Updated regulatory timeline for review of MAA in Europe.
Calliditas Therapeutics AB (publ) (”Calliditas” or the ”Company”) (Nasdaq Stockholm – CALTX; Nasdaq – CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced that the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP)) has decided to continue the assessment of the marketing authorization application (MAA) for Nefecon under standard procedure assessment timelines.Calliditas was in April, 2021 granted an accelerated assessment procedure on its MAA for Nefecon in IgA Nephropathy and