Infant Bacterial Therapeutics AB

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  1. Kvartalsrapport Q1 2026

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    Operational Progress

    • Continued constructive dialogue with the U.S. Food and Drug Administration (FDA) regarding IBP-9414.
    • Received a letter from the FDA on May 1, 2026, indicating that IBP-9414 study results, combined with other scientific information, could be considered sufficient for market approval submission without a post-marketing study.
    • Analytical work for…

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  2. Årsredovisning 2025

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    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…

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