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Gilead leans on CymaBay liver drug, Trodelvy readouts and long-active PrEP yet to come this year

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Gilead Sciences notched “fine” sales for the first quarter but the biopharma promised more to come.

Gilead reported sales of $6.6 billion, a 5% increase year-over-year, prompting Mizhuo analysts to write that the quarter “generally looks fine” on Thursday afternoon.

Executives emphasized seladelpar, a rare liver disease candidate that was picked up in its $4.3 billion CymaBay acquisition and has an August FDA decision date, in its Q1 earnings call Thursday. The potential primary biliary cholangitis treatment also is expected to get a decision in Europe in the first quarter of 2025.

Lenacapavir for HIV pre-exposure prophylaxis (PrEP) was another promise as Gilead plans a Phase 3 study update later this year and a potential launch of the twice-yearly PrEP option as early as late 2025. Lenacapavir is already approved as HIV treatment Sunlenca.

Gilead also highlighted three upcoming ASCO conference readouts, two for Trodelvy in lung cancer and a Phase 2 update for domvanalimab in gastric cancer.

When asked about how it plans to turn up the low single-digit Q1 revenue growth reported on Thursday, CEO Daniel O’Day pointed to Gilead’s HIV and oncology portfolio advances and Kite cell therapy in response.

“I’ll just remind you we’ve got close to 20 readouts this year,” O’Day said. “Within the company today, we have what it takes to drive a substantial growth in our business over the course of the next decade with focus on expense management as well,” he added.

Gilead appears to have formally ended work on magrolimab, an anti-CD47 antibody it was developing in several types of tumors. The update follows announcements in February that trials of the drug in acute myeloid leukemia were being put on hold after a heightened risk of death.

Other pipeline changes announced during the first quarter include:

  • A new PD-1 agonist, GS-0151, undergoing Phase 1 testing in inflammatory diseases.
  • Discontinuation of a first-line non-small cell lung cancer program with partner Arcus’ drugs domvanalimab and zimberelimab.
  • Discontinued programs for two cell therapies in blood cancers.

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