FDA Clears Whitehawk Therapeutics' IND Application for HWK-007

Reuters

Jan 08

FDA Clears Whitehawk <a href="https://laohu8.com/S/LENZ">Therapeutics</a>' IND Application for HWK-007

Whitehawk Therapeutics Inc. has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug $(IND)$ application for HWK-007, a PTK7-targeted antibody-drug conjugate $(ADC)$. The company has also submitted an IND to the FDA for HWK-016, a MUC16-targeted ADC, in December 2025, with a Phase 1 trial expected to begin recruiting this quarter. These regulatory milestones enable Whitehawk to advance its ADC programs into clinical trials, with initial clinical data anticipated in early 2027. No other beneficiary organizations were mentioned.

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. Whitehawk Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA58729) on January 08, 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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The company has also submitted an IND to the FDA for HWK-016, a MUC16-targeted ADC, in December 2025, with a Phase 1 trial expected to begin recruiting this quarter. These regulatory milestones enable Whitehawk to advance its ADC programs into clinical trials, with initial clinical data anticipated in early 2027. No other beneficiary organizations were mentioned.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>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. Whitehawk Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA58729) on January 08, 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":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260108:nNDL7L5wYl:1","article_id":"2601364560","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2601364560","pubTimestamp":1767877344,"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":"Whitehawk Therapeutics Inc. has received clearance from the U.S. Food and Drug Administration  for its Investigational New Drug  application for HWK-007, a PTK7-targeted antibody-drug conjugate . 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Whitehawk Therapeutics Inc. published the original content used to generate this news brief via PR Newswire  on January 08, 2026, and is","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","WHWK":"Whitehawk Therapeutics, Inc."},"translate_title":"FDA批准Whitehawk Therapeutics的HWK-007 IND申请","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"WHWK":0.9},"content_text":"FDA Clears Whitehawk Therapeutics' IND Application for HWK-007\n    \n\n        Whitehawk Therapeutics Inc. has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug $(IND)$ application for HWK-007, a PTK7-targeted antibody-drug conjugate $(ADC)$. The company has also submitted an IND to the FDA for HWK-016, a MUC16-targeted ADC, in December 2025, with a Phase 1 trial expected to begin recruiting this quarter. These regulatory milestones enable Whitehawk to advance its ADC programs into clinical trials, with initial clinical data anticipated in early 2027. No other beneficiary organizations were mentioned.\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. Whitehawk Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. 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