Biotalys Moves Closer to EVOCA Registration in California with Public Consultation Launch

Key Takeaways

Biotalys’ biofungicide EVOCA® has entered the public consultation phase in California after a positive health assessment.
The consultation allows stakeholders to comment until July 26, with a final regulatory decision expected later in 2026.
EVOCA® targets diseases like Botrytis and powdery mildew, with commercial launch plans for its next generation product by 2029 in the U.S.

Regulatory Progress for Biotalys’ EVOCA®

Biotalys NV, an AgTech firm specializing in protein-based biocontrol solutions, has progressed in the regulatory review of its biofungicide EVOCA® in the United States. The California Department of Pesticide Regulation (CDPR) initiated a public consultation phase on the EVOCA dossier, a significant step in the evaluation process. This milestone follows a favorable assessment from the CDPR’s Human Health Assessment Branch, which concluded that data from Biotalys supports the registration of EVOCA in California.

California is the largest agricultural state in the U.S., crucial for producing fruits and vegetables such as strawberries, tomatoes, and grapes. Biotalys’ receipt of regulatory approval for EVOCA earlier in Florida highlights its strategic expansion in the U.S. market.

The public consultation phase will last 30 days, allowing stakeholders to provide feedback on the proposed registration. After the consultation period closes on July 26, the CDPR will review submissions and aim for a regulatory decision in the latter half of 2026.

Carlo Boutton, CEO of Biotalys, underscored the importance of this step, emphasizing CDPR’s rigorous scientific data review and commitment to safety and environmental standards. He expressed confidence in the strength of their data and the potential of their AGROBODY® technology platform to pioneer a new generation of effective crop protection solutions. Boutton added that advancing through this process brings Biotalys closer to providing growers with sustainable farming tools, while acknowledging that multiple steps remain ahead.

EVOCA® is designed to combat fungal diseases like Botrytis (gray mold) and powdery mildew, making it relevant for fruit and vegetable growers. Its approval would also facilitate the subsequent regulatory submission for EVOCA NG, a next-generation product with the same active ingredient. The anticipated launch for EVOCA NG is set for 2029 in the U.S. and 2030 in Europe, targeting a combined market of approximately USD 1.1 billion.

Biotalys, established in 2013 as a spin-off from the VIB (Flanders Institute for Biotechnology), is dedicated to developing innovative, precision biocontrol solutions aimed at addressing essential agricultural challenges. The company operates out of Ghent, Belgium, and is publicly traded on Euronext Brussels.

For more information, Biotalys can be contacted via their official communication channels.

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