Biotalys EPA's review on Evoca in 4Q rather than by end September

In an update on the regulatory approval procedure in the US of Evoca, its first protein-based biocontrol product, Biotalys has received further guidance from EPA, the U.S. Environmental Protection Agency 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, Biotalys now expects the final steps of the registration procedure to be taken in 4Q25, rather than by the end of September as previously anticipated.


Although this delay is a setback, Biotalys indicated it continue to have a positive dialogue with the EPA and remain optimistic about concluding the review this year towards a favorable outcome for Evoca.