(BFM Bourse) – The AB Science stock soared by more than 30% on Tuesday on the Paris Stock Exchange after the biotech announced that it had received the green light from the Canadian health authority to request the marketing of its molecule beacon against multiple sclerosis.
Best performance of the entire tricolor rating on Tuesday, AB Science soared 34% to 9.85 euros around 4:30 p.m. after receiving authorization from the Canadian health authority (Health Canada) to submit a request for marketing of its lead product, masitinib, in the treatment of amyotrophic lateral sclerosis (ALS) under NOC/c status (for “Notice of Compliance with Conditions”). This is granted “to eligible products which have demonstrated promising clinical efficacy during clinical trials, these must be of high quality and present an acceptable risk-benefit profile” specifies the biotech.
As a reminder, this flagship product had been the subject of an interruption of clinical studies last June due to a signal of increased risks of heart disease – which the meta-analysis carried out by AB Science had not confirmed, allowing the resumption of the clinical trials in question. The company’s share had also dropped nearly 10% between the close of February 11 and that of February 14 after the AMF college requested fines totaling six million euros from the company. against biotech AB Science, its CEO and a financial adviser for various insider dealings dating back to 2017.
Going back to the announcement of the day, the status obtained is “limited to new treatments for which there is no other therapy available on the Canadian market and to products that provide a significant improvement in the benefit-risk profile compared to treatments existing ones” continues AB Science.
A serious, fatal and severely disabling disease
The biotech now has 60 days to file its registration dossier for mastinib in the treatment of amyotrophic lateral sclerosis (ALS) and then Health Canada will have 200 days to examine the request.
“We are delighted with HealthCanada’s decision to authorize the filing of the registration dossier for masitinib in ALS,” comments CEO and co-founder of AB Science Alain Moussy, quoted in the press release. “We are committed to working with HealthCanada on this submission, which could potentially result in the rapid availability of masitinib for ALS patients first under NOC/c status and then under full registration.” -he. Before thanking all the investigators and researchers who supported the development program “for several years”, the patients included in the B10015 study, whose efficacy data were sent to Health Canada as part of the pre- submission, being on average followed for 75 months from the diagnosis.
Currently, 3,000 people are living with amyotrophic lateral sclerosis (ALS) in Canada. Every year, about 1,000 people die of it and about 1,000 new cases of ALS are diagnosed in Canada, according to AB Science. ALS is in fact a serious, fatal and severely disabling disease, with a median survival of 2 years after diagnosis.
Note that despite its impressive rebound of the day, the biotech stock only returned to a one-month high, far from its peak at more than 20 euros hit in December 2020. The valuation of AB Science (which is also evaluating its flagship molecule in the treatment of Covid and that of mastocytosis, a potentially disabling hematological disease, as well as other molecules, in particular in acute myeloid leukemia) for its part, is once again familiar with the half-billion threshold euros.
Quentin Soubranne – ©2022 BFM Bourse
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