By Mariam Sunny (Reuters) -Shares of United Therapeutics surged 37% to an all-time high on Tuesday after its drug Tyvaso significantly improved lung function in patients with a progressive lung condition in a late-stage study, potentially opening a multi-billion dollar market opportunity. The inhaled drug, chemically known as treprostinil, is being tested in patients with […]
Health
United Therapeutics shares hit record high after late-stage win for lung disease drug
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By Mariam Sunny
(Reuters) -Shares of United Therapeutics surged 37% to an all-time high on Tuesday after its drug Tyvaso significantly improved lung function in patients with a progressive lung condition in a late-stage study, potentially opening a multi-billion dollar market opportunity.
The inhaled drug, chemically known as treprostinil, is being tested in patients with Idiopathic Pulmonary Fibrosis, an irreversible condition characterized by stiff and scarred lung tissue, leading to breathing difficulties.
In the 597-patient study, treprostinil significantly improved forced vital capacity (FVC) — the amount of air a person can forcibly exhale after a deep breath — compared with placebo after 52 weeks, meeting the main goal of the study, the company said.
FVC is a widely used indicator to assess disease progression in IPF patients.
Tyvaso also showed benefits in patients receiving standard-of-care oral antifibrotics, such as Roche’s Esbriet and Boehringer Ingelheim’s Ofev, as well as those not on background therapy, the company said.
“We note that new therapies in IPF have a relatively low bar for efficacy given poor prognosis of the disease and issues with the current standard-of-care,” TD Cowen analyst Joseph Thome said in a note.
United Therapeutics plans to file a U.S. marketing application after announcing data from another late-stage study in the first half of 2026. It also plans to meet with the FDA before year-end to discuss expediting the drug’s review for IPF.
The data significantly increases the probability of success for Tyvaso to get approval and launch in IPF, pending success of the second late-stage study, said UBS analyst Ashwani Verma.
Verma projects about $3 billion nominal peak sales for Tyvaso in IPF.
Tyvaso generated sales of $1.62 billion in 2024.
The drug is already approved in the U.S. to treat another rare lung condition called pulmonary arterial hypertension.
United Therapeutics shares were up 37% at $417.73.
(Reporting by Mariam Sunny in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)