The Bubs Australia Ltd (ASX: BUB) share price is defying the broader market sell-down today.
Shares in the infant formula company were up 3% in morning trade. At the time of writing on Thursday, shares are changing hands for 17 cents apiece, up 1.2%.
For some context, the All Ordinaries Index (ASX: XAO) is down 1.2% at this same time.
Here's what's piquing ASX investor interest.
What did the infant formula company report?
The Bubs share price is in the green today after the company reported it has started enrolment for its Growth Monitoring Study (GMS) clinical trial across the United States.
The GMS is intended to gauge the growth, tolerance and safety of new infant formulas. This is a standard part of the US regulatory process.
Planning for clinical trials has been underway since the beginning of 2023, in partnership with the US Food and Drug Administration (FDA).
Bubs said the first infant was enrolled in the study in late August. The company intends to enrol infants both online and through thirteen healthcare clinics in the US.
Bubs initially entered the US market in May 2022 as part of the US government's Operation Fly Formula program, launched in response to a shortfall in infant formula after contamination issues at a major domestic supplier.
Since then, management said the company "has cemented its position as the number one goat milk formula brand in the United States".
The ASX All Ords infant formula company said it is now following FDA guidelines so it can transition from temporary 'enforcement discretion' to a permanent market position in the world's top economy.
Commenting on the news sending the Bubs share price higher today, COO Richard Paine said:
Bubs answered the call when we were needed by American families, and in so doing established a trusted relationship with many US healthcare professionals, parents and caregivers. We are excited to build upon that relationship by providing the FDA with the data necessary for Bubs to take up its permanent place in the American market.
The company intends to submit results from the GMS to the FDA in 12 months, with a full infant formula submission by October 2024.
Bubs share price snapshot
Despite the welcome lift today, the Bubs share price remains down a painful 67% over the past 12 months.
