.20 log10 c/mL. Length of therapy for all treatment groups was 28 days. Study endpoints included change in HIV-1 RNA from baseline to Day 28 and from baseline to the end of the study and safety. Data from Part A and Part B of the Phase IIa proof-of-concept study support the further evaluation of BMS-955176 in novel treatment regimens such as nucleos(t)ide- and booster-sparing regimens to address key unmet needs for HIV-1 treatment-experienced patients. Two Phase IIb studies have started in 2015: a traditional dose-finding study in treatment-naive patients and a second Phase IIb study to evaluate a nucleos(t)ide- and booster-sparing regimen in treatment-experienced patients.
09:02 EDTBMYBristol-Myers Squibb receives FDA breakthrough designation for HIV-1 inhibitor
Bristol-Myers Squibb announced that the FDA has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral, or ARV, agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
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