Regulatory De-Risking and Expanding Indications Drive Attractive Risk–Reward for Protara Therapeutics’ TARA-002

Charles Zhu, an analyst from LifeSci Capital, maintained the Buy rating on Protara Therapeutics. The associated price target remains the same with $26.00.

Charles Zhu has given his Buy rating due to a combination of factors that, in his view, materially de-risk Protara Therapeutics’ lead asset and clarify its regulatory path. He highlights that TARA-002 has secured both Breakthrough Therapy and Fast Track designations from the FDA in macrocystic and mixed cystic pediatric lymphatic malformations, which he interprets as strong regulatory validation and a positive signal ahead of an anticipated registration-pathway discussion in 2026. He also notes that TARA-002’s inclusion in the FDA’s CMC Development and Readiness Pilot Program should help streamline manufacturing scale-up and support a smoother route to market.
In addition, Zhu emphasizes that these regulatory advantages are expected to benefit not only the pediatric LM program but also the company’s efforts in non–muscle invasive bladder cancer (NMIBC), broadening TARA-002’s commercial potential. He points to supportive clinical evidence, including recent positive Phase 2 STARBORN-1 data and prior experience with a closely related agent (OK-432) in Asia, as reinforcing confidence in the drug’s efficacy profile. Together with the company’s plans to meet the FDA in the first half of 2026 to finalize the registration strategy and the incremental derisking of both regulatory and CMC aspects, Zhu views the risk–reward as attractive at current valuation, justifying a Buy recommendation.