Calliditas Therapeutics AB American Depositary Shares - CALT STOCK NEWS

Calliditas Therapeutics AB (Nasdaq: CALT) has published a cost-effectiveness analysis of Nefecon (TARPEYO®) for treating Primary IgA Nephropathy (IgAN) in the U.S. The study, featured in ClinicoEconomics and Outcomes Research, shows an incremental cost-effectiveness ratio (ICER) of $15,428 per quality-adjusted life year (QALY) gained. This analysis highlights the potential advantages of Nefecon in maintaining less severe kidney disease stages compared to standard care. Andrew Udell, president of North America at Calliditas, expressed optimism about confirming TARPEYO's cost-effectiveness through future clinical data.

Calliditas Therapeutics (NASDAQ: CALT, CALTX) announced its participation in two upcoming investor conferences. The first is the Guggenheim Genomic Medicines and Rare Disease Days Conference on April 3, 2023, in New York, featuring a fireside chat with CEO Renee Aguiar-Lucander and a KOL panel on IgA nephropathy treatment. The second event is the Kempen Life Sciences Conference in Amsterdam on April 25-26, 2023. Both conferences will include one-on-one meetings with investors, emphasizing Calliditas' commitment to developing innovative therapies for renal and hepatic diseases.

Everest Medicines announced that its partner Calliditas Therapeutics reported positive topline results from the Phase 3 clinical trial NefIgArd, evaluating Nefecon in patients with primary IgA nephropathy (IgAN). The trial met its primary endpoint, showing a statistically significant improvement in estimated glomerular filtration rate (eGFR) with Nefecon compared to placebo (p < 0.0001). Results indicated an average eGFR increase of 5.05 mL/min/1.73 m² with Nefecon. The treatment appears well-tolerated, supporting its efficacy as a disease-modifying therapy. Calliditas plans to seek full FDA approval and additional regulatory submissions in 2023.

Calliditas Therapeutics (CALT, CALTX) announced positive topline results from its Phase 3 NefIgArd clinical trial demonstrating the efficacy of Nefecon (TARPEYO/Kinpeygo) in patients with primary IgA nephropathy (IgAN). The trial, which included 364 patients, met its primary endpoint, showing a statistically significant improvement in estimated glomerular filtration rate (eGFR) over two years (p < 0.0001). Notably, the eGFR was 5.05 mL/min/1.73 m² higher with Nefecon compared to placebo. The trial results support regulatory filings for full approval from the FDA and European Commission, highlighting Nefecon as a key treatment option for IgAN patients.

Calliditas Therapeutics reported strong financial performance for 2022, marking a successful transition to a commercial stage company. Total revenues reached SEK 802.9 million (approximately $79.3 million), representing a 250% increase from 2021. Notably, TARPEYO^®, the first approved drug for IgA nephropathy, generated net sales of SEK 372.2 million (about $36.8 million) since its launch. The company ended the year with a robust cash position of SEK 1,249 million (around $119.7 million), indicating a solid foundation for its ongoing growth strategy. For 2023, Calliditas expects TARPEYO net sales to range from USD 120-150 million.

Calliditas Therapeutics AB (CALT, CALTX) announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) granted Conditional Marketing Authorization for Kinpeygo® to treat primary immunoglobulin A (IgA) nephropathy in adults at risk of rapid disease progression. Kinpeygo is the first approved treatment for this rare kidney disease, affecting over 50% of patients who may progress to end-stage renal disease. The CMA follows the European Commission's approval in July 2022. Calliditas will transfer CMA rights to STADA, which is already commercializing Kinpeygo in Germany since October 2022, improving patient access across Europe.

Calliditas Therapeutics AB announced the issuance of 7,500 common shares in January 2023, linked to its long-term incentive program for 2019/2022. Post-issuance, the total number of shares and corresponding votes reached 59,580,087. This adjustment reflects ongoing efforts to align employee incentives with company performance. Calliditas is a biopharma company focused on developing treatments for orphan diseases, particularly in renal and hepatic fields. Its lead product, Nefecon, has received FDA accelerated approval as TARPEYO and conditional marketing authorization in Europe as Kinpeygo. The information was disclosed in compliance with the Swedish Financial Instruments Trading Act.

Calliditas Therapeutics and its partner Everest Medicines announced that the Center for Drug Evaluation of China's National Medical Products Administration has recommended a Priority Review for the New Drug Application of Nefecon, aimed at treating primary immunoglobulin A nephropathy (IgAN) in adults. The NDA acceptance in November 2022 points to a regulatory decision expected in the second half of 2023. This accelerated review could enhance approval timelines, potentially benefiting Calliditas's market position in China.

On December 30, 2022, Calliditas Therapeutics AB announced the issuance of 415,000 common shares related to its long-term incentive program 2019/2022. This issuance brings the total number of shares and votes to 59,572,587. The biopharma company, focusing on treatments for orphan diseases, has its lead product, Nefecon, granted accelerated FDA approval as TARPEYO® and conditional European authorization as Kinpeygo®. Calliditas is also advancing clinical trials for setanaxib, targeting primary biliary cholangitis and head and neck cancer.