Industry – PULMONARY HYPERTENSION

Progress on xenotransplantation and bioengineered organs, the potential next growth frontier for United Therapeutics

United Therapeutics is making a major strategic bet on xenotransplantation and bioengineered organs as its primary long-term growth driver. The is using genetically modified pig organs to reduce rejection risk — with its UHeart and UKidney programmes having already achieved transplants in living humans. In parallel, it is developing 3D-bioprinted lungs, livers and kidneys using […]

Progress on xenotransplantation and bioengineered organs, the potential next growth frontier for United Therapeutics Read Post »

Pulnovo Medical and Medtronic Join Forces to Advance Pulmonary Artery Denervation for Pulmonary Hypertension, Pulse 2.0, April 25, 2026

Pulnovo Medical, a Shanghai-based company developing therapies for pulmonary hypertension and heart failure, has raised $100 million in a strategic financing round led by Medtronic, which has also entered into a separate commercial agreement with the company exploring future commercialisation opportunities. Pulnovo’s flagship product is the Pulmonary Artery Denervation (PADN) System, a minimally invasive device

Pulnovo Medical and Medtronic Join Forces to Advance Pulmonary Artery Denervation for Pulmonary Hypertension, Pulse 2.0, April 25, 2026 Read Post »

GSK completes acquisition of 35Pharma, whose investigational drug HS235 for the treatment of pulmonary arterial hypertension targets the activin receptor signalling pathway

GSK has completed the acquisition of 35Pharma, a Canadian clinical-stage biopharmaceutical company. The key asset is HS235, a molecule targeting the activin receptor signalling pathway — the same pathway as sotatercept — designed for the treatment of pulmonary arterial hypertension. HS235 is engineered for greater selectivity than existing agents, with the aim of reducing side

GSK completes acquisition of 35Pharma, whose investigational drug HS235 for the treatment of pulmonary arterial hypertension targets the activin receptor signalling pathway Read Post »

Inhibikase Therapeutics begins pivotal phase 3 trial in pulmonary arterial hypertension, April 7, 2026

Inhibikase Therapeutics has enrolled the first patient in its global pivotal Phase 3 IMPROVE-PAH trial of IKT-001 for pulmonary arterial hypertension. The trial uses a two-part adaptive design: the first part evaluates change in pulmonary vascular resistance in approximately 140 patients over 12 weeks, followed by a second part focusing on six-minute walk distance in

Inhibikase Therapeutics begins pivotal phase 3 trial in pulmonary arterial hypertension, April 7, 2026 Read Post »

AllRock Bio Doses First Patients in Phase 2a Trial of ROC-101 for Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension with Interstitial Lung Disease (ILD-PH), April 9, 2026

AllRock Bio has dosed the first patients in its Phase 2a ROCSTAR trial, evaluating ROC-101 — a potential first-in-class oral pan-rho-associated protein kinase (ROCK) inhibitor — in patients with pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease. The open-label, multicenter, exploratory study will evaluate the safety, tolerability, and efficacy of ROC-101 in both

AllRock Bio Doses First Patients in Phase 2a Trial of ROC-101 for Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension with Interstitial Lung Disease (ILD-PH), April 9, 2026 Read Post »

Cereno Scientific reports favorable safety and tolerability after 12 months of CS1 treatment in pulmonary arterial hypertension (PAH) from the Expanded Access Program (EAP), March 31, 2026

Cereno Scientific has reported initial findings from a 12-month Expanded Access Program (EAP) with its oral drug candidate CS1 in pulmonary arterial hypertension (PAH), enrolling ten patients who had completed the previous Phase IIa trial. The results confirm a favourable safety and tolerability profile over long-term use, consistent with earlier findings, with no unexpected safety

Cereno Scientific reports favorable safety and tolerability after 12 months of CS1 treatment in pulmonary arterial hypertension (PAH) from the Expanded Access Program (EAP), March 31, 2026 Read Post »

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 »

Promising results for nebulised treprostinil (Tyvaso) in treating pulmonary hypertension associated with interstitial lung disease (PH-ILD), WHO Group 3

United Therapeutics reported positive results from TETON-1, its second Phase III trial testing nebulised Tyvaso (treprostinil) in idiopathic pulmonary fibrosis (IPF). The trial, involving 598 patients over 52 weeks, showed that nebulised Tyvaso was superior to placebo in improving forced vital capacity (FVC) by 130.1 mL, and also achieved statistical significance in reducing the risk

Promising results for nebulised treprostinil (Tyvaso) in treating pulmonary hypertension associated with interstitial lung disease (PH-ILD), WHO Group 3 Read Post »

Cereno Scientific receives approval to initiate FDA-aligned Phase I pharmacokinetic study of CS014 supporting Phase II development in pulmonary hypertension associated with interstitial lung diseases (PH-ILD)

Swedish biotech Cereno Scientific has received approval from the Swedish Medical Products Agency to begin a Phase I study of its experimental drug CS014, a new HDAC inhibitor being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study, designed in line with FDA guidance, will compare CS014’s pharmacokinetics to valproic acid (VPA),

Cereno Scientific receives approval to initiate FDA-aligned Phase I pharmacokinetic study of CS014 supporting Phase II development in pulmonary hypertension associated with interstitial lung diseases (PH-ILD) Read Post »

Martine Rothblatt, founder and CEO of United Therapeutics, included in Forbes’ America’s Greatest Innovators list

Martine Aliana Rothblatt (born 1954) is an American lawyer, author, and entrepreneur. She founded United Therapeutics in 1996, to make medicines for her daughter who suffered from pulmonary arterial hypertension, and is now developing genetically modified pig organs for human transplant. On the latter topic she has written a book titled “Your life or mine

Martine Rothblatt, founder and CEO of United Therapeutics, included in Forbes’ America’s Greatest Innovators list Read Post »

United Therapeutics announces results for its Phase 3 ADVANCE OUTCOMES study on ralenipag for pulmonary arterial hypertension, March 2, 2026

United Therapeutics has announced promising results from its pivotal Phase 3 ADVANCE OUTCOMES study of ralinepag, a new oral treatment for pulmonary arterial hypertension (PAH). Ralinepag is a highly selective prostacyclin (IP) receptor agonist that works through multiple pathways — vasodilatory, anti-proliferative, and anti-inflammatory. It is taken once daily orally, yet achieves sustained receptor activity

United Therapeutics announces results for its Phase 3 ADVANCE OUTCOMES study on ralenipag for pulmonary arterial hypertension, March 2, 2026 Read Post »

Nippon Shinyaku reports progress on trials on NS-863 targeting pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)

Nippon Shinyaku recently reported progress on two Phase 2 trials of its oral candidate NS-863, targeting pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), both serious cardiopulmonary conditions with high unmet need. By advancing NS-863 across two related indications, the company is signaling a deeper push into rare cardiopulmonary therapeutics,

Nippon Shinyaku reports progress on trials on NS-863 targeting pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) 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 »

GSK set to buy 35Pharma, currently investigating drug for pulmonary arterial hypertension and pulmonary hypertension due to heart failure with preserved ejection fraction, February 25, 2026

GSK, a UK pharmaceutical multinational, has agreed to acquire 35Pharma, a private Canadian clinical-stage biopharmaceutical company, for $950m in cash. The transaction will provide GSK with full ownership of 35Pharma and its lead investigational medicine, HS235, an activin receptor signalling inhibitor currently positioned for studies in pulmonary arterial hypertension (PAH) and pulmonary hypertension due to

GSK set to buy 35Pharma, currently investigating drug for pulmonary arterial hypertension and pulmonary hypertension due to heart failure with preserved ejection fraction, February 25, 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 »

Flolan, the first drug to be approved for the treatment of pulmonary arterial hypertension, has been discontinued after 30 years on the market

After 30 years on the market, Flolan (epoprostenol) was discontinued in November 2025, marking the end of an era for pulmonary arterial hypertension treatment. Healthcare professionals worked throughout 2025 to transition patients to alternative therapies. Veletri, a room temperature-stable version of epoprostenol, remains available. A recent article in the News section of the US Pulmonary

Flolan, the first drug to be approved for the treatment of pulmonary arterial hypertension, has been discontinued after 30 years on the market 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 »