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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 the release of its interim report for Q1 2024 on May 23, 2024, at 07:00 CET. The company will hold a combined audio cast and telephone conference at 14:30 CET the same day, featuring CEO Renée Aguiar-Lucander, CFO Fredrik Johansson, CMO Richard Philipson, and President North America Maria Törnsén. Stakeholders can participate via a webcast or register for the conference call to ask questions. The presentation will be in English, and further details can be obtained from Calliditas's Head of IR & Sustainability, Åsa Hillsten.
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 AB has scheduled its annual general meeting for June 17, 2024, in Stockholm. Shareholders must be registered by June 7, 2024, and can participate in person, by proxy, or via advance voting. Key agenda items include the election of board members and auditors, approval of financial statements, and resolutions on new share issues and long-term incentive programs. No dividend will be paid for 2023, and SEK 904,299,000 will be carried forward. The nomination committee has proposed re-electing current board members and Ernst & Young AB as auditors.
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.
