- Amoéba's first two biocontrol fungicides, AXPERA NOA and AXPERA GREEN, receive approval from the US Environmental Protection Agency (US EPA) for the first crops targeted by Amoéba;
- Amoéba is progressing in line with its strategic plan to begin marketing its biocontrol solution in Europe and the United States in 2026.
Chassieu (France), 16 October 2025 - 6:00 pm - Amoéba (FR0011051598 - ALMIB), industrial greentech specialized in the development of natural microbiological solutions based on the patented use of amoebae, announces that it has received regulatory approval from the US Environmental Protection Agency (US EPA) to market in the United States its biocontrol products AXPERA NOA and AXPERA GREEN, based on the lysate of Willaertia magna C2c Maky.
Federal authorisation for AXPERA NOA and AXPERA GREEN
Following the approval of Amoéba's biocontrol active substance in 2022, the US EPA has just approved AXPERA NOA and AXPERA GREEN, intended respectively for high-value speciality crops (vines, tomatoes, cucurbits, leafy green vegetables, legumes, berries), professional turf markets and ornamental plants.
These two biocontrol innovations have demonstrated their efficacy against a wide range of major fungal pathogens, such as downy mildew, powdery mildew, rust and fusarium, which are responsible for agricultural losses worldwide estimated at several billion euros.
Developed from a natural micro-organism isolated from thermal waters of Aix-les Bains, the AXPERA solution stands out for its unique mechanism and broad spectrum of action, unrivalled in the biocontrol market today.
The federal approval covers all US states, with the exception of California, where a separate mandatory procedure is underway: the application for registration was filed with the California Department of Pesticide Regulation (DPR) in February 2025, with a conclusion of evaluation expected in 2026.
In all the other states, the federal authorization will be supplemented by a simple administrative formality lasting a few weeks before the right to market the product becomes effective.
Amoéba is aiming for its first commercial campaign in the United States in 2026, primarily targeting the vegetable crop market (tomatoes, cucurbits, leafy vegetables) and vines against mildew and powdery mildew, as well as fusarium wilt in lawns.
A strengthened partnership strategy to accelerate commercialisation in one of the world's largest markets
This authorisation marks a decisive new step forward, particularly in the context of the agreement signed with Koppert for the commercial distribution of AXPERA in various markets in the United States and 18 European countries[1] . For the record, it grants Koppert exclusive distribution rights for the AXPERA solution for vineyards and greenhouse and open-field vegetable crops for a period of five years.
In order to prepare the local market as effectively as possible, Amoéba is planning an active presence in the main agricultural trade fairs in the United States alongside its partners to promote the unique potential of AXPERA NOA and AXPERA GREEN in terms of resistance management and yield optimization.
To this end, 2025 field trials are currently underway with renowned research centers such as the Gulf Coast Research and Education Center (squash powdery mildew, cucumber downy mildew), the Everglades Research and Education Center (lettuce downy mildew) and the Mid-Florida Research and Education Center (gerbera powdery mildew), three research entities of University of Florida.
With this critical milestone achieved, Amoéba continues to engage with global partners to expand the potential of its technology platform in a broad range of crops and markets.
Finally, production for this market will be carried out at the Amoéba site in Chassieu (France) and entrusted to CDMO (Contract Development and Manufacturing Organisations) production partners.
Amoéba is thus taking a new crucial step and reiterates that the results of the marketing authorisation applications for the AXPERA solution in nine targeted European countries are expected by early 2026 at the latest, having already obtained final approval for its biocontrol active substance from the European Commission, as well as several temporary marketing authorisations in order to meet the high expectations of winegrowers and farmers.
Jean-Baptiste EBERST, Director of Regulatory Affairs at Amoéba, states: "Obtaining this US regulatory approval, a few months after our emergency marketing authorisation in France and the approval of the active substance at European level, confirms the success of our commitment to agencies and the global potential of our solution."
Jean-François DOUCET, CEO of Amoéba and Jean-Marc PETAT, future Managing Director of Green 4 Agro, state: "With this new regulatory milestone in one of the world's largest agricultural markets, we are now ideally positioned to meet the needs of US farmers with strong distribution partners. We are extremely proud of the work accomplished and the results achieved by our teams, and we look forward to the commercial launch of our AXPERA products".
About Amoéba:
Founded in 2010, Amoéba is a greentech company based in Chassieu (Lyon, France) whose ambition is to become a major player in the treatment of microbiological risk based on the patented use of amoebae in the plant protection and cosmetics sectors.
With know-how that is unique in the world and protected by numerous patents, Amoéba is currently the only company capable of exploiting the full potential of the Willaertia amoeba on an industrial scale and cultivating it in sufficient volumes to offer biological solutions that constitute a viable alternative to the chemical products widely used today. Amoéba is currently focusing on the global biocontrol market for plant protection and on the cosmetics market. As the marketing of plant protection products is subject to obtaining local regulatory authorisations, the Company has carried out the necessary regulatory procedures and filed registration dossiers in Europe and the United States. The active substance has obtained approval in 2022 in the USA and in 2025 in Europe. Product approvals have been granted in the USA and are expected in the coming months in Europe.
The cosmetic application does not require prior approval from a competent authority in Europe or the United States. The cosmetic ingredient is already registered on the INCI (International Nomenclature of Cosmetic Ingredients) list, paving the way for it to be marketed worldwide except in China, where local approval is required.
Amoéba is listed on Euronext Growth (ALMIB). The company is a member of the Bpifrance Excellence network and is eligible for the PEA-PME scheme. For more information, visit www.amoeba-nature.com.
Contacts:
| Amoéba | ACTUS finance & communication | Droit Devant Agency | |
| Chief Executive Officer Jean-François DOUCET +33 (0)4 26 69 16 00 jf.doucet@amoeba-nature.com | Investor relations Pierre JACQUEMIN-GUILLAUME +33 (0)1 53 67 36 79 amoeba@actus.fr | Financial press relations Serena BONI +33 (0)4 72 18 04 92 sboni@actus.fr | Business and general public press relations Laëtitia PINTO +33 (0)7 64 83 39 85 pinto@droitdevant.fr |
Disclaimer
This press release contains certain forward-looking statements concerning Amoéba which are based on its own assumptions and estimates and on information that is currently available to us. However, Amoéba gives no assurance that the estimates contained in such forward-looking statements will be verified, with these estimates subject to numerous risks, including the risks set forth in Amoéba's universal registration document filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on April 17, 2025 under number D.25-0281 and available on the Amoéba website (www.amoeba-nature.com). The forward-looking statements contained in this press release are also subject to risks not yet known to Amoéba or not currently considered material by Amoéba . The occurrence of all or part of such risks could cause Amoéba's actual results, financial conditions, performance, or achievements to be materially different from such forward-looking statements.
[1] See the press release dated June 3, 2025.
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