PDS Biotech Submits Amended Phase 3 Trial Protocol for FDA Review

Reuters

Jan 09

PDS Biotech Submits Amended Phase 3 Trial Protocol for FDA Review

PDS Biotechnology Corporation has announced that it has submitted an amended protocol to the U.S. Food & Drug Administration (FDA) for its Phase 3 VERSATILE-003 clinical trial. Following a constructive Type C meeting with the FDA, the amendment proposes using progression free survival $(PFS)$ as the primary endpoint, which may enable accelerated approval of its lead immunotherapy candidate, PDS0101, for HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) and safety remain as requirements for full FDA approval.

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. PDS Biotechnology Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9622646-en) on January 09, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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ID: GNW9622646-en) on January 09, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"SG9999014021.USD","symbol_name":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260109:nNDL3YTf8F:1","article_id":"2602379179","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2602379179","pubTimestamp":1767966311,"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":"PDS Biotechnology Corporation has announced that it has submitted an amended protocol to the U.S. Food & Drug Administration  for its Phase 3 VERSATILE-003 clinical trial. 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Following a constructive Type C meeting with the FDA, the amendment proposes using progression free survival $(PFS)$ as the primary endpoint, which may enable accelerated approval of its lead immunotherapy candidate, PDS0101, for HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) and safety remain as requirements for full FDA approval.\n      \n\n\nDisclaimer: 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. PDS Biotechnology Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9622646-en) on January 09, 2026, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}