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|8-KFeb 24, 8:52 AM ET

Protara Therapeutics, Inc. 8-K

Research Summary

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Updated

Protara Therapeutics Reports Positive Phase 2 Interim Data for TARA-002

What Happened

  • Protara Therapeutics announced updated interim results from its Phase 2 open‑label ADVANCED‑2 trial of TARA‑002 for carcinoma in situ (CIS) ± Ta/T1 non‑muscle invasive bladder cancer (NMIBC). The company posted a press release Feb 23, 2026, investor materials Feb 24, 2026, and presented posters at the ASCO GU Symposium on Feb 27, 2026. Data reported were based on a Jan 28, 2026 cutoff.

Key Details

  • Data sets: 43 BCG‑Unresponsive patients and 31 BCG‑Naïve patients received ≥1 dose; 35 BCG‑Unresponsive and 29 BCG‑Naïve were evaluable for efficacy.
  • BCG‑Unresponsive cohort: CR (complete response) at any time 65.7% (23/35); 6‑month CR 68.2% (15/22); 12‑month CR 33.3% (5/15). KM estimate of maintaining CR at 6 months among responders: 71.1% (95% CI 46.7–95.5). Re‑induction converted 61.5% (8/13) of initial non‑responders to CR at 6 months.
  • BCG‑Naïve cohort: CR at any time 72.4% (21/29); 6‑month CR 66.7% (18/27); 12‑month CR 57.9% (11/19). KM 6‑month CR maintenance among responders: 73.1% (95% CI 52.9–93.4). Re‑induction converted 66.7% (4/6).
  • Safety: most treatment‑related adverse events (TRAEs) were Grade 1 and transient; no Grade ≥3 TRAEs, no related serious adverse events, and no discontinuations due to TRAEs. Most common TRAEs: dysuria (14%), bladder spasm (9%), fatigue (7%), urgency (5%).
  • Next steps: Protara expects to complete enrollment of the BCG‑Unresponsive registrational cohort in H2 2026; BCG‑Naïve enrollment is complete (31 patients), and the company remains on track to start the ADVANCED‑3 registrational trial in BCG‑Naïve patients in H2 2026.

Why It Matters

  • These interim results show meaningful complete response rates and a favorable safety profile in both BCG‑Unresponsive and BCG‑Naïve NMIBC cohorts, supporting TARA‑002’s continued clinical development. For investors, the data and the planned timing for completing registrational cohort enrollment and initiating ADVANCED‑3 are material milestones that affect the program’s regulatory and commercialization pathway.