Detecting pulmonary hypertension earlier? US Food and Drug Administration (FDA) clears Anumana’s AI echocardiogram algorithm

Anumana has received US Food and Drug Administration (FDA) 510(k) clearance for an AI-powered algorithm that detects early signs of pulmonary hypertension using standard 12-lead echocardiograms (ECGs) — making it the first pulmonary hypertension algorithm cleared for this widely available diagnostic tool. Previously granted US Food and Drug Administration “Breakthrough Device Designation”, the algorithm integrates […]

Detecting pulmonary hypertension earlier? US Food and Drug Administration (FDA) clears Anumana’s AI echocardiogram algorithm Read Post »

Tenax Therapeutics extends long-term study of oral levosimendan (TNX-103) in pulmonary hypertension with preserved ejection fraction (HFpEF) patients, February 2026

Tenax Therapeutics is conducting a long-term open-label extension study of TNX-103, an oral formulation of levosimendan, in patients with pulmonary hypertension associated with heart failure and preserved Ejection Fraction (HFpEF), Group 2 of the World Health Organisation classification. In its intravenous form TNX-103 is a drug authorized for use in 60 countries for acute decompensated

Tenax Therapeutics extends long-term study of oral levosimendan (TNX-103) in pulmonary hypertension with preserved ejection fraction (HFpEF) patients, February 2026 Read Post »

Results of the PROSERA study for seralutinib in pulmonary arterial hypertension released by Gossamer Bio on February 23, 2026

The PROSERA study for seralutinib in pulmonary arterial hypertension findings were released yesterday and report that it did not meet its primary endpoint in the full population. It appears that unexpected placebo results in some geographical areas may have been responsible for this happening. While this is disappointing news for the patient community the program

Results of the PROSERA study for seralutinib in pulmonary arterial hypertension released by Gossamer Bio on February 23, 2026 Read Post »

Cereno Scientific broadens development focus for CS014 to pulmonary hypertension associated with interstitial lung disease 

Cereno Scientific has expanded the development focus of its oral HDAC inhibitor CS014 to include pulmonary hypertension associated with interstitial lung disease (PH-ILD), a severe condition with very limited treatment options and high unmet medical need. Originally developed for idiopathic pulmonary fibrosis (IPF), CS014 targets shared disease mechanisms including vascular remodeling, fibrosis, thrombosis, and inflammation—making

Cereno Scientific broadens development focus for CS014 to pulmonary hypertension associated with interstitial lung disease  Read Post »

Phase 2 PHocus trial of mosliciguat completes enrollment in pulmonary hypertension associated with interstitial lung disease PH-ILD, Pulmonary Hypertension News, February 9, 2026

The February 9 2026 edition of Pulmonary Hypertension News reports that enrollment has been completed in under a year for the PHocus Phase 2 clinical trial testing mosliciguat, a once-daily inhaled therapy for pulmonary hypertension associated with interstitial lung disease (PH-ILD)—a condition where current treatment options remain limited and often poorly tolerated. Developed by Pulmovant,

Phase 2 PHocus trial of mosliciguat completes enrollment in pulmonary hypertension associated with interstitial lung disease PH-ILD, Pulmonary Hypertension News, February 9, 2026 Read Post »

Merck Receives Positive EU CHMP Opinion for Expanded Use of Sotatercept in Adults with Pulmonary Arterial Hypertension, December 12, 2025

The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has recommended expanding WINREVAIR™ (sotatercept) approval for pulmonary arterial hypertension (PAH) treatment to include World Health Organisation (WHO) Functional Class II, III, and IV patients (previously only II-III). The recommendation is based on the Phase 3 ZENITH trial, which showed a 76% reduction in risk

Merck Receives Positive EU CHMP Opinion for Expanded Use of Sotatercept in Adults with Pulmonary Arterial Hypertension, December 12, 2025 Read Post »

Cereno Scientific receives Food and Drug Administration (FDA) clearance to initiate global Phase IIb clinical trial of CS1 in pulmonary arterial hypertension (PAH), December 8, 2025

The Food and Drug Administration (FDA)’s recent clearance for a Cereno Scientific Phase IIb trial on CS1 builds on the favourable safety, tolerability and encouraging disease-modifying signals observed in the Phase IIa study. CS1, an HDACi that acts through epigenetic modulation, has also been granted Orphan Drug Designation and Fast Track designation in the US. The

Cereno Scientific receives Food and Drug Administration (FDA) clearance to initiate global Phase IIb clinical trial of CS1 in pulmonary arterial hypertension (PAH), December 8, 2025 Read Post »

PF-07868489: Pfizer’s New Biologic Enters Phase 2 for Pulmonary Arterial Hypertension

Pfizer has a new study ongoing on PF-07868489, a recombinant human IgG1 antibody that targets bone morphogenetic protein 9 (BMP9) and is administered through subcutaneous route for the treatment of PAH. PF-07868489 is currently in Phase 2 development and has received Orphan Drug designation in the US.  The study (NCT06137742) has two parts: Part A: An

PF-07868489: Pfizer’s New Biologic Enters Phase 2 for Pulmonary Arterial Hypertension Read Post »

Inhibikase Therapeutics Phase 3 study on IKT-001 – an anti-proliferative tyrosine kinase inhibitor – expected to be initiated in the first quarter of 2026

Inhibikase Therapeutics, Inc., a clinical-stage pharmaceutical company has announced that it expects to advance IKT-001 to a global pivotal Phase 3 clinical study in pulmonary arterial hypertension The Phase 3 study, named IMPROVE-PAH, is expected to be initiated in the first quarter of 2026. IKT-001 is an investigational novel pro-drug of imatinib mesylate. Imatinib is

Inhibikase Therapeutics Phase 3 study on IKT-001 – an anti-proliferative tyrosine kinase inhibitor – expected to be initiated in the first quarter of 2026 Read Post »

Winrevair (sotatercept) meets primary endpoint in Phase 2 CADENCE study on patients with a subset of pulmonary hypertension due to left heart disease (PH-LHD), November 18, 2025

Combined post- and precapillary pulmonary hypertension (CpcPH) represents a subset of pulmonary hypertension due to left heart disease (PH-LHD), also known as World Health Organisation Group 2 pulmonary hypertension. There are currently no treatments specifically approved for this condition. The CADENCE met its primary endpoint, showing a statistically significant and clinically meaningful reduction in pulmonary

Winrevair (sotatercept) meets primary endpoint in Phase 2 CADENCE study on patients with a subset of pulmonary hypertension due to left heart disease (PH-LHD), November 18, 2025 Read Post »

New pulmonary arterial hypertension therapy CM5480 delivers encouraging results in rat model, Pulmonary Hypertension News, November 14, 2025

CM5480 is an experimental therapy being developed by Calcimedica, a US clinical-stage biopharmaceutical company. The findings of a new study titled “Combination of Orai1 inhibitor CM5480 with specific therapy mitigates pulmonary hypertension and its cardiac dysfunction” reveals that CM5480 was helpful in rat models when used on its own and provided additional benefits when combined

New pulmonary arterial hypertension therapy CM5480 delivers encouraging results in rat model, Pulmonary Hypertension News, November 14, 2025 Read Post »

Cereno Scientific Submits Phase IIb Trial Protocol for CS1 in Pulmonary Arterial Hypertension (PAH) to the U.S. Food and Drug Administration (FDA), November 10, 2025

Cereno Scientific has submitted the clinical trial protocol for the planned global Phase IIb trial of its lead drug candidate CS1 to the U.S. Food and Drug Administration (FDA). CS1 is an oral histone deacetylase inhibitor (HDACi) intended as a disease-modifying therapy for pulmonary arterial hypertension (PAH), working through epigenetic modulation to target underlying mechanisms

Cereno Scientific Submits Phase IIb Trial Protocol for CS1 in Pulmonary Arterial Hypertension (PAH) to the U.S. Food and Drug Administration (FDA), November 10, 2025 Read Post »

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 »

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 »

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 »

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