ImmuCell shares surge 18.97% intraday as FDA Re-Tain rejection spurs strategic shift to First Defense expansion.

ImmuCell surged 18.97% intraday after announcing it would shift focus from Re-Tain to its First Defense franchise following an FDA Incomplete Letter for Re-Tain’s NADA. The company cited unresolved inspectional deficiencies at its contract manufacturer as the cause for the FDA’s delay, prompting a strategic pivot to prioritize First Defense, its profitable scours-prevention product. ImmuCell plans to expand First Defense sales and manufacturing, leveraging existing facilities, while recording a $2.3 million non-cash impairment. The move signals confidence in First Defense’s growth potential, with the stock’s sharp rise reflecting optimism about the reallocation of resources to a higher-margin product line and operational restructuring.