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August 15, 2014
Today's noteworthy initiations include: ARC Group (ARCW) initiated with a Buy at Janney Capital... Achillion (ACHN) initiated with an Outperform at FBR Capital... Enanta (ENTA) initiated with an Outperform at FBR Capital... G-III Apparel (GIII) initiated with a Buy at Wunderlich... Gilead (GILD) initiated with an Outperform at FBR Capital... Intercept (ICPT) initiated with an Underperform at FBR Capital... K+S (KPLUF) initiated with a Sell at Goldman... Mercantile Bank (MBWM) initiated with a Buy at Sandler ONeill... NPS Pharmaceuticals (NPSP) initiated with an Outperform at FBR Capital... NXP Semiconductors (NXPI) initiated with a Buy at Stifel... Palo Alto (PANW) initiated with an Outperform at Imperial Capital... Virtusa (VRTU) initiated with a Buy at Maxim... W.R. Grace (GRA) initiated with a Buy at UBS... iGATE (IGTE) initiated with a Buy at Maxim.
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November 17, 2015
08:05 EDTPANWPalo Alto volatility elevated into Q1 and outlook
Palo Alto November call option implied volatility is at 43, November weekly is at 69, December is at 54, January is at 46; compared to its 52-week range of 27 to 66, suggesting large near term price movement into the expected release of Q1 results on November 23.
07:42 EDTPANWPalo Alto checks point to above-consensus Q1 results, says Stephens
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07:37 EDTPANWPalo Alto results should beat expectations, says RBC Capital
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November 16, 2015
10:25 EDTNXPIUBS trims Apple target, says iPhone partner cut production forecast
Hon Hai, which manufactures Apple's (AAPL) iPhones, expects to assemble significantly fewer iPhones this quarter than in the same period in 2014, UBS wrote in a note to investors today. WHAT'S NEW: Hon Hai Precision Industry, also known as Foxconn, is expected to assemble 10% fewer iPhones this quarter than in the same period in 2014, said UBS analyst Steven Milunovich, citing work from fellow UBS analyst Arthur Hsieh. Previously, companies that supply force touch components for iPhones saw a 10%-15% reduction in their orders, the analyst reported. These developments "are not encouraging," but Apple had previously ordered a large number of iPhones for Q4, according to Milunovich. Overall iPhone demand "could still be decent," he believes. However, the analyst lowered his iPhone sales estimate for Apple's March quarter to 61M from 62.5M, asserting that iPhone sales on China's November 11 Singles Day holiday may have come in below expectations. Based on October search volumes, he continues to believe that demand for iPhone units in the fourth quarter of the calendar year will be 75M, in-line with the consensus outlook. Milunovich trimmed his price target on Apple to $140 from $150 but kept a Buy rating on the shares. WHAT'S NOTABLE In a note to investors on November 10, Credit Suisse reported that it was cutting its estimates for 2016 iPhone sales. The firm expects sales of the device to fall 10.4% in the first quarter versus the same period in 2015, and it predicts that iPhone sales will decline 5.5% year-over-year in 2016. Suppliers with greater than 10% exposure to Apple include Avago (AVGO), SanDisk (SNDK), Analog Devices (ADI), Broadcom (BRCM), Texas Instruments (TXN), NXP Semiconductors (NXPI) and Fairchild (FCS), Credit Suisse reported. The firm said it continues to have a negative view of the smartphone sector. PRICE ACTION: In early trading, Apple added nearly 1% to $113.34.
09:11 EDTENTAEnanta says ABT-493 study data show 'high sustained' response rates
Enanta Pharmaceuticals announced data from AbbVie's SURVEYOR studies of its investigational treatment regimen, consisting of ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment in non-cirrhotic patients with chronic hepatitis C virus infection. After 12 weeks of treatment, SVR12 rates achieved were 97%-100% in genotype 1 patients, 96-100 percent in genotype 2, and 83%-94% in genotype 3. These data will be presented at The Liver Meeting, which is the Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco. Separately, in a late-breaking presentation of the SURVEYOR-1 trial, additional data will show non-cirrhotic GT1 chronic HCV patients who received a shorter duration of treatment for 8 weeks with ABT-493 and ABT-530 achieved a SVR rate of 97%.
09:04 EDTGILDGilead says Phase 3 Zydelig study shows 'clinical benefit'
Gilead announced that its Phase 3 Study 115 evaluating Zydelig added to standard therapy in previously-treated chronic lymphocytic leukemia patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival and overall survival in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session at the Annual Meeting of the American Society of Hematology in Orlando, Florida taking place December 5-8. "The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting."
November 15, 2015
20:17 EDTGILDGilead presents results from four Phase 3 studies of sofosbuvir/velpatasvir
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15:47 EDTGILDGilead reports data from multiple studies of Viread, TAF, others
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15:08 EDTICPTIntercept reports analysis of Phase 3 obeticholic acid study, other data
Intercept announced results from three studies in primary biliary cirrhosis, recently renamed primary biliary cholangitis, for presentation at the American Academy for the Study of Liver Diseases annual meeting. The studies evaluate investigational use of obeticholic acid, Intercept's lead farnesoid X receptor agonist. In a presentation titled, "Clinical Epidemiology of Primary Biliary Cirrhosis based on a Large U.S. Laboratory Database: Incidence and Trends in Serum Alkaline Phosphatase," an analysis of a clinical database of more than 575,000 patients who received an anti-mitochondrial antibody test showed that, of those patients, 6,107 were classified as having probable PBC based on a positive AMA test and ALP greater than the upper limit of normal at any time prior to AMA testing or up to one month following AMA testing. The study found that 69% of those likely PBC patients continued to have elevated ALP two years after the first positive AMA test. Meanwhile, a presentation titled "A Trial-Based Model of Liver Transplant and Liver-Related Death in Patients with Primary Biliary Cirrhosis" includes an analysis of data from the Phase 3 POISE trial of OCA in PBC using the UK-PBC predictive model of transplant-free survival based on ALP, bilirubin, alanine transaminase, albumin and platelet count. Risk was assessed at 5, 10 and 15 years based on a 12-month change from baseline in patients treated with OCA plus or minus ursodiol or placebo plus or minus ursodiol at the end of the POISE study. The UK-PBC risk algorithm showed a significantly lower risk of liver transplant or liver-related death in OCA-treated patients compared to placebo. Lastly, a presentation titled "Physician versus Patient Perceptions of Medical Care Quality in Primary Biliary Cirrhosis" showed that patients may not be properly informed about their ALP scores and the nature of PBC symptoms.
14:38 EDTICPTIntercept reports analyses of OCA in fatty liver patients
Intercept Pharmaceuticals announced new results from the non-invasive evaluation of liver fibrosis in patients from the FLINT trial of obeticholic acid, or OCA, for the treatment of nonalcoholic steatohepatitis, or NASH. In the trial, treatment with once daily 25 mg OCA was shown to reverse fibrosis in a "significant proportion" of biopsy-proven NASH patients, as observed by repeat liver biopsy at the end of the double-blind treatment phase at week 72, according to the company. Post-hoc analysis evaluated the early predictive value of three known non-invasive fibrosis tests -- FIB-4, APRI and NFS -- in identifying patients who experienced improvement in fibrosis. Each was assessed at baseline and over the course of treatment and then correlated with histologic changes observed in the OCA and placebo patients. The analysis demonstrated that OCA treatment of NASH patients led to a statistically significant decrease in FIB-4 from baseline as compared to placebo. Further, a decline in FIB-4 of 10% after 24 weeks of treatment predicted improvement in fibrosis by at least one stage as assessed by biopsy at 72 weeks, according to Intercept. Similarly, OCA-treated patients experienced a significant decrease in APRI as compared to placebo, and a 34% reduction in APRI at 24 weeks predicted improvement in fibrosis by at least one stage at 72 weeks. On average, OCA treatment reduced the FIB-4 score to less than 1.3 and the APRI score to less than 0.5, the respective cut-off values associated with advanced fibrosis, while placebo patients remained above these cut-offs. While NFS declined in the OCA-treated patients and increased in the placebo patients, it did not appear to be sensitive to changes in fibrosis, the company said.
14:30 EDTENTAEnanta confirms interim Phase 3b data on Viekira Pak
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November 13, 2015
17:04 EDTNXPIThird Point gives quarterly update on stakes
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16:40 EDTNXPIAppaloosa gives quarterly update on stakes
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15:35 EDTICPTIntercept to host investor meeting
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08:28 EDTENTA, ICPTAmerican Association for Study of Liver Diseases to hold annual meeting
The Liver Meeting 2015 is being held in San Francisco on November 13-17.
November 12, 2015
17:55 EDTGILDGilead announces FDA approval of Harvoni
Gilead Sciences announced that the U.S. FDA has approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014.
09:59 EDTNXPISterne Agee sees 'great buying opportunity' in NXP pullback
The weakness in NXP Semiconductors (NXPI) following its third quarter results gives investors "a great buying opportunity," research firm Sterne Agee wrote in a note to investors today. NXP Semiconductors is a chip maker that agreed to acquire another player in the space, Freescale (FSL), last March. WHAT'S NEW: Synergies from the Freescale deal could increase NXP's EPS by 31c in 2016 and 92c in 2017, Sterne Agee CRT analyst Douglas Freedman wrote. Moreover, NXP's ability to generate stronger earnings growth than its peers despite a tough demand environment is "impressive," contended the analyst. The company's outperformance and debt deleveraging should cause its stock's multiple to rise, forecast Freedman, who kept a $107 price target and Buy rating on the shares. WHAT'S NOTABLE: NXP Semiconductors was among the chip makers whose stock rose after Apple (AAPL) reported stronger than expected results on October 27. However, Credit Suisse on November 10 cut its estimates for iPhone shipments going forward into 2016, noting that NXP is one of the chip makers that gets 10% or more of its revenue from Apple. PRICE ACTION: In early trading, NXP lost 0.4% to $80.98.
08:42 EDTVRTUSunTrust to hold a conference
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08:38 EDTGIIIG-III Apparel price target lowered to $60 from $75 at Cowen
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08:33 EDTGIIIG-III Apparel estimates lowered at Stephens following Macy's report
Stephens analyst Rick Patel lowered his estimates for G-III Apparel (GIII) and cut his price target on the stock to $70 from $79 in response to the weaker than expected Q3 results reported by its customer Macy's (M). Patel notes that Macy's accounts for only 18% of G-III sales, but also acknowledges that implications of weak consumer demand could have a broader impact. He keeps an Overweight rating on G-III, however, citing its long-term opportunity, and said the recent pullback presents a good buying opportunity for patient investors.
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