---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-21-052250"
form_type: "8-K"
ticker: "TARA"
cik: "0001359931"
company_name: "Protara Therapeutics, Inc."
filed_at: "2021-10-12T23:59:59+00:00"
generated_at: "2026-06-28T21:21:50.856576+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Protara Therapeutics receives FDA IND clearance for TARA-002 in non-muscle invasive bladder cancer

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-21-052250
- form_type: 8-K
- ticker: TARA
- cik: 0001359931
- company_name: Protara Therapeutics, Inc.
- filed_at: 2021-10-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1359931/000121390021052250/0001213900-21-052250-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1359931/000121390021052250/ea148683-8k_protara.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-21-052250
- JSON: https://secwatch.observer/filing/0001213900-21-052250.json
- Plain text: https://secwatch.observer/filing/0001213900-21-052250.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.