Genelux Announces Alignment with FDA on Key Elements of the Approval Pathway for Olvi-Vec in Platinum Resistant/Refractory Disease
Genelux Corporation (GNLX)
Company Research
Source: GlobeNewswire
- U.S. Food and Drug Administration states that data from the ongoing OnPrime/GOG-3076 Phase 3 registrational trial could potentially support traditional approval - WESTLAKE VILLAGE, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that Genelux has concluded a productive Type D meeting with the U.S. Food and Drug Administration (FDA) for Olvi-Vec in the treatment of platinum resistant/refractory ovarian cancer (PRROC). Currently, Olvi-Vec is being evaluated in the OnPrime/GOG-3076 Phase 3 registrational trial in the United States, with the primary endpoint of progression free survival (Clinicaltrials.gov identifier NCT05281471). The purpose of the FDA meeting was to discuss the FDA’s expectations with respect to the requirements necessary for the granting of traditional approval of Olvi-Vec. In response to a question seeking the FDA’s guidance on their expectations regarding a confirmator
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- 12/11/25 - Form 4
- 12/11/25 - Form 4
- 12/11/25 - Form 4
- GNLX's page on the SEC website