United Therapeutics Co.

At the Wells Fargo Healthcare Conference, United Therapeutics presented a pipeline of 14 products that the company says could generate long-term annual pharmaceutical sales of USD 50–100 billion. Near-term catalysts include approvals for Ralinepag (PDUFA date), Tyvaso variants for IPF/PPF and progress in xenotransplantation. Management announced an accelerated USD 500 million share repurchase program and raised the operating budget target for pipeline funding to 55% of last year’s revenue, but warned of execution risks in trials, manufacturing and high investment costs for xenotransplantation. » Altro su de.investing.com

The phase‑3 ADVANCE OUTCOMES study of Ralinepag in pulmonary arterial hypertension met its primary endpoint, showing a 55% reduction in the risk of clinical worsening events versus placebo (HR 0.45; 95% CI 0.33–0.62; p<0.0001). The study included 687 patients, 80% of whom received dual background therapy; key secondary endpoints showed significant improvements in NT‑proBNP (−24.3%) and a placebo‑adjusted gain of 20.4 m in the 6‑minute walk test. Ralinepag increased the likelihood of clinical improvement by 47%; common adverse events were headache, diarrhea, nausea and myalgia, with no new safety signals. United Therapeutics submitted a regulatory application to the FDA in June 2026; the drug is not yet approved. » Altro su de.investing.com

The FDA granted United Therapeutics’ subsidiary Lung Bioengineering premarket approval for the LungFX device for centralized ex‑vivo assessment of recovered donor lungs. LungFX enables normothermic perfusion and ventilation of previously cold‑stored lungs and is intended for reassessment of donor lungs in adult primary transplant recipients; cumulative preservation time must not exceed 20 hours. Lung Bioengineering plans to include the device in its service offering from 2027 and already operates facilities in Silver Spring and Jacksonville. In the approval‑relevant study, however, the predefined 12‑month survival goal was not met and mortality rates were higher than those in the control group. » Altro su de.investing.com