News

Following Chiesi's evaluation of the seralutinib development program and the PROSERA Phase 3 study results, Chiesi and Gossamer Bio have agreed to terminate their Collaboration and License Agreement related to the development and commercialization of seralutinib for the treatment of patients with pulmonary hypertension (PAH) and additional indications.    As part of the agreement announced today, Chiesi is returning the worldwide development and commercial rights related to seralutinib to Gossamer Bio, while remaining entitled to a capped royalty on worldwide net sales of seralutinib, as well as payments upon the achievement of specified regulatory and commercial milestones.     The work carried out by the companies on seralutinib provided important contributions to advancing scientific understanding in this area, and Chiesi remains committed to turning top notch science into innovative solutions for patients living with chronic respiratory diseases.     While this collaboration has been concluded, Chiesi's long-standing commitment to respiratory medicine continues to be a strategic pillar for the company, and we remain focused on delivering innovation for people living with asthma, COPD, and other respiratory conditions.   For more information, read the press release on the Gossamer Bio website.     

Chiesi today announces MHRA approval in the UK of Clenil Modulite (beclometasone; 100mcg and 200mcg) formulated with a non-PFAS, low-GWP, next generation propellant (HFA-152a). These are the first pMDIs to use HFA-152a worldwide, with the UK being the first country to approve these products. Chiesi’s propellant transition is expected to cut the carbon footprint of their beclometasone products by up to 90% versus the current propellant and aims to ensure continuity of care for patients by preserving device choice while addressing the environmental impact of these pMDIs.   Read more here: https://www.chiesi.uk.com/media/press-releases/2026-07-21-clenil-mhra-approval   Discover how we’re transforming respiratory care for people and the planet: Air | Chiesi Farmaceutici S.p.A.

Chiesi Group and Oak Hill Bio Holdings have announced the completion of patient enrollment in the Phase 2b FOOTPRINTS study evaluating OHB-607 for the prevention of bronchopulmonary dysplasia (BPD), a leading cause of chronic lung disease in premature infants for which there are currently no approved therapies.    OHB-607 is an investigational therapy designed to restore physiological insulin-like growth factor-1 (IGF-1) levels following extremely premature birth.    The FOOTPRINTS study enrolled 352 extremely premature infants born between 23 and 28 weeks of gestation across neonatal centers in North America, Europe, the United Kingdom, Japan, and Australia. The primary endpoint of the study is the reduction in the incidence of severe BPD or mortality by 36 weeks postmenstrual age (PMA) compared with standard neonatal care alone. The study will also assess longer-term respiratory, safety, and neurodevelopmental outcomes through 24 months corrected age.    Topline results from the FOOTPRINTS study are expected in early 2027.    Read more on the website of Oak Hill Bio Holdings.  

Parma, Italy – 18 May 2026   Chiesi announces that the U.S. Food and Drug Administration (FDA) has approved its single-inhaler triple therapy (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; BDP/FF/G) for the maintenance treatment of asthma in adults.    The approval was supported by two Phase 3 clinical trials (TRIMARAN and TRIGGER) that evaluated safety and efficacy in more than 2,500 adults with uncontrolled asthma. Across the studies, BDP/FF/G demonstrated improvements in lung function compared with BDP/FF.    The safety profile was comparable with BDP/FF, with commonly reported adverse events including asthma exacerbation, nasopharyngitis and headache (among others).    Outside the United States, Chiesi’s single-inhaler triple therapy is commercialized in nearly 50 countries, including the European Union, the United Kingdom and China.

Gossamer Bio released today the topline results from the Phase 3 PROSERA clinical study evaluating seralutinib, an investigational inhaled therapy, in people living with pulmonary arterial hypertension (PAH). Gossamer Bio and Chiesi are jointly developing seralutinib under a global collaboration agreement.   Please click here to read Gossamer’s press release.    Chiesi is working with Gossamer Bio to review the full dataset for PAH and finalize the next steps.    Chiesi would like to thank all patients, investigators and clinical teams involved in the PROSERA study for their commitment and collaboration throughout the programme. Their dedication and contribution were essential to the conduct of this global clinical study.

Parma, Italy – 18 December 2025   Chiesi announces the submission of the Carbon Minimal pressurised metered-dose inhaler (pMDI) containing beclometasone in 100 mcg and 200 mcg strengths to the UK Medicines and Healthcare products Regulatory Agency (MHRA) on 5th December 2025.   This submission is part of Chiesi’s Carbon Minimal Inhaler programme, designed to reduce the environmental impact of pMDIs by transitioning to HFA-152a, a next-generation propellant with significantly lower global warming potential. The programme is expected to reduce the carbon footprint of Chiesi pMDIs by up to 90%, while maintaining the highest standards of safety and efficacy. In addition, it aims to ensure a seamless transition for patients, combining therapeutic continuity and sustainability.   As a Certified B Corp, Chiesi is committed to delivering healthcare solutions that benefit both patients and the planet, supporting our ambition to achieve Net Zero emissions by 2035.   Discover how we’re transforming respiratory care for people and the planet—learn more about our Carbon Minimal Inhaler programme: https://www.chiesi.com/en/carbon-minimal-inhaler-cmi-therapeutic-equivalence-bts-winter-meeting/ https://www.chiesi.com/en/pmdi-carbon-minimal-clinical-development-regulatory-submissions/