Bubs Australia forecasts full US FDA market access approval by October 2025

Infant formula powder player Bubs Australia (ASX:BUB) has predicted it will have the US FDA’s full blessings in just over a year’s time.

You may remember the stock causing a lot of hubbub during the COVID years when a baby formula shortage in the United States caused eyes to start scouring the local market for value.

Bubs and A2 Milk were widely the most popular stocks attached to that proposition.

Now, the company has seen its 400th patient enrolled in an ongoing infant powder trial to establish safety and benefits of the product. That study comes on the back of a 2022 regulatory directive from the FDA.

“Bubs first began importing its infant formulas into the United States in May 2022 as a response to the infant formula shortage that year,” the company wrote on Tuesday.

“Bubs was the first company to offer assistance from abroad, participating in the US government’s ‘Operation Fly Formula’ program, and Bubs was the 2nd company in the world to be granted ‘temporary enforcement discretion’ .

“Bubs will transition from ‘temporary enforcement discretion’ to permanent market access, upon FDA approval, expected in October 2025,” the company wrote on Tuesday.

The clinical trial is US-wide and referred to as a “Growth, Tolerance and Safety” study. That the company has clocked its 400th participant after launching 13 months ago Bubs said on Tuesday is testament to its acumen.

BUB last traded at 12cps.