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Calliditas Therapeutics AB (symbol: CALTX) is a biopharmaceutical company based in Stockholm, Sweden, dedicated to identifying, developing, and commercializing innovative treatments for rare diseases with unmet medical needs. The company recently announced positive results from the Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab for squamous cell carcinoma of the head and neck. The trial demonstrated statistically significant improvements in progression-free survival and overall survival, along with changes in tumor biology supporting the mechanism of action of setanaxib. Calliditas is also engaged in ongoing clinical trials in other indications, such as primary biliary cholangitis and idiopathic pulmonary fibrosis, showing promising results. The company focuses on anti-fibrotic effects and the development of its first-in-class NOX platform.
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Calliditas Therapeutics AB announced positive results from the NefIgArd Open Label Extension study, showing consistent treatment response in terms of proteinuria reduction and eGFR stabilization at 9 months for all IgAN patients. The study followed the successful Phase 3 NefIgArd study, which led to FDA approval in December 2023, and the full data set was published in The Lancet. CEO Renée Aguiar-Lucander expressed excitement about the results and highlighted the upcoming presentation of data at the ERA EDTA symposium.
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Calliditas Therapeutics presented additional data analyses from the Phase 3 NeflgArd trial of Nefecon in Primary IgA Nephropathy at the ISN World Congress of Nephrology 2024. The data showed consistent improvement in kidney function, reduced risk of kidney failure, and positive quality of life outcomes across different patient populations.
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Calliditas Therapeutics AB (CALT) announces its participation in key investor and industry conferences in April 2024, with top management presenting at various panels and offering one-on-one meetings. The company aims to showcase its expertise and engage with stakeholders.
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Calliditas Therapeutics AB (CALT) announces upcoming data presentations and a sponsored symposium at the ISN World Congress of Nephrology. The presentations will cover results from the Phase 3 NefIgArd trial with Nefecon in patients with IgA nephropathy, highlighting eGFR results, quality of life data, and benefits for patients with lower UPCR levels.
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Calliditas Therapeutics (CALT) receives a Notice of Allowance from the USPTO for a patent application related to cancer treatment with setanaxib and PD-1 inhibitors. The patent is anticipated to expire in 2038, providing extended protection for the global setanaxib franchise in oncology.
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Everest Medicines' licensing partner, Calliditas Therapeutics, has received a seven-year orphan drug exclusivity period from the U.S. FDA for Nefecon®, a drug to reduce kidney function loss in adults with primary IgAN. This exclusivity covers all adult patients with primary IgAN at risk of disease progression, reflecting a significant clinical benefit on kidney function.
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Calliditas Therapeutics AB (Nasdaq: CALT) has received a seven-year orphan drug exclusivity period for TARPEYO®, expiring in December 2030, after obtaining full approval for a new indication to reduce kidney function loss in adults with primary IgAN. The exclusivity covers all adult patients with primary IgAN at risk of disease progression, reflecting a clinical benefit on kidney function.
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Calliditas Therapeutics AB (Nasdaq: CALT) announces CEO's participation in March 2024 conferences, including Carnegie Healthcare Seminar and Jefferies Biotech Summit. For more details, contact Head of IR & Sustainability, Åsa Hillsten.
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Calliditas Therapeutics AB (CALT) achieved full approval for TARPEYO in the US in 2023, marking a successful year. Net sales and operating income increased in Q4 2023 compared to Q4 2022. Cash decreased, but net sales and TARPEYO sales saw significant growth in 2023. The company anticipates revenue growth in 2024.
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Calliditas Therapeutics AB (CALT) secures a new patent for TARPEYO in the US, extending product protection until 2043. The patent covers treatment of IgA nephropathy with NEFECON, showcasing the company's commitment to innovation and global expansion.
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FAQ
What is Calliditas Therapeutics AB focused on?
Calliditas is dedicated to identifying, developing, and commercializing novel treatments for orphan indications with significant unmet medical needs.
What recent trial results did Calliditas announce?
Recent results from the Phase 2 trial of setanaxib in combination with pembrolizumab for squamous cell carcinoma of the head and neck showed statistically significant improvements in progression-free survival and overall survival, supporting the drug's mechanism of action.
What other clinical trials is Calliditas conducting?
The company has ongoing clinical trials for primary biliary cholangitis, idiopathic pulmonary fibrosis, and Alport syndrome, with expected data readouts in the near future.
What is the focus of Calliditas' research and development efforts?
Calliditas emphasizes anti-fibrotic effects and is advancing its first-in-class NOX platform, demonstrating positive clinical evidence in targeted indications.
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