Biotech Business - May 23, 2022
Calliditas receives positive CHMP opinion
Calliditas Therapeutics has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisation for Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine […]
Biotech Business - September 16, 2021
The FDA extends the PDUFA goal date for Calliditas’ NDA
Calliditas Therapeutics has announced that the U.S. Food and Drug Administration has extended the PDUFA goal date for its New Drug Application (NDA) seeking accelerated approval for Nefecon to December 15, 2021. In March 2021 Calliditas filed for FDA approval using the Accelerated Approval Program, based on the proteinuria endpoint as previously discussed with the […]
Pharma Business - May 3, 2021
FDA grants priority review for Calliditas’ Nefecon
Calliditas Therapeutics has announced that the U.S. Food and Drug Administration has accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy (IgAN.) The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, […]
Acquisition - December 21, 2020
Calliditas now controls 86.2% of the shares in Genkyotex
Calliditas has announced the final outcome of simplified mandatory offer to the shareholders of Genkyotex. Calliditas Therapeutics submitted a simplified public mandatory offer to the shareholders of Genkyotex on 26 November 2020. After the end of the acceptance period on December 11, Calliditas now controls 86.2 percent of the shares in Genkyotex. Calliditas acquired 7,236,515 […]
Business Award - December 10, 2020
Calliditas is the winner of the 2020 SwedenBIO Award
Calliditas Therapeutics received the award in recognition of its successful clinical development program of Nefecon, which culminated in the recent positive topline data readout of the Phase 3 NefIgArd trial. “This year’s winner has shown impressive professionalism and staying power with regards to the development of a completely new treatment for patients with IgA Nephropathy, […]
Clinical Trials - November 15, 2020
Positive results from Calliditas
Calliditas Therapeutics has announced positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN). The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 […]
