GSK, a global biopharmaceutical company, announced today an agreement to acquire 35Pharma Inc., a Canada-based clinical-stage biopharmaceutical firm, for $950 million in cash. The deal centers around HS235, an investigational medicine showing promise in the treatment of cardiopulmonary diseases, particularly pulmonary hypertension (PH). This acquisition signals a significant move for GSK to bolster its pipeline in a therapeutic area with substantial unmet needs and a growing market, projected to reach $18 billion by 2032, with activin signaling inhibitors expected to comprise half of that value, according to an Evaluate Pharma consensus estimate.
Pulmonary hypertension is a progressive and debilitating condition characterized by high blood pressure in the lungs. Affecting an estimated 82 million people worldwide, the disease leads to breathlessness, fatigue, and chest pain, ultimately resulting in heart failure. Despite its prevalence, treatment options remain limited, and the five-year survival rate is only around 50%. The acquisition of HS235 represents a potential breakthrough, offering a differentiated approach to treating PH with a focus on reducing bleeding risk and improving metabolic health – factors often overlooked in current therapies.
HS235: A Novel Approach to Pulmonary Hypertension
HS235 is designed as an activin signaling inhibitor, targeting a clinically validated pathway in PH. What sets HS235 apart is its enhanced selectivity, minimizing binding to ligands like BMP9 and BMP10, which have been linked to adverse events such as bleeding and telangiectasia (broken blood vessels). This targeted approach aims to address a critical limitation of existing PH treatments, as many patients require concurrent anticoagulant or antiplatelet therapy, increasing their risk of bleeding complications. The drug has completed Phase 1 clinical trials in healthy volunteers, and studies are slated to begin imminently in patients with pulmonary arterial hypertension (PAH) and PH due to heart failure with preserved ejection fraction (PH-HFpEF).
Beyond Lung Health: Metabolic Benefits of HS235
The potential benefits of HS235 extend beyond the pulmonary system. Early clinical studies suggest the drug may offer broad metabolic advantages, including fat-selective weight loss, preservation of lean muscle mass, and improved insulin sensitivity. These effects are linked to positive changes in inflammation and adipokines – hormones produced by fat tissue. Given the high prevalence of obesity and insulin resistance among PH patients, these metabolic benefits could significantly enhance the clinical and commercial value of HS235.
“Pulmonary hypertension affects millions of people worldwide, yet patients are underserved,” said Tony Wood, Chief Scientific Officer at GSK. “We’re delighted to add HS235 to our pipeline, a potential best-in-class medicine with a differentiated profile to reduce risk of bleeding and provide potential metabolic benefits clinically relevant to PH patients. HS235’s potential protective effects on vascular function, alongside potential benefits on fat-derived markers of metabolism and inflammation, also offer new development opportunities within our RI&. I portfolio to achieve broader coverage across the metabolic, inflammatory, vascular and fibrotic drivers of multiple chronic diseases that affect the lung, liver and kidney.”
A Synergistic Partnership
Ilia Tikhomirov, CEO of 35Pharma, expressed enthusiasm about the collaboration, stating, “In recent years, we witnessed a revolution in our understanding of pulmonary hypertension and how this life-threatening disease could be reversed. We are pleased to be joining forces with GSK, a leader in respiratory and inflammatory drivers of disease, who shares our vision of HS235’s potential to transform the treatment of this debilitating condition.”
Regulatory and Financial Details
The $950 million acquisition is subject to customary closing conditions, including regulatory approvals under the Hart-Scott-Rodino Act in the United States and the Competition Act in Canada, as well as a filing under the Investment Canada Act. GSK expects the transaction to close in the coming months. The company will acquire 100% of 35Pharma’s equity upon completion of the deal.
GSK cautions that forward-looking statements are subject to risks and uncertainties, as detailed in its Annual Report on Form 20-F for 2024 and its Q4 Results for 2025.
The acquisition of HS235 represents a strategic investment for GSK, positioning the company to address a significant unmet medical need and capitalize on the growing market for pulmonary hypertension therapies. The next step in the process will be the commencement of Phase 2 clinical trials in PAH and PH-HFpEF patients, which will provide crucial data on the efficacy and safety of HS235. Further updates on the progress of these trials and the integration of 35Pharma into GSK’s operations are expected throughout 2026 and beyond.
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