ImmuCell Pauses Re-Tain Investment, Increases First Defense Sales Force by 50%

ImmuCell Corporation announced that it received an Incomplete Letter from the FDA on December 23 for its Re-Tain New Animal Drug Application, or NADA, and simultaneously that it is increasing its First Defense field sales force by 50% and expanding its First Defense manufacturing capabilities. In seeking FDA approval to bring its innovative Re-Tain product to market, ImmuCell received Complete Letters from the FDA for four of the five Technical Sections required for NADA approval. It pursued a two-pronged manufacturing approach to reduce capital expenditure and limit technical risk for the remaining fifth Technical Section pertaining to manufacturing. ImmuCell manufactured the active pharmaceutical ingredient using a proprietary process in its own facility and hired an experienced 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 its market leading First Defense franchise, which it believes to have significant revenue and profit growth capacity. 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. 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. Neither approach would require further capital investment or in-house manufacturing capability, meaning that ImmuCell will prioritize cash and other resources for maximizing the value of its market leading First Defense franchise.