Welcome to our dedicated page for Calliditas Therapeutics AB American Depositary Shares news (Ticker: CALT), a resource for investors and traders seeking the latest updates and insights on Calliditas Therapeutics AB American Depositary Shares stock.
Calliditas Therapeutics AB (NASDAQ: CALT, Nasdaq Stockholm: CALTX) is a clinical and commercial-stage biopharmaceutical company dedicated to identifying, developing, and commercializing novel treatments specifically targeting orphan indications with significant unmet medical needs, particularly in renal and hepatic diseases. Headquartered in Stockholm, Sweden, Calliditas is pioneering therapies aimed at addressing complex conditions with limited treatment options.
The company's lead product, TARPEYO® (also known as Nefecon outside the United States), is an innovative medication designed to reduce proteinuria in patients suffering from IgA nephropathy (IgAN), a progressive autoimmune disease affecting the kidneys. TARPEYO® has received full approval from the U.S. FDA and conditional marketing authorization in the EU, marking a significant milestone in the treatment landscape for IgAN. Recent data from the ongoing global Phase 3 NefIgArd study and its Open Label Extension (OLE) demonstrate the drug's consistent efficacy and safety profile over an extended period.
Besides TARPEYO®, Calliditas' robust pipeline includes setanaxib, a NOX enzyme inhibitor showing promise in various indications, including squamous cell carcinoma of the head and neck (SCCHN). Recent Phase 2 trial results indicated statistically significant improvements in progression-free survival and overall survival, thus reinforcing the potential of setanaxib in oncological applications.
Calliditas is also expanding its market presence through strategic global partnerships. A notable achievement is the commercial launch of Nefecon in China by its partner, Everest Medicines. This launch is a critical step in addressing the high prevalence and unmet medical needs of IgAN patients in Asia.
Financially, Calliditas continues to strengthen its position, driven by ongoing commercial efforts and strategic equity initiatives. The company remains committed to enhancing shareholder value through advancements in its pipeline, strategic collaborations, and robust operational execution.
On April 26, 2023, Calliditas Therapeutics announced the availability of its 2022 Annual Report on the company's website. The report provides insights into the company's performance, including developments in their lead product, Nefecon, which received FDA accelerated approval as TARPEYO® and conditional marketing authorization in the EU as Kinpeygo®. Additionally, Calliditas is advancing clinical trials for its NOX inhibitor product candidate, setanaxib, targeting primary biliary cholangitis and head & neck cancer. Contact for investor relations is Åsa Hillsten, available via phone or email. The company cautioned that the report contains forward-looking statements that are subject to risks and uncertainties regarding future performance.
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