---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-117577"
form_type: "8-K"
ticker: "TARA"
cik: "0001359931"
company_name: "Protara Therapeutics, Inc."
filed_at: "2025-12-03T23:59:59+00:00"
generated_at: "2026-05-16T15:03:39.863744+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Protara reports 72% CR for TARA-002 in BCG-Naïve NMIBC; FDA backs registrational path

## Summary
- CR at any time 72% (21/29); 69% at 6 months, 50% at 12 months in BCG-Naïve NMIBC.
- No Grade 3+ treatment-related adverse events; no discontinuations due to TRAEs.
- FDA agreed BCG not required as comparator; intravesical chemo acceptable for registrational trial.
- On track for interim BCG-Unresponsive cohort data in Q1 2026; enrollment completion expected 2H 2026.
- Re-induction salvaged 80% (4/5) non-responders; all maintained CR at 12 months.

## SEC filing metadata
- accession: 0001213900-25-117577
- form_type: 8-K
- ticker: TARA
- cik: 0001359931
- company_name: Protara Therapeutics, Inc.
- filed_at: 2025-12-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1359931/000121390025117577/0001213900-25-117577-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1359931/000121390025117577/ea0268248-8k_protara.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-117577
- JSON: https://secwatch.observer/filing/0001213900-25-117577.json
- Plain text: https://secwatch.observer/filing/0001213900-25-117577.txt

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