Mirum's CTEXLI™ (chenodiol) Tablets Receives FDA Approval for Treatment of Cerebrotendinous Xanthomatosis (CTX) [Yahoo! Finance]
Mirum Pharmaceuticals, Inc. - common stock (MIRM)
Last mirum pharmaceuticals, inc. - common stock earnings: 3/12 04:02 pm
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Source: Yahoo! Finance
CTEXLI granted U.S. FDA Orphan Drug exclusivity for the treatment of CTX FOSTER CITY, Calif., February 24, 2025 BUSINESS WIRE )--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved CTEXLI™ (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous xanthomatosis (CTX). CTEXLI is the first and only treatment approved for this rare, progressive and debilitating disease. The approval is based on data from the Phase 3 RESTORE study evaluating the safety and efficacy of CTEXLI in adult patients with CTX by measurement of urine bile alcohols and other secondary measures. The primary endpoint of reduction in bile alcohols (urine 23S-pentol) was highly statistically significant (p In CTX, a deficiency of the bile acid chenodeoxycholic acid (CDCA) leads to a buildup of bile alcohols which precedes a toxic accumulation of cholestanol. Cholestanol is the key driver of symptomatic burden and diseas
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MIRM
Earnings
- 11/4/25 - Beat
MIRM
Sec Filings
- 12/22/25 - Form 144
- 12/19/25 - Form 4
- 12/19/25 - Form 144
- MIRM's page on the SEC website