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Stock Market & Financial Investment News

News Breaks
March 5, 2014
10:33 EDTMRK, ABBV, GILD, OSUROraSure climbs after CMS proposes coverage of HCV tests
Shares of OraSure (OSUR), whose hepatitis C virus test has been approved by the FDA, are climbing after the Centers for Medicare & Medicaid Services yesterday proposed a rule that would enable Medicare and Medicaid to cover HCV tests in some circumstances. Orasure's OraQuick HCV test detects HCV antibodies in fingerstick and venipuncture whole blood. WHAT'S NEW: CMS proposed a rule under which the government would cover HCV tests that have been approved by the FDA. In order to be covered, the test must be ordered by beneficiaries' doctors, and performed by an eligible Medicare provider, CMS stated. Additionally, under the proposal the government would only cover tests for adult beneficiaries who are at high risk for HCV infection, and for those people born between 1945 and 1965. Individuals who have used illegal drugs or received blood transfusions before 1992 would be considered at risk individuals for the purposes of the rule, the agency stated. ANALYST REACTION: In a note to investors earlier today, Mizuho Securities analyst Peter Lawson wrote that the CMS' decision is positive for OraSure. The company has the largest exposure to HCV testing among publicly traded companies, the analyst indicated. The company could obtain over $1B of revenue by providing HCV tests for beneficiaries born between 1945 and 1965, the analyst estimated. Moreover, HCV drug developers will also use OraSure's test in the wake of CMS' decision, added Lawson, who reiterated a $9 price target and Outperform rating on the stock. PRICE ACTION: In early trading, OraSure climbed 11cv, or 1.5%, to $7.50. OTHERS TO WATCH: Companies developing HCV treatments include AbbVie (ABBV), Merck (MRK) and Gilead (GILD).
News For OSUR;ABBV;MRK;GILD From The Last 14 Days
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July 24, 2015
09:37 EDTABBVAbbVie sees Q3 operating revenue growth of about 20%, excluding forex
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09:36 EDTABBVAbbVie sees Q3 adjusted EPS $1.05-$1.07, consensus $1.08
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09:33 EDTABBVAbbVie sees FY15 Lupron sales roughly in line with 2014
AbbVie sees "modest growth" for Synthroid in FY15. Sees AndroGel sales "somewhat above" $500M for 2015.
09:21 EDTABBVAbbVie sees IMBRUVICA U.S. sales of about $1B for 2015
AbbVie Chairman and CEO Richard Gonzalez said the company continues to expect IMBRUVICA to drive U.S. sales of approximately $1B for the full calendar year 2015. Since the company completed the Pharmacyclics transaction, it has seen "additional positive data" and progress on its regulatory objectives, including readouts from two Phase 3 studies, HELIOS and RESONATE-2, noted Gonzalez during the company's Q2 earnings conference call.
07:56 EDTABBVAbbVie reports Q2 Viekira sales $385M, Q2 Imbruvica sales $234M
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07:55 EDTABBVAbbVie reports Q2 Global Humira sales up 16.4% to $3.54B
Strong U.S. HUMIRA growth continued, driven by double-digit growth across all three major market categories, rheumatology, dermatology and gastroenterology. Reported international HUMIRA sales growth in the quarter was reduced by nearly 18 percent due to unfavorable foreign exchange. First-half 2015 international HUMIRA sales grew nearly 9 percent on an operational basis, consistent with planning expectations and the full year forecast for international HUMIRA sales growth of 9 to 10 percent on an operational basis. As noted last quarter, the first-quarter international operational growth rate of nearly 15 percent was favorably impacted by the timing of shipments in select markets. Consequently, sales growth in the second quarter was negatively impacted by shipment timing.
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
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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July 22, 2015
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.
July 20, 2015
07:33 EDTGILD, OSURInternational AIDS Society to hold a conference
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