05:01 PM EDT, 06/24/2025 (MT Newswires) -- Cue Biopharma ( CUE ) said late Tuesday it received pre-investigational new drug feedback from the US Food and Drug Administration on its trial design for the CUE-401 drug candidate to treat T-cell mediated autoimmune and inflammatory diseases.

As a result, the company said it plans to file an IND pending completion of final IND enabling studies.

The FDA review involves Cue Biopharma's ( CUE ) plans for dose escalation, proposed populations, and safety monitoring strategy, according to a statement.

Shares were up 3.6% in after-hours trading.