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Gilead Sciences Says HIV Combo NDA Gets FDA Priority Review

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Gilead Sciences (GILD) said Wednesday the US Food and Drug Administration accepted its new drug application for an investigational once-daily HIV treatment combining bictegravir and lenacapavir, granting priority review with a target action date of Aug. 27.

The application is backed by Phase 3 ARTISTRY-1 and ARTISTRY-2 trials, which showed the regimen maintained virological suppression at 48 weeks and was generally well tolerated in adults with HIV, including those switching from multi-tablet regimens or Biktarvy, the company said.

The bictegravir 75-milligram and lenacapavir 50-mg combination remains investigational and has not been approved globally, with its safety and efficacy yet to be fully established, the company said.

Price: $128.49, Change: $-0.77, Percent Change: -0.60%

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