Jul. 1 at 4:04 PM
$IFRX bow wow
On June 30, 2026
The Company today announced that it is assessing the feasibility of broadening its development and registrational strategy for AAV in Europe. The Company has initiated this assessment given the recommendation of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to revoke the marketing authorization for Tavneos in the European Union, announced on June 26, 2026.
In addition, the Company announced it intends to engage with EMA regarding both its anti-C5a antibody vilobelimab, which is approved under exceptional circumstances as GOHIBIC in Europe for SARS-CoV-2-induced acute respiratory distress syndrome, in addition to its next-generation oral C5aR inhibitor izicopan. This will be part of the Company’s overall development goal to determine the most efficient development pathway to bring the C5a / C5aR inhibition mechanism to patients. Together, vilobelimab and izicopan provide the Company with a complementary biologic