Infant Bacterial Therapeutics

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FDA Grants Infant Bacterial Therapeutics AB’s Request for a Type B Pre-BLA Meeting

Infant Bacterial Therapeutics AB (IBT) announced today that the U.S. Food and Drug Administration (FDA), has granted the company’s request for a Type B Pre-BLA (Pre-Biologics License Application) meeting regarding IBP-9414, IBT’s drug candidate for premature infants. The meeting will take place on October 29, 2026, in Washington.
Staffan Strömberg, CEO of IBT, says:
“The FDA’s approval of the Type B Pre-BLA meeting is a significant step toward our goal of obtaining marketing approval for IBP-9414 in the U.S.”