$UTHR (+1.66%)

The Phase III TETON-2 study with United Therapeutics' inhaled drug Tyvaso has met its primary endpoint and could mark a significant advance in the treatment of idiopathic pulmonary fibrosis.

United Therapeutics has announced positive results from the pivotal Phase III TETON-2 trial for the treatment of idiopathic pulmonary fibrosis (IPF). The inhaled drug Tyvaso (active ingredient: treprostinil) showed a significant improvement in lung function compared to placebo in the 52-week study. The primary endpoint, the change in absolute forced vital capacity (FVC), was achieved with a mean difference of 95.6 mL in favor of Tyvaso (p < 0.0001).

There were also statistically significant advantages over placebo for several secondary endpoints. These included the time to the first clinical deterioration event, the change in the percentage predicted FVC and improvements in quality of life (K-BILD questionnaire) and lung function (DLCO). Although the difference in time to first acute exacerbation and overall survival after 52 weeks was not significant, there was a trend in favor of Tyvaso here as well.

Broad efficacy and stable safety situation

The positive effects were observed across different subgroups: regardless of concomitant medication, smoking status or additional oxygen therapy. The safety profile corresponded to previous studies with Tyvaso, and no new safety concerns arose.

The data from TETON-2, together with the pending results of the ongoing TETON-1 study, will serve as the basis for an application to the US Food and Drug Administration (FDA) to expand the indication. A meeting with the agency is planned for the end of 2025 to discuss a potential accelerated review. Results from TETON-1 are expected in the first half of 2026.

Tyvaso has orphan drug designation for IPF treatment from both the FDA and the European Medicines Agency. Further data will be presented at the European Respiratory Society Congress in Amsterdam on September 28, 2025.

Conclusion: With today's jump in the share price, the United Therapeutics share could end its correction of several months. It would be important for the share price to establish itself above USD 417.82.

https://stock3.com/news/united-therapeutics-40-sprung-nach-studiendaten-16631403

Small update

$UTHR (+1.66%) time is running out and I'm getting downright panicky. Not even a month left until $LQDA (-0.09%) the sale of the PAH drug starts (PH-ILD approval still pending). Liquidia CEO (former CEO of UTHR) aims to gain 80-90% of market share.

My opinion on $LQDA (-0.09%)

Anyone interested in BioTech shares should definitely take a look here.

Disclaimer: I am well aware of the moral reprehensibility of investing in drugs that are essential for patients' survival. PAH is incurable.

The company recently won the patent case against $UTHR (+1.66%) won. Now there is a counterclaim. The drug in question is already approved by the FDA for the treatment of PAH, now only the additional approval for PH-ILD is pending. The market for both is worth billions and their drug is superior to UTHR (especially in ease of administration and efficacy), so it is expected to gain a relatively large share of this rapidly growing market (7.3 billion). PAH and PH-ILD drugs are real cash cows, growth forecast is >5% per year.

Personal price target is 60-70$ per share if they gain at least 5% market share (approx. 300-400 million in revenue)

with more optimistic developments you can imagine how sales can develop.

There is also the possibility that the company will be bought out.

For me personally, risk and reward are absolutely acceptable here.

PAH market: https://www.precedenceresearch.com/pulmonary-arterial-hypertension-market/amp

The drug:

https://liquidia.com/static-files/83cf40bb-70ba-4345-90ed-307e89e0bafb