3 ASX Stocks to Watch After New Deals, FDA Approval and US Expansion

Top high gainer ASX stock supported by new business and product development boosting future earnings expectations and reinforcing its long term investment case.

Clever Culture Systems Limited (ASX: CC5)

One of the top gaining healthcare stocks with a current market capitalisation of $30.55M.

CC5 has announced on 7 September 2026 that they have received a purchase order from Novo Nordisk for two additional APAS independence instruments. This purchase order increased its installed base to three, at the sales price consistent with previously disclosed targeted pricing.

In addition to that, the purchase order includes the development of an advanced integration solution for Novo Nordisk’s global Laboratory Information Management Solution (LIMS).

CC5 also stated that Novo Nordisk's order is an ideal example of its Land and Expand sales strategy. They expect a significant increase from FY27 onwards, supported by replacement orders from existing customers and new customers completing evaluations and converting into paying customers.

Bubs Australia Limited (ASX: BUB)

One of the top high gaining ASX stocks with a massive product development and market capitalisation of $89.41M.

BUB has announced on 7 September 2026 that they have received a permanent regulatory authorisation from the FDA for its three infant formula products, which are Bubs Goat, Bubs 365 Day Grass Fed and Bubs Essential. The authorisation confirms that these products, manufacturing systems and scientific evidence satisfy USA regulatory requirements for safety, nutritional adequacy and quality, providing a permanent pathway to supply one of the world's largest infant formula markets.

The approval will allow BUB the platform to accelerate its US growth strategy, deepen retailer partnerships, strengthen consumer awareness of the Bubs brand and expand consumer reach across a market where we are already represented in more than 10,000 stores nationwide.

This will create an additional opportunity to broaden its product offering and evaluate participation in the US private label infant nutrition segment, subject to further regulatory, technical and commercial milestones.

Immuron Limited (ASX: IMC)

One of the top gaining healthcare ASX stocks, which is currently trading at a market capitalisation of $12.91M.

IMC has announced on 4 September 2026 that they have executed an exclusive distribution agreement for their drug known as PROIBS in the United States with Calmino Group AB, which they had already launched in Australia in FY26.

PROIBS is a medical device used for abdominal pain, bloating and unsettled bowel movements. It is suitable for long-term use, with an excellent safety profile and no interactions with other medications known.

IMC mentioned that the overall US digestive/gut health supplement market is valued at US$4.16B. Immuron Limited had already launched its flagship drug, Travelan, in the US. IMC had seen a rapid growth in the sales volume of Travelan, supported by product quality and industry growth. Considering all these facts, IMC had developed a commercial growth strategy to bring a portfolio of innovative digestive health products to market.

PROIBS will provide a great opportunity to further expand its digestive health portfolio by providing access to its customer with a proven premium product that delivers improvement in daily life.

Conclusion

These three are the top gaining ASX stocks supported by a recent announcement primarily driven by a new business update that will boost the future revenue and cash flow generating ability.

(Source: Company Announcements)