regulatory
confidence high
sentiment positive
materiality 0.65
Theriva Biologics receives FDA Rare Pediatric Drug Designation for VCN-01 in retinoblastoma
Theriva Biologics, Inc.
- FDA grants Rare Pediatric Drug Designation for VCN-01, a stroma-degrading oncolytic adenovirus, to treat retinoblastoma.
- Prior orphan drug designation for same indication; RPDD may provide a Priority Review Voucher upon BLA approval.
- Holders of Series C Convertible Preferred Stock converted 135,431 shares into 888,072 common shares at $1.22 per share.
- Positive Phase 1 results from investigator-sponsored trial of intravitreal VCN-01 in pediatric refractory retinoblastoma inform clinical pathway.