Shares of Protara Therapeutics TARA rallied 70% on Wednesday after the company announced compelling results from the pre-planned interim analysis of its ongoing mid-stage study evaluating intravesical TARA-002 for treating non-muscle invasive bladder cancer (NMIBC).

TARA-002 is Protara’s investigational cell therapy, which is currently in development for treating NMIBC and lymphatic malformations (LMs). The candidate enjoys the FDA’s Rare Pediatric Disease designation for treating these indications in the United States.

Patients enrolled in the ongoing phase II ADVANCED-2 study were high-risk NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.

NMIBC patients treated with TARA-002 achieved a complete response (CR) rate of 72% at six months and 70% at any time across BCG exposures with 100% of patients maintaining a CR from three months to six months. Protara also reported that two out of three treated patients maintained a CR at nine months.

In the past three months, shares of TARA have skyrocketed 227.2% against the industry’s 7.3% decline. 

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More Data From Protara’s Mid-Stage NMIBC Study

In the pivotal cohort of the ADVANCED-2 study focusing on BCG-unresponsive patients, the CR rate was 100% at six months and 80% at any time. In the proof-of-concept cohort involving BCG-naïve patients, the CR rate was 64% at six months and 67% at any time.

TARA-002 exhibited a favorable safety and tolerability profile. All treatment-related adverse events reported were mild in severity and no patient discontinued treatment due to adverse events.

Based on the encouraging clinical activity across BCG exposures, along with its ease of use and low procedural burden for physicians, Protara believes that TARA-002 has significant potential to become an important treatment option for NMIBC patients.

Bladder cancer ranks as the sixth most common cancer in the United States, with NMIBC accounting for about 80% of cases. Each year, approximately 65,000 individuals in the United States are diagnosed with NMIBC, a type of cancer confined to the bladder's inner lining that has not penetrated the muscle layer.

TARA’s Clinical Pipeline Development Programs

Protara continues to evaluate TARA-002 in the phase II ADVANCED-2 study for NMIBC and expects to report initial data from 12-month evaluable patients in mid-2025.

The company is also evaluating TARA-002 in an ongoing phase II STARBORN-1 study to treat pediatric patients with macrocystic and mixed cystic LMs. The study is currently enrolling patients with initial results expected in the first half of 2025.

Apart from TARA-002, Protara’s clinical pipeline comprises an investigational IV phospholipid substrate replacement therapy, IV Choline Chloride, which is being developed as a source of choline for adult and adolescent patients on parenteral support (PS). The company is currently gearing up to initiate dosing PS patients with IV Choline Chloride in its registrational phase IIb/III THRIVE-3 study in the first quarter of 2025. 

TARA’s IV Choline Chloride enjoys the FDA’s Fast Track designation in the United States for the PS indication.

Protara Therapeutics, Inc. Price and Consensus

Protara Therapeutics, Inc. price-consensus-chart | Protara Therapeutics, Inc. Quote

TARA’s Zacks Rank & Stocks to Consider

Protara currently carries a Zacks Rank #3 (Hold).

Some better-ranked pharma stocks are Alnylam Pharmaceuticals ALNY, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, Alnylam Pharmaceuticals’ loss estimates have narrowed from 42 cents to 39 cents per share for 2024, while that for 2025 has narrowed from 49 cents to 13 cents. ALNY shares have lost 0.5% in the past three months.

Alnylam Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.

In the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 12.8% in the past three months.

Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.

In the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 18% in the past three months.

Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.

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