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IBT Pursues Accelerated Approval for IBP-9414 After FDA Discussions

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IBT Pursues Accelerated Approval for IBP-9414 After FDA Discussions

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Infant Bacterial Therapeutics AB ( ($SE:IBT.B) ) just unveiled an announcement.

Infant Bacterial Therapeutics AB has decided to pursue an accelerated approval pathway for its live biotherapeutic product, IBP-9414, following discussions with the FDA. This decision allows for expedited approval of the drug, which has shown significant potential in reducing mortality among premature infants. The company plans to apply for marketing authorization in the USA by the first half of 2026, with the validation of the manufacturing process currently underway. The accelerated approval pathway reflects IBT’s commitment to addressing unmet medical needs in the field of neonatal care.

More about Infant Bacterial Therapeutics AB

Infant Bacterial Therapeutics AB (IBT) is a Stockholm-based pharmaceutical company focused on developing and commercializing drugs for diseases affecting premature babies. The company’s primary product is IBP-9414, a live biotherapeutic product derived from a bacterial strain found in human breast milk, aimed at reducing mortality in premature infants. IBT is also developing other drug candidates targeting rare and serious conditions in premature infants.

Average Trading Volume: 15,057

Technical Sentiment Signal: Sell

Current Market Cap: SEK679M

For a thorough assessment of IBT.B stock, go to TipRanks’ Stock Analysis page.

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