Calliditas Therapeutics Gets Orphan Drug Designation From FDA for Alport Syndrome Treatment
September 27 2023 - 02:15PM
Dow Jones News
By Ben Glickman
Calliditas Therapeutics has received orphan drug designation
from the U.S. Food and Drug Administration for setanaxib in the
treatment of Alport syndrome.
The Stockholm-based pharmaceutical company said Wednesday that,
based on pre-clinical work, the company would begin a Phase 2 study
of setanaxib in Alport syndrome in about 20 patients in the fourth
quarter of 2023.
Alport syndrome is a genetic disorder which can cause kidney
disease, loss of hearing and eye abnormalities. The company said
that Alport affects 30,000 to 60,000 people in the U.S.
Orphan drug status is given in the development of treatments for
rare diseases. Recipients can receive tax credits, exemptions from
fees and potential market exclusivity after approval.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
September 27, 2023 14:00 ET (18:00 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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