Tag Archive for: calliditas

Interim Report Q2, 2023

Filing for full approval of TARPEYO FINANCIAL SUMMARY FOR THE GROUP Key Figures April 1 – June 30, 2023 Net sales amounted to SEK 269.4 million, of which TARPEYO® net sales amounted to SEK 259.2 million, for the three months ended June 30, 2023. For the three months ended June 30, 2022, net sales amounted […]

Calliditas Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Full Approval of TARPEYO®

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced the submission of a supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) seeking full approval of TARPEYO® (budesonide) delayed release capsules for the entire study population from the Phase 3 NeflgArd study. TARPEYO is currently approved under accelerated approval to reduce […]

Renée Aguiar-Lucander, CEO of Calliditas Therapeutics: Blazing a trail in rare diseases

Calliditas is one of European biopharma’s big success stories, bringing a rare disease drug to market and commercializing it using its own sales force. Richard Staines from Optimum Strategic Communications spoke with CEO Renée Aguiar-Lucander who outlined the challenges the company has faced on its journey. Lengthy experience as a life science investor has helped […]

Calliditas Announces Primary Endpoint Successfully Met in Phase 3 NefIgArd Trial Evaluating Nefecon[®] in IgA Nephropathy

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (TARPEYO®/Kinpeygo® (budesonide) delayed release capsules) versus placebo in patients with primary IgA nephropathy (IgAN). The trial met its primary endpoint with Nefecon demonstrating a highly […]

Raising awareness of Rare Disease

Each year, Rare Disease Day aims to raise awareness of rare diseases and encourage positive change to patients’ lives. A disease is considered rare when it affects fewer than 1 in 2,000 people and there are 300 million people with rare diseases across the world.1 On Rare Disease Day 2023, we want to celebrate the […]