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23 January 2025

The AMF Enforcement Committee fines Pharnext and its former directors a total of €800,000

In its decision of 20 January 2025, the Enforcement Committee imposed a fine of €500,000 on Pharnext, and fines of €200,000 and €100,000 on its former directors, Daniel Cohen and David Horn Solomon, for having failed to disclose inside information as soon as possible, and for having disseminated false or misleading information.

Pharnext is a biotechnology company specialising in the development of therapies for neurodegenerative diseases. The AMF Board reproached the company for having belatedly disclosed two pieces of inside information relating to the company's application to the US Food and Drug Administration (FDA) for marketing authorisation for a drug (drug candidate). The Board also accused Pharnext for having disseminated false or misleading information in press releases and letters to shareholders in relation to this drug candidate.

The Committee found that the piece of information that the FDA had asked Pharnext to carry out an additional study for the drug candidate constituted inside information from 10 April 2019. It considered that this piece of information had not been communicated to the market as soon as possible, as it was only made public on 30 August 2019. The Committee also held that the piece of information relating to the FDA's ‘non-agreement’ as regards Pharnext's request to implement a procedure aimed at obtaining agreement on the design of the second clinical study planned to support a marketing authorisation application constituted inside information from 28 October 2020. The Committee considered that this second piece of information had not been communicated to the market as soon as possible, as it had not been made public. It therefore found that Pharnext had committed breaches of the obligation to publish inside information as soon as possible.

The Committee also found that Pharnext had disseminated false or misleading information relating to these two pieces of inside information. In particular, it emphasised that the market was anticipating the marketing of the drug candidate and was therefore attentive to information relating to the stages prior to a possible marketing authorisation, noting that the company had not yet marketed any product.

The Committee held that these breaches were attributable to its former directors at the time of the facts, Mr Cohen and Mr Solomon.

An appeal may be lodged against this decision.

Application by Mr David Horn Solomon to the Paris Court of Appeal for a stay of execution of decision SAN-2025-01

M. David Horn Solomon has filed an application for a stay of enforcement of the decision of the Enforcement Committee of 20 January 2025.

Appeal lodged by Pharnext, Mr Daniel Cohen and Mr David Horn Solomon before the Paris Court of Appeal against decision SAN-2025-01

Pharnext, Mr Daniel Cohen and Mr David Horn Solomon have lodged an appeal before the Paris Court of Appeal against the Enforcement Committee's decision of 20 January 2025.

About the Enforcement Committee
The Enforcement Committee, which is made up of judges and professionals, has total freedom to make decisions. It can impose sanctions on any person or company whose practices contravene laws and regulations that fall within the jurisdiction of the AMF. It ratifies settlement agreements signed by the Secretary General and respondents. And it takes part in the AMF’s educational efforts by clarifying financial regulations when explaining its decisions.

AMF Communications Directorate