AB Science announces an update in the marketing authorization application of masitinib in amyotrophic lateral sclerosis at the European Medicines Agency

AB Science announces an update in the marketing authorization application of masitinib in amyotrophic lateral sclerosis at the European Medicines Agency




AB Science announces an update in the marketing authorization application of masitinib in amyotrophic lateral sclerosis at the European Medicines Agency

PRESS RELEASE

AB SCIENCE ANNOUNCES AN UPDATE IN THE MARKETING AUTHORIZATION APPLICATION OF MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS AT THE EUROPEAN MEDICINES AGENCY

A DECISION FROM THE EUROPEAN MEDICINES AGENCY IS EXPECTED DURING THE SECOND QUARTER OF 2024

Paris, 26 January, 2024, 6pm CET

AB Science SA (Euronext – FR0010557264 – AB) announced that the Committee for Medicinal Products for Human Use (CHMP) has proposed that AB Science submit a written response to the List of Outstanding Issues at D195 of the procedure, instead of addressing these issues through the Oral Explanation.

At D195 of the procedure, certain major objections remained, and an Oral Explanation was scheduled on January 24, 2024 to address these objections.

This week, before the date planned date of the Oral Explanation, the CHMP has proposed that AB Science addresses these objections in writing instead of the Oral Explanation.

AB Science has accepted this proposal, which is unusual at this stage of the procedure, as it offers AB Science the possibility of giving more detailed responses than what would be possible during an Oral Explanation, and provides CHMP with more time to evaluate the responses. A new Oral Explanation is not mandatory and will be scheduled only if major objections remain after the review of the written responses.

AB Science now expects an opinion from the CHMP in the second quarter of 2024.

About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.

AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).

Forward-looking Statements – AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.

These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan” as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.

For additional information, please contact:

AB Science
Financial Communication & Media Relations
investors@ab-science.com

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