Tag Archive for: calliditas

Calliditas Year-end report, January – December 2023

OCTOBER – DECEMBER 2023(COMPARED TO OCTOBER – DECEMBER 2022) Net sales amounted to SEK 451.6 million, of which TARPEYO® net sales amounted to SEK 347.3 million, for the three months ended December 31, 2023. For the three months ended December 31, 2022, net sales amounted to SEK 429.0 million, of which TARPEYO net sales amounted […]

Calliditas Therapeutics announces full FDA approval of TARPEYO®, the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved in December 2021 under accelerated […]

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 […]