Inovio Pharmaceuticals Inc. Begins Rolling Submission of BLA for INO-3107 for RRP Treatment, Aiming for FDA Approval by End of 2025

Reuters

08/26

Inovio Pharmaceuticals Inc. Begins Rolling Submission of BLA for INO-3107 for RRP Treatment, Aiming for FDA Approval by End of 2025

INOVIO Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has agreed to their rolling submission plan for the Biologics License Application (BLA) for INO-3107, a treatment for adults with Recurrent Respiratory Papillomatosis (RRP). The company is on track to complete the submission in the second half of 2025 and aims for file acceptance by the end of the year. INOVIO, which focuses on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases, is leveraging its Breakthrough Therapy designation to expedite discussions with the FDA. This development is seen as a significant step toward providing a new therapeutic option for patients suffering from RRP. There is no mention of grant or funding being obtained by multiple organizations; the announcement pertains solely to INOVIO Pharmaceuticals Inc.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Inovio Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH58699) on August 26, 2025, and is solely responsible for the information contained therein.

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Begins Rolling Submission of BLA for INO-3107 for RRP Treatment, Aiming for FDA Approval by End of 2025\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time smaller\">2025-08-26 20:05</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Inovio Pharmaceuticals Inc. Begins Rolling Submission of BLA for INO-3107 for RRP Treatment, Aiming for FDA Approval by End of 2025\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        INOVIO Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has agreed to their rolling submission plan for the Biologics License Application (BLA) for INO-3107, a treatment for adults with Recurrent Respiratory Papillomatosis (RRP). The company is on track to complete the submission in the second half of 2025 and aims for file acceptance by the end of the year. INOVIO, which focuses on developing DNA medicines for HPV-related diseases, cancer, and infectious diseases, is leveraging its Breakthrough Therapy designation to expedite discussions with the FDA. This development is seen as a significant step toward providing a new therapeutic option for patients suffering from RRP. 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ID: PH58699) on August 26, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"INO","symbol_name":"伊諾維奧製藥","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250826:nNDL1hwbl:1","article_id":"2562735150","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2562735150","pubTimestamp":1756209920,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Inovio Pharmaceuticals Inc. 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