Welcome to our dedicated page for United Therapeutics news (Ticker: UTHR), a resource for investors and traders seeking the latest updates and insights on United Therapeutics stock.
United Therapeutics Corporation develops and markets therapies for rare cardiopulmonary and related diseases, with a pulmonary arterial hypertension franchise built around treprostinil products such as Tyvaso DPI, Tyvaso Inhalation Solution, Remodulin and Orenitram. News commonly covers product sales, quarterly results, clinical data for pulmonary hypertension, idiopathic pulmonary fibrosis and interstitial lung disease, and updates on ralinepag and the TETON program.
The company also reports developments in manufactured-organ and transplant-support technologies, including EVLP, xenotransplantation, and Miromatrix Medical programs such as miroliverELAP and mirokidney. Governance updates, board composition, share repurchase activity and its status as a public benefit corporation are recurring corporate themes.
United Therapeutics Corporation (Nasdaq: UTHR) announced it will present data from the BREEZE clinical trial of Tyvaso DPI™ at the European Respiratory Society International Congress 2021, virtually from September 5-8. The study involved 51 patients transitioning from Tyvaso Inhalation Solution to Tyvaso DPI to evaluate safety and tolerability over three weeks. Secondary outcomes include six-minute walk distance and patient-reported outcomes. Tyvaso DPI aims to offer a more convenient treatment for pulmonary arterial hypertension (PAH) pending FDA approval in October 2021.
United Therapeutics Corporation (Nasdaq: UTHR) reported a 23% year-over-year revenue growth to $446.5 million for Q2 2021, up from $362.0 million in Q2 2020. Net income increased 61% to $172.6 million, with diluted EPS up 51% to $3.65. Key growth drivers included Tyvaso and Unituxin, with notable increases in patient referrals. Ongoing clinical trials for Tyvaso in COPD-associated pulmonary hypertension and IPF are progressing. However, the company faces challenges from generic competition affecting international Remodulin revenues.
United Therapeutics Corporation (Nasdaq: UTHR) will present an update on its business in a fireside chat at the 2021 Wedbush PacGrow Healthcare Virtual Conference on August 11, 2021, from 8:35 a.m. to 9:05 a.m. EDT. This session will be accessible via a live webcast on the company's website, with an archived version available for 90 days post-event. United Therapeutics focuses on biotechnology innovation and expanding organ supply through its subsidiary, Lung Biotechnology PBC, addressing the shortage of transplantable organs.
United Therapeutics Corporation (Nasdaq: UTHR) will release its second quarter 2021 financial results on August 4, 2021, before markets open. A public webcast will be held on the same day at 9:00 a.m. Eastern Time, accessible through their website. The company emphasizes its commitment to innovation in biotechnology and its role in addressing the shortage of transplantable organs through its subsidiary, Lung Biotechnology PBC. Forward-looking statements highlight potential risks and uncertainties that could affect future results.
United Therapeutics Corporation (Nasdaq: UTHR) has announced the publication of a post-hoc analysis from the INCREASE study of Tyvaso® (treprostinil) in pulmonary hypertension associated with interstitial lung disease (PH-ILD). The results showed significant improvements in forced vital capacity (FVC) among patients treated with Tyvaso compared to placebo over 16 weeks. This analysis supports the ongoing TETON study, which aims to evaluate Tyvaso's efficacy in patients with idiopathic pulmonary fibrosis (IPF). Tyvaso is FDA-approved for treating both PAH and PH-ILD.
MannKind Corporation (Nasdaq: MNKD) and United Therapeutics Corporation (Nasdaq: UTHR) announced the FDA's acceptance for priority review of the New Drug Application (NDA) for Tyvaso DPI™. This inhaled treatment addresses pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The review is set to conclude by October 2021, with no identified review issues thus far. This marks the second FDA review for a product developed using MannKind's Technosphere® technology, following the approved Afrezza®.
United Therapeutics Corporation (Nasdaq: UTHR) announced the FDA's acceptance for priority review of the New Drug Application (NDA) for Tyvaso DPI™ to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The review is expected to conclude by October 2021, with no identified review issues so far. Tyvaso DPI is a next-generation dry powder formulation, promising improved administration methods compared to traditional nebulization. The NDA includes data from the BREEZE study, which demonstrated the safety and tolerability of Tyvaso DPI.
On June 7, 2021, United Therapeutics Corporation (Nasdaq: UTHR) announced it is pursuing trade secret misappropriation claims against Liquidia Technologies, Inc. (Nasdaq: LQDA) and a former employee. The lawsuit stems from evidence suggesting the employee took confidential documents to Liquidia during the development of LIQ861, a product competing with United Therapeutics' Tyvaso. The FDA's approval of LIQ861 is on hold pending the outcome of the litigation, which is scheduled for trial in March 2022. United Therapeutics seeks monetary and injunctive relief due to these allegations.
United Therapeutics Corporation (Nasdaq: UTHR) has initiated the TETON study, enrolling its first patient. This phase 3 clinical trial, involving approximately 396 adults with idiopathic pulmonary fibrosis (IPF), aims to assess the efficacy of Tyvaso in improving forced vital capacity (FVC) over a 52-week period. IPF affects around 100,000 people in the U.S., presenting a critical unmet need despite existing treatment options. Positive insights from previous studies may validate Tyvaso's potential antifibrotic effects. Successful results could lead to FDA approval and seven years of market exclusivity for IPF treatment.
United Therapeutics Corporation (Nasdaq: UTHR) announced that CFO James Edgemond will present at the Jefferies Virtual Healthcare Conference on June 1, 2021, from 3:30 p.m. to 3:55 p.m. EDT. The session will be accessible via a live webcast on the company's website, with a recorded version available for 90 days post-event. United Therapeutics focuses on innovative biotechnology solutions and aims to address the shortage of transplantable organs through its subsidiary, Lung Biotechnology PBC, committed to enhancing organ availability.