Genelux (GNLX) said Tuesday that during a review of the approval pathway for Olvi-Vec in platinum-resistant ovarian cancer, the US Food and Drug Administration recommended conducting an interim overall survival analysis alongside the primary progression-free survival analysis
The company said the agency indicated that data from the ongoing phase 3 trial could support traditional approval if it shows a "clinically meaningful" progression-free survival benefit without a decline in overall survival.
Genelux said the FDA suggested the company request a pre-Biologics License Application meeting after topline safety and efficacy results are available. Genelux said it expects to report these results in H1 2026.
Shares of the company fell 14% in recent Tuesday trading.
Price: 3.29, Change: -0.60, Percent Change: -15.42
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