AB Science updates conditional marketing application for masitinib in ALS

On May 29, 2024, AB Science SA, a pharmaceutical company listed on Euronext Paris, provided an update regarding their application for conditional marketing authorisation of masitinib, a treatment for amyotrophic lateral sclerosis (ALS). The announcement followed the latest meeting of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), where a trend toward a negative opinion was observed.

During the CHMP meeting on May 28, 2024, AB Science presented an oral explanation supporting its application. Despite this, the CHMP has not shown favor toward approving masitinib for ALS treatment at this time. The committee is scheduled to formalize its opinion at the upcoming meeting from June 24-27, 2024. AB Science remains committed to collaborating with the CHMP to explore potential paths forward, which may include requesting a re-examination of the application.

AB Science has organized a live webcast for May 30, 2024, from 5.30pm to 6.30pm CET. This webcast will address the primary clinical objections raised by the CHMP and discuss the possible arguments for a re-examination request. The presentation will be followed by a Q&A session to provide further clarity.

In light of these developments, AB Science has requested the suspension of its share listing on the Euronext market, effective immediately, pending the publication of a summary press release post-webcast.

AB Science, established in 2001, focuses on the research, development, and commercialization of protein kinase inhibitors (PKIs). These inhibitors play a crucial role in cellular signaling pathways and are targeted toward diseases with significant unmet medical needs, including those that are often lethal or rare. Their lead compound, masitinib, is already registered for veterinary use and is being developed for human medicine in various fields such as oncology, neurological diseases, inflammatory diseases, and viral diseases.

The company, based in Paris, France, emphasizes that the webcast will provide comprehensive insights into the current status of masitinib’s marketing authorisation application and outline the company’s future steps. Investors and stakeholders are advised to join the webcast for detailed information and to participate in the ensuing Q&A session.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!