Achieved over the last 12 months

Anticipated in the next 12 months

COVA

  • Interim analysis for Part 2 (155 patients) in Q3 2021
  • Early Access Program (EAP) authorization in Brazil in February 2022
  • Early termination of patient enrolment in April 2022
  • Phase 2/3 study results expected in Q3 2022
  • Application for conditional approval in Europe and the EUA in the US in 2023

SARA

  • Positive topline study results in August 2021
  • Full study results communicated during ICFSR in September 2021
  • Regulatory agency meetings (FDA, EMA) in Q2/Q3 2022
  • Start of Phase 2/3 study with 1st patient enrolled in H2 2022

MYODA

  • US and Belgian IND regulatory approvals in Q1 2020
  • Clinical batch production in 2021
  • Study to start end of 2022 / beginning of 2023