secwatch.observer — SEC 8-K summary
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Issuer:     Protara Therapeutics, Inc. (TARA)
CIK:        0001359931
Form:       8-K
Filed at:   2025-12-03T23:59:59+00:00
Accession:  0001213900-25-117577
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1359931/000121390025117577/0001213900-25-117577-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1359931/000121390025117577/ea0268248-8k_protara.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-117577

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer