Genelux Announces FDA Guidance on Olvi-Vec Phase 3 Trial

MT Newswires Live

Mar 25, 2025

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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Genelux said it expects to report these results in H1 2026.</p><p>Shares of the company fell 14% in recent Tuesday trading.</p><p>Price: 3.29, Change: -0.60, Percent Change: -15.42</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"GNLX","symbol_name":"Genelux Corporation","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2522161008","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2522161008","pubTimestamp":1742912466,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. 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