United Therapeutics Corp - UTHR STOCK NEWS

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.

United Therapeutics Corporation (Nasdaq: UTHR) reported a 6% year-over-year increase in total revenue for Q1 2021, reaching $379.1 million, compared to $356.3 million in Q1 2020. The company faced a significant net income decline of 79%, totaling $28.3 million, alongside a non-GAAP earnings increase of 2% to $162.1 million. Major revenue contributors included Tyvaso, which grew 20%, while Remodulin sales dipped by 10%. The report highlighted new product launches and ongoing clinical trials, including the TETON study, signaling positive growth prospects despite some challenges.

United Therapeutics Corporation (Nasdaq: UTHR) will report its first quarter 2021 financial results on May 5, 2021, before market opening. A teleconference is scheduled for the same day at 9:00 a.m. Eastern Time, accessible by phone and via webcast on the company's website. The company emphasizes its commitment to innovation and addressing the organ shortage crisis through its subsidiary, Lung Biotechnology. Forward-looking statements highlight potential risks and uncertainties that could impact future performance.

United Therapeutics Corporation (Nasdaq: UTHR) announced on April 19, 2021, the submission of a new drug application (NDA) to the FDA for its investigational product, Tyvaso DPI™, aimed at treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The submission includes results from the BREEZE clinical study, which indicated safety and efficacy similar to existing treatments. If approved, Tyvaso DPI is expected to enhance patient convenience and potentially double the number of patients on Tyvaso therapy by the end of 2022.

United Therapeutics Corporation (Nasdaq: UTHR) has received FDA approval for Tyvaso (treprostinil) Inhalation Solution, now indicated for treating pulmonary hypertension associated with interstitial lung disease (PH-ILD). This marks Tyvaso's second FDA approval since its initial release for pulmonary arterial hypertension in 2009. With approximately 30,000 patients affected in the U.S., the approval is expected to significantly improve patient management. United Therapeutics aims to double the number of Tyvaso patients by the end of 2022, leveraging a 40% expansion in their field teams.