zabilugene almadenorepvec — FDA meeting
in Q3 2026
Plan to discuss the proposed clinical trial protocol with the FDA in Q3 2026.Source filing
TOVX biotech catalysts & pipeline
THERIVA BIOLOGICS INC · Data as of 2026-09-08
Upcoming catalysts
zabilugene almadenorepvec — Regulatory decision
Sep 30
If a Biologics License Application for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30, 2026, we may be eligible to receive a Priority Review Voucher.Source filing
zabilugene almadenorepvec — Initial data
by Q3 2027
VIRAGE2 is expected to complete enrollment during the second half of 2026, and initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027.Source filing
zabilugene almadenorepvec — NDA/BLA submission
2029
If a protocol is ultimately submitted to, and agreed by, the FDA, we expect the first patient to be enrolled in January 2027, with rolling BLA submissions expected to be made in 2029 (if successful), targeting potential approval of the BLA prior to the current legislative deadline of September 30, 2029 to be eligible to receive a Priority Review Voucher.Source filing
zabilugene almadenorepvec — PDUFA
Sep 30
If a Biologics License Application (BLA) for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30, 2029, we may be eligible to receive a Priority Review Voucher, which can be monetized.Source filing