Gilead Sciences won its third FDA approval in four months on Aug. 27, lifting shares more than 21 percent this year as it diversifies beyond its dominant HIV franchise through acquisitions and a pipeline spanning oncology and virology. The company guided full-year revenue to $30.1 billion to $30.4 billion and faces PDUFA decisions on anito-cel in December and Yeztugo in February.
Shares of Gilead Sciences have climbed more than 21 percent this year, nearly doubling the S&P 500's gain, after the biotech secured its third regulatory clearance in under four months on Aug. 27.
The company cleared Bixlenvo as a daily pill for virologically suppressed adults with HIV, following Trodelvy's two new approvals for triple-negative breast cancer on June 24 and Hepcludex's accelerated approval for chronic hepatitis delta virus on May 22. Gilead has said it plans seven new HIV launches by the end of 2033, and it reported $7.6 billion in second-quarter revenue, up 8 percent from a year earlier, with adjusted earnings per share of $2.27, up 13 percent.
The approvals come as Gilead prepares for the eventual loss of exclusivity on its legacy HIV therapies. Its flagship daily regimen, Biktarvy, posted $3.8 billion in second-quarter sales, up 8 percent, with a patent runway extending to 2036, while quarterly PrEP sales topped $1 billion for the first time, up 101 percent, led by Descovy at $801 million, up 60 percent.
Gilead is also diversifying through acquisitions and a pipeline that reaches beyond virology. Anito-cel, a BCMA-directed CAR-T therapy for multiple myeloma, showed a 96 percent overall response rate and a 74 percent complete response rate in heavily pretreated patients, meaning roughly three-quarters showed no detectable cancer. The drug's PDUFA target date is Dec. 23, and the once-weekly oral HIV prevention pill Yeztugo carries a Feb. 2 target date that would make it the first long-acting oral PrEP option, an alternative to twice-yearly injections. A once-weekly oral combination of lenacapavir with Merck's islatravir for virologically suppressed adults is slated for 2027.
The company guided full-year revenue to $30.1 billion to $30.4 billion, up from $29.44 billion in 2025, and raised its quarterly dividend 3.8 percent to $0.82, the 11th consecutive annual increase, for a yield near 2.15 percent. Gross margins held at 87 percent in the second quarter, and Gilead bought back $774 million of stock in the first half of 2026, while cutting its debt-to-equity ratio by more than 34 percent over the past decade.
The approval cadence and diversification give Gilead a path to re-rate beyond the mature HIV cash generation the market has long discounted, with the stock still trading below most large-cap pharma peers on trailing and forward earnings. Investors will watch the anito-cel PDUFA decision on Dec. 23 and the Yeztugo decision on Feb. 2 as the next catalysts for that reassessment.
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