TARA Skyrockets 21.1849% as STARBORN-1 Trial Hits 100% Clinical Success in Pediatric LMs

Protara Therapeutics (Nasdaq: TARA) surged 21.1849% in pre-market trading on November 19, 2025, following the release of positive interim Phase 2 STARBORN-1 trial data for its investigational therapy TARA-002 in pediatric lymphatic malformations (LMs). The trial demonstrated 100% clinical success in eight evaluable patients at eight weeks, with 80% of treated patients achieving sustained outcomes after one to four doses. Notably, 83% of macrocystic patients achieved complete responses, and the safety profile remained favorable, with no serious adverse events reported.

The STARBORN-1 trial, evaluating intracystic TARA-002 in 29 pediatric participants, highlighted rapid responses and durable effects. One patient with a large macrocystic lesion required four doses but achieved full resolution. While the small sample size and short-term follow-up limit immediate conclusions, the data reinforce TARA-002’s potential as a first-line therapy for LMs, a condition lacking approved treatments. The company’s leadership emphasized the therapy’s differentiation from invasive surgical alternatives and off-label chemotherapies, which carry significant risks for pediatric patients.

Backtest assumptions suggest a momentum-driven strategy could capitalize on the stock’s volatility. A hypothetical buy signal triggered by the 21% pre-market jump, followed by a trailing stop-loss at 15% below the peak, aligns with historical patterns in biotech stocks responding to phase-2 catalysts. Investors may monitor 32-week follow-up data from the trial for confirmation of long-term efficacy, which could further validate TARA-002’s commercial potential.

Protara’s pre-market performance underscores growing optimism among investors. The recent trial data may attract attention from major stakeholders, potentially accelerating TARA-002’s path toward regulatory approval. However, investors should remain cautious, as the stock is still in an early-stage development phase and is subject to clinical and regulatory risks. The company also plans to expand its pipeline to include other rare diseases, which could diversify its long-term value proposition.