Calliditas Therapeutics AB (publ) is a clinical‐stage biopharmaceutical company focused on the development and commercialization of novel therapies for orphan kidney diseases. Headquartered in Stockholm, Sweden, the company specializes in targeted formulations designed to address the underlying mechanisms of rare renal disorders. By leveraging proprietary drug delivery technology, Calliditas aims to improve treatment outcomes and quality of life for patients suffering from progressive kidney conditions.
The company’s lead product, Nefecon (budesonide oral targeted-release), is a delayed‐release formulation designed to deliver therapy directly to the ileum-associated lymphoid tissue. Nefecon has received approvals from both the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of primary IgA nephropathy, a rare autoimmune kidney disease. Beyond IgA nephropathy, Calliditas is advancing additional indications, including lupus nephritis and ANCA-associated vasculitis, through ongoing clinical trials that explore the broad potential of its targeted-release technology.
Calliditas markets Nefecon in the United States under the trade name TARPEYO and in Europe under the Nefecon brand, with a commercial footprint that extends across North America, Europe, and select international markets. The company has established strategic alliances and distribution partnerships to support patient access and to facilitate reimbursement discussions with healthcare payers. Its commercialization infrastructure combines direct sales teams and partner networks to address the unique needs of nephrology specialists and their patients.
Founded in 2006, Calliditas began as a research-driven enterprise and transitioned to a public company with its listing on the Nasdaq Stockholm exchange, followed by a dual listing on the Nasdaq Global Market in the United States. Under the leadership of President and Chief Executive Officer Kåre Engkilde, along with an executive team experienced in nephrology drug development and global commercialization, Calliditas continues to build on its scientific heritage. The company’s board of directors includes experts in rare disease strategy, regulatory affairs, and international business, guiding its mission to deliver transformative therapies to patients with high unmet medical needs.
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