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Amendment to the guidance on communication by biotech companies

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The FSMA has amended its Biotech Opinion following the entry into force in June 2026 of the provisions of the Listing Act that amended the Market Abuse Regulation with regard to protracted processes.

The Opinion takes into account Delegated Regulation (EU) 2026/789[1], which was published in July 2026 and contains, amongst others, a non-exhaustive list of final events or final circumstances in protracted processes.

[1]Commission Delegated Regulation (EU) 2026/789 of 8 April 2026 supplementing Regulation (EU) n° 596/2014 of the European Parliament and of the Council as regards disclosure of inside information in protracted processes and delay of disclosure