US Food and Drug Administration (FDA) accepts for review a New Drug Application (NDA) for ralinepag, an investigational prostacyclin IP receptor agonist to treat pulmonary arterial hypertension (PAH), Biospace, August 24, 2026

The US Food and Drug Administration (FDA) has accepted for review a New Drug Application from United Therapeutics Corporation for ralinepag, an investigational prostacyclin IP receptor agonist intended to treat pulmonary arterial hypertension (PAH). The filing rests on results from the Phase III ADVANCE OUTCOMES study See our previous article on this topic here. Read more at […]

US Food and Drug Administration (FDA) accepts for review a New Drug Application (NDA) for ralinepag, an investigational prostacyclin IP receptor agonist to treat pulmonary arterial hypertension (PAH), Biospace, August 24, 2026 Read Post »

Insmed Announces Positive 12-Month Data from the Ongoing Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Patients with Pulmonary Arterial Hypertension, July 16, 2026

Insmed announced on July 16 positive 12-Month data from the ongoing open-label extension (OLE) study evaluating treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1). The OLE study is a non-placebo-controlled trial and was designed to evaluate the long-term safety, tolerability, and effectiveness of

Insmed Announces Positive 12-Month Data from the Ongoing Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Patients with Pulmonary Arterial Hypertension, July 16, 2026 Read Post »

Activin Signaling Inhibitors in Pulmonary Hypertension: A State-of-the-Art Review via the Pulmonary Vascular Research Institute (PVRI), Pulmonary Circulation, July 14, 2026

A review recently published in Pulmonary Circulation brings together academic and industry researchers (via the PVRI Innovative Drug Discovery Initiative) to consolidate current knowledge on activin signaling inhibitors (ASIs), the role of specific Bone morphogenetic protein (BMP) ligands, efficacy/safety data, and considerations for developing next-generation activin signaling inhibitors. Key points: Open questions remain about: the

Activin Signaling Inhibitors in Pulmonary Hypertension: A State-of-the-Art Review via the Pulmonary Vascular Research Institute (PVRI), Pulmonary Circulation, July 14, 2026 Read Post »

Ralinepag for the treatment of pulmonary arterial hypertension (ADVANCE OUTCOMES): findings from the phase 3 study, The Lancet, July 26, 2026

ADVANCE OUTCOMES is a phase 3, randomised, double-blind trial tested oral ralinepag against placebo in pulmonary arterial hypertension patients, measuring time to first clinical worsening (death, hospitalisation, need for parenteral/inhaled prostacyclin therapy, disease progression, or unsatisfactory clinical response). Patients were enrolled between Jan 24, 2019, and June 20, 2025. Of 1037 patients screened for eligibility,

Ralinepag for the treatment of pulmonary arterial hypertension (ADVANCE OUTCOMES): findings from the phase 3 study, The Lancet, July 26, 2026 Read Post »

U.S. Food and Drug Administration (FDA) grants orphan drug status to IKT-001, an experimental formulation of imatinib to treat pulmonary arterial hypertension, July 23, 2026

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IKT-001, an experimental formulation of imatinib that Inhibikase Therapeutics is developing to treat pulmonary arterial hypertension (PAH). Orphan drug designation is granted to investigational medications aimed at treating rare diseases — conditions affecting fewer than 200,000 people in the U.S. The designation is meant to give

U.S. Food and Drug Administration (FDA) grants orphan drug status to IKT-001, an experimental formulation of imatinib to treat pulmonary arterial hypertension, July 23, 2026 Read Post »

Respiratory inhaler devices market positioned for notable expansion through 2030, Open PR, July 13, 2027

An article recently published in Open PR notes that inhaler devices are seeing broadening use for managing several respiratory conditions, with pulmonary arterial hypertension listed alongside asthma and COPD as one of the areas of application. The report is about the respiratory inhaler devices market overall — smart/connected inhalers, market size projections (forecast to reach

Respiratory inhaler devices market positioned for notable expansion through 2030, Open PR, July 13, 2027 Read Post »

Flolan discontinuation confirmed in the UK as of April 2028 – 150 patients in the UK will need to transition to another formulation of epoprostenol, PHA UK News, June 17, 2026

GSK has confirmed it will discontinue Flolan, a drug used to treat pulmonary arterial hypertension, in the UK from 2028 — having already pulled it from the US (see our article on this topic here), and other markets. Around 150 UK patients, including children, currently rely on the drug. With production ending in April 2028

Flolan discontinuation confirmed in the UK as of April 2028 – 150 patients in the UK will need to transition to another formulation of epoprostenol, PHA UK News, June 17, 2026 Read Post »

Do financial conflicts of interest influence medical prescribing practices? A Yale study published in Medical XPress, June 16, 2026

A Yale study, published in Pulmonary Circulation, examined links between pharmaceutical industry payments and prescribing patterns among physicians treating pulmonary arterial hypertension (PAH) — a field chosen because therapies are costly and prescribing is concentrated among a small group of specialists. Using CMS Open Payments data, researchers found that physicians receiving drug-specific industry payments were

Do financial conflicts of interest influence medical prescribing practices? A Yale study published in Medical XPress, June 16, 2026 Read Post »

Liquidia (LQDA) presents new YUTREPIA data at the US Pulmonary Hypertension Association (PHA)s International Annual conference in Dallas, June 11-14, 2026

Earlier this month, Liquidia Corporation presented four posters at the US Pulmonary Hypertension Association (PHA)’s International Conference in Dallas, sharing 24‑week ASCENT study data and broader insights on YUTREPIA (treprostinil) inhalation powder in pulmonary hypertension. Beyond clinical outcomes, the company highlighted patient‑reported cough data, the mental health strain on caregivers and the evolving role of

Liquidia (LQDA) presents new YUTREPIA data at the US Pulmonary Hypertension Association (PHA)s International Annual conference in Dallas, June 11-14, 2026 Read Post »

Exploring the therapeutic potential of GLP-1 receptor agonists in pulmonary arterial hypertension, European Respiratory Journal, May 2026

GLP-1 receptor agonists (GLP-1RAs) are drugs originally developed for diabetes and obesity. In experimental models of pulmonary arterial hypertension GLP-1RA’s administration attenuates the severity of pulmonary hypertension. Additional studies highlight their ability to protect against lung fibrosis and preserve endothelial function. No clinical trials have yet tested GLP-1RAs specifically in pulmonary arterial hypertension, though observational

Exploring the therapeutic potential of GLP-1 receptor agonists in pulmonary arterial hypertension, European Respiratory Journal, May 2026 Read Post »

Corsair Pharma Announces Three Presentations of Phase 1 Clinical Data for TRX-248 Transdermal System at the 2026 Pulmonary Hypertension Association Conference

Corsair Pharma‘s experimental skin patch designed to deliver treprostinil, an approved treatment for pulmonary arterial hypertension (PAH), appears to be working as intended, according to newly announced data from an early clinical trial in healthy volunteers. Several treprostinil formulations are already approved for pulmonary arterial hypertension: subcutaneous 24/7 infusion (Remodulin and generics), oral (Orenitram, not

Corsair Pharma Announces Three Presentations of Phase 1 Clinical Data for TRX-248 Transdermal System at the 2026 Pulmonary Hypertension Association Conference Read Post »

Regeneron Pharmaceuticals expands Into pulmonary arterial hypertension with Phase 2 trial for REGN13335

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

Regeneron Pharmaceuticals expands Into pulmonary arterial hypertension with Phase 2 trial for REGN13335 Read Post »

United Therapeutics presents positive data from ongoing research at the American Thoracic Society’s International Conference, May 15-20, Orlando (US)

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

United Therapeutics presents positive data from ongoing research at the American Thoracic Society’s International Conference, May 15-20, Orlando (US) Read Post »

CalciMedica advances novel oral therapy for pulmonary hypertension, PRN Newswire, May 12, 2026

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

CalciMedica advances novel oral therapy for pulmonary hypertension, PRN Newswire, May 12, 2026 Read Post »

South Korean biotech GI Innovation files patent for next-generation pulmonary arterial hypertension candidate, The Bio, April 29, 2026

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

South Korean biotech GI Innovation files patent for next-generation pulmonary arterial hypertension candidate, The Bio, April 29, 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 »

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