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press release
AB Sciences Announces Update on European Medicines Agency Marketing Authorization Application for Masinib in Amyotrophic Lateral Sclerosis
Decision from the European Medicines Agency is expected to be decided during the second quarter of 2024
Paris, January 26, 2024, 6:00 PM CET
AB Science SA (Euronext – FR0010557264 – AB) The Committee for Medicinal Products for Human Use (CHMP) has issued a written response to the list of outstanding issues in D195 of the procedure, rather than addressing these issues through an oral briefing. announced that they have proposed to AB Science to submit the following. .
Several major objections remained in proceeding D195, and oral briefing was scheduled for January 24, 2024, to address these objections.
This week, ahead of the scheduled date for the oral briefing, CHMP proposed that AB Science address these objections in writing in lieu of an oral briefing.
AB Science accepted this proposal. This proposal is unusual at this stage of the proceedings, as it offers AB Science the possibility of providing a more detailed answer than would be possible with an oral explanation, and gives CHMP more time to assess the answer. . A new oral briefing is not required and will only be scheduled if significant objections remain after consideration of the written response.
AB Science currently expects an opinion from CHMP in the second quarter of 2024.
About AB Science
AB Science, founded in 2001, is a pharmaceutical company specializing in the research, development, and commercialization of protein kinase inhibitors (PKIs), a type of target protein whose actions are key in intracellular signaling pathways. . Our programs target only diseases with high unmet medical need, diseases that are often fatal with short survival times, or diseases that are rare or refractory to previous treatments.
AB Science has developed a unique portfolio of molecules, and its lead compound, masitinib, is already registered for veterinary medicine and is being developed in human medicine in oncology, neurological diseases, inflammatory diseases, and viral diseases. It has been. 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 and the underlying assumptions, financial results, events, operations, future services, product developments, and projects, objectives, intentions and expectations regarding their potential or future performance. Contains descriptions.
These forward-looking statements often refer to the words “expect,” “anticipate,” “believe,” “intend,” “estimate,” or “plan,” or other similar terminology. can be identified by Although AB Science believes that these forward-looking statements are reasonable, investors should note that these forward-looking statements involve a number of risks and conditions that are difficult to predict and generally beyond AB Science’s control. Please note that there are uncertainties and that results and actual events may be implied. may differ materially from that expressed, implied or anticipated in any forward-looking information or statements. These risks and uncertainties include uncertainties related to the development of our products, which may not be successful, uncertainties related to marketing authorizations granted by competent authorities and, more generally, Includes factors that may affect your ability to market the products you develop. As developed or identified in public documents published by AB Science. AB Science disclaims any obligation or undertaking to update forward-looking information and statements pursuant to applicable regulations, in particular Sections 223-1 et seq. Provisions of the AMF General Regulations.
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AB Science
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