First clinical site now open for large trial testing seralutinib for people with pulmonary hypertension associated with interstitial lung disease (PH-ILD), Pulmonary Hypertension News, November 7, 2025

The first clinical site is now active for a global Phase 3 study that will evaluate Gossamer Bio’s therapy candidate seralutinib for people with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study, titled SERANATA, aims to enroll around 480 patients aged 18 to 80, randomised to receive either 90 mg or 120 mg […]

First clinical site now open for large trial testing seralutinib for people with pulmonary hypertension associated with interstitial lung disease (PH-ILD), Pulmonary Hypertension News, November 7, 2025 Read Post »

How Medicine Missed Viagra’s True Potential, MedPage Today, October 15, 2025

A recent article by Bharat Desai, an American physician specializing in internal medicine and pulmonary disease, argues that sildenafil could have revolutionized cardiovascular prevention, but was relegated to being an erectile dysfunction drug due to the at-the-time medical environment’s obsession with cholesterol. The Forgotten Origins Sildenafil was originally developed in the early 1990s as a

How Medicine Missed Viagra’s True Potential, MedPage Today, October 15, 2025 Read Post »

Gossamer Bio and Respira Therapeutics have entered into an option agreement to develop Respira’s pulmonary hypertension treatment candidate RT234, Pulmonary Hypertension News, September 26, 2024

Gossamer Bio has an option to acquire Respira Therapeutics and its inhaled pulmonary arterial hypertension treatment RT234. Gossamer plans to develop RT234 for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), the same two indications for which it is already developing its own inhaled treatment candidate, seralutinib. RT234 is an inhaled formulation

Gossamer Bio and Respira Therapeutics have entered into an option agreement to develop Respira’s pulmonary hypertension treatment candidate RT234, Pulmonary Hypertension News, September 26, 2024 Read Post »

Allrock Bio Raises $50M to advance pulmonary arterial hypertension (PAH) and pulmonary hypertension due to interstitial lung disease (PH-ILD) Treatment ROC-101 into Phase 2a Trials

Allrock Bio raised $50M to fund Phase 2a trials of ROC-101, an oral treatment for pulmonary hypertension. The ROCSTAR trial will test ROC-101 combined with standard therapies in pulmonary arterial hypertension (PAH) and pulmonary hypertension due to underlying interstitial lung disease (PH-ILD) patients, starting late 2025. ROC-101 blocks ROCK1 and ROCK2 proteins to reduce inflammation,

Allrock Bio Raises $50M to advance pulmonary arterial hypertension (PAH) and pulmonary hypertension due to interstitial lung disease (PH-ILD) Treatment ROC-101 into Phase 2a Trials Read Post »

Data on investigational treprostinil transdermal patch system to be presented at professional symposium organised by the US Pulmonary Hypertension Association, September 18-20, 2025

Corsair Pharma will present preclinical data on their TRX-248 transdermal patch at the Pulmonary Hypertension Professional Network Symposium (PHPPN), Sept 18-20, 2025. The once-daily patch delivers treprostinil for pulmonary arterial hypertension treatment. These data provide additional support for the clinical program which is currently in a first-in-human Phase 1 study. The transdermal patch has the

Data on investigational treprostinil transdermal patch system to be presented at professional symposium organised by the US Pulmonary Hypertension Association, September 18-20, 2025 Read Post »

TETON-2 Pivotal Study of Tyvaso® Meets Primary Endpoint for the Treatment of Idiopathic Pulmonary Fibrosis, September 2, 2025

United Therapeutics has announced that the pivotal TETON-2 study of nebulized Tyvaso® (treprostinil) for the treatment of idiopathic pulmonary fibrosis (WHO Group III) met its primary endpoint—and several key secondary endpoints—with statistical significance. Read more on the press release at this link

TETON-2 Pivotal Study of Tyvaso® Meets Primary Endpoint for the Treatment of Idiopathic Pulmonary Fibrosis, September 2, 2025 Read Post »

Terumo Corporation Acquires OrganOx Limited, thus entering into the organ transplantation-related sector, Biospace, August 24, 2025

Terumo, a leading medical technology company based in Japan, has announced a definitive agreement to acquire all outstanding shares of OrganOx, for approximately $1.5 billion. OrganOx specializes in advanced organ preservation devices using Normothermic Machine Perfusion technology, which preserves organs longer by circulating oxygen and nutrient-rich fluids through organs at near-body temperature. This technology enables

Terumo Corporation Acquires OrganOx Limited, thus entering into the organ transplantation-related sector, Biospace, August 24, 2025 Read Post »

Cereno Scientific Granted FDA Fast Track Designation for CS1 Investigational Drug for Pulmonary Arterial Hypertension (PAH)

Cereno Scientific announced on August 26, 2025 that the US Food and Drug Administration (FDA) has granted Fast Track designation to CS1, its lead drug candidate for treating pulmonary arterial hypertension (PAH). This designation accelerates development and regulatory review for treatments addressing serious conditions with high unmet medical need. In a Phase IIa trial, it

Cereno Scientific Granted FDA Fast Track Designation for CS1 Investigational Drug for Pulmonary Arterial Hypertension (PAH) Read Post »

Why negative trials in pulmonary arterial hypertension should be made public, Current Opinion in Pulmonary Medicine, July 8, 2025

A review published on Current Opinion in Pulmonary Medicine on July 8, 2025 examines recent negative clinical trials in pulmonary arterial hypertension (PAH) research, emphasizing the valuable insights these studies provide despite their unsuccessful outcomes. The article reviews several recent negative trials testing various therapeutic approaches in pulmonary arterial hypertension, including tocilizumab (an anti-inflammatory drug),

Why negative trials in pulmonary arterial hypertension should be made public, Current Opinion in Pulmonary Medicine, July 8, 2025 Read Post »

Phase 3 pulmonary arterial hypertension trial of ralinepag now fully enrolled, results are expected in 2026, Pulmonary Hypertension News, June 27, 2025

Ralinepag is a novel prostacyclin receptor agonist. It is designed to mimic prostacyclin, a molecule that reduces blood pressure by relaxing blood vessels. It is a once-daily oral formulation. United Therapeutics has announced the completion of enrollment for its ADVANCE OUTCOMES, a Phase 3 clinical trial testing ralinepag for pulmonary arterial hypertension (PAH). The study

Phase 3 pulmonary arterial hypertension trial of ralinepag now fully enrolled, results are expected in 2026, Pulmonary Hypertension News, June 27, 2025 Read Post »

Enrollment completed in ongoing PROSERA Phase 3 study for seralutinib in pulmonary arterial hypertension

Gossamer Bio, Inc. today announced enrollment completion for the ongoing, global registrational Phase 3 PROSERA Study evaluating seralutinib in Functional Class II and III pulmonary arterial hypertension patients. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement. See also our previous article about the PROSERA study at this link

Enrollment completed in ongoing PROSERA Phase 3 study for seralutinib in pulmonary arterial hypertension Read Post »

UK-wide study validates the digital version of the emPHasis-10 QOL questionnaire for pulmonary arterial hypertension patients, European Respiratory Journal, May 2025

The emPHasis-10 questionnaire, designed to reflect that lived experience, has long been a trusted tool in both clinics and studies but until now, it was only available on paper. In a new UK-wide study, researchers led by Dr. Joseph Newman and colleagues tested the first digital version of emPHasis-10 using the Atom5™ smartphone app. Their

UK-wide study validates the digital version of the emPHasis-10 QOL questionnaire for pulmonary arterial hypertension patients, European Respiratory Journal, May 2025 Read Post »

Cereno Scientific receives endorsement from the US Food and Drug Administration for their Phase IIb trial of CS1 in pulmonary arterial hypertension

The investigational drug CS1 aims to reverse the pathological vascular remodeling of the small pulmonary arteries. A successful Phase IIa trial was concluded in 2024 (see our article here). Insights into the long-term use of CS1 are being gathered in an expanded access program with 10 patients from the Phase IIa trial. Preparations are currently

Cereno Scientific receives endorsement from the US Food and Drug Administration for their Phase IIb trial of CS1 in pulmonary arterial hypertension Read Post »

US Food and Drug Administration approves YUTREPIA, a treprostinil inhalation powder for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease

Yutrepia is a dry powder formulation of treprostinil, a prostacyclin analog. It is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort. Yutrepia was was tentatively approved by the Food and Drug Administration last year (see our article here), but the agency was waiting for regulatory exclusivity of a competing product

US Food and Drug Administration approves YUTREPIA, a treprostinil inhalation powder for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease Read Post »

Breaking news! Important update on the ZENITH trial on Winrevair (sotatercept) in pulmonary arterial hypertension from the American College of Cardiologists Scientific Annual Scientific Session, March 31, 2025

A very important update on the phase 3 ZENITH trial for Winrevair (sotatercept) in pulmonary arterial hypertension was presented today at the American College of Cardiologists Annual Scientific Session in Boston, USA. The ZENITH trial evaluated Winrevair compared to placebo in adults with PAH, WHO Group 1, functional class III or IV, at high risk

Breaking news! Important update on the ZENITH trial on Winrevair (sotatercept) in pulmonary arterial hypertension from the American College of Cardiologists Scientific Annual Scientific Session, March 31, 2025 Read Post »

The US Food and Drug Administration (FDA) has accepted the new drug application resubmission for YUTREPIA™ (treprostinil) inhalation powder, March 28, 2025

Link: Liquidia Corporation announced on March 28, 2025, that the US Food and Drug Administration has accepted its resubmitted new drug application for YUTREPIA (treprostinil) inhalation powder. The treatment targets pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA had previously granted tentative approval for both indications (see our

The US Food and Drug Administration (FDA) has accepted the new drug application resubmission for YUTREPIA™ (treprostinil) inhalation powder, March 28, 2025 Read Post »

The Aeson Total Artificial Heart helps three heart failure patients with pulmonary hypertension become heart transplant-eligible, The Journal of Heart and Lung Transplantation, February 5, 2025

Three heart failure patients with pulmonary hypertension (WHO Group II) became eligible for heart transplants after receiving the Aeson Total Artificial Heart, which effectively took place after 243, 155 and 109 days respectively. This innovative device, implanted with the help of the advanced Carmat system, replaces the heart’s ventricles and maintains continuous blood circulation, stabilizing

The Aeson Total Artificial Heart helps three heart failure patients with pulmonary hypertension become heart transplant-eligible, The Journal of Heart and Lung Transplantation, February 5, 2025 Read Post »

Cereno Scientific launches sub-study on drug candidate CS1 for Pulmonary Arterial Hypertension, February 19, 2025

Cereno Scientific has received approval to initiate a sub-study within its Expanded Access Program (EAP) for CS1, a drug candidate aimed at treating pulmonary arterial hypertension. The study will use Functional Respiratory Imaging (FRI) technology, developed by Fluidda, to monitor changes in small pulmonary arteries over a 12-month period. This innovative approach aims to explore

Cereno Scientific launches sub-study on drug candidate CS1 for Pulmonary Arterial Hypertension, February 19, 2025 Read Post »

New data on seralutinib presented at the Pulmonary Vascular Research Institute conference in Rio, January 29-February 1, 2025

Gossamer Bio, Inc. presented clinical and preclinical data related to its investigational drug seralutinib at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress that took place January 29th through February 1st in Rio de Janeiro, Brazil. Of particular interest the data on sustained benefit of seralutinib over nearly 1.5 years, and the evidence, from preclinical

New data on seralutinib presented at the Pulmonary Vascular Research Institute conference in Rio, January 29-February 1, 2025 Read Post »

Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis

Merck/MSD announced today that the Phase 3 HYPERION trial on pulmonary arterial hypertension patients (Group 1 World Health Organisation) in functional class II-III was suspended. Patients in the study will be offered the option of receiving WINREVAIR through the Phase 3 SOTERIA open-label extension study. Findings from the HYPERION study will be available later this

Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis Read Post »

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