News Related to Gilead Sciences

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FDA Grants Priority Review to Gilead's Once-Daily Bictegravir/Lenacapavir HIV Regimen

Jun 18, 2026

The FDA has accepted Gilead's New Drug Application for the investigational once-daily HIV regimen bictegravir/lenacapavir and granted priority review, with a PDUFA action date of August 27, 2026. The filing is supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 data showing comparable efficacy in maintaining virological suppression. If approved, BIC/LEN would be the smallest single-tablet regimen for HIV treatment.

WHO Launches Clinical Trial for Bundibugyo Ebola Treatments in DRC

Jul 12, 2026

WHO has launched the PARTNERS clinical trial testing MBP134 and remdesivir for Bundibugyo virus disease in the DRC. Advisers recommend limiting all candidate Ebola drugs to clinical trials. The outbreak has caused 1,792 confirmed cases and 625 deaths as of July 9.

Gilead's Lenacapavir Advances: FDA Accepts Weekly Oral PrEP Application, Global Access Expands

Jun 16, 2026

The U.S. FDA has accepted Gilead's application for an investigational once-weekly oral lenacapavir for HIV prevention, with a review date set for February 2027. Concurrently, PEPFAR and The Global Fund are expanding access to the twice-yearly injectable version to a total of 3 million people by 2028. Gilead will present new data on both lenacapavir and a novel bictegravir/lenacapavir combination at CROI 2026.

Gilead Q1 2026 Sales Rise 5% to $6.9B; Full-Year Revenue Guidance Raised by $400M

Jun 08, 2026

Gilead Sciences reported Q1 2026 total product sales of $6.9 billion, up 5% year over year, with HIV revenue growing 10% to $5.0 billion. The company raised its full-year 2026 base business revenue guidance by $400 million to $29.4–$29.8 billion. Non-GAAP diluted EPS was $2.03, up 12%, while the company advanced its oncology and cell therapy pipeline.

Pharmaceutical Market Reports Highlight Key Players Across Multiple Therapeutic Areas

Apr 01, 2026

Market analysis reports project substantial growth through 2033 across sarcopenia treatments, oncology injection drugs, and ASO-based therapies. Major pharmaceutical companies including Pfizer, Merck, Roche, Novartis, and Amgen feature prominently across all three therapeutic areas. The reports cover market segmentation, geographic analysis, and competitive landscapes for each sector.

AI's Mixed Impact on Pharma: Accelerating Drug Development While Facing Clinical Trial Realities

Apr 01, 2026

AI could compress drug development from 10-15 years to as little as six years, accelerating discovery and reducing late-stage trial failures. However, clinical trial execution remains heavily dependent on human oversight, with AI estimated to cut costs only 10-15% while facing regulatory and liability constraints. Major pharma companies like Gilead are investing in AI research centers despite practical limitations in trial implementation.