Why this ASX small-cap share is back in focus after a US market update

Shares in Bubs Australia Ltd (ASX: BUB) are back on investors’ radars today. This comes after the infant formula company released a fresh update on its progress in the United States.

The announcement centres on Bubs’ pathway toward permanent regulatory approval in the US, which remains the company’s most important growth market.

At the time of writing, Bubs shares are trading around 13.5 cents, giving the company a market capitalisation of roughly $121 million.

So, what exactly did Bubs say, and why does it matter?

Progress continues on US approval

According to the release, Bubs confirmed that the US Food and Drug Administration (FDA) continues to review the company’s New Infant Formula Submissions (NIFS).

These submissions cover all three of Bubs’ infant formula ranges currently sold in the US:

• Bubs Essential
• Bubs 365 Day Grass Fed
• Bubs Goat powder infant formulas

Management said the FDA review process remains on track, and importantly, there are currently no outstanding requests for information from the regulator.

Products can stay on shelves for now

One of the more reassuring parts of today’s update is around near-term sales continuity.

Bubs said the FDA has confirmed it will continue to allow the importation, sale, and distribution of Bubs’ infant formula products in the US after 31 December 2025, while the final review process is completed.

This will occur under the FDA’s ‘Enforcement Discretion’ framework, which has allowed certain international suppliers to operate in the US since the infant formula shortages emerged.

Why the US market matters so much

The US is already Bubs’ largest and most strategic market.

Earlier this year, Bubs completed what it described as the world’s largest single clinical infant formula trial, enrolling 478 infants over 16 months. The results from that trial formed a critical part of the data submitted to the FDA as part of the company’s approval process.

Permanent regulatory approval would move Bubs from a temporary supplier to a fully approved participant in the US infant formula market. That shift would open the door to broader distribution, longer-term contracts, and more predictable growth.

The bigger picture for investors

Bubs operates in a highly regulated industry, so progress can sometimes feel slow. However, today’s update points to steady progress for the company.

With the FDA still engaged, no new data requests, and ongoing access to the US market confirmed, Bubs appears to be nearing the final stages of its approval process.

For investors, timing is now the main focus. Formal approval remains the key hurdle, and until that happens, sentiment is likely to move around.

The post Why this ASX small-cap share is back in focus after a US market update appeared first on The Motley Fool Australia.

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Motley Fool contributor Aaron Teboneras has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.