Acticor Biotech SAS is discussing with FDA to set up a Type C meeting for early 2023 with the same objective as for the recent meeting with the European Agency EMA. With this Type C meeting, Acticor Biotech intends to pursue the discussion with the FDA on its clinical development program. The objective will be to validate the design and statistical analysis of the international Phase 2/3 study, ACTISAVE to support a potential future marketing authorization application in the US, BLA (Biologic License Application), as it has been recently done with the EMA.

At the same time, although it was recognized by the FDA that acute ischemic stroke (AIS) is a serious condition and that glenzocimab development program is designed to demonstrate an effect on a serious aspect of the condition, additional clinical evidence is requested by the Agency to accept a Fast Track designation for glenzocimab, at this stage. This request for Fast Track designation was submitted to the FDA on October 11th, 2022 on the basis of the Phase 1b/2a ACTIMIS study results. The FDA acknowledged the conduct of the ongoing Phase 2/3 ACTISAVE and is encouraging Acticor Biotech to submit a new request for Fast Track with additional supportive data from the ACTISAVE study.