Calliditas Therapeutics

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

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STOCKHOLM, June 21, 2023 /PRNewswire/ — 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 … Read more

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

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STOCKHOLM, June 21, 2023 /PRNewswire/ — 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 … Read more

Calliditas Therapeutics: Interim Report Q1, 2023

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STOCKHOLM, May 16, 2023 /PRNewswire/ —  Strong eGFR Data from Positive NefIgArd Phase 3 Trial Readout “In March we announced that the global NefIgArd Phase 3 trial successfully met its primary endpoint, estimated glomerular filtration rate (eGFR), with a p value < 0.0001. Achieving this clinically relevant endpoint of kidney filtration capability represents a crowning … Read more

Calliditas Therapeutics: Interim Report Q1, 2023

by

STOCKHOLM, May 16, 2023 /PRNewswire/ —  Strong eGFR Data from Positive NefIgArd Phase 3 Trial Readout “In March we announced that the global NefIgArd Phase 3 trial successfully met its primary endpoint, estimated glomerular filtration rate (eGFR), with a p value < 0.0001. Achieving this clinically relevant endpoint of kidney filtration capability represents a crowning … Read more