Gilead reports Q2 2026 results with three FDA approvals, three positive Phase 3 readouts

Gilead Sciences said it made significant clinical progress in the quarter with three FDA approvals and three positive Phase 3 updates, and looks forward to two more potential launches in oncology and HIV in the second half of the year.¹

On the regulatory front, the FDA accepted a supplemental New Drug Application for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral HIV PrEP formulation, with a PDUFA target action date of February 2, 2027.¹ The company also received FDA accelerated approval for Hepcludex to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis, making it the first and only FDA-approved HDV treatment in the U.S.¹ Separately, Trodelvy received FDA approval for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer, either as monotherapy or in combination with Keytruda or Keytruda Qlex for PD-L1-expressing tumors.¹

On the trial side, Gilead and Merck announced positive Phase 3 results from the ISLEND-1 and ISLEND-2 trials evaluating a once-weekly oral combination of islatravir and lenacapavir in virologically suppressed HIV patients switching from Biktarvy or standard antiretroviral regimens.¹ However, the companies discontinued the Phase 3 EVOKE-03 study of Trodelvy plus Keytruda in first-line metastatic non-small cell lung cancer, based on an external Data Monitoring Committee recommendation after review of progression-free and overall survival data.¹ In liver disease, positive Phase 3 IDEAL study results supported Livdelzi's potential for primary biliary cholangitis patients with elevated alkaline phosphatase whose disease remains inadequately controlled on ursodeoxycholic acid or who are intolerant to it.¹

Gilead also completed two acquisitions during the quarter: Tubulis for $3.15 billion upfront, bringing antibody-drug conjugate assets including GS-8824, a NaPi2b-directed topoisomerase-I inhibitor ADC, plus an ADC development platform¹, and Ouro Medicines for $1.675 billion upfront, adding gamgertamig, an investigational BCMAxCD3 T cell engager for autoimmune disease, completed in collaboration with Lakefront, which shared the upfront payment equally.¹

On guidance, Gilead raised full-year 2026 product sales guidance to $30.1 billion to $30.4 billion, up from $30.0 billion to $30.4 billion previously, while lowering Veklury sales expectations to about $300 million from about $600 million.¹ Cash position declined sharply: as of June 30, 2026, Gilead had $3.2 billion in cash, cash equivalents and marketable debt securities, down from $10.6 billion at year-end 2025, driven by $11.3 billion in acquisition-related outflows, $2.8 billion in debt repayments, $2.1 billion in dividends and $774 million in buybacks, partly offset by $4.1 billion in debt financing proceeds and $6.1 billion in operating cash flow.¹