IBT changes the IBP-9414 pathway for approval following discussions with the FDA
November 25, 2025

Following today's meeting with the FDA concerning IBT's live biotherapeutic product, IBT has decided to pursue an accelerated approval pathway for IBP-9414.

The FDA's Accelerated Approval Program allows expedited approval of drugs that treat serious or life-threatening diseases with an unmet medical need. To obtain an accelerated approval, a postmarketing clinical trial is expected.

“It is too early to state exactly what will be required. Our plan to apply for a marketing authorization in the USA remains in the first half of 2026. This means that instead of the planned Pre-BLA meeting, IBT now anticipates having interactions with the FDA to discuss the details of the accelerated approval pathway. The validation of the manufacturing process for IBP-9414 is proceeding as planned and must be completed before the product can be launched. Our plans for Europe remain as communicated earlier, with MAA submission in 2026” says Staffan Strömberg, CEO.