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Calliditas Therapeutics announced an in-person and virtual R&D day on May 30, 2024. The event will feature presentations on the anti-fibrotic effects of Setanaxib and the mode of action of TARPEYO (Nefecon) in treating IgA nephropathy, supported by preclinical and clinical data. Keynote speakers include Gareth J. Thomas, PhD, and Jonathan Barratt, PhD, FRCP. The program will cover supportive preclinical data and a Phase 2 POC trial for Setanaxib in squamous cell carcinoma of the head and neck (SCCHN), as well as a review of upcoming clinical data from the NOX platform. The event will also include a live Q&A session.
Calliditas Therapeutics announced its participation in the 61st European Renal Association (ERA) Congress in Stockholm, Sweden, from May 23 to 26, 2024. The company will present data on Nefecon (TARPEYO® (budesonide) delayed-release capsules) for primary immunoglobulin A nephropathy (IgAN) and real-world challenges with systemic glucocorticoids (SGC) in IgAN. Key presentations include an efficacy analysis of Nefecon and a real-world analysis of SGC challenges. The company will also host a symposium discussing clinical markers in IgAN.
Calliditas Therapeutics (Nasdaq: CALT) announced that its partner, Everest Medicines, has launched Nefecon® in China. China has up to 5 million patients with IgA nephropathy (IgAN), a progressive autoimmune disease. IgAN accounts for 35% to 50% of primary glomerular diseases, with over 100,000 new cases yearly. The Phase 3 NefIgArd trial showed a 66% reduction in kidney function loss in Chinese patients treated with Nefecon, outperforming global results.
Nefecon received conditional approval from China’s National Medical Products Administration (NMPA) in November 2023 and has since been launched in Macau, Hong Kong, and Singapore. The drug is also under review in Taiwan and South Korea.
Calliditas Therapeutics AB (CALT) announced positive results from a Phase 2 trial of setanaxib in combination with pembrolizumab for head and neck cancer treatment. The trial demonstrated significant improvements in progression-free survival and overall survival compared to placebo, with a positive impact on tumor biology. The treatment was well-tolerated, showing an increase in CD8+ T-cells in tumor tissue, indicating enhanced immunological activity. The company plans to present more data at an upcoming R&D day in Stockholm.