Regeneron Pharmaceuticals, a U.S. biotech, is running a Phase 2 trial of REGN13335, an Anti-PDGF-B monoclonal antibody, in adults with pulmonary arterial hypertension who are already on standard treatment. It’s a randomized, placebo-controlled, quadruple-blind study (patients, doctors, investigators, and assessors are all kept in the dark during the main phase) to gauge what extra benefit […]
Qureight is an end-to-end imaging Clinical Research Organization (CRO) that provides enterprise-grade imaging and precision endpoints for clinical trials with a focus on lung and heart disease. It is developing its deep learning AI imaging models to support ongoing clinical trials in the pulmonary hypertension field, where there is demand for robust non-invasive ways to
Swedish biotech Cereno Scientific has announced a collaboration with PHA Europe & Global, aimed at integrating the patient perspective more systematically into clinical trial design and execution. Cereno is developing two experimental medications that could expand choices in this space: CS1 for pulmonary arterial hypertension (PAH) and CS014 for pulmonary hypertension associated with lung disease (PH-ILD). The
United Therapeutics announced positive data from the TETON-1 phase 3 pivotal study of inhaled treprostinil in idiopathic pulmonary fibrosis (IPF), and of the ADVANCE OUTCOMES and ARTISAN studies on pulmonary arterial hypertension at the American Thoracic Society’s International Conference on May 15-20, in Orlando (see also our previous article at this link) The following posters
CalciMedica, a clinical-stage biopharmaceutical company, is developing CM5480, an oral CRAC channel inhibitor, as a potential first-in-class therapy for pulmonary hypertension, including pulmonary arterial hypertension. The drug targets pulmonary vascular and right ventricular remodeling, which are key drivers of disease progression in pulmonary hypertension. Preclinical studies are currently underway to evaluate its pharmacology, safety and
Tenax Therapeutics has reported good progress on their Phase 3 LEVEL study investigating TNX-103, a therapy for PH-HFpEF – pulmonary hypertension associated with heart failure with preserved ejection fraction, Group 2 of the World Health Organisation, WHO, classification. Topline data expected in the third quarter of 2026, and enrolment is also advancing in LEVEL-2, a
GI Innovation, a South Korean bio-venture company, announced on April 29, 2026, that it has filed a domestic patent application for GI-214 (development code), a pulmonary arterial hypertension (PAH) treatment candidate. GI-214 is positioned as a next-generation candidate targeting the same disease-associated signaling pathway (the activin pathway) as sotatercept, the therapy developed by MSD (Merck
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
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
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
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
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
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
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
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
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),
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
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
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,
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
