AB Science SA (Euronext - FR0010557264 - AB) today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a trending toward a negative opinion on the application for conditional marketing authorisation of masitinib in the treatment of amyotrophic lateral sclerosis (ALS), following an oral explanation held at the 28 May meeting of the CHMP.
PRESS RELEASE
AB SCIENCE PROVIDES AN UPDATE ON THE APPLICATION FOR CONDITIONAL MARKETING AUTHORISATION OF MASITINIB IN THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS
Paris, 29 May, 2024, 6pm CET
AB Science SA (Euronext - FR0010557264 - AB) today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a trending toward a negative opinion on the application for conditional marketing authorisation of masitinib in the treatment of amyotrophic lateral sclerosis (ALS), following an oral explanation held at the 28 May meeting of the CHMP.
The CHMP is expected to adopt a formal opinion on the MAA at its next meeting, which will be held June 24-27, 2024. AB Science will continue to work with the CHMP to determine the appropriate pathway forward, including a possible request for re-examination.
AB Science will host a live webcast on Thursday May 30, 2024, from 5.30pm to 6.30pm CET.
The agenda of this live webcast will be to explain the main clinical objections leading the CHMP not to consider approving at this time masitinib for treatment of ALS, and the arguments potentially justifying a request for re-examination.
The presentation will be followed by a Q&A session.
AB Science has asked Euronext to suspend the listing of its shares on the Euronext market, with effect from the publication of this press release, pending the publication of the press release summarizing the webcast.
Webcast Information
- Webcast date: Thursday May 30, 2024. US: 11.30am-12.30pm ET; Europe: 5.30pm-6.30pm CET
- Access to the webcast (audio + presentation): Access to the webcast
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).
Further information is available on AB Science’s website:
www.ab-science.com.
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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