Highlights

  • ImmuCell received an FDA Incomplete Letter for Re-Tain® on December 23, 2025.
  • First Defense® U.S. field sales force will expand by 50% with manufacturing enhancements.
  • Re-Tain® assets may incur a non-cash impairment of approximately USD 2.3 million.

ImmuCell Corporation (Nasdaq:ICCC), an animal health company, announced that the U.S. Food and Drug Administration (FDA) issued an Incomplete Letter for its Re-Tain® New Animal Drug Application (NADA) on December 23, 2025. Four of the five technical sections required for approval were accepted by the FDA. Approval for the remaining section, related to manufacturing, was not granted due to unresolved inspectional deficiencies at the contract manufacturer handling aseptic filling.

To reduce technical risks and capital expenditure, ImmuCell had pursued a dual manufacturing approach, producing the active pharmaceutical ingredient in its own facility while using a contract manufacturer for filling. The company’s facility passed FDA inspection in 2024. Following the FDA decision and with the pending expiration of its contract in March 2026, ImmuCell has opted to pause further in-house investment in Re-Tain® and continue investigational studies. The company may seek licensing or partnerships for Re-Tain® without additional capital or in-house manufacturing.

Shift to First Defense®
ImmuCell plans to increase investment in its First Defense® product line. This includes a 50% expansion of the U.S. field sales force and enhancements to manufacturing capabilities. First Defense® employs colostrum hyper-immunization technology for calf scour prevention. In 2025, it held a 29% share of U.S. spending on scours prevention and ranked first in the Hoard’s Dairyman Continuing Market Study.

The company also announced plans for international expansion and product development using the bioactive properties of colostrum. Facilities and equipment previously used for Re-Tain® will be repurposed to support First Defense® manufacturing and distribution.

Financial Considerations
ImmuCell expects a non-cash impairment of approximately USD 2.3 million related to Re-Tain® assets in Q4 2025. This includes adjustments to laboratory and manufacturing equipment and construction in progress. The company will finalize this figure after reviewing alternative uses and net realizable value of the assets.

Ongoing Operations
ImmuCell continues to conduct Re-Tain® investigational studies to evaluate claims for preventing and treating mastitis in dairy cows. First Defense® operations include creating new U.S. sales territories and hiring senior personnel to support international strategy. A multi-year manufacturing improvement program has been initiated to optimize product costs and capacity.

Stock Performance Overview
ICCC closed at USD 6.12 on December 26, 2025, marking a 5.52% gain during the day. In after-hours trading, shares traded slightly lower at USD 6.09, down 0.49%.