15/09/2026
Chiesi appoints David Khougazian as Group Chief Executive Officer to lead the next phase of innovation-driven growth
15/09/2026
Chiesi appoints David Khougazian as Group Chief Executive Officer to lead the next phase of innovation-driven growth
08/09/2026
Chiesi Group delivers solid H1 2026 performance, combining growth, continued investment in innovation and positive economic impact across communities
08/09/2026
Chiesi Group delivers solid H1 2026 performance, combining growth, continued investment in innovation and positive economic impact across communities
03/09/2026
Chiesi advances its Carbon Minimal Inhaler journey as European submissions for its Single Inhaler Triple Therapy (SITT) and ICS/LABA combination next-generation propellant pMDIs are validated
03/09/2026
Chiesi advances its Carbon Minimal Inhaler journey as European submissions for its Single Inhaler Triple Therapy (SITT) and ICS/LABA combination next-generation propellant pMDIs are validated
31/07/2026
Chiesi receives European Marketing Authorisation for its Single Inhaler Triple Therapy delivered via NEXThaler® for the maintenance treatment of Asthma
31/07/2026
Chiesi receives European Marketing Authorisation for its Single Inhaler Triple Therapy delivered via NEXThaler® for the maintenance treatment of Asthma
22/06/2026
Chiesi Global Rare Diseases Announces European Commission Approval of LOJUXTA® (lomitapide) ▼ Capsules for Paediatric Use in Homozygous Familial Hypercholesterolaemia (HoFH)
22/06/2026
Chiesi Global Rare Diseases Announces European Commission Approval of LOJUXTA® (lomitapide) ▼ Capsules for Paediatric Use in Homozygous Familial Hypercholesterolaemia (HoFH)
15/09/2026
Chiesi appoints David Khougazian as Group Chief Executive Officer to lead the next phase of innovation-driven growth
Highlights: David Khougazian appointed Group Chief Executive Officer to lead Chiesi's next phase of innovation-driven growth, effective 15 October 2026. Bringing over 25 years of international healthcare leadership experience and a strong track record in innovation and transformation, David joins Chiesi from Flagship Pioneering. Parma, Italy – 15 September 2026 - Chiesi Group (Chiesi) today announced the appointment of David Khougazian as Group Chief Executive Officer (CEO), effective 15 October 2026. David joins Chiesi following a distinguished international career spanning more than 25 years across the global healthcare and life sciences sectors. Most recently, he served as Executive Partner, Growth, and Head of Global Engagement at Flagship Pioneering, where he supported the growth and development of science-driven healthcare companies and worked closely with leadership teams on long-term value creation, partnerships, financing and organizational development. Following a thorough selection process led by the Board of Directors, David will succeed Interim Group CEO Jean-Marc Bellemin, who has successfully led the Group since 15 May 2026, while also continuing in his permanent role as Group CFO. Maria Paola Chiesi, Chiesi Group Chair, commented: “We are delighted to welcome David to Chiesi at a time of strong momentum for the company. Innovation has always been at the heart of Chiesi's mission and long-term vision. David's appointment reflects our ambition to accelerate this journey and strengthen Chiesi’s ability to innovate in a healthcare environment that is changing faster than ever. He brings a unique combination of global healthcare leadership, operational experience and exposure to some of the most dynamic areas of biotech innovation, which makes him exceptionally well positioned to guide Chiesi through this next chapter. On behalf of the Board, I would like to express my sincere gratitude to Jean-Marc Bellemin for his commitment and stewardship during this transition period. I would also like to thank the entire Group Executive Leadership Team for their dedication and collective leadership, which have been instrumental in maintaining the Group's focus and preparing the organization for the next steps." David Khougazian commented: “I am honored and excited to join Chiesi, a company widely recognized for its strong values, scientific excellence, entrepreneurial mindset and commitment to patients. The healthcare landscape is evolving rapidly, creating extraordinary opportunities to advance innovation and transform patient outcomes. Chiesi has built an impressive foundation, combining scientific expertise and a clear commitment to sustainable growth across generations. I look forward to working alongside Chiesi colleagues around the world to further strengthen the Group's innovation capabilities, advance its pipeline and partnerships, and create lasting value for patients, healthcare systems and society.” Chiesi remains firmly committed to executing its patient-centric strategy, advancing innovation across its therapeutic areas, and delivering sustainable growth for the benefit of patients, healthcare systems, communities and the planet. ****** About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By adopting the legal form of Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi meets verified standards for social and environmental business practices. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,900 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit www.chiesi.com or the website of your local Chiesi affiliate. ****** Press Info: Anna Bonisoli Alquati, Head of Global External Communications: mediarelations@chiesi.com Michela Lijoi, Global External Communications Sr. Manager: mobile +39 328.6353044, e-mail: m.lijoi@chiesi.com Davide Paterlini, Global External Communications Sr. Manager: mobile +39 345.7983132, e-mail: d.paterlini@chiesi.com
08/09/2026
Chiesi Group delivers solid H1 2026 performance, combining growth, continued investment in innovation and positive economic impact across communities
HIGHLIGHTS H1 2026 revenues of €1.89 billion, up +3.6% at CER versus H1 2025, driven by growth in the inhaled triple therapy portfolio and strong momentum in the rare diseases therapeutic area Continued investment in innovation with €426 million invested in R&D (22.5% of sales) Completed strategic investment for treatment of hereditary angioedema (HAE) with acquisition of KalVista Pharmaceuticals EBITDA continues to remain close to 30%, reflecting continued strong profitability and disciplined resource allocation Recent Economic Footprint study highlights Chiesi's contribution to economic development, supporting 56,488 jobs globally, generating €6.0 billion in GDP impact and €2.0 billion in taxes and public revenues worldwide Parma, Italy, 9 September 2026 – Chiesi Group ("Chiesi"), an international research-focused biopharmaceutical company and certified B Corp, today announced its financial results for the six months ended 30 June 2026 ("H1 2026"). Performance across therapeutic areas and regions Chiesi reported revenues of €1.89 billion, representing growth of +3.6% at constant exchange rates (CER) compared with H1 2025. These results do not include the impact of the recent acquisition of KalVista Pharmaceuticals. The Group's growth is supported by continued expansion of its global rare diseases area (+€45m; +9.9% @CER), and sustained performance in neonatology and specialty care therapeutic areas (+6.5% @CER). The respiratory health area remains broadly stable (-0.8% @CER) fueled by the strong growth in our inhaled triple therapy portfolio. Driven by the ongoing execution of its international growth strategy, Chiesi continued to expand its presence in key markets, with particularly strong momentum in the United States (+9.6% @CER), while maintaining resilient performance across Europe (+0.9% @CER) and a continuous development of the remaining geographies (+5.5% @CER). EBITDA margin was 29.4%, reflecting continued strong profitability, disciplined resource allocation and operational focus. The Group also maintained solid cash generation from operations, enabling continued investment in its research pipeline, manufacturing capabilities, and strategic acquisitions. Continued commitment to innovation The focus on innovation remains central to Chiesi's strategy. During the first half of 2026, the Group invested €426 million in Research & Development, representing approximately 22.5% of revenues. Investments were focused on advancing the pipeline across respiratory health, rare diseases and specialty care, while also supporting the development of the Group's Carbon Minimal Inhaler (CMI) platform and strengthening the industrial capabilities required to support its future rollout. This included the strategic partnership with Bespak, aimed at delivering lower carbon inhaled therapies through CMIs at scale, without compromising clinical choice or continuity of care for patients. During the first half of the year, Chiesi also completed the acquisition of KalVista Pharmaceuticals, a US-based pharmaceutical company with a differentiated oral, on demand treatment for hereditary angioedema (HAE), further strengthening its global rare disease platform and pipeline in areas of high unmet medical need. Creating positive impact beyond healthcare: Chiesi's Economic Footprint Chiesi's impact extends well beyond the healthcare solutions it delivers to patients. According to its recent Economic Footprint assessment conducted with PwC Italy (part of an international professional services network), in 2025 the Group generated approximately €6 billion in total GDP worldwide, supported 56,488 jobs, and contributed nearly €2 billion in taxes and public revenues across the countries in which it operates. As a European-headquartered company with innovation deeply rooted across the region, Chiesi generated €4.1 billion in total GDP across Europe, supported almost 30,000 jobs and contributed approximately €1.4 billion in taxes and public revenues. The study also found that Europe accounted for 78% of Chiesi's global R&D investment and 60% of all suppliers engaged by the Group, highlighting the region's central role in driving innovation, employment and economic growth. At the same time, Chiesi continues to expand its contribution in key international markets, generating more than €1.1 billion in GDP impact in the U.S. while supporting almost 4,000 jobs in the country. It also contributes €800 million in GDP impact across China, Brazil, Australia, Mexico and rest of the world, and more than 22,000 jobs across these markets. These findings demonstrate Chiesi's long-standing commitment to strengthening the overall healthcare ecosystem and creating value for patients, healthcare systems, local communities and economies across the world. Jean Marc Bellemin, CFO and Interim CEO of Chiesi Group, commented: "Our first-half results for 2026 reflect the resilience of our strategy and the strength of our global footprint. As we continue to deliver a solid performance, we remain focused on innovation, sustainable growth, and creating long-term value for patients, society and the environment. The acquisition of KalVista further strengthens our position in rare diseases and expands our presence in the U.S., while our Economic Footprint study illustrates Chiesi’s broader contribution to the economies and communities in which we operate. We remain focused on combining sustainable growth with continued innovation and long-term value creation for patients and society.” ****** About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By adopting the legal form of Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit www.chiesi.com ****** Press Info: Anna Bonisoli Alquati, Head of Global External Communications: mediarelations@chiesi.com Michela Lijoi, Global External Communications Sr. Manager: mobile +39 328.6353044, e-mail: m.lijoi@chiesi.com Davide Paterlini, Global External Communications Sr. Manager: mobile +39 345.7983132, e-mail: d.paterlini@chiesi.com
03/09/2026
Chiesi advances its Carbon Minimal Inhaler journey as European submissions for its Single Inhaler Triple Therapy (SITT) and ICS/LABA combination next-generation propellant pMDIs are validated
Key Highlights Regulatory submissions for next-generation propellant pMDIs (pressurized metered-dose inhalers) across Chiesi’s Single Inhaler Triple Therapy (SITT; or ICS/LABA/LAMA) and fixed double ICS/LABA combination (inhaled corticosteroid with a long-acting bronchodilator) range have been validated by Regulatory Agencies in Europe. Transition to HFA‑152a, a next‑generation propellant classified as non‑PFAS* and with low global warming potential (GWP), aims to reduce the carbon footprint of Chiesi’s pMDIs by up to 90% compared to current ones.1-3 Designed for a seamless transition for patients and HCPs, maintaining established efficacy, safety and usability and supporting continuity of care.4-8 The validation supports Chiesi’s ambition to reach Net Zero+ across its full value chain by 20359, following MHRA approval of Chiesi’s beclometasone pMDIs formulated with HFA-152a. Parma, Italy – 3rd September 2026 – Chiesi Group, an international research-focused biopharmaceutical company and certified B Corp, today announces a further step in its Carbon Minimal Inhaler (CMI) journey with the validation of regulatory submissions in Europe for its SITT and ICS/LABA pMDIs. The start of regulatory assessment in Europe marks a significant step towards Chiesi’s transition to carbon minimal pMDIs across its respiratory portfolio, combining innovation with responsibility. This supports the Company’s broader ambition to reduce the environmental impact of respiratory care, while enabling a seamless transition for patients and healthcare professionals. In July 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Chiesi’s beclometasone pMDIs formulated with HFA-152a, marking the first UK approval of this next-generation propellant in a pressurised metered-dose inhaler. Chiesi’s pMDIs are transitioning to HFA-152a, a next-generation propellant classified as non-PFAS* and with low-GWP, designed to reduce the products’ carbon footprint by up to 90% compared with current ones1-3, while maintaining established efficacy, safety, and usability.4-8 “Innovation in patient care and environmental responsibility are not a trade-off. Our next-generation carbon minimal pMDIs provide the same level of care, while reducing emissions of up to 90% compared to the ones in use today and at the same level of dry powder inhalers (DPI).” said Andrea Bizzi, Executive Vice President, Region Europe TOP 5 & Interim AIR Franchise, “These submissions are another step on our progression towards a full extrafine CMI portfolio across pMDIs and DPIs.” “The transition to carbon minimal pMDIs is not only a critical step in reducing the environmental impact of respiratory care,” said Sara Panigone, Senior Director, Global Project Leader AIR Franchise, “but also helps to guarantee the long-term availability of a full range of effective inhaled medicines, protecting patient lives, ensuring access and continuity of care.” Chiesi’s CMI portfolio transition is focused on reducing the carbon footprint associated with pMDIs, which remains an important option in asthma and COPD care. Transitioning our pMDIs to the next‑generation propellant HFA-152a, supports the decarbonization of respiratory care while helping to safeguard access and continuity of care over the long term.1-8, 10-12 *PFAS: per- and polyfluoroalkyl substances, non-PFAS means also non-forever chemical Notes to Editors - Regulatory procedures Single Inhaler Triple Therapy (SITT or ICS/LABA/LAMA, beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium bromide) pMDIs have been submitted under the EU centralized procedure to the European Medicines Agency. ICS/LABA (beclometasone dipropionate/formoterol fumarate dihydrate) pMDIs are being managed through a coordinated multi-country regulatory procedure with BfArM – the German Federal Institute for Drugs and Medical Devices - acting as Reference Member State. +Net Zero Commitment Chiesi plans to be the first pharmaceutical company to achieve Net Zero greenhouse gas emissions across its entire value chain by 2035, 15 years ahead of the European Climate Neutrality target. This commitment covers all emission scopes. Chiesi’s targets were validated by the Science Based Targets initiative (SBTi) in April 2024. The Group has consolidated its greenhouse gas inventory in line with ISO 14064 and the GHG Protocol standards, with annual audits carried out by independent third parties. The transition to the next-generation propellant HFA-152a is one of the most impactful actions in Chiesi’s Net Zero roadmap, as inhaler propellants represent the single largest source of the Group’s greenhouse gas emissions. About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By adopting the legal form of Benefit Corporation in Italy, the US, France, and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit www.chiesi.com ****** Press info: Vera Valota Head of Global Communications, AIR & CARE Tel: +44 734 188 99 92 Email: v.valota@chiesi.com References: Panigone S et al 2020, BMJ Open Respiratory Research: Environmental impact of inhalers for respiratory diseases: decreasing the carbon footprint while preserving patient-tailored treatment (https://doi.org/10.1136/bmjresp-2020-000571) EU ECHA Webinar: Restriction of per- and polyfluoroalkyl substances (PFAS) under REACH OECD Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances 2021 Rony F et al 2024, Pulmonary Pharmacology & Therapeutics: Evaluating the pharmacokinetics of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurized metered-dose inhaler using a low global warming potential propellant. (https://doi.org/10.1016/j.pupt.2024.102299) Almeida M et al. Relative lung availability and total systemic exposure after inhalation of medium or high strength doses of beclometasone dipropionate/formoterol fumarate, formulated as pMDI with a next generation propellant. Thorax 2025 BTS Winter meeting Salvadori M et al 2025, Pulmonary Pharmacology & Therapeutics: The low global warming potential propellant HFA-152a does not induce bronchoconstriction or impair mucociliary clearance (https://doi.org/10.1016/j.pupt.2025.102358) Singh D et al 2026, Respiratory Medicine: Safety and tolerability of the low global warming potential propellant HFA-152a in patients with asthma receiving beclometasone dipropionate/formoterol fumarate/glycopyrronium: The TRECOS study (https://doi.org/10.1016/j.rmed.2026.108814) Matturro A et al 2025, An Official Journal of the American Association of Pharmaceutical Scientists: Innovative drug development approach to address the transition to low global warming potential propellant using hydrofluoroalkane‑152a, for triple combination pressurized metered‑dose inhaler products targeting small airways (https://doi.org/10.1208/s12249-025-03057-z) Chiesi’s Sustainability Report 2025 https://www.chiesi.com/en/sustainability/sustainability-report Pernigotti D et al 2021, BMJ Open Respiratory Research: Reducing carbon footprint of inhalers: analysis of climate and clinical implications of different scenarios in five European countries (https://doi.org/10.1136/bmjresp-2021-001071) Attar-Zadeh D et al 2021, Journal of Health Economics and Outcomes Research: Health-care Resource Requirements and Potential Financial Consequences of an Environmentally Driven Switch in Respiratory Inhaler Use in England (https://doi.org/10.36469/001c.26113) Usmani O et al 2022, Journal of Allergy Clinical Immunology Practice. Real-World Impact of Nonclinical Inhaler Regimen Switches on Asthma or COPD: A Systematic Review. (https://doi.org/10.1016/j.jaip.2022.05.039)
31/07/2026
Chiesi receives European Marketing Authorisation for its Single Inhaler Triple Therapy delivered via NEXThaler® for the maintenance treatment of Asthma
Key Highlights This European Authorisation reinforces Chiesi’s commitment to provide a broad range of formulations and devices to asthma patients. NEXThaler® is a dry powder inhaler (DPI), specifically designed for Chiesi’s extrafine formulations. With the addition of the DPI in the asthma indication, Chiesi is moving towards a range of Carbon Minimal Inhalers for asthma and COPD patients, supporting Chiesi’s ambition to reach Net Zero* across its full value chain by 2035. Parma, Italy - 31 July 2026 – Chiesi Group, an international research-focused biopharmaceutical company and certified B Corp, today announced that the European Commission (EC) has granted marketing authorisation for its Single Inhaler Triple Therapy (SITT or beclometasone dipropionate, formoterol fumarate, glycopyrronium) medium strength (88/5/9 µg) delivered via the NEXThaler® device, for the maintenance treatment of asthma in adult patients in the European Union. The EC approval follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in May 2026. With this approval, Chiesi further expands its range of extrafine formulations in asthma, offering a DPI single inhaler triple therapy option for patients whose asthma is not adequately controlled on dual combination therapy. “This approval marks an important step forward in our commitment to improving the management of asthma.” said Simon Manners, Vice President, Global Commercial AIR Franchise “By expanding the extrafine SITT range, we aim to support healthcare professionals with more tailored treatment options and help address the needs of patients living with asthma.” Asthma is a chronic inflammatory disease affecting an estimated 363 million people worldwide.1 According to the Global Initiative for Asthma (GINA), uncontrolled asthma is characterised by poor symptom control and/or frequent exacerbations, including those requiring oral corticosteroids or leading to hospitalisation.2 Effective asthma management, including appropriate and timely treatment, is essential to achieve symptom control, reduce the risk of exacerbations, and support patients in living active, fulfilling lives.3 This approval further reinforces Chiesi’s longstanding expertise in respiratory care and its focus on advancing innovative treatment solutions. Availability of Chiesi SITT NEXThaler® medium strength for asthma will vary across EU countries and will be subject to national regulatory and reimbursement processes. References World Health Organization. Asthma [Internet]. Geneva: WHO; 2026 - Available from: https://www.who.int/news-room/fact-sheets/detail/asthma Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2025 update. Available from: https://ginasthma.org Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2026 update. Available from: https://ginasthma.org *Net Zero Commitment Chiesi plans to be the first pharmaceutical company to achieve Net Zero greenhouse gas emissions across its entire value chain by 2035, 15 years ahead of the European Climate Neutrality target. This commitment covers all emission scopes. Chiesi’s targets were validated by the Science Based Targets initiative (SBTi) in April 2024. The Group has consolidated its greenhouse gas inventory in line with ISO 14064 and the GHG Protocol standards, with annual audits carried out by independent third parties. The transition to the next-generation propellant HFA-152a is one of the most impactful actions in Chiesi’s Net Zero roadmap, as inhaler propellants represent the single largest source of the Group’s greenhouse gas emissions. About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By adopting the legal form of Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet verified standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,900 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information please visit www.chiesi.com Press info: Vera Valota Head of Global Communications, AIR & CARE Tel: +44 734 188 99 92 Email: v.valota@chiesi.com Anna Bonisoli Alquati Head of Global External Communications E-mail: mediarelations@chiesi.com
22/06/2026
Chiesi Global Rare Diseases Announces European Commission Approval of LOJUXTA® (lomitapide) ▼ Capsules for Paediatric Use in Homozygous Familial Hypercholesterolaemia (HoFH)
PARMA, Italy – June 5, 2026 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today announced that the European Commission (EC) has approved lomitapide capsules for use in children 5 years of age and older with Homozygous Familial Hypercholesterolaemia (HoFH), for use alongside diet and other lipid-lowering treatments, including LDL-apheresis where available. The EC decision follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the expanded indication. Lomitapide has been approved for use in the European Union (EU) for adult patients with HoFH since 2013. "This European Commission approval marks an important milestone for children living with HoFH and their families," said Mitch Goldman, MD, PhD, SVP Research & Development, Chiesi Global Rare Diseases. "HoFH is a condition that can begin causing irreversible cardiovascular damage from the earliest years of life, and the unmet need remains for younger patients despite existing treatment options. By expanding the indication of lomitapide to children aged 5 years and older, we are offering families and their physicians a meaningful treatment option that is backed by robust clinical evidence. This approval reflects our deepest commitment: ensuring that having a rare disease never means being overlooked at any stage of life, across generations.” The EC approval is based on evidence from a Phase 3, open-label, single-arm, multicentre study evaluating lomitapide in 43 pediatric participants aged 5 to 17 years with HoFH. The APH-19 study achieved its primary endpoint, demonstrating a mean 53.5% reduction in LDL‑C from baseline at week 24 (p<0.0001). Significant reductions (all p<0.0001) were also achieved in non‑HDL‑C, total cholesterol, VLDL‑C, apolipoprotein B, and triglycerides at week 24 (secondary outcomes). Adverse events were mostly mild, and gastrointestinal and hepatic in nature. Adverse events of special interest were reported for five (12%) patients (gastrointestinal in two patients and hepatic in three). One serious treatment-emergent adverse event was reported (also classed as an adverse event of special interest): an increase in hepatic enzymes, resulting in two dose interruptions, two dose reductions, and a repeated dose escalation. Overall, no new adverse event signals were identified, and the results were consistent with the known profile of lomitapide.1 About HoFH Homozygous familial hypercholesterolaemia (HoFH) is a rare condition causing very high levels of cholesterol in the body since birth.2 In HoFH, the arteries become clogged, with people affected often having more than 10 times the target, or acceptable level of so called bad cholesterol in their blood (LDL-C), leading to severe heart disease, premature atherosclerosis and cardiovascular events.2 Early diagnosis and management in HoFH are critical, however, many patients remain undiagnosed and undertreated.2,3 About lomitapide Lomitapide is a prescription-only medicine used along with a low-fat diet, exercise and other low-density lipoprotein (LDL) lowering medicines to reduce LDL-C in adults and children 5 years of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).4 Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolaemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded. About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. Chiesi Media Contact Chiara Travagin Head of Global Communications, Rare E-mail: c.travagin@chiesi.com Anna Bonisoli Alquati Head of Global External Communications E-mail: mediarelations@chiesi.com References Masana, L., Zambon, A., Schmitt, C. P., Taylan, C., Driemeyer, J., Cohen, H., Buonuomo, P. S., Alashwal, A., Al-Dubayee, M., Kholaif, N., Diaz-Diaz, J. L., Maatouk, F., Martinez-Hervas, S., Mangal, B., Löwe, S., & Cunningham, T. (2024). Lomitapide for the treatment of paediatric patients with homozygous familial hypercholesterolaemia (APH-19): Results from the efficacy phase of an open-label, multicentre, phase 3 study. The Lancet Diabetes & Endocrinology, 12(12), 880–889. Borberg H. The lower the better: target values after LDL-Apheresis and semi selective LDL-elimination therapies. Transfus Apher Sci. 2013;48(2):203-206. Cuchel M, Raal FJ, Hegele RA, et al. 2023 Update on European Atherosclerosis Society Consensus Statement on Homozygous Familial Hypercholesterolaemia: new treatments and clinical guidance. Eur Heart J. 2023;44(25): 2277-2291. European Medicines Agency. (2025, January 27). Lojuxta, INN-lomitapide: EPAR product information. https://www.ema.europa.eu/en/documents/product-information/lojuxta-epar-product-information_en.pdf
11/06/2026
Chiesi Group Completes Acquisition of KalVista Pharmaceuticals
Parma, Italy and Framingham, Mass., USA – 11 June, 2026 – Chiesi Group (“Chiesi”), an international research-focused biopharmaceutical group and certified B Corp, today announced the completion of its acquisition of KalVista Pharmaceuticals, Inc. (“KalVista”). KalVista is now part of Chiesi Group and will contribute to the growth of the Rare Diseases business unit, focused on research, development and commercialization of therapies for rare and ultra-rare conditions. With the completion of the transaction, Chiesi assumed ownership of EKTERLY® (sebetralstat), the first and only oral, on-demand treatment for hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. EKTERLY is already approved in the United States, United Kingdom, European Union, Japan and other regions, with ongoing studies exploring its use for treating HAE attacks in children aged 2 to 11, and multiple regulatory applications under review in key global markets. Completion of the Tender Offer and Transaction Details On June 11, 2026, Chiesi successfully completed its tender offer for all outstanding shares of KalVista common stock for $27.00 per share in cash and accepted for payment all shares validly tendered and not validly withdrawn as of the expiration time of the tender offer, which shares represented approximately 77.8% of KalVista’s outstanding shares. Following completion of the offer, Chiesi completed its acquisition of KalVista through a merger of a wholly owned subsidiary of Chiesi with and into KalVista, in connection with which the outstanding shares of KalVista common stock were cancelled and converted into the right to receive the same $27.00 per share in cash. As a result of the merger, KalVista became a wholly owned subsidiary of Chiesi and KalVista’s common stock ceased trading on the Nasdaq Global Market. Additional details regarding the tender can be found in a form 8-K filed by KalVista today with the Securities and Exchange Commission. Advisors Lazard served as exclusive financial advisor to Chiesi and Ropes & Gray LLP served as legal advisor. Centerview Partners LLC acted as financial advisor to KalVista and Kirkland & Ellis LLP and Fenwick & West LLP served as legal advisors. ****** About EKTERLY® (sebetralstat) EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity. About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet verified standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,900 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For more information, visit www.chiesi.com or the website of your local Chiesi affiliate. About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. For more information, visit www.chiesirarediseases.com. About KalVista Pharmaceuticals, Inc. KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed sebetralstat—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram. FORWARD-LOOKING STATEMENT This communication contains forward-looking statements related to Chiesi and KalVista. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “target,” “seek,” “believe,” “project,” “estimate,” “expect,” “position,” “strategy,” “future,” “likely,” “may,” “should,” “will” or the negative of these terms or similar references to future periods, although not all forward-looking statements contain these words. In this communication, forward-looking statements include statements about the post-closing operations and the outlook for the parties’ businesses, including, without limitation, the ability to commercialize current and future product candidates (including further commercialization of EKTERLY). Forward-looking statements are subject to certain risks, uncertainties or other factors that are difficult to predict, and could cause actual events or results to differ materially from those currently indicated in any such statements due to a number of risks and uncertainties. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of U.S. Food and Drug Administration approvals or actions, if any; the impact of competitive products and pricing; the risk that the businesses will not be integrated successfully and that Chiesi may not realize the potential benefits of the transactions; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; actual or contingent liabilities; the success of the parties’ efforts to commercialize EKTERLY, including revenues from sales of EKTERLY; the ability to successfully obtain additional foreign regulatory approvals for sebetralstat; expectations about the safety and efficacy of sebetralstat; and expectations regarding market adoption and utilization trends. You should not place undue reliance on these statements. All forward-looking statements are based on information currently available to Chiesi and KalVista, and Chiesi and KalVista disclaim any obligation to update the information contained in this communication as new information becomes available. Press Info Chiesi Group Contacts: Anna Bonisoli Alquati, Head of Global External Communications: mediarelations@chiesi.com Chiara Travagin, Head of Global Communications, Rare: mobile +39 348.8818985, e-mail: c.travagin@chiesi.com Michela Lijoi, Global External Communications Sr. Manager: mobile +39 328.6353044, e-mail: m.lijoi@chiesi.com PP-RA-02172 V1.0