United Therapeutics Shares Up With Tyvaso Nearing FDA Milestone

May 26, 2026
United Therapeutics Shares Up With Tyvaso Nearing FDA Milestone

New York, May 26, 2026, 14:03 (EDT)

United Therapeutics shares gained 1.4% to $576.30 in early-afternoon trade Tuesday. The stock opened at $564.61 and reached as high as $576.99 intraday. Market cap was about $27.2 billion.

Nasdaq opened again after the Memorial Day break, pushing broader stock indexes higher in early U.S. trading. Tech stocks took the lead, with the Nasdaq out in front. Growth-focused healthcare shares also got a lift compared to trading before the holiday.

United Therapeutics isn’t just moving on Tuesday’s price action. The company is looking to expand Tyvaso, now its core pulmonary hypertension drug, into treatment for idiopathic pulmonary fibrosis, or IPF. IPF is a progressive lung disease marked by scarring.

TETON-1, a Phase 3 trial testing nebulized Tyvaso, posted a 130.1 mL gain in forced vital capacity over placebo this month. FVC tracks how much air a patient can force out after breathing in deeply. The trial also showed a 33% lower risk of clinical worsening. When TETON-1 and TETON-2 results were pooled, the data pointed to a 48% cut in acute IPF exacerbations. Overall survival came in higher for treatment, but didn’t hit significance.

United Therapeutics said it expects to file a supplemental New Drug Application by the end of the summer, aiming for priority review from the FDA to speed up the process. Tyvaso is still investigational for IPF.

The company is steering attention toward growth, following a mixed start to the year. Revenue was down 2% at $781.5 million. Net income slid 15% to $274.9 million. Total Tyvaso revenue also slipped 2% to $457.5 million, as gains in Tyvaso DPI could not cover weaker nebulized Tyvaso numbers.

CEO Martine Rothblatt said the TETON program is a “truly important advancement” for IPF patients. Product development chief Peter Smith cited Tyvaso’s “multi-pathway activity” through fibrotic, vascular and inflammatory pathways. Steven Nathan, chair of the TETON steering group, said TETON-1 confirmed the earlier TETON-2 results and called the combined findings “truly impressive.” Unither Investors

Most analysts are still positive but some have questions about the stock’s valuation. TD Cowen kept its Buy and $675 target last week following a lunch meeting with a pulmonologist in the TETON trials. An analyst poll from Investing.com counted 12 Buys, three Holds and no Sells, with the average 12-month target sitting at $665.23.

Competition is already here. Liquidia’s Yutrepia, an inhaled treprostinil, got FDA approval in 2025 to treat pulmonary arterial hypertension and pulmonary hypertension tied to interstitial lung disease. Liquidia posted Yutrepia net product sales of around $130 million for Q1 2026.

Insmed is on the radar too. The company’s treprostinil palmitil inhalation powder, or TPIP, is in a Phase 3 trial for pulmonary hypertension tied to interstitial lung disease. TPIP is also in Phase 2 studies for IPF and progressive pulmonary fibrosis, Insmed’s pipeline shows.

But the risks are on the table. The FDA still needs to take up and review the IPF filing, the survival data hasn’t hit significance, and Tyvaso is already seeing rivals in the inhaled-prostacyclin space. United Therapeutics President Michael Benkowitz called the market “dynamic” back in May, saying the “competitive landscape for inhaled prostacyclins remains dynamic,” words that may show up again before the next event. Unither Investors

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