FDA Clears Atossa Therapeutics to Proceed with (Z)-Endoxifen Trial for Metastatic Breast Cancer

Reuters

01/06

FDA Clears Atossa <a href="https://laohu8.com/S/LENZ">Therapeutics</a> to Proceed with <a href="https://laohu8.com/S/Z">$(Z)$</a>-Endoxifen Trial for Metastatic Breast Cancer

Atossa Therapeutics Inc. has received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA) for its investigational new drug application of (Z)-endoxifen for metastatic breast cancer. This regulatory milestone allows Atossa to advance clinical studies of (Z)-endoxifen, a selective estrogen receptor modulator/degrader (SERM/D) with a distinct safety profile and pharmacology from tamoxifen. The company is evaluating the drug’s potential in treating metastatic ER+/HER2- breast cancer, including cases resistant to other endocrine therapies. Atossa’s (Z)-endoxifen is not yet approved for any indication.

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. Atossa Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: SF56883) on January 06, 2026, and is solely responsible for the information contained therein.

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This regulatory milestone allows Atossa to advance clinical studies of (Z)-endoxifen, a selective estrogen receptor modulator/degrader (SERM/D) with a distinct safety profile and pharmacology from tamoxifen. The company is evaluating the drug’s potential in treating metastatic ER+/HER2- breast cancer, including cases resistant to other endocrine therapies. Atossa’s (Z)-endoxifen is not yet approved for any indication.\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. Atossa Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: SF56883) on January 06, 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":"ATOS","symbol_name":"Atossa Genetics Inc","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260106:nNDL46cVHM:1","article_id":"2601972758","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2601972758","pubTimestamp":1767705329,"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":"Atossa Therapeutics Inc. has received a \"Study May Proceed\" letter from the U.S. Food and Drug Administration  for its investigational new drug application of -endoxifen for metastatic breast cancer. 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