Six Circles Multi-Strategy - CALTX STOCK NEWS

Everest Medicines' partner, Calliditas Therapeutics, announced the publication of the full data from the NeflgArd Phase 3 trial with Nefecon® in adults with primary IgA nephropathy (IgAN). The trial met its primary endpoint, showing significant kidney protective effects of Nefecon® over placebo. Nefecon® demonstrated a highly statistically significant and clinically relevant benefit compared to placebo in estimated glomerular filtration rate (eGFR) over a two-year period. The reduction in urine protein-to-creatinine ratio (UPCR) observed with Nefecon® treatment was durable, reflecting a long-lasting treatment effect during the follow-up period. Nefecon® was generally well tolerated with mild or moderate adverse events.

Calliditas Therapeutics announces publication of Phase 3 NefIgArd Study data in The Lancet, demonstrating the kidney protective effect of Nefecon in adults with Primary IgA nephropathy. The study showed a significant and clinically relevant benefit in estimated glomerular filtration rate (eGFR) compared to placebo over a two-year period. Nefecon also demonstrated a durable reduction in proteinuria. The drug was well tolerated with minimal adverse events. Nefecon is currently approved under accelerated approval and the company is seeking full approval based on the study data.

Calliditas Therapeutics announces encouraging interim data from Phase 2 trial for squamous cell carcinoma of the head and neck

Calliditas Therapeutics has submitted a supplemental New Drug Application to the FDA seeking full approval of TARPEYO® (budesonide) delayed release capsules for the entire study population from the Phase 3 NeflgArd study. The submission is based on the full data set from the Phase 3 NefIgArd clinical trial, which showed a highly statistically significant benefit of TARPEYO over placebo in estimated glomerular filtration rate (eGFR). Calliditas is also seeking full approval of Nefecon (branded as Kinpeygo®) in Europe.

Everest Medicines partner, Calliditas Therapeutics, presented data from the NeflgArd Phase 3 Study at a medical congress. The study showed that Nefecon, a treatment for IgA nephropathy, demonstrated significant benefits over placebo, including a 50% reduction in kidney function loss. The treatment also showed sustained effects on reducing proteinuria and microhematuria. Chinese subpopulation results are expected in Q3 2023.

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.

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.