regulatory
confidence high
sentiment positive
materiality 0.65
Protara Therapeutics receives FDA IND clearance for TARA-002 in non-muscle invasive bladder cancer
Protara Therapeutics, Inc.
- FDA cleared IND for TARA-002, an investigational cell-based therapy for NMIBC.
- Phase 1 trial planned to initiate by year-end 2021 in high-grade NMIBC patients.
- TARA-002 manufactured from same cell bank as OK-432, approved in Japan and Taiwan.
- Confirmatory GMP-scale comparability data submitted and reviewed by FDA.