(CercleFinance.com) – Biophytis announced on Friday that it had received feedback from European and American health authorities with a view to planning the next regulatory steps for its project dedicated to the development of Sarconeos, its main candidate, in severe forms of Covid-19 .
After filing requests for pre-submission meetings with the European Medicines Agency (EMA) and the US FDA, the biotech now plans to meet with scientists from both agencies.
According to Biophytis, the objective of these meetings will be to collect the recommendations of the EMA and the FDA with the aim of refining the development plan of the project, called ‘COVA’, until its marketing authorization. on the market.
These exchanges must in particular enable him to take stock of the available data (preclinical, clinical and relating to the product and its industrialization) and to specify the additional information to be produced, in particular the protocol of a confirmatory phase 3 clinical study.
Biophytis also intends to present to the two agencies the possibility of extending the scope of its indication to other respiratory viral pathologies than Covid-19, such as influenza.
Following these announcements, the action of the biotechnology company rose by more than 6% on Wednesday morning on the Paris Stock Exchange, which does not prevent it from yielding another 68% since the beginning of the year.
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