Report
Biotalys Regulatory update points to end of 3Q25 for Evoca's US approval decision
Biotalys announced regulatory progress for its lead biofungicide candidate, Evoca, in both the US and Europe. In the US, the EPA confirmed that Biotalys has met its data requirements and expects to complete its review by September 30, 2025. In Europe, Dutch authorities have positively evaluated Evoca's active ingredient as low risk, paving the way for EU-level peer review with Biotalys expecting a potential decision in 2H26. The update provides greater clarity on regulatory timelines, supporting our Buy rating and €5.2 TP.
Underlying
BIOTALYS NV
Provider
KBC Securities
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Thomas Vranken
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