Tag Archive for: calliditas

Optimum’s Year-End Review  

2023 was an exciting year for Optimum’s clients who overcame many of the market challenges to make significant strides forward with their vital life sciences research. Here are some of the highlights from what has been an exceptionally busy and successful year.   M&A & deals Synaffix continued to build momentum – Lonza acquired the […]

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 […]