Bubs Australia (ASX:BUB) shares ended the week in focus after the infant formula company entered a trading halt while preparing an announcement relating to an update from the US Food and Drug Administration.
BUB was last trading at A$0.10 on Friday, September 4, up 7.53% from Thursday’s A$0.093 close. The stock traded between A$0.095 and A$0.105 during the session, with around 3.24 million shares changing hands before trading stopped.
The halt has left investors with one major question heading into the weekend: what exactly is the FDA update, and what could it mean for Bubs’ growing US business?
Why Are Bubs Australia Shares Halted?
Bubs requested the trading halt while it prepares an announcement concerning an update from the FDA.
Under the company’s request, BUB shares are expected to remain halted until the announcement is released or normal trading begins on Tuesday, September 8, whichever occurs first.
As of September 5, Bubs has not publicly revealed the contents of the FDA update.
That is an important distinction. Investors should not assume that the halt means the FDA review has been completed or that Bubs has already secured permanent US market access.
For now, the only confirmed information is that an FDA-related announcement is coming.
What Is Bubs Waiting for From the FDA?
Bubs has been working toward long-term regulatory certainty for its infant formula products in the United States.
In June 2025, the company lodged New Infant Formula Submissions with the FDA covering three products:
- Bubs Essential
- Bubs 365 Day Grass Fed
- Bubs Goat
The submissions are part of the process required for Bubs to move beyond the temporary enforcement discretion arrangements that have allowed its products to remain available in the US.
Bubs said in its recent FY26 results that the FDA process had reached the final review stage, making Friday’s trading halt especially significant for investors.
It is also worth noting that the FDA does not technically “approve” infant formula in the same way that it approves certain drugs. The key issue is whether Bubs successfully completes the FDA review process and satisfies the requirements for ongoing US market access.
Why Does the FDA Update Matter So Much?
The United States has become Bubs’ largest and most important growth market.
US revenue increased 24% in FY26 to A$65.8 million, compared with total group revenue of A$111.9 million. That means the US generated close to 59% of Bubs’ revenue for the year.
Bubs has also significantly expanded its American retail footprint, with distribution growing to more than 10,000 stores across all 50 states.
That makes the outcome of the FDA process particularly important.
Successful completion of the review could remove a major source of regulatory uncertainty around Bubs’ US growth strategy. Any further requirements or delays could create a very different reaction from investors.
BUB Shares Were Already Gaining Momentum
Friday’s 7.53% rise was part of a broader move higher.
BUB was trading around A$0.086 at the beginning of the week before reaching A$0.10 on Friday, representing a gain of roughly 17%.
The stock also gained 5.68% on Thursday.
That shows investor interest in Bubs had already been building before Friday’s halt.
However, there is currently no public evidence that investors knew the contents of the FDA update before trading stopped. The market will need to wait for the company’s official announcement.
How Is Bubs’ Business Performing?
Bubs’ FY26 results showed continued growth, led by the United States.
Group revenue increased 9.2% to A$111.9 million, while underlying EBITDA rose to A$5.3 million from A$1.2 million in the previous year.
Reported EBITDA remained negative at A$1.8 million after additional costs, including air freight, tariffs and regulatory-related expenses.
The results show a business that is growing, particularly in the US, but still working to improve profitability.
That is another reason why the FDA update matters. The US is not simply another market for Bubs. It has become central to the company’s growth strategy.
What Happens to BUB Shares Next?
The next move in Bubs shares will depend heavily on what the company announces.
Investors should focus on three things:
- What the FDA update actually says
- Whether it completes or materially advances Bubs’ regulatory review
- When BUB shares will resume trading
It is impossible to say whether Bubs shares will rise or fall when trading resumes until the details are released.
A favourable outcome could provide greater certainty around the company’s US operations. Further regulatory requirements or delays could create renewed uncertainty.
Conclusion
Bubs Australia shares were last trading 7.53% higher at A$0.10 on Friday before the company entered a trading halt ahead of an FDA-related announcement.
The timing is important. Bubs has said its FDA process is in the final review stage, while the United States now contributes the majority of its revenue.
But as of September 5, the outcome has not been announced.
For BUB investors, the focus is now firmly on the company’s next ASX release and what the FDA update means for Bubs’ long-term future in the US infant formula market.
