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United Therapeutics Corporation (UTHR) delivers innovative therapies for pulmonary arterial hypertension and rare diseases through cutting-edge research and targeted drug development. This news hub provides investors, healthcare professionals, and stakeholders with timely updates on regulatory milestones, clinical trial progress, and strategic initiatives shaping the biopharmaceutical landscape.
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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 Interested parties can access the live webcast through the company's website, with an archived version available 24 hours post-event for 30 days.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.
United Therapeutics Corporation (Nasdaq: UTHR) presented new clinical data on Tyvaso (treprostinil) Inhalation Solution for pulmonary hypertension associated with interstitial lung disease (PH-ILD) at the CHEST 2020 conference. The phase 3 INCREASE study showed that patients receiving Tyvaso experienced fewer exacerbations of lung disease and improvements in forced vital capacity (FVC) compared to placebo. With an estimated 30,000 PH-ILD patients in the U.S. and no current FDA-approved therapies, the data underscore Tyvaso's potential in addressing this serious condition.
United Therapeutics Corporation (Nasdaq: UTHR) announced it will report its third quarter 2020 financial results on October 28, 2020, before market opens. A teleconference will follow at 9:00 a.m. ET, accessible via phone and webcast on their website. The company emphasizes a commitment to innovation and quality, alongside efforts to address the shortage of transplantable organs through its subsidiary, Lung Biotechnology PBC. They caution that forward-looking statements may be subject to risks that could cause actual results to differ.