AB Science provides an update on the application for conditional marketing authorisation of masitinib in ALS
29 Maggio 2024 - 6:02PM
AB Science provides an update on the application for conditional
marketing authorisation of masitinib in ALS
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 ScienceFounded 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
ScienceThis 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 ScienceFinancial
Communication & Media Relations investors@ab-science.com
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