Biotalys Provides Regulatory Review Update for EVOCA in the U.S.
03 September 2025, Belgium: Biotalys (Euronext – BTLS) today provides an update on the regulatory approval procedure in the United States of its first protein-based biocontrol product, EVOCA™*.
Biotalys has received further guidance from the U.S. Environmental Protection Agency (EPA) on the regulatory review of EVOCA. The EPA has confirmed that the scientific review of the dossier is progressing, and that all the requests for additional information have been addressed. While the agency continues to work diligently on the review, the company now expects the final steps of the registration procedure to be taken in Q4, rather than by the end of September as previously anticipated.
Kevin Helash, Chief Executive Officer of Biotalys, said: “Biotalys is at the forefront of introducing precision biocontrols, a new class of crop protection solutions that has the potential to disrupt the industry, and create long term value for growers and investors alike. EVOCA is the first product developed using our AGROBODY™ technology platform and has a new mode of action, showcasing our ability to create products that combine the safety and sustainability of biologicals with the performance and reliability growers expect from traditional chemistries. We continue to have a positive dialogue with the EPA and remain optimistic about concluding the review this year towards a favorable outcome for EVOCA.”
The first biocontrol developed on Biotalys’ AGROBODY technology platform, EVOCA helps safely control fungal diseases Botrytis (grey mold) and powdery mildew for fruit and vegetable growers looking to add effective, biodegradable solutions to their spray rotation programs to reduce chemical applications.
* EVOCA™: Pending regulatory review. This product is not currently registered for sale or use in the United States, the European Union, or elsewhere and is not being offered for sale and no assurance can be given if, when and under which conditions registration will be obtained.
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