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REG - GSK PLC - GSK enters agreement to acquire 35Pharma

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RNS Number : 2517U  GSK PLC  25 February 2026

 

Issued: 25 February 2026, London UK

 

GSK enters agreement to acquire 35Pharma Inc.

 

·   Acquisition includes HS235, a potentially best-in-class activin
signalling inhibitor in clinical development for treatment of cardiopulmonary
diseases

·   HS235 offers potential to treat pulmonary hypertension (PH) patients
while reducing the risk of bleeding and providing unique metabolic benefits
compared to existing therapies

·   HS235's profile bolsters an emerging pipeline of products with
protective benefits on metabolic and vascular function, providing scalable
opportunities in GSK's Respiratory, Immunology and Inflammation (RI&I)
portfolio

 

 

 

GSK plc (LSE/NYSE: GSK) today announced that it has entered an agreement to
acquire 35Pharma Inc., a Canada-based, private, clinical-stage
biopharmaceutical company specialised in the development of novel
protein-based therapeutics. The acquisition includes HS235, a potential
best-in-class investigational medicine that has completed phase I healthy
volunteer clinical trials with studies to start imminently in pulmonary
arterial hypertension (PAH) and pulmonary hypertension due to heart failure
with preserved ejection fraction (PH-HFpEF).

 

PH is a progressive, life-shortening disease marked by high blood pressure in
the lungs. Early symptoms are breathlessness, fatigue and chest pain leading
to heart failure as the disease progresses. It affects approximately 82
million people worldwide across multiple disease forms, yet treatment options
remain limited and the five‑year survival rate is only around 50%.(1,2) By
2032, the global market for PH therapies is forecast to reach $18 billion,
with activin signalling inhibitors expected to account for 50% of this.(3)

 

HS235 targets the activin receptor signalling pathway, a clinically validated
therapeutic target in PAH. HS235 is designed with enhanced selectivity,
reducing binding to BMP9 and BMP10 - ligands associated with adverse events
such as bleeding and telangiectasia (broken blood vessels). By potentially
lowering the risk of bleeding, HS235 may address a key limitation in current
PH treatment, particularly as a significant proportion of patients require
concomitant anticoagulant or antiplatelet therapy.

 

The underlying mechanism of HS235 offers the potential for broad metabolic
benefits, including fat-selective weight loss, preservation of lean mass, and
improved insulin sensitivity, supported by beneficial changes in inflammation
and adipokines (fat hormones) observed in early clinical studies. These
attributes may offer additional clinical and commercial value given the high
prevalence of obesity and insulin resistance in the PH population.

 

Tony Wood, Chief Scientific Officer, GSK, said: "Pulmonary hypertension
affects millions of people worldwide, yet patients are underserved. 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."

(https://www.gsk.com/en-gb/innovation/our-leading-scientists/kaivan-khavandi/)

Ilia Tikhomirov, CEO, 35Pharma, said: "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 combining our
efforts 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."

 

Financial considerations

Under the terms of the agreement, GSK will acquire 100% of the equity of
35Pharma Inc. for $950 million, payable in cash at closing.

 

This transaction is subject to customary conditions, including applicable
regulatory agency clearances under the Hart-Scott-Rodino Act in the US and the
Competition Act in Canada, along with a filing under the Investment Canada
Act.

 

About pulmonary hypertension

There are different types of PH such as Pulmonary Arterial Hypertension (PAH)
and PH due to Heart Failure with preserved Ejection fraction (PH-HFpEF). PH is
treated in specialised academic centres by pulmonologists and cardiologists,
where PH programs sit within larger lung, respiratory and critical care
centres. Around 82 million people worldwide are affected by PH and in the US,
the addressable patient population for PAH and PH-HFpEF is approximately
100,000 people.(1,4,5)

 

About 35Pharma Inc.

35Pharma is a clinical-stage biopharmaceutical company developing novel
TGF-beta superfamily therapeutics. 35Pharma's lead candidate, HS235, is being
developed for the treatment of cardiopulmonary diseases with clinical trials
initiated in Pulmonary Arterial Hypertension and PH due to Heart Failure with
preserved Ejection fraction. For more information visit www.35pharma.com

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at www.gsk.com
(https://www.gsk.com) .

 

 GSK enquiries
 Media:               Tim Foley          +44 (0) 20 8047 5502  (London)
                      Sarah Clements     +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn     +1 202 603 5003       (Washington DC)
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 Investor Relations:  Constantin Fest    +44 (0) 7831 826525   (London)
                      James Dodwell      +44 (0) 20 8047 2406  (London)
                      Mick Readey        +44 (0) 7990 339653   (London)
                      Steph Mountifield  +44 (0) 7796 707505   (London)
                      Sam Piper          +44 (0) 7824 525779   (London)
                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 3126       (Philadelphia)

 

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q4 Results for 2025.

 

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WC1A 1DG

 

References

1. Humbert, M. et al. (2022) 2022 ESC/ERS Guidelines for the diagnosis and
treatment of pulmonary hypertension, European Heart Journal, 43(38), pp.
3618-3731. doi:10.1093/eurheartj/ehac237.

2. Caravita S, Faini A, D'Araujo SC, et al. Clinical phenotypes and outcomes
of pulmonary hypertension due to left heart disease: Role of the pre-capillary
component. PLOS ONE. 2018;13(6):e0199164. doi:10.1371/journal.pone.0199164.

3. Evaluate Pharma consensus estimate; accessed Feb 2026.

4. Leary, Peter J et al. The Lancet Respiratory Medicine, Volume 13, Issue 1,
69-79.

5. GSK Internal data.

 

 

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