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

By Thomson Reuters Sep 7, 2026 | 1:34 AM

Sept 7 (Reuters) – Bubs Australia 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 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)