Infant Bacterial Therapeutics AB

Clinical and Regulatory Milestones

• The FDA granted IBP-9414 "Breakthrough Therapy Designation" in March 2025 for its potential to reduce gastrointestinal-related mortality.
• The Clinical Study Report (CSR) for the Phase 3 "The Connection Study" was submitted to the FDA in May 2025.
• IBT decided to proceed with an accelerated approval process for IBP-9414 in November…