The FSMA published in October 2020 an opinion on considerations and good practices relating to inside information disclosures by listed biotech companies in Belgium.
Under the Market Abuse Regulation (MAR), listed companies must disclose inside information as soon as possible. The MAR defines inside information as " information of a precise nature, which has not been made public, and which would be likely to have a significant effect on the share price." This definition can be challenging to apply for biotech companies that conduct clinical research and have to find a right balance between constantly shifting scientific and clinical information, on the one hand, and appropriate disclosure to investors, on the other hand.
The clinical development of a product candidate by a biotech company is a gradual process with several phases, characterised by an increase over time in patient enrolment, efficacy and safety data, as well as an ongoing dialogue with medical product regulatory authorities. Inside information may arise at various moments during the clinical development before the full pivotal and confirmatory phase III results are known and a decision about marketing authorisation is made.
It can be particularly challenging for biotech companies to decide which information to disclose, and when, to their investors who have different degrees of familiarity with the scientific and clinical specificities of the company's activity.
The FSMA wishes to assist biotech companies in better understanding how to apply specific inside information disclosure requirements and prevent market abuse infringements, based on examples and circumstances that are specific to the biotech sector. At the same time, the FSMA also described some good practices for biotech companies when communicating with investors. The opinion of the FSMA is mainly addressed to biotech companies with a limited pipeline of product candidates and covers several facets of inside information, which will be explored in three subsequent insights:
Please do not hesitate to reach out to the team of experts at Osborne Clarke for further information about the existing legislation and recommendations for biotech companies in Belgium.