Welcome to our dedicated page for Gilead Sciences news (Ticker: GILD), a resource for investors and traders seeking the latest updates and insights on Gilead Sciences stock.
Gilead Sciences develops and commercializes medicines for HIV, viral hepatitis, COVID-19 and cancer. Company updates regularly cover product sales and operating results, HIV franchises such as Biktarvy, Yeztugo and lenacapavir, and clinical or regulatory activity for investigational HIV regimens that combine established antiretroviral agents with newer mechanisms.
Recurring developments also include oncology pipeline expansion through Kite cell-therapy programs, the completed acquisition of Arcellx and its investigational BCMA-directed CAR T-cell therapy anitocabtagene autoleucel for multiple myeloma, collaboration activity using real-world evidence in oncology R&D, shareholder matters, and capital-structure disclosures tied to material agreements and acquisitions.
Gilead Sciences (Nasdaq:GILD) received U.S. FDA approval for Bixlenvo™ (bictegravir 75 mg/lenacapavir 50 mg), a once-daily single tablet regimen (STR) for virologically suppressed adults with HIV, including those on complex multi-tablet regimens who cannot use existing STRs.
Bixlenvo combines guideline-recommended INSTI bictegravir with first-in-class capsid inhibitor lenacapavir, targeting multiple stages of the HIV life cycle. Approval is supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 trials, which showed maintenance of virologic suppression at Week 48 and a generally well-tolerated safety profile, with headache, nausea and diarrhea as the most common adverse reactions.
The regimen requires a two-day oral initiation with Bixlenvo plus Sunlenca, followed by once-daily Bixlenvo. It is indicated as a complete regimen to replace current therapy in virologically suppressed adults with no known or suspected resistance to its components.
Gilead Sciences (Nasdaq: GILD) announced that its executives will present at three upcoming investor conferences: the Wells Fargo Annual Healthcare Conference on Wednesday, September 9 at 11:00 AM ET, the Cantor Global Healthcare Conference on Thursday, September 10 at 10:55 AM ET, and the Morgan Stanley Global Healthcare Conference on Tuesday, September 15 at 10:45 AM ET. Live webcasts and 30-day replays will be available via the company’s investor website.
Gilead Sciences (Nasdaq:GILD) announced that the European Commission granted marketing authorization for Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) as first-line treatment for adult patients with unresectable, locally advanced or metastatic triple‑negative breast cancer (TNBC) whose tumors are PD‑L1‑positive (CPS ≥10). The approval covers the EU’s 27 member states, Norway, Iceland and Liechtenstein. This follows a separate EC approval of Trodelvy monotherapy for first‑line metastatic TNBC patients who are not candidates for PD‑1/PD‑L1 inhibitors, which together establish Trodelvy as a backbone option across PD‑L1 status in Europe. According to Gilead, Phase 3 ASCENT‑04/KEYNOTE‑D19 data showed Trodelvy plus Keytruda reduced the risk of disease progression or death by 35% versus standard chemotherapy plus Keytruda.
Gilead Sciences (Nasdaq: GILD) reported second quarter 2026 revenues of $7.8 billion, up 10% year-over-year, with total product sales of $7.6 billion. Product sales excluding Veklury rose 10%, driven by HIV, Trodelvy and Livdelzi, while Veklury declined 81% to $23 million.
HIV revenue increased 12% to $5.7 billion, including Biktarvy up 7% to $3.8 billion and Descovy up 48% to $967 million. Trodelvy sales grew 26% to $457 million, while Cell Therapy fell 14% to $417 million. Diluted loss per share was $(8.45) and non-GAAP diluted loss per share was $(6.75), mainly reflecting $11.2 billion of acquired IPR&D expenses from the Arcellx, Tubulis and Ouro Medicines deals.
Cash, cash equivalents and marketable debt securities were $3.2 billion at June 30, 2026 versus $10.6 billion at year-end 2025, after $11.3 billion of acquisition-related outflows. Gilead updated 2026 guidance, slightly raising product sales excluding Veklury, cutting expected Veklury sales to about $300 million and reaffirming a full-year GAAP and non-GAAP loss per share including roughly $9.08 of IPR&D-related impact.
Gilead Sciences (Nasdaq:GILD) reported second quarter 2026 revenues of $7.8 billion, up 10% year-over-year, with total product sales of $7.6 billion. Product sales excluding Veklury rose 10% to $7.6 billion, led by HIV (+12% to $5.7 billion), including Biktarvy (+7% to $3.8 billion) and Descovy (+48% to $967 million), as well as Trodelvy (+26% to $457 million) and Livdelzi. Veklury sales fell 81% to $23 million.
Gilead recorded a diluted loss per share of $(8.45) and non-GAAP diluted loss per share of $(6.75), mainly from $11.2 billion of acquired IPR&D expenses tied to Arcellx, Tubulis and Ouro Medicines. Operating cash flow was $3.6 billion. Full-year 2026 product sales guidance is now $30.1–$30.4 billion, with product sales excluding Veklury raised to $29.8–$30.1 billion and Veklury guidance cut to about $300 million. GAAP diluted loss per share is guided to $(3.75)–$(3.40) and non-GAAP diluted loss per share to $(0.65)–$(0.30).
Gilead Sciences (Nasdaq: GILD) reported that the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) as first-line treatment for adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors are PD-L1–positive (CPS ≥10). A European Commission decision is anticipated later in 2026.
The recommendation is based on Phase 3 ASCENT-04/KEYNOTE-D19, where Trodelvy plus Keytruda showed a highly statistically significant progression-free survival benefit and a 35% reduction in risk of disease progression or death versus standard chemotherapy plus Keytruda. Gilead noted this would build on existing Trodelvy monotherapy approvals in metastatic TNBC.
Gilead Sciences (Nasdaq: GILD) will release its second quarter 2026 financial results and guidance on Tuesday, August 4, 2026, after the market close. Management will host a webcast at 4:30 p.m. Eastern Time to review results and provide a business update.
The live webcast will be available in the Investors section of www.gilead.com and will be archived there for one year. Gilead is a biopharmaceutical company focused on medicines for HIV, viral hepatitis, COVID-19 and cancer, headquartered in Foster City, California.
Gilead Sciences (Nasdaq: GILD) and Merck (NYSE: MRK) reported detailed Phase 3 ISLEND-1 and ISLEND-2 Week 48 results for the investigational once-weekly oral HIV regimen islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in virologically suppressed adults who switched from daily antiretroviral therapy.
According to Gilead and Merck, ISL/LEN was noninferior to BIKTARVY in ISLEND-1, with 0% vs 0.3% of participants having HIV-1 RNA ≥50 copies/mL, and noninferior to standard of care in ISLEND-2, with 0.3% vs 1.3% above this threshold. Overall safety, serious adverse events and discontinuations were generally low and similar to comparators, though ISLEND-2 showed a higher rate of treatment-related adverse events with ISL/LEN. CD4+ T-cell counts, lymphocyte counts and body weight remained stable, and ISLEND-2 participants reported higher treatment satisfaction and lower treatment burden. These data will support planned regulatory submissions; ISL/LEN remains investigational and not approved.
Gilead Sciences (Nasdaq: GILD) will present extensive new HIV research at the 26th International AIDS Conference (AIDS 2026) in Rio de Janeiro from July 26-31. Key data include 52-week open-label extension results from the Phase 3 PURPOSE 1 and PURPOSE 2 PrEP trials of twice-yearly lenacapavir, showing continued high efficacy, very high adherence (96% and 92%) and a consistent safety profile with no new signals. PURPOSE 1 recorded zero HIV infections during the extension, while PURPOSE 2 reported one infection among participants continuing lenacapavir. Gilead and Merck (NYSE: MRK) will also present full Phase 3 ISLEND-1 and ISLEND-2 results on a once-weekly investigational islatravir/lenacapavir oral regimen, alongside multiple Biktarvy and long-acting pipeline studies. Gilead highlights progress on its global access strategy for twice-yearly lenacapavir PrEP, expanding its no-profit supply program target from 2 million to up to 3 million people through 2028 and reporting availability in 10 priority sub-Saharan African countries.
Gilead (Nasdaq:GILD) received U.S. FDA approval for Trodelvy as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). Trodelvy can be used alone in PD-(L)1–ineligible patients or with Keytruda/Keytruda Qlex in PD-L1 CPS ≥10 tumors.
Approval is based on Phase 3 ASCENT-03 and ASCENT-04 data, where Trodelvy-based regimens reduced risk of progression or death by 38% and 35% versus chemotherapy-based comparators and extended median duration of response to 12.2 vs 7.2 months and 16.5 vs 9.2 months.