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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Ab Science Sa | LSE:0Q77 | London | Ordinary Share | FR0010557264 | AB SCIENCE ORD SHS |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 3.835 | 3.74 | 3.93 | 803 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Pharmaceutical Preparations | 970k | -11.99M | -0.2572 | -4.55 | 54.52M |
PRESS RELEASE
SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT
Paris, March 7, 2024, 3pm CET
AB Science SA (Euronext - FR0010557264 - AB) is providing a summary of the live webcast held on March 4, 2024, giving an update on AB Science development.
The webcast presentation is available on the company’s website, in the section « Press Releases »: https://www.ab-science.com/news-and-media/press-releases/
The presentation covered four topics:
Status of conditional approval application of masitinib in ALS with EMA and Health Canada
Of note, the press release dated 26 February 2024 incorrectly stated that Health Canada issued a Notice of Non Compliance – Withdrawal (NON/w) when the decision issued was in fact a Notice of Deficiency – Withdrawal (NOD-W).
The issuance of NOD-W or NON-W indicate different regulatory decisions. A NOD-W is issued if, during the scientific review of the response to a Notice of Deficiency (NOD), it is found that the submission/application remains deficient. On the other hand, a Notice of Non-Compliance Withdrawal is issued when, during the scientific review of the response to a Notice of Non-Compliance (NON), it is determined that the submission remains non-compliant.
Three key major clinical objections and intended counterarguments for reconsiderations have been presented. They are the following:
Based on the supporting arguments and counterarguments outlined above, AB Science intends to submit a Request for Reconsideration. Other points of concern identified by the agency will also be responded to.
Status of the masitinib platform clinical development program
Masitinib offers a late stage and diversified platform of 8 indications, primarily centered around neuro-degenerative diseases (namely, amyotrophic lateral sclerosis, progressive form of multiple sclerosis, mild and moderate Alzheimer’s disease) and mast cell diseases (indolent systemic mastocytosis, mast cell activation syndrome), but also sickle cell disease, metastatic castrate refractory prostate cancer eligible to docetaxel, and COVID-19.
Status of masitinib licensing partnership
Discussions for masitinib licensing with a pharmaceutical company are ongoing and the process is expected to be completed by the end of 2024.
The scope of the license is mainly neurodegenerative indications, including ALS.
The discussions are with companies that do not condition the signature of a binding offer to a positive opinion from EMA and Health Canada in ALS.
AB Science is currently aiming to develop a liquid formulation for masitinib in ALS. A liquid formulation would be beneficial for ALS patients because they have difficulties in swallowing. A liquid formulation is beneficial for the masitinib development plan as differential pricing will be facilitated between ALS (liquid formulation) and other indications (tablets). The development of any new formulation will require bioequivalence studies and is expected to take two years.
Status of the microtubulin platform clinical development program
The microtubule destabilizer agents (MDAs) platform is focused in haemato-oncology with two drugs, AB8939 and AB12319.
AB8939 has the potential to improve acute myeloid leukemia (AML) treatment based on three differentiating features of its mechanism of action.
The phase 1 study of AB8939 has completed its first step (determination of maximum tolerated dose following 3 consecutive days of AB8939 treatment), and key agencies have authorized this study to proceed with the next step (determination of maximum tolerated dose following 14 consecutive days of AB8939 treatment).
The phase 1 is expected to be completed in 2024 and a phase 2 will be initiated in 2025 with an intention to design the study to support accelerated approval.
Status of masitinib and AB8939 intellectual property
Masitinib intellectual property rights are protected until 2036 in mastocytosis, until 2037 in ALS, and potentially until 2041 in MS and ALZ and 2042 in prostate cancer.
AB8939 intellectual property rights in AML are secured until 2036 through a ‘composition of matter’ patent and potentially until 2044 in AML with chromosome abnormality (MECOM) through a ‘second medical use’ patent.
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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