BioConnection B.V.

Infant Bacterial Therapeutics Advances Toward FDA Approval for IBP-9414 in Premature Infants

- Infant Bacterial Therapeutics received positive FDA feedback in May 2026, indicating existing evidence may be sufficient for market approval submission without requiring additional post-marketing studies. - The company's live biotherapeutic product IBP-9414, containing L. reuteri bacteria, targets mortality reduction in very low birth weight premature infants based on Phase III "Connection Study" results. - Manufacturing validation work is proceeding on schedule with analytical methods now complete and Process Performance Qualification runs planned for June-July 2026 at partner facilities. - IBT maintains its goal to submit a Biologics License Application to the FDA during 2026 while simultaneously pursuing European regulatory approval.