1. ImmuCell received an Incomplete Letter from the FDA for Re-Tain® NADA. 2. The company will pause investment in Re-Tain® and expand First Defense® operations. 3. Significant revenue growth expected from First Defense®, with a focus on market expansion. 4. A non-cash impairment write-down of $2.3 million is anticipated due to Re-Tain® setbacks. 5. ImmuCell's First Defense® holds a 29% market share in U.S. scour prevention.
FAQ
Why Neutral?
While FDA issues can affect short-term perception, expansion of First Defense® is positive.
How important is it?
The FDA decision is a concern, but resource allocation toward First Defense® indicates future growth potential.
Why Short Term?
Short-term impact due to FDA news; longer growth from First Defense® expansion expected.
ImmuCell Shifts Focus to First Defense® Following FDA Incomplete Letter for Re-Tain®
Portland, Maine, December 24, 2025 – ImmuCell Corporation (Nasdaq: ICCC), a leader in animal health, announced a strategic shift towards its First Defense® product line after receiving an Incomplete Letter from the FDA regarding its Re-Tain® New Animal Drug Application (NADA). The decision aims to enhance growth opportunities within its First Defense® franchise while addressing current challenges in regulatory approval.
FDA Incomplete Letter Details
On December 23, 2025, ImmuCell was informed that it received an Incomplete Letter from the FDA concerning its Re-Tain® product. This letter follows the receipt of Complete Letters for four out of the five Technical Sections required for NADA approval. ImmuCell had pursued a dual manufacturing approach to manage costs and technical risks for the necessary fifth Technical Section.
The company produced the active pharmaceutical ingredient in its own facility and relied on a contract manufacturer authorized for animal health products for the aseptic filling process. Despite passing FDA inspections in 2024, deficiencies related to the contract manufacturer led to the FDA's current stance.
Strategic Shift to First Defense®
In light of the FDA's decision and to mitigate potential delays, including an impending contract expiration with the manufacturer in March 2026, ImmuCell has decided to halt further investments in Re-Tain® and instead bolster its First Defense® sales force by 50%. This strategic realignment reflects ImmuCell’s confidence in the revenue and profit growth potential of its First Defense® line.
Olivier te Boekhorst, President and CEO of ImmuCell, stated, “While it is disappointing news that we will be unable to achieve NADA approval with this contract manufacturer, this has only strengthened our resolve to allocate our resources to our highest return opportunity, namely First Defense®.”
Opportunities and Market Potential
First Defense® is poised to capitalize on an estimated $900 million total addressable market for calf scours prevention. ImmuCell’s proprietary colostrum hyper-immunization technology offers a competitive edge, with the brand holding a dominant position in the U.S. market, including a #1 ranking for scour-prevention in the 2025 Hoard’s Dairyman Continuing Market Study.
- First Defense® holds a 29% share of the U.S. spend on scours prevention.
- Historical annual revenue growth from $4.4 million to approximately $27.8 million as of September 30, 2025.
- Plans for expanding international sales and product development leveraging antibody-rich colostrum.
Financial Implications and Future Outlook
As a consequence of this strategic pivot, ImmuCell anticipates a non-cash impairment write-down of property, plant, and equipment, expected to be roughly $2.3 million. Timothy Fiori, CFO, emphasized that these adjustments are necessary for repurposing resources towards enhancing First Defense® capacity.
Looking ahead, ImmuCell plans to disclose its topline revenue results for the fourth quarter and the year ending December 31, 2025, on January 8, 2026, with a follow-up conference call scheduled for January 9, 2026.