Amendment to the guidance on communication by biotech companies

The update provides a non-exhaustive list of final events or circumstances in protracted processes, offering greater clarity for listed biotech issuers on when inside information must be disclosed or delayed. For compliance teams, this means revisiting disclosure policies, particularly around R&D milestones, clinical trial outcomes, regulatory approvals, and financing events that unfold over time. Firms should map protracted processes against the delegated regulation's examples, document delay decisions robustly, and ensure timely market disclosure.

Legal and advisory teams should update client guidance. The changes are not entirely new obligations but refine existing MAR requirements; early alignment reduces enforcement risk and supports investor confidence. Action points: review the amended Opinion, train relevant staff, update insider lists and disclosure procedures, and monitor FSMA communications for further clarifications.

While biotech issuers are most directly affected, investors and advisers should also note the enhanced transparency expectations.