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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 (CALT) appoints Maria Törnsén as President North America, announces full FDA approval of TARPEYO®, and targets top line read out of several Phase 2 clinical trials with setanaxib in 2024.
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Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 9th, 2024, providing an update on the company.
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Calliditas Therapeutics AB (CALT) secures 92 million Euro term loan with Athyrium Capital Management, LP, extending debt repayment by 3 years and ensuring continued access to non-dilutive capital. The loan will be used to fully repay the existing 68 million Euro loan with Kreos Capital, with the principal amount of the new loan being 24 million Euros greater than that of the prior facility.
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Everest Medicines (HKEX 1952.HK) licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) announced that the U.S. FDA has fully approved Nefecon® delayed release capsules for adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Nefecon® demonstrated a significant benefit over placebo in reducing kidney function loss, with a 50% less deterioration in kidney function compared to placebo over a 2-year period. The drug is also approved in China and showed a greater treatment effect in the Chinese subpopulation compared to the global population. Nefecon® is considered a revolutionary therapeutic option for IgAN patients, offering a disease-modifying treatment with sustained and clinically meaningful reduction in eGFR declines and proteinuria. The drug's approval represents a significant milestone for Everest Medicines and its partner Calliditas Therapeutics AB, with plans for a China launch in 2024.
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Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) announced FDA approval of TARPEYO (budesonide) to reduce kidney function loss in adults with primary IgAN. TARPEYO is the first fully FDA-approved treatment for IgAN based on a measure of kidney function, showing a 50% reduction in kidney function deterioration in TARPEYO-treated patients compared to placebo-treated patients over a 2-year period.
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Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) has received a Notice of Allowance from the United States Patent and Trademark Office for a new patent application covering TARPEYO, strengthening its intellectual property protection and global value proposition.
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Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) has announced the addition of a new member to its management team, Head of Technical Operations Lars Stubberud, and the appointment of Brian Gorman as its new Group General Counsel, effective 1 January 2024.
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Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) has initiated a Phase 2 clinical study to evaluate setanaxib in Alport syndrome, a rare genetic disease leading to kidney failure. The study aims to assess the safety, tolerability, and effectiveness of setanaxib in approximately 20 patients with Alport syndrome and significant proteinuria despite treatment with a renin-angiotensin system (RAS) blocker. Dr. Rachel Lennon, the Coordinating Investigator for the study, highlighted the urgent clinical need for treatments that delay the progression to kidney failure in Alport syndrome. Setanaxib is also being evaluated in Phase 2 studies for other conditions like squamous cell carcinoma of the head and neck, primary biliary cholangitis, and idiopathic pulmonary fibrosis.
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Calliditas Therapeutics AB (CALT) and Everest Medicines (1952.HK) have announced the approval of Nefecon® for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression by China's National Medical Products Administration (NMPA). This approval addresses a significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries, with an estimated five million IgAN patients in China alone.
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Calliditas Therapeutics AB (Nasdaq: CALT) announces participation in several upcoming investor conferences, including the Jefferies London Healthcare Conference and the Stifel Healthcare Conference. CEO Renee Aguiar-Lucander and President of North America, Andrew Udell, will be presenting at these events.
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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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