Protara Stock Surges 116% on Breakthrough Bladder Cancer Trial Results

Protara Therapeutics, Inc. (Nasdaq: TARA) announced promising results from its Phase 2 ADVANCED-2 trial, sending its stock soaring 116%. The trial evaluated TARA-002, the company’s investigational cell-based therapy for Non-Muscle Invasive Bladder Cancer (NMIBC), and demonstrated significant efficacy and safety across both Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naïve patient cohorts.

Data Highlights:

• BCG-Unresponsive Patients: Achieved a 100% complete response (CR) rate at six months and 80% at any time.
• BCG-Naïve Patients: Demonstrated a 64% CR rate at six months and 67% at any time.
• Durability: All patients who responded maintained a complete response from three to six months, with an 80% reinduction salvage rate.
• Safety: Favorable profile, with no Grade 2 or greater treatment-related adverse events reported.

“These results reinforce TARA-002’s potential to reimagine NMIBC treatment with meaningful activity and a favorable safety profile,” said CEO Jesse Shefferman during the company’s investor call. He further highlighted the therapy’s ease of use, noting that TARA-002 requires only a simple 15-minute catheter-based administration and does not involve special handling.

Management Insights from the Investor Call
During the investor call, Protara’s leadership emphasized the broader implications of the data. CEO Jesse Shefferman underscored the differentiated value of TARA-002 as a next-generation bacterial immune potentiator, uniquely positioned in the NMIBC treatment landscape. He noted that the 100% six-month CR rate in BCG-Unresponsive patients and the encouraging results in BCG-Naïve settings reinforce the therapy’s potential across multiple stages of disease.

In addition, the favorable safety profile—coupled with TARA-002’s durable responses and ease of administration—was described as a key advantage for patients and physicians alike. Management also expressed optimism about ongoing efforts to accelerate enrollment in the BCG-Unresponsive cohort, including the expansion of clinical sites internationally in regions such as South America and Asia.

Dr. Jackie Zimmer, Chief Scientific Operations Officer, highlighted the potential for TARA-002 to fill a critical gap in NMIBC care. “Patients with BCG-unresponsive disease face limited options, often leading to radical cystectomy. These data suggest TARA-002 could provide a meaningful alternative for this patient population,” Zimmer said.

Expanding the Reach of TARA-002
Looking ahead, Protara plans to meet with the FDA in 2025 to confirm development pathways for BCG-Naïve patients. Management believes the therapy’s strong performance in this setting could position it as an alternative to BCG in earlier stages of treatment.

Acknowledgment of Stakeholders
During the call, Protara’s leadership also thanked patients, families, and clinicians for their critical roles in advancing the trial, as well as investors and stakeholders for their continued support.

About ADVANCED-2
The Phase 2 ADVANCED-2 trial is assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ (CIS ± Ta/T1) who are either BCG-Unresponsive (n≈100) or BCG-Naïve (n=27). The BCG-Unresponsive cohort has been designed to align with the FDA’s 2024 guidance for NMIBC therapies.

Financial Position
As of September 30, 2024, Protara reported cash, cash equivalents, and investments in marketable debt securities totaling approximately $81.5 million, sufficient to fund planned operations and milestones into 2026.