FDA Accepts UTHR's sNDA for Tyvaso in Idiopathic Pulmonary Fibrosis

United Therapeutics UTHR recently announced that the FDA has accepted its supplemental new drug application (sNDA) for review, seeking approval for expanded use of its marketed drug, nebulized Tyvaso, in idiopathic pulmonary fibrosis (IPF). A regulatory decision is expected in late April 2027. If approved, the product would be the first FDA-approved inhaled anti-fibrotic treatment for the said indication.

United Therapeutics already markets nebulized Tyvaso for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease. Besides the nebulized formulation, the drug is also approved as a dry powder inhalation (DPI) version for the same indications. The company generates majority of its revenues from the Tyvaso franchise.

IPF is a progressive lung-scarring disease that gradually impairs oxygen transfer, often leading to respiratory failure and death. It primarily affects older adults and may be associated with smoking, genetic factors, environmental exposures and acid reflux. In the United States, at least 100,000 people are estimated to live with IPF, highlighting a significant unmet medical need.

Year to date, shares of United Therapeutics have risen 0.9% compared with the industry’s 0.6% growth.

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UTHR’s Tyvaso sNDA for IPF Backed by TETON Data

The sNDA was submitted in June, based on positive top-line data from the TETON program, which consisted of two parallel phase III studies, TETON-1 (conducted in the United States and Canada) and TETON-2 (internationally), designed to evaluate nebulized Tyvaso in patients with IPF. Both studies met their primary endpoints, demonstrating statistically significant improvement in lung function for IPF patients, including a meaningful increase in forced vital capacity (FVC). The studies also reduced the risk of clinical worsening and showed favorable trends across key secondary endpoints.

Integrated analyses of studies reinforced these findings, showing a 111.8 mL FVC benefit and broad secondary endpoint improvements.

In addition to IPF, United Therapeutics is conducting a late-stage TETON PPF study to evaluate the therapy in progressive pulmonary fibrosis (PPF). The company completed patient enrollment in August, with top-line data anticipated in the second half of 2027.

UTHR's Zacks Rank & Stocks to Consider

United Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Precigen PGEN, currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune ACIU and Aldeyra Therapeutics ALDX, carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 30 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents per share to earnings of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents per share. PGEN shares have surged 68% year to date.

Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.

Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 9.6% year to date.

AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.

Over the past 30 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 71.1% year to date.

Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.

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