United Therapeutics Shares Surge 32.83% on $1.31B Volume Rank 58th as Tyvaso Trial Hits IPF Targets

Generated by AI AgentAinvest Volume Radar
Tuesday, Sep 2, 2025 8:50 pm ET1min read
Aime RobotAime Summary

- United Therapeutics shares surged 32.83% on $1.31B volume after positive phase 3 trial results for Tyvaso in IPF treatment.

- The TETON-2 study showed Tyvaso improved FVC by 95.6 mL and met secondary endpoints like clinical worsening and quality-of-life metrics.

- UTHR plans to submit an FDA supplemental application to expand Tyvaso’s indications, with regulatory discussions expected by year-end.

- Additional data will be presented at the European Respiratory Society Congress, reinforcing UTHR’s focus on unmet medical needs.

On September 2, 2025,

(UTHR) surged 32.83% with a trading volume of $1.31 billion, marking a 929.41% increase from the previous day’s volume and ranking 58th in market activity. The stock’s sharp rise followed the release of pivotal clinical trial results for its inhaled therapy Tyvaso.

The TETON-2 phase 3 study demonstrated Tyvaso’s efficacy in treating idiopathic pulmonary fibrosis (IPF), meeting its primary endpoint of improving forced vital capacity (FVC) by 95.6 mL compared to placebo. The drug also showed statistically significant benefits in secondary endpoints, including time to clinical worsening and quality-of-life metrics. Positive outcomes were observed across diverse patient subgroups, including those on standard anti-fibrotic therapies.

United Therapeutics highlighted the trial’s potential to reshape IPF treatment, as existing therapies offer limited efficacy and significant side effects. The company plans to submit a supplemental New Drug Application to the FDA to expand Tyvaso’s approved indications. Regulatory discussions with the agency are anticipated before year-end, pending results from the ongoing TETON-1 study, expected in early 2026.

Additional TETON-2 data will be presented at the European Respiratory Society Congress in September 2025. The trial’s success has positioned Tyvaso as a promising option for IPF patients, with United Therapeutics emphasizing its commitment to advancing therapies for unmet medical needs.

There are no results to present for the backtest segment.

Comments



Add a public comment...
No comments

No comments yet