Biotalys (BTLS.BR) announced that the U.S. Environmental Protection Agency (EPA) has granted regulatory approval for its breakthrough biofungicide, EVOCA. Developed using the company's proprietary AGROBODY technology platform, EVOCA is the first protein-based biofungicide ever approved by the EPA.
Designed as a precision biocontrol solution, EVOCA introduces a novel mode of action to combat botrytis (grey mold) and powdery mildew in high-value fruits and vegetables. The product minimizes risks to beneficial organisms and the environment, offering growers a sustainable alternative to conventional crop protection methods.
With EPA approval secured, Biotalys will now advance state registration dossiers in California and Florida, two of the most critical fruit and vegetable growing regions in the U.S. In Europe, EVOCA has entered the peer review phase, with the Netherlands—acting as rapporteur member state—proposing approval subject to the submission of additional data requested during the review.
Looking ahead, Biotalys is preparing the U.S. regulatory submission for EVOCA NG, its next-generation biofungicide currently in late-stage development. EVOCA NG, which shares the same active ingredient as EVOCA but benefits from enhanced formulation and production methods, is expected to undergo a faster regulatory review. Biotalys anticipates registrations in the U.S. by 2028-29, followed by approvals in the EU and Brazil by 2029-30, paving the way for commercial launches across these markets valued at approximately $1.2 billion.
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