TARA Protara Therapeutics
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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.
Actionable Insight
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.
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
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3295716 |
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| Type | Now | ||||
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May 26, 2026
14d ago
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EFFECT
| $4.80 $4.34 | ▲ +9.58% | ▲ +10.80% | $3.97 (+17.29%) |
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May 16, 2026
24d ago
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ANALYST-UPGRADE
| $6.20 $5.60 | ▼ −9.68% | ▼ −8.34% | $3.97 (−35.97%) |
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May 15, 2026
25d ago
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Press Release
| $5.10 $4.92 | ▼ −3.53% | ▼ −4.49% | $3.97 (−22.16%) |
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May 13, 2026
27d ago
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8-K
| $5.20 $4.34 | ▼ −16.54% | ▼ −15.38% | $3.97 (−23.65%) |
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May 13, 2026
27d ago
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Press Release
| $5.20 $4.34 | ▼ −16.54% | ▼ −15.38% | $3.97 (−23.65%) |
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Apr 28, 2026
6w ago
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DEFA14A
| $5.17 $5.66 | ▲ +9.48% | ▲ +6.37% | $3.97 (−23.21%) |
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Apr 16, 2026
7w ago
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ANALYST-UPGRADE
| $5.13 $5.26 | ▲ +2.53% | ▲ +1.55% | $3.97 (−22.61%) |
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Apr 16, 2026
7w ago
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ANALYST-UPGRADE
| $5.13 $5.26 | ▲ +2.53% | ▲ +1.55% | $3.97 (−22.61%) |
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Apr 16, 2026
7w ago
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ANALYST-UPGRADE
| $5.13 $5.26 | ▲ +2.53% | ▲ +1.55% | $3.97 (−22.61%) |
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Apr 16, 2026
7w ago
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ANALYST-UPGRADE
| $5.13 $5.26 | ▲ +2.53% | ▲ +1.55% | $3.97 (−22.61%) |
US Market Status
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