Bubs Australia secures permanent FDA nod for infant formula sales in US, shares jump

Bubs Australia

07/09/2026 07:32

Sept 7 (Reuters) - Bubs Australia BUB.AX said on Monday it secured permanent authorisation from the U.S. Food and Drug Administration to sell three infant formula products in the country, putting the stock on course for its biggest one-day gain since May 2022.

Here are the details:
Shares of the infant formula maker jumped as much as 45% to A$0.145, its highest level since January 14.
The company said it secured FDA approval for Bubs Goat, Bubs 365 Day Grass Fed and Bubs Essential.
The firm is also evaluating an entry into the U.S. private label infant nutrition segment, following the approval.
The approval comes amid tighter regulations and supply chain disruptions for infant nutrition companies in Australia and New Zealand.
Last month, Bubs reported an annual Earnings Before Interest, Taxes, Depreciation, and Amortization (EBITDA) loss of A$1.8 million ($1.30 million).
However, the company said it expects a stronger first half in 2027, supported by growing demand in the U.S., a key market in its strategy to diversify beyond China.
Meanwhile, New Zealand-based dairy firm a2 Milk ATM.NZ said in its annual results last month that supply constraints hurt earnings, highlighting the operational and regulatory complexities facing companies in the sector.

($1 = 1.3881 Australian dollars)

 (Reporting by Aamir Shaik Khalid in Bengaluru; Editing by Eileen Soreng)
 ((Aamir.SheikKhalid@thomsonreuters.com;))