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 plans for dose escalation, proposed populations, and safety monitoring strategy, according to a statement.
Shares were up 3.6% in after-hours trading.
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