ImmuCell Pauses Investment in Cow Mastitis Drug After Receiving FDA Incomplete Letter
By Nicholas G. Miller
ImmuCell paused investment in its Re-Tain drug to treat mastitis in dairy cows after receiving an incomplete letter from the Food and Drug Administration.
The company said Wednesday the FDA is declining to approve its application for the drug because the contract manufacturer used in the filling of the product into syringes has not satisfactorily addressed inspectional deficiencies. ImmuCell said it would pause further investment in Re-Tain due to the practical implications of the resulting delays.
It said it would increase its investment in its First Defense franchise, which gives calves immediate immunity from certain scours pathogens. The company will boost its First Defense field sales force by 50% and expand the franchise's manufacturing capabilities.
ImmuCell will complete ongoing investigational studies with Re-Tain and will seek to license the product or partner with a global manufacturer.
The company expects a non-cash impact to profit of $2.3 million in the fourth quarter as a result of the strategic shift.
Write to Nicholas G. Miller at nicholas.miller@wsj.com.
(END) Dow Jones Newswires
December 24, 2025 13:55 ET (18:55 GMT)
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