Investigational Lenacapavir Receives Positive CHMP Opinion for People With Multi-Drug Resistant HIV

– Recommendation is Based on Week 26 Data from the CAPELLA Trial Showing Twice-Yearly Lenacapavir Achieved High Rates of Virologic Suppression in Heavily Treatment-Experienced People with HIV – ...

FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV

– All Clinical Studies Evaluating Injectable Lenacapavir to Resume – – Decision Based on Review of Vial Compatibility Data – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, ...

Gilead’s Investigational Lenacapavir Demonstrates Sustained Long-Acting Efficacy Through Week 26 in Data Presented at CROI

– Lenacapavir Maintained High Rates of Virologic Suppression Among Heavily Treatment-Experienced People with Multi-Drug Resistant HIV – – Late-Breaking Preclinical Data Support Further Study of Lenacapavir ...

Gilead Receives Complete Response Letter From U.S. FDA for Investigational Lenacapavir Due to Vial Compatibility Issues

– CRL Cites Issues Related to Compatibility of Vials and Lenacapavir Solution – – No New Clinical Studies Requested in the CRL – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead ...

New Clinical Data Support the Sustained Efficacy of Long-acting Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor

– One-Year Data From the CAPELLA and CALIBRATE Trials Show Lenacapavir Leads to High Rates of Virologic Suppression in Heavily Treatment-Experienced People Living with Multi-Drug Resistant HIV ...

New Phase 3 Data Support the Sustained, Long-Acting Efficacy of Lenacapavir, Gilead's Investigational HIV-1 Capsid Inhibitor

– Week 26 Data From the CAPELLA Trial Show Lenacapavir Leads to High Rates of Virologic Suppression in Heavily Treatment-Experienced People Living With Multi-Drug Resistant HIV – FOSTER CITY, Calif.--(BUSINESS ...

Gilead Announces First Global Regulatory Approval of Sunlenca® (Lenacapavir), the Only Twice-Yearly HIV Treatment Option

– European Commission Grants Marketing Authorization for Sunlenca, Helping to Address a Critical Unmet Clinical Need for People with Multi-Drug-Resistant HIV Who Have Very Limited Treatment Choices ...

Gilead Announces Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns

-- Pause Due to Concerns About Compatibility of the Vial Type with the Drug Solution -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the ...

Gilead Sciences Presents Data Supporting a Potential Six-Month Dosing Interval for Investigational HIV-1 Capsid Inhibitor Lenacapavir (GS-6207)

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from an ongoing Phase 1 study, which showed that a sustained-delivery subcutaneous formulation of the ...

Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor

–NDA Resubmission Addresses Issues Related to Vial Compatibility – – If Approved, Lenacapavir Would be the First and the Only HIV-1 Treatment Option Administered Twice-Yearly – FOSTER CITY, Calif.--(BUSINESS ...