United Therapeutics shares surge as lung disease drug meets main study goal
Shares of United Therapeutics surged over 42% in premarket trading on Tuesday after its lung disease treatment, treprostinil, met the main goal in a late stage study.
The inhaled drug, marketed as Tyvaso, demonstrated substantial improvement in lung function in patients with Idiopathic Pulmonary Fibrosis, a debilitating and irreversible condition characterized by stiff and scarred lung tissue, making breathing increasingly difficult.
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, the company said.
FVC is a widely used indicator to assess disease progression in IPF patients.
The drug is already approved in the U.S. to treat another rare lung condition called pulmonary arterial hypertension, which causes high blood pressure in vessels connecting the lungs to the heart.
United Therapeutics said it plans to meet with the FDA before year-end to discuss expanding the drug’s label to include IPF.
Current treatment options for patients include Swiss drugmaker Roche’s oral drug Esbriet and Boehringer Ingelheim’s Ofev.
Shares of MannKind Corp which partners with United Therapeutics for a dry powder version of Tyvaso, rose nearly 36% to $6.22 before the bell.
