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 (UTHR) is a pioneering biotechnology company dedicated to developing and commercializing innovative products that address unmet medical needs for patients with chronic and life-threatening conditions. The company's core business revolves around the creation of treatments for pulmonary arterial hypertension (PAH), a rare and progressive disease characterized by high blood pressure in the lungs' arteries. United Therapeutics' therapies predominantly focus on the prostacyclin pathway, with many treatments based on the molecule treprostinil.
With five approved products on the market, United Therapeutics is relentless in its mission to deliver 'medicines for life.' The company's long-term vision includes providing an unlimited supply of transplantable organs to those in need. Employees collaborate across the United States, Europe, and Asia to achieve this ambitious goal.
In addition to its focus on PAH, the company is also dedicated to researching and developing treatments for cardiovascular and pulmonary diseases, pediatric cancers, and other orphan diseases. United Therapeutics markets a pediatric oncology drug, but its primary focus remains on advancing therapeutics for PAH.
United Therapeutics has seen significant achievements in recent years, continually pushing the boundaries of medical science. Their financial condition remains robust, driven largely by sales within the United States. The company is actively engaged in various partnerships and projects aimed at enhancing their therapeutic offerings and expanding their global footprint.
United Therapeutics Corporation (Nasdaq: UTHR) has announced the commercial launch of the Remunity® Pump for Remodulin®, designed for patients with pulmonary arterial hypertension (PAH). The Remunity Pump is the first subcutaneous delivery system that offers prefilled cassettes for patient convenience, significantly improving on existing options. Initially cleared by the FDA in May 2019, the pump aims to enhance patient experience, addressing the specific needs of the PAH community during the COVID-19 pandemic. The Remunity Pump is positioned to optimize treatment with its discreet design and ease of use.
United Therapeutics Corporation (Nasdaq: UTHR) announced positive results from the BREEZE study for Tyvaso DPI, a dry powder formulation of treprostinil for pulmonary arterial hypertension (PAH). The study met its primary objective, showing safety and tolerability in 51 patients transitioning from Tyvaso Inhalation Solution. Results indicated that 96% of participants completed the treatment phase without drug-related adverse events. The company plans to submit a New Drug Application to the FDA in April 2021, seeking indications for PAH and pulmonary hypertension associated with interstitial lung disease.
United Therapeutics Corporation (Nasdaq: UTHR) announced the publication of the INCREASE clinical study results for Tyvaso® in the New England Journal of Medicine. The study, the largest on pulmonary hypertension associated with interstitial lung disease (PH-ILD), demonstrated significant improvements in exercise capacity, highlighted by a 31-meter increase in six-minute walk distance (6MWD) at Week 16 (p<0.001). The sNDA for Tyvaso in PH-ILD has been accepted by the FDA, with a review expected to be complete in April 2021.
United Therapeutics Corporation (Nasdaq: UTHR) announced that CEO Martine Rothblatt will present at the 39th J.P. Morgan Healthcare Conference on January 11, 2021. The presentation, focusing on the company's business updates, will be held virtually from 10:50 a.m. to 11:30 a.m. EST. Interested parties can access the live webcast through the company's website, with an archived version available 24 hours post-event for 30 days.
United Therapeutics aims to tackle organ shortages through innovative technologies.
United Therapeutics Corporation (Nasdaq: UTHR) has announced the acquisition of a Rare Pediatric Disease Priority Review Voucher (PRV) for $105 million. This PRV will allow the company to expedite the review of its forthcoming New Drug Application (NDA) for Tyvaso DPI, expected in the first half of 2021. The PRV reduces the review period from 12 to 8 months, enhancing the potential for timely market entry. The Tyvaso DPI aims to improve treatment for pulmonary hypertension, providing a more convenient delivery method compared to existing therapies.
United Therapeutics Corporation (Nasdaq: UTHR) announced that the FDA has granted orphan drug designation to treprostinil for treating idiopathic pulmonary fibrosis (IPF). The company plans to initiate a phase 3 study named TETON to evaluate Tyvaso (treprostinil) Inhalation Solution in IPF patients, with enrollment expected in 2021. This designation provides potential benefits like seven years of market exclusivity post-approval and may extend to the Treprostinil Technosphere upon approval. IPF affects around 100,000 individuals in the U.S. annually.
United Therapeutics Corporation (Nasdaq: UTHR) released its inaugural Corporate Responsibility Report, highlighting 2019 data and selected 2020 updates. This report outlines the company’s commitment to environmental, social, and governance (ESG) priorities, developed with guidance from its Board of Directors and based on GRI and SASB metrics. CEO Martine Rothblatt emphasized the company's long-standing focus on corporate responsibility. United Therapeutics plans to continue these reports annually, with the next expected around mid-2021.
United Therapeutics Corporation (Nasdaq: UTHR) announced that CFO James Edgemond will present at the Jefferies Virtual London Healthcare Conference on November 17, 2020, from 6:45 to 7:15 p.m. GMT. The live webcast will be available on their website, with an archived version accessible for 90 days post-event. United Therapeutics emphasizes innovation and quality in their biotechnology model and addresses organ shortages through their subsidiary, Lung Biotechnology PBC.
United Therapeutics Corporation (Nasdaq: UTHR) announced that President and COO Michael Benkowitz will present at the Credit Suisse 29th Annual Virtual Healthcare Conference. The presentation is scheduled for November 9, 2020, from 2:45 to 3:25 p.m. EST, and will be accessible via a live webcast on the company's website. An archived version will be available 24 hours post-event for 90 days. United Therapeutics focuses on innovation and sustainability in biotechnology, particularly through its subsidiary Lung Biotechnology PBC, which addresses the shortage of transplantable organs.
United Therapeutics (Nasdaq: UTHR) reported Q3 2020 revenues of $380.1 million, down 5% from $401.5 million in Q3 2019. Despite this decline, net income rose by 29% to $171.2 million, translating to $3.86 per basic share. The company anticipates revenue growth from upcoming product launches, including Tyvaso's label expansion and the introduction of the Remunity Pump. Year-over-year, sales for Tyvaso and Orenitram increased by 17% and 20%, respectively, while Remodulin revenues fell by 26% due to competition and a distributor order issue.
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