United Therapeutics files two rare pulmonary disease NDAs, sets sights on approvals in 2027
The company said it submitted new drug applications for ralinepag tablets in PAH and Nebulized Tyvaso in IPF, with more filings and organ program milestones expected by year end.
United Therapeutics reported second quarter 2026 financial results on August 5, 2026. CEO Martine Rothblatt said the company had just submitted what it believes are two of the most important NDAs in rare pulmonary disease history: ralinepag tablets in PAH and Nebulized Tyvaso in IPF.1
Rothblatt said the company plans further filings later this year, including an IND application for ralinepag DPI and an NDA for treprostinil SMI, which it believes may open the door to a substantial increase in growth by the end of the decade.1 She said the company expects potential approvals for Nebulized Tyvaso in IPF and ralinepag tablets in PAH by next year, which it described as potentially transformative, multi-billion-dollar catalysts for growth.1 She added that Tyvaso DPI is expected to follow Nebulized Tyvaso into IPF and then into progressive pulmonary fibrosis.1
On organ manufacturing, Rothblatt said the pipeline is progressing, with clinical trials underway or planned for liver, kidney, heart, and lung products, and the company plans to open two xeno-organ production facilities in Minnesota and Texas later this year.1
President and COO Michael Benkowitz said Tyvaso DPI closed the quarter with its highest ever quarterly totals for new patient starts, referrals, commercial patients and overall patients, which he linked to strong demand.1 He said the company is confident it can extend its position in the inhaled prostacyclin market, citing its device, clinical experience, and remaining opportunity in PH-ILD.1
The company said competition from rival therapies weighed on sales of Nebulized Tyvaso, Tyvaso DPI, and Remodulin during both the three and six month periods ended June 30, 2026.1
On capital allocation, United Therapeutics noted that its Board approved a $2.0 billion share repurchase program in March 2026, running through March 9, 2027,1 and that $500 million remained available under that program as of June 30, 2026.1 The company reported cash, cash equivalents, and marketable investments of $3,803.4 million as of that date.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.