Key Highlights

  • The FDA approved Bixlenvo (bictegravir/lenacapavir) on August 27, following Hepcludex on May 22 and Trodelvy's first-line TNBC approvals on June 24.
  • Q2 2026 Revenue rose 10% to $7.8 billion, with HIV sales up 12% to $5.7 billion; Acquisition charges drove a GAAP loss of $8.45 per share.
  • Gilead raised 2026 product sales guidance excluding Veklury to $29.8 billion to $30.1 billion; a once-weekly Yeztugo PDUFA date is set for February 2, 2027.
  • Gilead shares were up more than 21% year to date as of early September, roughly double the rise in the S&P 500.

Gilead Sciences, Inc. (NASDAQ:GILD) has added a third U.S. Food and Drug Administration approval in roughly four months, and together they show a company broadening its growth base beyond its flagship HIV drug Biktarvy. On August 27, the FDA approved Bixlenvo, a once-daily single-tablet regimen for adults with HIV who are virologically suppressed, including people on complex multi-pill regimens.

Bixlenvo followed two other U.S. decisions this year. The FDA granted Accelerated Approval to Hepcludex for chronic hepatitis Delta virus infection on May 22, and on June 24 Trodelvy received approvals in first-line metastatic triple-negative breast cancer. Gilead shares were up more than 21% year to date as of early September, roughly double the rise in the S&P 500.

For investors, the string of approvals matters less for any single product's near-term sales than for what it says about durability. Gilead is using its HIV franchise, which generated $5.7 billion of product sales last quarter, to fund new launches and acquisitions intended to extend growth into the next decade.

What Bixlenvo Adds to the HIV Franchise

Bixlenvo combines bictegravir 75 mg, the integrase inhibitor in Biktarvy, with lenacapavir 50 mg, Gilead's first-in-class capsid inhibitor. Gilead said in its August 27 release that Bixlenvo is now the smallest once-daily single-tablet regimen and the first and only such option for virologically suppressed people with HIV who are on complex regimens and cannot take existing single-tablet treatments.

The approval rests on the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials, which showed comparable efficacy in maintaining viral suppression at Week 48 with no significant or new safety concerns, according to the company. ARTISTRY-1 enrolled a heavily treatment-experienced group with a median age of 60, a median of 28 years on therapy and participants taking between two and 11 pills a day. The most common side effects were headache, nausea and diarrhea.

"Our goal at Gilead is to provide multiple Options for HIV treatment and prevention and with a pipeline of potential daily, weekly and longer acting options, today's approval could be the first of many in the years ahead," Chairman and Chief Executive Daniel O'Day said in the release. Bixlenvo requires a two-day starting dose of Sunlenca, after which patients take one tablet daily. The combination is not yet approved outside the United States.

The Three-Approval Run in Context

Each of the three approvals targets a different part of the portfolio. Hepcludex became, in Gilead's words, the first and only FDA-approved treatment for hepatitis delta in the U.S., strengthening its liver disease business. The Trodelvy decision moved the antibody-drug conjugate into first-line treatment of triple-negative breast cancer, either alone or combined with Merck's (NYSE:MRK) Keytruda for patients whose tumors express PD-L1.

In its second-quarter release on August 4, Gilead said it had made "significant clinical progress with three FDA approvals and three positive Phase 3 updates," and flagged two more potential launches in oncology and HIV in the second half of the year. Bixlenvo appears to be the HIV launch referenced; the company did not specify the oncology product in that statement.

Second-Quarter Numbers and a Raised Outlook

Total second-quarter revenue rose 10% to $7.8 billion. Product sales excluding the COVID-19 antiviral Veklury grew 10% to $7.6 billion. HIV sales increased 12% to $5.7 billion, with Biktarvy up 7% to $3.8 billion and Descovy up 48% to $967 million. Yeztugo, the twice-yearly lenacapavir injection for HIV prevention, generated $232 million. Trodelvy sales rose 26% to $457 million, and Livdelzi more than doubled to $167 million.

Headline Earnings were distorted by acquisitions. Gilead posted a diluted loss of $8.45 per share and a non-GAAP diluted loss of $6.75, reflecting a $9.08-per-share hit from acquired in-process Research and Development charges tied to its purchases of Arcellx (NASDAQ:ACLX), Tubulis and Ouro Medicines. Operating Cash Flow was $3.6 billion in the quarter.

Gilead raised its 2026 product sales guidance excluding Veklury to $29.8 billion to $30.1 billion from $29.4 billion to $29.8 billion. Total product sales guidance moved to $30.1 billion to $30.4 billion. The company now expects a non-GAAP diluted loss of $0.30 to $0.65 per share, an improvement from its May range, with the acquisition charges again the main factor.

Competitive Landscape in HIV and Oncology

HIV remains a market where Gilead leads, competing chiefly with ViiV Healthcare, which is majority-owned by GSK (NYSE:GSK). Long-acting prevention and treatment is the next battleground, and Gilead is pursuing daily, weekly and twice-yearly options. The company said the FDA accepted a filing for a once-weekly oral Yeztugo tablet for prevention, and it reported positive Phase 3 results, with partner Merck, for a once-weekly islatravir and lenacapavir treatment regimen.

Oncology is more contested. Cell therapy sales fell 14% to $417 million in the quarter because of what Gilead called ongoing competitive headwinds, with Yescarta down 12%. The company also discontinued the Phase 3 EVOKE-03 lung cancer study of Trodelvy with Keytruda after an independent data monitoring committee's review.

Balancing the Risks

Gilead's Balance Sheet has tightened after an active year of dealmaking. Cash, cash equivalents and marketable Debt securities fell to $3.2 billion at June 30 from $10.6 billion at the end of 2025, driven by $11.3 billion of acquisition outflows. The company also recorded a $1.75 billion Impairment on Assets acquired from Immunomedics.

Pricing is another pressure point. Gilead's forward-looking statements cite Medicare Part D reform under the Inflation Reduction Act, the expiration of Affordable Care Act subsidies and its most-favored-nation pricing agreement with the U.S. government. New launches such as Bixlenvo also face the commercial challenge of persuading stable patients and physicians to switch regimens, and it is too early to know how much of Bixlenvo's use will add to Gilead's HIV revenue rather than shift it from existing products. Gilead's older HIV therapies face eventual loss of exclusivity, though major concerns for the Franchise are not expected until the next decade.

The Next Launch to Watch: Yeztugo's 2027 Decision

The next major event is Gilead's third-quarter 2026 report, which has not yet been formally dated but has historically come in late October or early November. Investors will look for early Bixlenvo uptake, Yeztugo's trajectory and whether the base Business stays on track for the raised guidance.

Further out, the FDA has set a target action date of February 2, 2027, for once-weekly oral Yeztugo for HIV prevention. Progress on integrating Arcellx's multiple myeloma cell therapy, anito-cel, and on the Tubulis antibody-drug conjugate platform will also shape whether this year's approvals mark the start of a longer run.