Bubs Australia Confirms US FDA Submission for its Infant Milk Formulas, Shares Rise 4%

MT Newswires Live

2025/06/16

Bubs Australia (ASX:BUB) confirmed that it formally lodged its new infant formula submission with the US Food and Drug Administration (FDA) to cover all three of its infant milk formulas, goat, 365 day grass fed, and essential, which are all currently sold in the US market, according to a Monday Australian bourse filing.

The firm said that it is expected that the regulator will immediately commence its formal review of Bubs' submission.

By the end of the second quarter of the fiscal year, Bubs enrolled a total of 478 infants over 16 months, completing its infant enrollment for the US clinical trial. The firm has been conducting the large-scale clinical trial as part of its commitment to obtain permanent regulatory approval in the US market.

Its shares rose 4% in recent trading on Monday, reaching their highest point in over 52 weeks.

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