$GILD (Gilead Sciences Inc.)

$GILD {{ '2016-04-15T09:43:22+0000' | timeago}} • Announcement

Biopharma company $GILD said 2 Phase 3 trials, Studies 108 and 110, evaluating once-daily TAF 25 mg in adults with HBeAg-negative and HBeAg-positive chronic HBV infection met their primary endpoints of non-inferiority versus Viread 300 mg. TAF also showed improved renal and bone lab safety parameters versus Viread.

$GILD {{ '2017-07-18T20:14:00+0000' | timeago}} • Announcement

$GILD said the US FDA has approved Vosevi tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults previously treated with or without an NS5A inhibitor-containing regimen. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies.

$GILD {{ '2017-07-13T13:10:29+0000' | timeago}} • Announcement

$GILD said its Marketing Authorization Application for an investigational, once-daily single tablet regimen containing bictegravir and emtricitabine/tenofovir alafenamide, formulations for treatment of HIV-1 infection in adults, has been fully validated. Currently, they are under evaluation by the European Medicines Agency.

$GILD {{ '2017-06-23T12:05:41+0000' | timeago}} • Announcement

$GILD said the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency(EMA), has adopted a positive opinion on its Marketing Authorization Application (MAA) for Vosevi for the treatment of chronic hepatitis C virus (HCV)-infected patients.

$GILD {{ '2017-06-12T15:03:28+0000' | timeago}} • Announcement

$GILD has submitted a New Drug Application to the FDA for an investigational, once-daily single tablet regimen for the treatment of HIV-1 infection in adults.

$GILD {{ '2017-05-30T14:13:41+0000' | timeago}} • Announcement

$GILD announced that four Phase 3 studies evaluating a fixed-dose combination of bictegravir (50mg) (BIC)  and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the treatment of HIV-1 infection met their primary objectives of non-inferiority.

$GILD {{ '2017-05-05T19:17:07+0000' | timeago}} • Infographic

$GILD Gilead Sciences Earnings AlphaGraphics: Q1 2017 highlights

$GILD {{ '2017-05-02T21:57:30+0000' | timeago}} • Webcast

$GILD stated that the news about futility analysis is a rumor. The company clarified that it does not have an interim analysis planned in Phase III study. The study will be carried out for 48 weeks, $GILD said.

$GILD {{ '2017-05-02T21:45:49+0000' | timeago}} • Webcast

$GILD stated that about 55% of HIV sales is from public and about 45% is from the private in U.S. Of that 55%, 20% or so is from AIDS Drug Assistance Program (ADAP).

$GILD {{ '2017-05-02T21:24:29+0000' | timeago}} • Announcement

$GILD BoD has declared a cash dividend of $0.52 per share of common stock for 2Q17. The dividend is payable on June 29, 2017, to stockholders of record as on June 16, 2017.

$GILD {{ '2017-05-02T20:29:54+0000' | timeago}} • Announcement

$GILD's total product sales for 1Q17 were $6.4Bil compared to $7.7Bil for the same period in 2016. Geographically, sales were $4.5Bil in the US, $1.3Bil in Europe and $661MM in other locations.This compares to prior-year period's sales of $4.4Bil in the US, $1.6Bil in Europe and $1.7Bil in other locations.

$GILD {{ '2017-05-02T20:24:45+0000' | timeago}} • Announcement

$GILD reiterated its FY17 guidance provided on February 7, 2017. Product sales are predicted in the range of $22.5-24.5Bil, while Product Gross Margin is expected between 86% and 88%.

$GILD {{ '2017-05-02T20:18:20+0000' | timeago}} • Announcement

Biotechnology company $GILD posted lower revenue and earnings in 1Q17. Revenue slid 16% to $6.5Bil, hurt by lower product sales, which declined 17% YoY.  Net income was $2.7Bil or $2.05 per share, compared to $3.6Bil or $2.53 per share last year. Excluding special items, $GILD earned $2.23 per share.

$GILD {{ '2017-04-21T12:55:32+0000' | timeago}} • Announcement

$GILD announced results from an open-label, proof-of-concept study evaluating GS-0976, an investigational inhibitor of Acetyl-CoA carboxylase, in patients with nonalcoholic steatohepatitis. The data indicated treatment was associated with statistically significant improvements in liver fat content and noninvasive markers of fibrosis.

$GILD {{ '2017-04-07T17:24:03+0000' | timeago}} • Announcement

$GILD said  the U.S. Food and Drug Administration (FDA) has approved supplemental indications for Harvoni tablets and Sovaldi tablets in pediatric patients 12 years and older with chronic hepatitis C virus (HCV) infection.

$GILD {{ '2017-02-15T12:50:26+0000' | timeago}} • Announcement

$GILD announced 144-week data from two Phase 3 studies evaluating the safety and efficacy of Genvoya for treatment of HIV-1 infection in treatment-naïve adults. Through week 144, Genvoya demonstrated higher rates of virologic suppression compared to Stribild. Patients receiving Genvoya also showed favorable renal and bone laboratory parameters.

$GILD {{ '2017-02-08T12:47:26+0000' | timeago}} • Announcement

$GILD said its BoD declared an increase of 10% in the quarterly cash dividend, beginning in 1Q17. The increase will result in a quarterly dividend of $0.52 per share of common stock. The dividend is payable on March 30, 2017, to stockholders of record on March 16, 2017.

$GILD {{ '2017-02-07T22:59:31+0000' | timeago}} • Webcast

$GILD has different countries in different stages of the TAF-based products rollout and this will have an impact on the entry of generics into various countries. The company is getting good uptick of TAF in early launch markets. Germany and Spain are doing well and $GILD expects strong performance from TAF in France.

$GILD {{ '2017-02-07T22:57:37+0000' | timeago}} • Infographic

$GILD Gilead Sciences Earnings AlphaGraphics: Q4 2016 Highlights

$GILD {{ '2017-02-07T22:38:20+0000' | timeago}} • Webcast

$GILD said the efforts to try to open up access to less severely ill patients will be instrumental in helping stabilize patient volumes and this will be one of the company’s focuses for 2017. $GILD is investing in direct-to-patient initiatives and disease awareness campaigns in order to ensure a steady flow of patients going forward.

$GILD {{ '2017-02-07T22:09:23+0000' | timeago}} • Webcast

In Japan, $GILD’s product sales for 4Q16 were $340MM, down 77% YoY and down 31% sequentially due to the decline in patient starts and the entry of another company’s product to the market.  In the US, Letairis and Ranexa revenue totaled $436MM for 4Q16 and achieved nearly $1.5Bil for 2016.

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