The strong durability and safety profile of TARA-002 in BCG-Naïve NMIBC could de-risk the program and support regulatory path. Focus on completion of BCG-Unresponsive cohort enrollment in 2H 2026 and initiation of ADVANCED-3. Trading on clinical data updates can be volatile; monitor for any financing needs as the company advances toward registrational trials.
Price Chart
Executive Summary
Protara Therapeutics announced positive updated 12-month data from its Phase 2 ADVANCED-2 trial of TARA-002 in BCG-Naïve NMIBC patients, showing a 72.4% complete response rate at any time, 67% at 6 months, and 55% at 12 months, with no Grade 3+ treatment-related adverse events. The company remains on track to initiate the registrational ADVANCED-3 trial in 2H 2026. These data support TARA-002's potential as a differentiated treatment in a large unmet need market.
Key Facts
- 72.4% complete response (CR) rate at any time in BCG-Naïve NMIBC patients (21/29 evaluable).
- 66.7% CR rate at 6 months and 55.0% CR rate at 12 months.
- No Grade 3 or greater treatment-related adverse events; most TRAEs were Grade 1 and transient.
- Registrational ADVANCED-3 trial planned to initiate in 2H 2026 in BCG-Naïve and potentially BCG-Exposed patients.
- TARA-002 has FDA Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations for certain indications.
Financial Impact
No financial data provided; clinical catalyst only.
Risk Factors
- Clinical trial risks: Phase 2 data may not replicate in larger registrational study.
- Regulatory risks: FDA may require additional data or raise concerns.
- Competitive landscape: existing and pipeline therapies for NMIBC could limit commercial potential.
- Financing risk: Protara may need to raise capital to fund ADVANCED-3 and ongoing operations.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3295716 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 11, 2026 7w ago | 8-K | $3.91 $3.83 | ▼ −2.05% | ▼ −0.99% | $2.70 (−30.95%) |
Aug 11, 2026 7w ago | Press Release | $3.91 $3.83 | ▼ −2.05% | ▼ −0.99% | $2.70 (−30.95%) |
Jun 29, 2026 13w ago | 8-K | $3.82 $4.04 | ▲ +5.76% | ▲ +6.79% | $2.70 (−29.32%) |
May 26, 2026 18w ago | EFFECT | $4.80 $4.06 | ▲ +15.52% | ▲ +13.57% | $2.70 (+43.75%) |
May 15, 2026 20w ago | Press Release | $5.10 $3.94 | ▼ −22.75% | ▼ −24.86% | $2.70 (−47.06%) |
May 13, 2026 20w ago | 8-K | $5.20 $3.65 | ▼ −29.81% | ▼ −29.19% | $2.70 (−48.08%) |
May 13, 2026 20w ago | Press Release | $5.20 $3.65 | ▼ −29.81% | ▼ −29.19% | $2.70 (−48.08%) |
Apr 28, 2026 22w ago | DEFA14A | $5.17 $4.75 | ▼ −8.12% | ▼ −14.17% | $2.70 (−47.78%) |
Mar 10, 2026 29w ago | Press Release | $5.71 $5.22 | ▼ −8.58% | ▼ −8.43% | $2.70 (−52.71%) |
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