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.
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.
May 01, 2026
FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
Apr 23, 2026
Eli Lilly, AbbVie, Vertex, Gilead Sciences and Pfizer were identified as pharmaceutical stocks to watch, with Abbott Laboratories and McKesson appearing on a separate seven-stock list.
Feb 26, 2026
A once-daily single-tablet combination of bictegravir and lenacapavir demonstrated non-inferiority to existing HIV treatments in Phase 3 trials, offering simplified treatment for people living with HIV who are virologically suppressed.
