Bictegravir and Lenacapavir - (ARTISTRY-2)

May 7, 2026: Gilead Sciences, Inc. (NASDAQ: GILD) reported Q1 2026 results and highlighted multiple 2026 regulatory and business catalysts. Q1 revenues rose 4% to $7.0B; product sales rose 5% to $6.9B (excluding Veklury +8% to $6.8B). Key product trends: HIV sales +10% to $5.0B (Biktarvy +7% to $3.4B; Descovy +38% to $807M); Trodelvy +37% to $402M; Livdelzi supported liver-disease portfolio (+1% to $767M); Veklury -52% to $144M; cell therapy sales -12% (Yescarta -14% to $332M; Tecartus -4% to $75M). Full-year 2026 product sales guidance was raised to $30.0B–$30.4B (excluding Veklury $29.4B–$29.8B), while GAAP and non-GAAP EPS guidance was reduced due to anticipated acquired IPR&D charges and financing costs tied to acquisitions.

Catalyst updates:

• BIC/LEN (bictegravir/lenacapavir) HIV switch regimen: FDA accepted NDA under priority review; PDUFA target action date Aug 27, 2026. Late-breaking Phase 3 ARTISTRY-1/2 Week 48 results presented at CROI 2026 supported global filings.
• Anito-cel (anitocabtagene autoleucel) in 4L+ relapsed/refractory multiple myeloma: FDA accepted BLA; PDUFA target action date Dec 23, 2026.
• Tecartus: FDA granted full approval in adult R/R mantle cell lymphoma; label updated with Cohort 3 ZUMA-2 data.
• M&A: completed acquisition of Arcellx; announced definitive agreements to acquire Tubulis (ADC platform; lead TUB-040 in Phase 1b/2 for platinum-resistant ovarian cancer and NSCLC) and Ouro (autoimmune T-cell engagers; lead OM336), both pending customary/regulatory conditions.