Human Immunodeficiency Virus
GILDGilead SciencesCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Bictegravir/Lenacapavir (BIC/LEN) (Antiretroviral Combination) in Human Immunodeficiency Virus. The expected timing is based on the latest available company guidance and may change.
02/17/26:- Ph3 ARTISTRY-1/2 BIC/LEN late-breaking results to be presented at CROI 2026. 02/24/26:- Late-breaking Ph3 ARTISTRY-1/2 48-week CROI 2026 results showed noninferior virologic suppression and no emergent resistance. 04/27/26:- FDA accepted BIC/LEN NDA with priority review; PDUFA action date August 27, 2026.
Verification
Confirm timing and program details against the company announcement or filing.