Protara Therapeutics disclosed that its Phase 2 ADVANCED‑2 trial of the intravesical cell‑based therapy TARA‑002 achieved a 68% complete‑response rate at six months in patients with BCG‑unresponsive non‑muscle invasive bladder cancer. The interim analysis, based on 35 evaluable participants, shows that 22 patients were assessed at six months and 15 at 12 months as of a January 28, 2026 data cutoff. All responders who achieved a complete response at six months maintained that response through nine to twelve months in the subset of patients with available data, underscoring the durability of the effect.
The safety profile of TARA‑002 was favorable. No Grade 3 or higher treatment‑related adverse events were reported, and no patients discontinued therapy because of adverse events. The most common treatment‑related events were dysuria, bladder spasm, fatigue, and micturition urgency; all were transient and resolved quickly, supporting the tolerability of the intravesical approach.
CEO Jesse Shefferman said, "These interim data are highly encouraging with respect to TARA‑002's efficacy and safety... The results in the BCG‑Unresponsive cohort demonstrate compelling six‑month response rates with maturing 12‑month data showing promising signals of durability. These clinically meaningful response rates and favorable tolerability profile make TARA‑002 a potentially promising treatment option." He added, "In addition to demonstrating impressive efficacy and safety, TARA‑002 overcomes the limitations of existing NMIBC treatments that burden patients as well as urologists and their practices. We look forward to continuing to advance TARA‑002's clinical development as we work to bring this treatment to patients."
The trial results reinforce Protara's strategic path toward regulatory approval. The company plans to complete enrollment of the BCG‑unresponsive registrational cohort of the ADVANCED‑2 trial in the second half of 2026 and to initiate the ADVANCED‑3 registrational trial in BCG‑naïve patients in the same timeframe. TARA‑002, derived from the same cell bank as the approved immunopotentiator OK‑432, has received FDA designations including Rare Pediatric Disease, Breakthrough, and Fast Track, positioning it favorably in a market where BCG shortages limit standard therapy options. Protara’s strong financial position—cash and liquid assets exceeding short‑term obligations and an $86 million public offering completed in January 2026—provides a runway through 2028, although the company remains unprofitable with a diluted EPS of –$1.39 over the last twelve months.
Investors appeared unsure about the latest readout, reflecting a cautious market stance toward the interim data despite the positive clinical findings.
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