Bengaluru — 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 multibillion-dollar market opportunity.
The inhaled drug, chemically known as treprostinil, is being tested in patients with idiopathic pulmonary fibrosis, an irreversible condition characterised 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 US marketing application after announcing data from another late-stage study in the first half of 2026. It also plans to meet 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 $3bn nominal peak sales for Tyvaso in IPF.
Tyvaso generated sales of $1.62bn in 2024.
The drug is already approved in the US to treat another rare lung condition called pulmonary arterial hypertension.
United Therapeutics shares were up 37% at $417.73.
Reuters
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