Registration work for IBT’s drug candidate IBP-9414 continues in the US and Europe
October 13, 2025
Communication with the FDA continues, and IBT is focused on obtaining drug approval for IBP-9414 in the US as soon as possible. The next step is a Pre-BLA (Biologics License Application) meeting with the FDA. The purpose of the meeting is for the company and the agency to review important issues to ensure that the BLA meets all regulatory requirements, as well as the timing of the submission. At the Pre-BLA meeting, we expect discussions on the clinical data previously received by the FDA and outstanding manufacturing-related documents. The company expects that after the Pre-BLA meeting, it will be in a better position to estimate the point of time when a possible market authorization will be in place..
The validation of the manufacturing process for IBP-9414 is proceeding according to plan. We expect to complete our last analysis method shortly and plan to run a full-scale production as part of the validation work.
In addition to the work on registration in the US, IBT has initiated contact with the EMA regarding the application for market approval in the EU.
“We are working intensively to compile all the documentation required for market approval in both the US and Europe and estimate that we have completed approximately 90% of this work,” says Staffan Strömberg, CEO of Infant Bacterial Therapeutics.