Bubs Australia Ltd (ASX: BUB) shares have returned from their trading halt with a bang on Monday.
At the time of writing, the infant formula stock is up 40% to 14 cents, after trading as high as 14.5 cents earlier this morning.
That is quite a turnaround. Bubs shares were down around 27% in 2026 when trading was halted on Friday. After today's jump, the stock is now slightly higher for the year.
So, what has sent Bubs shares flying today?
Image source: Getty Images
The wait is finally over
According to the release, Bubs has secured permanent regulatory authorisation from the US Food and Drug Administration (FDA).
The approval covers 3 infant formula products: Bubs Goat, Bubs 365 Day Grass Fed, and Bubs Essential.
It confirms that the products, manufacturing systems, and supporting scientific evidence meet US requirements around safety, nutritional adequacy, and quality.
It also makes Bubs the only Australian infant formula brand, and one of a limited number of international manufacturers, permanently authorised to supply the US market.
CEO Joe Coote called it a "transformational milestone" and said the approval gives Bubs a platform to accelerate its US growth strategy.
The decision could also support a broader product range and possible entry into the US private-label infant nutrition market.
Why this is such a big deal
The US is already Bubs' biggest market.
US revenue rose 24% to $65.8 million in FY26, out of total group revenue of $111.9 million. Its products are also now sold in more than 10,000 stores across the country.
Until now, Bubs had been able to continue selling in the US while the FDA worked through its review.
That process is now complete, removing one of the biggest uncertainties hanging over the business.
With well over half of group revenue now coming from the US, securing permanent approval is a major step for the company.
The director buying is worth a look
There's another detail here that stands out.
Bubs chair Paul Jensen bought 1.5 million shares across 31 August and 1 September, paying between 8.55 cents and 8.7 cents per share.
In total, he spent around $130,500 just days before today's FDA announcement.
And Jensen has been buying Bubs shares for some time. He also bought 1 million shares across 3 on-market trades in March, after picking up another 630,890 shares across 2 trades last September.
At today's 14-cent share price, his latest 1.5 million shares are worth around $210,000. That's roughly $80,000 more than he paid.
But he wasn't the only director buying last week. Pascal De Petrini bought 800,000 shares, while Lori Tauber Marcus purchased her first 100,000 shares at 9.5 cents each.
