ImmuCell Increasing First Defense Field Sales Force By 50%, Expanding First Defense Production Capabilities After Receiving FDA's Incomplete Letter For Its Re-Tain New Animal Drug Application

ImmuCell Corporation (NASDAQ:ICCC) ("ImmuCell"), an animal health company that develops, manufactures and markets products that improve cattle health and productivity today announced that it received an Incomplete Letter from the United States Food and Drug Administration (FDA) on December 23, 2025 for its Re-Tain® New Animal Drug Application (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.