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FDA decision on sotatercept for PAH expected in March

The U.S. Food and Drug Administration (FDA) has agreed to review an application seeking approval of sotatercept as a treatment for adults with pulmonary arterial hypertension (PAH). The FDA has given the application priority review, shortening the review time from the usual 10 months to six months. A decision…

Approval decision on Yutrepia for PH-ILD expected in January

Note: This story was updated Jan. 30, 2024, to correct the approved indications of available treprostinil formulations. Amid ongoing litigation, the U.S. Food and Drug Administration (FDA) has agreed to review an application from Liquidia that seeks to extend the approval of Yutrepia — an inhaled dry powder…

Corsair raises $23M to support testing of treprostinil skin patch

Corsair Pharma has secured $23 million in financing to support clinical testing of a skin patch for the delivery of treprostinil to treat pulmonary arterial hypertension (PAH), the company announced. The transdermal patch is intended to provide continuous and consistent levels of treprostinil, similar to those achieved with…

Experimental therapy targets PAH-driving serotonin receptor

Treatment with VU6047534, an experimental therapy that blocks the activity of a specific type of serotonin receptor, reduced strain on the heart in a mouse model of pulmonary arterial hypertension (PAH) in a new study. The study, “Development of a Peripherally Restricted 5-HT2B Partial Agonist for Treatment…

Us2.ai, Duke University team up to develop better tools using AI

A joint initiative between a Singapore-based medical technology company and Duke University is aiming to develop and commercialize artificial intelligence, or AI, tools for echocardiography — using ultrasounds to visualize the heart. Researchers from Us2.ai, the first new company created from an 11-country cardiovascular research platform, have teamed up…

Gradient raises €14M in support of ultrasound-based device for PH

Gradient Denervation Technologies has raised €14 million (around $14.9 million) in funding to support the clinical development and testing of an ultrasound-based catheter device for the treatment of pulmonary hypertension (PH). The minimally invasive catheter device is designed for use in the pulmonary arteries. It delivers therapeutic ultrasound…

Sotatercept improves blood flow, heart health in PAH: STELLAR trial

Treatment with sotatercept in addition to standard pulmonary arterial hypertension (PAH) therapies significantly improved measures of heart health for adults with the disease, according to a new analysis of the STELLAR trial. Results from the Phase 3 trial had already shown the therapy enhanced walking abilities in the participants…

People with severe CTEPH see improved risk profile with treprostinil

Treatment with treprostinil improved the risk profile in people with inoperable or persistent severe chronic thromboembolic pulmonary hypertension (CTEPH). The risk profile was assessed using a risk score established to predict a response to treatment and survival in people with pulmonary arterial hypertension (PAH), the most common type…

Janssen stops Phase 3 trial testing high-dose Opsumit in CTEPH

A Phase 3 clinical trial testing high-dose Opsumit (macitentan) in people with chronic thromboembolic pulmonary hypertension (CTEPH) has ended early after an analysis showed the treatment is unlikely to help patients. The announcement was made in a press release from Janssen, the company that markets Opsumit. Opsumit…