<div id="readability-page-1">Animal health firm ImmuCell Corporation ( ICCC ) received an Incomplete Letter from the United States Food and Drug Administration (FDA) on Tuesday for its Re-Tain New Animal Drug Application (NADA). Re-Tain is the company’s intramammary treatment for subclinical mastitis in lactating cows. ImmuCell ( ICCC ) will complete ongoing investigational studies with Re-Tain to assess opportunities for an improved set of claims for preventing and treating mastitis in dairy cows. Also Read: Animal Health Focused Elanco Details Pipeline Momentum, US Investments, Cost-Saving Plans <h2>Manufacturing Strategy</h2> It pursued a two-pronged manufacturing approach to reduce capital expenditure and limit technical risk for the remaining fifth Technical Section related to manufacturing. ImmuCell ( ICCC ) manufactured the active pharmaceutical ingredient using a proprietary process in its own facility and hired a contract manufacturer with FDA approvals for animal health products for the aseptic filling of the product into syringes. ImmuCell ( ICCC ) passed FDA inspection of its own facility in 2024. It is ImmuCell’s understanding that the FDA is now declining to approve the NADA because the contract manufacturer has not satisfactorily addressed inspectional deficiencies. After considering the practical implications of the resulting delays, including the pending expiration of ImmuCell’s contract with the manufacturer in March 2026, ImmuCell ( ICCC ) has decided to pause further investment in Re-Tain and increase its investment in the First Defense franchise. It will seek to license the product to interested parties or, depending on the outcome of the studies, may seek to partner with a global manufacturer. <h2>First Defense Expansion</h2> Simultaneously, the company said it is increasing its First Defense field sales force by 50% and expanding its First Defense manufacturing capabilities. As a result of this strategic change in focus, ImmuCell ( ICCC ) expects to record a non-cash impairment write-down of property, plant, and equipment during the fourth quarter of 2025. As previously disclosed, the net book value of Re-Tain assets was approximately $15.5 million as of September 30, 2025. The company anticipates adjustments to laboratory and manufacturing equipment and construction in progress, resulting in an estimated non-cash impact to profit of approximately $2.3 million. ICCC Price Action: ImmuCell ( ICCC ) shares were up 1.73% at $5.900 during premarket trading on Friday, according to Benzinga Pro data. Read Next: <ul> <li>Russia’s New Soyuz 5 Rocket Grounded Over Last-Minute Checks</li> </ul> Photo by Panchenko Vladimir via Shutterstock</div>

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ImmuCell Corporation 收到了 FDA 對其 Re-Tain NADA 的不完整信函，這導致公司暫停對 Re-Tain 的投資，轉而專注於其 First Defense 品牌。ImmuCell 計劃許可 Re-Tain 或與全球製造商合作。公司將擴大其 First Defense 銷售團隊和製造能力，預計將有 230 萬美元的非現金減值損失。ImmuCell 的股票在盤前交易中上漲了 1.73%

ImmuCell 在收到 FDA 信函後暫停了 Re-Tain 項目