Key Takeaways
- Biotalys has received updated guidance from the U.S. Environmental Protection Agency (EPA) on the review of its first protein-based biocontrol product, EVOCA™.
- The EPA confirmed the scientific review is progressing and that all requests for additional information have been addressed.
- Final steps in the regulatory approval process are now expected in Q4 2025, later than the company’s earlier September timeline.
- EVOCA, developed on Biotalys’ AGROBODY™ platform, targets Botrytis and powdery mildew in fruits and vegetables.
- The company continues constructive dialogue with the EPA and remains optimistic about securing approval.
Biotalys Provides Update on Regulatory Timeline
Biotalys announced progress in the regulatory approval procedure for EVOCA™, its first protein-based biocontrol product in the United States.
The U.S. Environmental Protection Agency (EPA) confirmed that the dossier review is advancing and that all requests for additional information have been resolved. However, the company now expects the registration process to conclude in the fourth quarter of 2025, rather than by the end of September as previously projected.
EVOCA: First Biocontrol on AGROBODY™ Platform
EVOCA is the first product developed using Biotalys’ AGROBODY™ technology platform. It introduces a novel mode of action, offering fruit and vegetable growers a biodegradable solution to control fungal diseases such as Botrytis (grey mold) and powdery mildew.
The product is intended for integration into spray rotation programs, helping reduce reliance on chemical applications while maintaining crop protection performance.
Biotalys Leadership Perspective on Progress
Kevin Helash, Chief Executive Officer of Biotalys, commented: “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.”
Next Steps in the Review Process
The EPA’s ongoing scientific evaluation highlights the potential for EVOCA to become one of the first protein-based biocontrol solutions available in the U.S. market. Biotalys stated that it remains committed to working closely with regulators to complete the approval process and bring new options to growers seeking sustainable crop protection.
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