On June 26, Gilead Sciences rose 3.18% in regular trading, trading at $127.55/share, with turnover of $127 million. The rally was driven by a landmark regulatory milestone for the company's core oncology asset.
The U.S. FDA officially approved Trodelvy for first-line treatment of adults with advanced triple-negative breast cancer, both as a standalone therapy for patients ineligible for PD-1 inhibitor-based treatment and in combination with Merck's Keytruda for PD-L1-positive patients. The National Comprehensive Cancer Network subsequently updated its guidelines, recommending Trodelvy as a category 1 preferred first-line option for metastatic triple-negative breast cancer regardless of PD-L1 status.
Additionally, the European Commission granted marketing approval for Trodelvy in a similar indication days earlier, covering patients not eligible for PD-(L)1 inhibitor therapy. The dual regulatory approvals in the U.S. and EU significantly expand Trodelvy's commercial opportunity in the breast cancer market, building on Phase 3 ASCENT-03 data that demonstrated a 38% reduction in the risk of disease progression or death versus standard chemotherapy.
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