GILD - Gilead Sciences, Inc.

Power Block MOSFET from Diodes Incorporated Increases Power Converter Efficiency and Saves PCB Space

Diodes Incorporated (Nasdaq: DIOD) today announced the availability of the first in a new generation of discrete MOSFETs. The DMN3012LEG delivers increased efficiency in a smaller package to provide significant cost, power, and space savings in a wide variety of power conversion and control applications.

Diodes Incorporated to Participate at Upcoming Virtual Financial Conferences

Diodes Incorporated (Nasdaq: DIOD), today announced that management will participate at the following virtual financial conferences.

Gilead and Galapagos Announce Positive Topline Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis

Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase 2b/3 trial evaluating the efficacy and safety of the investigational, oral, once-daily, selective JAK1 inhibitor filgotinib in 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC). Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo. Filgotinib 100 mg did not achieve statistically significant clinical remission at Week 10.

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Industry-First, Automotive-Compliant ReDriver from Diodes Incorporated Enables DisplayPort via USB Type-C

Diodes Incorporated (NASDAQ: DIOD) today announced the industry's first automotive AEC-Q100 grade 3 qualified 10Gbps USB-C® DisplayPort™ Alternate (DP-Alt) mode linear ReDriver™ IC. The DP-Alt mode allows the transfer of DisplayPort signals through a USB Type-C® connector. Supporting 8.1Gbps DP1.4 and the 10Gbps USB 3.2 specifications, the PI3DPX1207Q provides a transparent, protocol-agnostic ReDriver capability for a range of automotive applications including infotainment systems and cluster display panels.

Gilead and Kite Continue to Advance Next Generation Cancer Therapies at 2020 American Society of Clinical Oncology Annual Meeting

Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, today announced the acceptance of nine abstracts, including three oral presentations across its immuno-oncology research and development program, during the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting being held from May 29-31, 2020. Data at ASCO include abstracts highlighting Kite’s leading cell therapy portfolio and magrolimab, an investigational anti-CD47 monoclonal antibody developed by Forty Seven, Inc., which was recently acquired by Gilead.

Gilead Announces Approval of Veklury® (remdesivir) in Japan for Patients With Severe COVID-19

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States.

Gilead’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, enabling access to remdesivir at additional hospitals across the country. Allocation of the currently limited available supply of remdesivir will be made based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government.

Gilead Sciences Announces Second Quarter 2020 Dividend

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Board of Directors has declared a cash dividend of $0.68 per share of common stock for the second quarter of 2020. The dividend is payable on June 29, 2020, to stockholders of record at the close of business on June 12, 2020. Future dividends will be subject to Board approval.

Gilead Sciences Announces First Quarter 2020 Financial Results

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the first quarter 2020.

Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID-19

Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19

Gilead Sciences. Inc. (Nasdaq: GILD) is aware of positive data emerging from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of the investigational antiviral remdesivir for the treatment of COVID-19. We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.

Gilead, Kite and oNKo-innate Announce Research Collaboration to Discover Cancer Immunotherapies Focused on Natural Killer (NK) Cells

Gilead Sciences, Inc. (Nasdaq: GILD), Kite, a Gilead Company, and oNKo-innate announced the companies have entered into a three-year cancer immunotherapy research collaboration to support discovery and development of next-generation drug and engineered cell therapies focused on natural killer (NK) cells.

Gilead Sciences to Release First Quarter 2020 Financial Results on Thursday, April 30, 2020

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its first quarter 2020 financial results will be released on Thursday, April 30, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s first quarter 2020 financial results and will provide a business update.

Gilead Provides Additional Information Regarding 2020 Annual Meeting of Stockholders Due to COVID-19 Precautions

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that due to the COVID-19 pandemic and to support the health and safety of the company’s stockholders, employees, Board of Directors and surrounding communities, Gilead’s 2020 Annual Meeting of Stockholders will be held in a virtual-only format instead of as an in-person meeting. In light of this change, stockholders will not be able to attend the Annual Meeting in person.

Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine

Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis. The majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with remdesivir treatment. Compassionate use data have limitations and multiple Phase 3 studies are ongoing to determine the safety and efficacy of remdesivir for the treatment of COVID-19. The detailed results of this analysis were published today in The New England Journal of Medicine.

Gilead Announces $20 Million Philanthropic Fund to Support Nonprofit Organizations Impacted by the COVID-19 Crisis

Gilead Sciences, Inc. (Nasdaq: GILD) announced the creation of the global Gilead CARES (COVID-19 Acute Relief and Emergency Support) Grantee Fund to provide financial support to current grantees facing an imminent closure or termination of vital services due to losses attributable to the COVID-19 pandemic. The fund will provide up to $20 million in donations to these nonprofit groups.

Gilead Completes Acquisition of Forty Seven, Inc.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction for Toro Merger Sub, Inc., a wholly owned subsidiary of Gilead ("Purchaser"), to acquire Forty Seven, Inc. (Nasdaq: FTSV) for $95.50 per share, net to the seller in cash, without interest, or approximately $4.9 billion in the aggregate.

Gilead Sciences and Second Genome Announce Strategic Collaboration in Biomarker and Inflammatory Bowel Disease Drug Discovery

Gilead Sciences, Inc. (Nasdaq: GILD) and Second Genome, a leader in microbiome science, today announced that the companies have entered into a four-year strategic collaboration to identify biomarkers associated with clinical response in up to five of Gilead’s pipeline compounds in inflammation, fibrosis and other diseases, and to identify potential new targets and drug candidates for the treatment of inflammatory bowel disease (IBD).

Kite Licenses Antibodies and Establishes Collaboration With Teneobio in Multiple Myeloma

Kite, a Gilead Company (Nasdaq: GILD), and Teneobio, Inc. announced the companies have entered into a license and collaboration agreement through which Kite will receive exclusive rights to certain antibodies directed to B-cell maturation antigen (BCMA). The fully human variable heavy chain of one such antibody is currently undergoing clinical evaluation in a chimeric antigen receptor (CAR) format for the treatment of patients with multiple myeloma in a Phase 1 clinical trial at the National Cancer Institute. Kite and Teneobio will also collaborate on the discovery of antibodies directed to four additional targets, using Teneobio’s proprietary Human Heavy-Chain Antibodies (UniAb®) platform, to be used in CAR T cell therapies for multiple myeloma and other cancers.

Gilead Announces Expiration of Hart-Scott-Rodino Waiting Period for Forty Seven Tender Offer

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) with respect to Gilead's cash tender offer for Forty Seven, Inc. expired at 11:59 p.m. on March 27, 2020.

U.S. Food And Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection

Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment of people with chronic hepatitis C infection (HCV) as young as 6 years of age or weighing at least 17 kg, regardless of HCV genotype or liver disease severity. The recommended dosage of Epclusa in children ages 6 years and older is based on weight and liver function. Epclusa is the first pan-genotypic, protease inhibitor-free regimen approved in the United States for adults and children.

New Clinical Study Data for Gilead’s Investigational HIV-1 Capsid Inhibitor GS-6207 Presented at CROI 2020

Gilead Sciences, Inc. (NASDAQ: GILD) today announced data from clinical and preclinical studies exploring the use of GS-6207, an investigational, novel, first-in-class inhibitor of HIV-1 capsid function, as a potential long-acting therapy for people living with HIV. Results from a Phase 1b proof-of-concept study of a subcutaneous formulation showed antiviral activity with GS-6207 through the last day of monotherapy, Day 10, with significantly greater reductions in HIV-1 RNA versus placebo across all treatment groups (20 to 750 mg; all p<0.0001). These data were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2020 in Boston.

Treatment With Gilead’s Vesatolimod Is Evaluated for Safety and Virologic and Immunologic Response Versus Placebo in Phase 1B HIV Functional Cure Study

Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from a Phase 1b trial evaluating the company’s investigational toll-like receptor 7 (TLR7) agonist vesatolimod as part of a human immunodeficiency virus (HIV) cure research program. These findings mark the first clinical data showing TLR7 stimulation by vesatolimod is associated with a modestly increased time to viral rebound compared to placebo, as well as enhanced immune function and decreased levels of intact HIV DNA. These results will be presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2020, along with additional preclinical studies evaluating the potential of combination regimens with vesatolimod to achieve viral remission in the absence of antiretroviral therapy (ART).

Gilead Presents 96-week DISCOVER Trial Data Demonstrating Favorable Renal and Bone Safety Profile of Descovy® for HIV PrEP in At-Risk Populations

Gilead Sciences, Inc. (Nasdaq: GILD) today presented longer-term results from the DISCOVER trial of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets, F/TAF) for pre-exposure prophylaxis (PrEP), demonstrating continued non-inferior efficacy and continued favorable changes in key markers of renal and bone safety at Week 96 compared with Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, F/TDF) for PrEP. These results were achieved in the overall study population of men and transgender women at risk for HIV infection, as well as in study sub-populations of participants age 50 and older, those younger than 25 years, and those with moderate renal impairment. A separate analysis of the DISCOVER trial demonstrated that Descovy and Truvada were effective and well-tolerated in Black and Hispanic/Latinx participants. These data were presented at the 2020 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

New Data on Gilead’s Biktarvy® Presented at CROI 2020, Including Data in Black Americans and Older Adults

Gilead Sciences Inc. (Nasdaq: GILD) today announced data from the BRAAVE 2020 study, a Phase 3 clinical trial evaluating the safety and efficacy of switching to Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, BIC/FTC/TAF) in virologically suppressed adults living with HIV who self-identified as Black or African American. The data show that, at 24 weeks, switching to Biktarvy from a standard regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent may potentially be an effective and well-tolerated treatment regimen in patients with a history of treatment failure or pre-existing resistance, and did not result in treatment emergent resistance to study drugs with Biktarvy. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational.