UTHR News & Events

United Therapeutics has acquired Thymmune Therapeutics, a privately held, preclinical stage biotechnology company developing scalable, regenerative thymic cell therapies for the potential treatment of post-transplant organ tolerance, immunodeficiencies, and autoimmune diseases. Thymmune has a proprietary process for converting human-induced pluripotent stem cells into thymic cells, which - once inside the body - mature into cell types that can restore healthy T-cell function. Thymmune's lead candidate, THY-100, is in preclinical development for congenital athymia, an ultra-rare and life-threatening condition in which infants are born without a functional thymus. United Therapeutics acquired Thymmune for $140M in cash, subject to certain post-closing adjustments, plus potential earn-out payments to former Thymmune equityholders of up to $160M based upon the achievement of certain clinical and regulatory milestones by the end of 2031.

Leerink views the FDA's premarket approval of LungFX as "an incremental positive" for United Therapeutics and the transplantation space overall, the analyst tells investors. The approval represents "another important regulatory step forward," further validating the company's long-term organ manufacturing platform and strengthening its potential leadership role in centralized ex vivo lung perfusion, says the analyst, who has an Outperform rating on United Therapeutics shares.

United Therapeutics announced that the U.S. FDA has granted premarket approval of the LungFX device for use in centralized ex vivo lung perfusion, a procedure that enables donor lungs to be assessed outside the body after procurement and before transplantation. The PMA, submitted by United Therapeutics' wholly owned subsidiary, Lung Bioengineering, included comprehensive safety and effectiveness data supporting use of LungFX to perform EVLP in a centralized facility.

United Therapeutics Corporation announced that the New England Journal of Medicine has published the full results of its TETON-1 study, as well as combined analyses of its TETON-1 and TETON-2 studies, evaluating the use of nebulized Tyvaso for the treatment of IPF. A summary of the publication was also presented today during a symposium at the annual meeting of the American Thoracic Society International Conference in Orlando. The use of nebulized Tyvaso for IPF has not been approved by the U.S. Food and Drug Administration and remains investigational for IPF. The results of TETON-1 were also presented at ATS during the Breaking News: 2026 Clinical Trial Results in Pulmonary Medicine session on Sunday, May 17. Combined results from TETON-1 and TETON-2 were presented today during an oral session at ATS. TETON-1 met its primary efficacy endpoint, with nebulized Tyvaso demonstrating statistically significant improvement in absolute FVC relative to placebo from baseline to week 52 in an IPF population broadly treated with background therapy. The median change in FVC at week 52 was -43.3 mL in the nebulized Tyvaso group and -196.2 mL in the placebo group; between-group difference was 130.1 mL.