Biophytis Seeks Early Access Authorization For Its COVID-19 Treatment In France

Biophytis SA BPTS has begun the early access application process in France for Sarconeos (BIO101) for the treatment of severe COVID-19.
A pre-submission meeting with the French National Authority for Health (HAS) is scheduled for March. The application for early access authorization should be submitted shortly after to obtain authorization in the second quarter of 2023.
In the Phase 2-3 COVA trial, the final analysis of BIO101 demonstrated a 44% statistically significant reduction in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with a positive Post-Hoc analysis released in November 2022.
An early access program was already approved in 2022 in Brazil to treat COVID-19 patients at a critical stage in Intensive Care Units.
Biophytis continues to prepare conditional marketing authorization applications in Europe and the U.S.
The HAS grants early access in France after the National Agency for the Safety of Medicines and Health Products (ANSM) has given its opinion on the presumption of efficacy and safety.
The system allows the provision and early financial coverage, on an exceptional and derogatory basis, of certain medicinal products that have not yet been authorized in a therapeutic indication.
Price Action: BPTS shares traded lower by 4.36% at $0.4010 on the last check Monday.