New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
February 19, 2013
08:32 EDTGILDGilead's Sofosbuvir for hepatitis C meets primary endpoint in Phase 3 study
Gilead Sciences announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus infection who failed prior treatment. The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response rate of 25%. In FUSION, 50% of patients in the 12-week arm and 73% of patients in the 16-week arm achieved SVR12. “This study demonstrates that all-oral therapy with sofosbuvir provides significant efficacy among difficult-to-treat hepatitis C patients who could not be cured by prior regimens containing pegylated interferon and now have limited treatment options,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “With positive results from all four Phase 3 trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter.”
News For GILD From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | all recent GILD news | >>
October 16, 2014
13:31 EDTGILDGilead announces Harvoni Notice of Compliance from Health Canada
Gilead Sciences announced that Health Canada has issued a Notice of Compliance for Harvoni. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, granted marketing authorization under the tradename Sovaldi in December 2013. The efficacy of Harvoni has been established in patients with chronic hepatitis C virus genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naive patients without cirrhosis who have baseline HCV viral load below 6M IU/mL. New Drug Submission applications are pending in Australia and New Zealand.
October 15, 2014
09:57 EDTGILDLeerink biotech analysts hold an analyst/industry conference call
Subscribe for More Information
09:38 EDTGILDActive equity options trading on open
Subscribe for More Information
07:30 EDTGILDGilead headlines on taxes, price war create buying opportunity, says UBS
Subscribe for More Information
October 14, 2014
16:22 EDTGILDOn The Fly: Closing Wrap
The Wall Street averages were mixed after three of the U.S.'s largest banks reported on their quarterly results and Germany slashed its economic forecasts for this year and next. Following the mostly solid earnings reports from the banks and Dow member Johnson & Johnson (JNJ) investors appeared to breathe a sigh of relief and sent the averages higher in early trading. With oil prices falling almost 5% and settling at a recent low, the averages pared their gains and struggled in positive ground. Another late day slide ended with the averages mixed, as the Nasdaq led and the Dow lagged. ECONOMIC EVENTS: In the U.S., the International Energy Agency said in its monthly oil market report that world oil demand growth would be weaker than previously expected. Afterward, WTI crude oil futures fell 4.6% at $81.84, marking their biggest percentage drop since late 2012 and the lowest settlement for the benchmark in over two years. The National Federation of Independent Business' small business optimism index came in at 95.3, versus the consensus expectation for a 95.8 reading. In Europe, Germany's government cut its forecasts for gross domestic product growth to 1.2% in 2014 and 1.3% next year from its prior view of 1.8% growth this year and 2% in 2015. COMPANY NEWS: The first of America's big banks issued their quarterly reports, with JPMorgan's (JPM) headline earnings per share coming in below analysts’ consensus estimate, Wells Fargo (WFC) reporting in-line earnings and improved credit quality and Citigroup (C) posting better than expected adjusted third quarter profit. Citi, which also announced plans to pull back from retail banking in eleven countries and said it will disband a legacy Banamex unit after an investigation uncovered illegal conduct, saw its stock fare the best among the three, rising $1.57, or 3.15%, to $51.47... Another Dow member, Johnson & Johnson, reported better than expected profits and revenues and raised its FY14 EPS outlook, but its stock slid $2.11, or 2.13%, to $97.01. MAJOR MOVERS: Among the notable gainers was Domino's Pizza (DPZ), which rose $8.58, or 11.33%, to $84.30 after the pizza chain owner and franchisor reported better than expected third quarter earnings per share and revenue. Also higher was Skyworks (SWKS), which advanced $3.59, or 7.92%, to $48.91 after the supplier of chips to Apple (AAPL) raised its fourth quarter earnings per share outlook and revenue guidance. Among the noteworthy losers was Exactech (EXAC), which dropped $4.09, or 16.63%, to $20.50 after the company warned its Q3 income and revenue will likely miss its prior guidance. Also lower were shares of Gilead (GILD), which fell $4.26, or 4.2%, to $97.18 amid a number of developments. Competitor Johnson & Johnson said it would seek to make its own hepatitis C treatment accessible and "competitive," which some may have read as an indication of a potential price cut, and Ireland said it plans to close its "Irish Double" tax loophole, which currently benefits Gilead. INDEXES: The Dow slipped 5.88, or 0.04%, to 16,315.19, the Nasdaq rose 13.52, or 0.32%, to 4,227.17, and the S&P 500 added 2.96, or 0.16%, to 1,877.70.
16:00 EDTGILDOptions Update; October 14, 2014
iPath S&P 500 VIX Short-Term Futures down 40c to 39.11. Option volume leaders: AAPL TSLA TWTR AMZN GILD C JNJ AA NFLX PBR according to Track Data.
12:41 EDTGILDGilead retreats following Johnson & Johnson comments on HCV drug
Shares of Gilead (GILD), which has developed a hepatitis C treatment, are retreating after Johnson & Johnson (JNJ) said it would seek to make its own hepatitis C treatment accessible and competitive. Some investors believe that Johnson & Johnson's comments suggest that it will cut the price of its hepatitis C drug. WHAT'S NEW: Johnson & Johnson said on its earnings conference call today that it was "committed" to its treatment for hepatitis C virus, or HCV. The company added that it intends to remain competitive in the space and would look to make its HCV treatment, Olysio, accessible. In a separate development today, The Wall Street Journal reported that Abbvie (ABBV), which also has an HCV treatment, may have to consider pricing its HCV drug more aggressively after Gilead received FDA approval for Harvoni, the first combination pill approved to treat chronic HCV genotype 1 infection. One analyst quoted by The Journal, Roger Longman, said that AbbVie should consider pricing its drug at $76,000 for a 12 week regimen, representing a 20% discount to Harvoni, which will be priced at $94,500 for a full 12 week regimen. ANALYST REACTION: In a note to investors earlier today, RBC Capital analyst Michael Yee wrote that the weakness in Gilead's stock today has created a buying opportunity. Johnson & Johnson probably can't reduce the price of its Olysio drug much, since it is often used in combination with Gilead's Sovaldi, which costs $84,000 for 12 weeks, RBC Capital analyst Michael Yee wrote in a note to investors today. The price of AbbVie's treatment is unlikely to be much below Sovaldi's price, the analyst stated. WHAT'S NOTABLE: Gilead, along with a number of other drug companies, may also be under pressure because Ireland is reportedly closing its "Irish Double" tax loophole. Gilead is one of the companies that currently benefits from the "Irish Double," but Yee says that closing the loophole should only have a "minimal" impact on Gilead. PRICE ACTION: In early afternoon trading, Gilead fell 3.3% to $98.10, AbbVie gained 1.7% to $54.53 and Johnson & Johnson lost 0.6% to $98.52.
11:52 EDTGILDStocks with call strike movement; APC GILD
Subscribe for More Information
11:10 EDTGILDGilead weakness today overdone, says Deutsche Bank
Subscribe for More Information
10:51 EDTGILDGilead weakness a buying opportunity, says RBC Capital
Subscribe for More Information
10:41 EDTGILDGilead weakness a buying opportunity, says RBC Capital
Subscribe for More Information
10:11 EDTGILDGilead volatility increases on wide price movement
Subscribe for More Information
10:05 EDTGILDAbbVie could cause Hep C price tipping point with aggressive pricing, WSJ says
Subscribe for More Information
09:37 EDTGILDActive equity options trading on open
Subscribe for More Information
09:14 EDTGILDJ&J sees FY14 pre-tax operating margin significantly improved vs. FY13
Subscribe for More Information
October 13, 2014
16:02 EDTGILDOptions Update; October 13, 2014
iPath S&P 500 VIX Short-Term Futures up 3.71 to 39.56. Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX SUNE GILD BAC PBR according to Track Data.
09:56 EDTGILDBernstein biotech analyst to hold an analyst/industry conference call
Subscribe for More Information
08:36 EDTGILDGilead HARVONI launch should be strong, says BMO Capital
Subscribe for More Information
07:56 EDTGILDGilead Harvoni pricing 'very reasonable,' says RBC Capital
Subscribe for More Information
07:39 EDTGILDPharmaceutical Care Management Association to hold annual meeting
Subscribe for More Information
1 | 2 | all recent GILD news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use