Certa Therapeutics’ FT011 Granted US FDA Fast Track for the Treatment of Systemic Sclerosis

Darren and Ann from Certa

Melbourne, Australia 19 February 2024: Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma), having previously granted Orphan Drug Designation. […]

Certa Therapeutics presents positive data from a Phase 2 clinical study highlighting the potential benefit of FT011 as a novel treatment for scleroderma

Melbourne, Australia: 16 November 2023 – Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, announces the presentation of results of its Phase 2 clinical trial of FT011 in patients with scleroderma at ACR Convergence 2023, the annual scientific meeting of the American College of Rheumatology being […]

Certa Therapeutics’ FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis

Melbourne, Australia: 23 October 2023- Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma). Orphan Drug Designation is granted by the […]

Certa Therapeutics represented at Biotechnology Innovation Organisation (BIO) International Convention in Boston

Melbourne, Australia, 05 June 2023: Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases, announced today that its Executive Chair, Professor Darren Kelly and Chief Commercial Officer, Dr Gareth Lewis, will be attending the 2023 Biotechnology Innovation Organisation International Convention (BIO) from 5-8 June in Boston.   […]

Listen to Professor Darren Kelly’s interview with Dr Moira Gunn for her TechNation Radio Podcast

Melbourne, Australia: Certa Therapeutics’ founder and CEO, Professor Darren Kelly, had the privilege of speaking with Dr Moira Gunn on an episode of her TechNation Radio podcast. Professor Kelly spoke about his multi-decade scientific research, which has led to the development of a treatment for Scleroderma, the life-threatening autoimmune condition characterised by inflammation and fibrosis […]

Ground-breaking results in Phase 2 scleroderma study by Certa Therapeutics demonstrates improvement in more than 60% of patients

Melbourne, Australia: Certa Therapeutics (Certa) today announces ground-breaking clinical trial data for FT011, its novel therapy for the treatment of serious inflammatory and fibrotic diseases. Certa has recently completed a global Phase 2, multi-centre, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in patients with scleroderma. Scleroderma is […]

Certa Therapeutics joins 41st J.P. Morgan Healthcare Conference, San Francisco

Melbourne, Australia, 9th January 2023: Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases, are pleased to announce Chief Executive Officer, Professor Darren Kelly, and Chief Commercial Officer Dr Gareth Lewis will be participating in the 41st Annual J.P. Morgan Healthcare Conference and associated partnering […]

Certa Therapeutics’ investigational drug FT011 delivers breakthrough results as a potential novel treatment for serious inflammatory and fibrotic diseases

Melbourne, Australia, 4th November 2022 – New research presented today by the University of Michigan reveals ground-breaking results for Certa Therapeutics’ FT011, a novel potential treatment of serious inflammatory and fibrotic diseases. The results in a chronic kidney disease (CKD) study presented at Kidney Week 2022, the annual scientific meeting of the American Society of […]

Certa Therapeutics team to meet with biotech industry leaders during AusBiotech conference in Perth, Australia

Melbourne, Australia, 20 October 2022: Certa Therapeutics, a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases. This year’s AusBiotech Convention will be attended by OccuRx’s Chief Operating Officer, Dr Michelle Bradney. AusBiotech is scheduled to take place 26 – 28 October 2022 in Perth, Western Australia and […]

Certa Therapeutics team to meet with biotech industry leaders during BIO-Europe® conference in Germany

Melbourne, Australia, 17 October 2022: Certa Therapeutics,a biotechnology company focused on improving lives by developing innovative precision treatments for inflammatory and fibrotic diseases. This year’s BIO-Europe Convention will be attended by Certa Therapeutics Chief Executive Officer, Professor Darren Kelly and Chief Commercial Officer, Dr Gareth Lewis. BIO-Europe® is scheduled to take place 24 – 26 […]