United Therapeutics Corp - UTHR STOCK NEWS

On October 21, 2021, United Therapeutics (Nasdaq: UTHR) presented significant clinical data at CHEST 2021 regarding pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The highlight was the new pharmacokinetic data from the BREEZE study of Tyvaso DPI, which showed comparable systemic exposure to existing Tyvaso treatments with reduced variability. The data indicate successful transitions from Tyvaso to Tyvaso DPI, enhancing patient outcomes, such as improved walking distance and overall satisfaction.

United Therapeutics Corporation (Nasdaq: UTHR) announced a setback in the FDA review of its new drug application for Tyvaso DPI™ for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). On October 15, 2021, the FDA issued a complete response letter citing a single deficiency at a third-party testing facility, delaying approval. The company aims to resolve this issue and anticipates resubmission by summer 2022.

United Therapeutics Corporation (Nasdaq: UTHR) announced the presentation of new data on pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) at the CHEST 2021 meeting, scheduled for October 17-20, 2021. The company will showcase 10 abstracts, including pharmacokinetic data from the BREEZE study of Tyvaso DPI™. This study involved 51 PAH patients and aimed to assess the safety and tolerability of Tyvaso DPI. Highlights also include real-world analyses of Orenitram and implications for patient care.

On September 30, 2021, United Therapeutics Corporation (Nasdaq: UTHR) announced its conversion to a public benefit corporation (PBC) following shareholder approval. This marks the first conversion of a public biotech company to a PBC, aligning its corporate structure with its mission to improve patient health, enhance employee engagement, and address sustainability. The company aims to advance the development of novel pharmaceuticals and organ transplant technologies while ensuring strong shareholder returns. Stakeholder support for this initiative underlines its commitment to responsible corporate practices.

United Therapeutics Corporation (Nasdaq: UTHR) released its second annual Corporate Responsibility Report highlighting its commitment to environmental, social, and governance (ESG) priorities for 2020. The report utilizes frameworks from Global Reporting Initiative (GRI), Sustainability Accounting Standards Board (SASB), and Task Force on Climate-Related Financial Disclosures (TCFD). Dewey Steadman stated that the report demonstrates progress in transparency and reaffirms the company's leadership in ESG management. More details are available at corporateresponsibility.unither.com.

United Therapeutics Corporation (Nasdaq: UTHR) showcased the BREEZE study results for Tyvaso DPI™ at the European Respiratory Society Congress 2021. This next-generation inhalation solution for pulmonary arterial hypertension (PAH) demonstrated significant safety and tolerability, with 96% completion rate in a three-week trial. Key findings included an 11.5-meter increase in six-minute walk distance and enhanced patient satisfaction with the device. The FDA is expected to review Tyvaso DPI's NDA in October 2021, which could enhance therapeutic accessibility for PAH patients.

On August 25, 2021, United Therapeutics Corporation (Nasdaq: UTHR) announced its collaboration with former NFL player Devon Still and his daughter Leah to launch 'Braving NeuroBLASToma,' an educational initiative aimed at raising awareness about neuroblastoma, a rare cancer in children. Neuroblastoma accounts for 7-10% of childhood cancers in the U.S., with about 800 new cases annually. The initiative includes a toolkit, a resource-rich website, and a series of illustrated books addressing different treatment stages, aimed at supporting families affected by this challenging cancer.

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.