Animal health firm ImmuCell Corporation (NASDAQ: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 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.
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Manufacturing Strategy
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 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 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 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.
First Defense Expansion
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 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 shares were up 1.73% at $5.900 during premarket trading on Friday, according to Benzinga Pro data.
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