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

Protara Therapeutics, Inc.

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.

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