United Therapeutics Corp

United Therapeutics Corp(UTHR)资讯与事件

$563.490

+9.805 (+1.74%)收盘时

UTHR 资讯

UTHR 事件

10/22 07:30

United Therapeutics Authorizes Up to $2 Billion Share Repurchase Program

United Therapeutics announced that the company's Board of Directors has authorized a new share repurchase program for up to $2 billion of the company's common stock, available through October 21, 2027. "We have the balance sheet and free cash flow to fund our long-term ambitions and the confidence to act decisively when our own shares represent a compelling investment," said James Edgemond, Chief Financial Officer and Treasurer of United Therapeutics. "This authorization is a clear reflection of our deep conviction in the future of our company, our disciplined approach to capital allocation, and our commitment to delivering durable long-term value for shareholders."

10/20 07:30

United Therapeutics Opens Third Designated Pathogen-Free Facility in Texas

United Therapeutics announced the opening of its third Designated Pathogen-Free facility, The Dr. Bartley P. Griffith and Dr. Robert A. Montgomery Xenograft Production Facility, in Houston, Texas. United Therapeutics opened its first DPF facility in Christiansburg, Va. in 2024 to produce xenografts for ongoing clinical trials. The two new facilities in Stewartville and Houston are designed to enable United Therapeutics to scale commercial production of its xeno-organs following approval of these products.

10/19 07:30

United Therapeutics Receives FDA Clearance for SUMMIT Clinical Trial

United Therapeutics announced that the U.S. Food and Drug Administration has granted clearance under the company's investigational new drug application to proceed with the SUMMIT clinical trial of treprostinil SMI in PH-COPD. The phase 2, 16-week, double blind SUMMIT study will evaluate the safety and tolerability of treprostinil SMI in approximately 40 patients with PH-COPD. The study's secondary endpoints will evaluate the efficacy of treprostinil SMI on exercise capacity and N-terminal pro-B-type natriuretic peptide, a critical biomarker for heart failure. Eligible patients in the SUMMIT study will be able to enroll in an open-label extension study to evaluate the long-term safety, tolerability, and efficacy of treprostinil SMI. Assuming a successful outcome in the SUMMIT study, United Therapeutics anticipates commencing a subsequent phase 3 registration study for treprostinil SMI in PH-COPD in 2028. Treprostinil SMI includes a portable, handheld soft mist inhaler designed to deliver a preserved formulation of inhaled treprostinil solution in a single breath. The product will be available for the clinical study in multiple dose strengths to support individualized titration and long-term maintenance dosing, administered four times daily. Each single-load cartridge is designed to support up to two weeks of use, and the product can be stored at room temperature, offering patients a convenient, easy-to-carry delivery option. United Therapeutics also plans to develop treprostinil SMI for pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, idiopathic pulmonary fibrosis, and progressive pulmonary fibrosis. Treprostinil SMI is an investigational-stage product, and is not yet approved in any jurisdiction for any indication.

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