ImmuCell Pauses Investment in Cow Mastitis Drug After Receiving FDA Incomplete Letter

Dow Jones

2025/12/25

By Nicholas G. Miller

ImmuCell paused investment in its Re-Tain drug to treat mastitis in dairy cows after receiving an incomplete letter from the Food and Drug Administration.

The company said Wednesday the FDA is declining to approve its application for the drug because the contract manufacturer used in the filling of the product into syringes has not satisfactorily addressed inspectional deficiencies. ImmuCell said it would pause further investment in Re-Tain due to the practical implications of the resulting delays.

It said it would increase its investment in its First Defense franchise, which gives calves immediate immunity from certain scours pathogens. The company will boost its First Defense field sales force by 50% and expand the franchise's manufacturing capabilities.

ImmuCell will complete ongoing investigational studies with Re-Tain and will seek to license the product or partner with a global manufacturer.

The company expects a non-cash impact to profit of $2.3 million in the fourth quarter as a result of the strategic shift.

Write to Nicholas G. Miller at nicholas.miller@wsj.com.

(END) Dow Jones Newswires

December 24, 2025 13:40 ET (18:40 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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Miller \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  ImmuCell paused investment in its Re-Tain drug to treat mastitis in dairy cows after receiving an incomplete letter from the Food and Drug Administration. \n</p>\n<p>\n  The company said Wednesday the FDA is declining to approve its application for the drug because the contract manufacturer used in the filling of the product into syringes has not satisfactorily addressed inspectional deficiencies. ImmuCell said it would pause further investment in Re-Tain due to the practical implications of the resulting delays. \n</p>\n<p>\n  It said it would increase its investment in its First Defense franchise, which gives calves immediate immunity from certain scours pathogens. The company will boost its First Defense field sales force by 50% and expand the franchise's manufacturing capabilities. \n</p>\n<p>\n  ImmuCell will complete ongoing investigational studies with Re-Tain and will seek to license the product or partner with a global manufacturer. \n</p>\n<p>\n  The company expects a non-cash impact to profit of $2.3 million in the fourth quarter as a result of the strategic shift. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  Write to Nicholas G. Miller at nicholas.miller@wsj.com. \n</p>\n<pre style=\"white-space: pre\">\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  December 24, 2025 13:40 ET (18:40 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\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://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2594409967","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2594409967","pubTimestamp":1766601600,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"ImmuCell paused investment in its Re-Tain drug to treat mastitis in dairy cows after receiving an incomplete letter from the Food and Drug Administration.The company said Wednesday the FDA is declining to approve its application for the drug because the contract manufacturer used in the filling of the product into syringes has not satisfactorily addressed inspectional deficiencies. ImmuCell said it would pause further investment in Re-Tain due to the practical implications of the resulting delays.It said it would increase its investment in its First Defense franchise, which gives calves immediate immunity from certain scours pathogens. The company will boost its First Defense field sales force by 50% and expand the franchise's manufacturing capabilities.ImmuCell will complete ongoing investigational studies with Re-Tain and will seek to license the product or partner with a global manufacturer.The company expects a non-cash impact to profit of $2.3 million in the fourth quarter as a re","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","ICCC":"伊芙美尔医疗"},"translate_title":"ImmuCell在收到FDA不完整信函后暂停投资奶牛乳腺炎药物","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ICCC":1.5},"content_text":"By Nicholas G. Miller \n\n\n \n\n\n  ImmuCell paused investment in its Re-Tain drug to treat mastitis in dairy cows after receiving an incomplete letter from the Food and Drug Administration. \n\n\n  The company said Wednesday the FDA is declining to approve its application for the drug because the contract manufacturer used in the filling of the product into syringes has not satisfactorily addressed inspectional deficiencies. ImmuCell said it would pause further investment in Re-Tain due to the practical implications of the resulting delays. \n\n\n  It said it would increase its investment in its First Defense franchise, which gives calves immediate immunity from certain scours pathogens. The company will boost its First Defense field sales force by 50% and expand the franchise's manufacturing capabilities. \n\n\n  ImmuCell will complete ongoing investigational studies with Re-Tain and will seek to license the product or partner with a global manufacturer. \n\n\n  The company expects a non-cash impact to profit of $2.3 million in the fourth quarter as a result of the strategic shift. \n\n\n \n\n\n  Write to Nicholas G. Miller at nicholas.miller@wsj.com. \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  December 24, 2025 13:40 ET (18:40 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}