ImmuCell Announces Strategic Focus on First Defense® After Receiving an FDA Incomplete Letter for Re-Tain®
ImmuCell Corporation (ICCC)
US:NASDAQ Investor Relations:
immucell.com/investors
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Source: GlobeNewswire
PORTLAND, Maine, Dec. 24, 2025 (GLOBE NEWSWIRE) -- 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
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News
- ImmuCell Announces Strategic Focus on First Defense® After Receiving an FDA Incomplete Letter for Re-Tain® [Yahoo! Finance]Yahoo! Finance
- ImmuCell's Two-Product Edge in Cattle Health Fuels Growth [Yahoo! Finance]Yahoo! Finance
- ImmuCell (NASDAQ:ICCC) had its "sell (d)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- ImmuCell signals operational excellence and targets $30M annual production capacity amid management transition [Seeking Alpha]Seeking Alpha
- ImmuCell Corporation (ICCC) Q3 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
ICCC
Sec Filings
- 12/4/25 - Form 4/A
- 12/3/25 - Form 4
- 11/28/25 - Form 4
- ICCC's page on the SEC website