Biopharmaceutical company Monopar Therapeutics, Inc. (MNPR) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to ALXN1840 (tiomolibdate choline, TMC), the Company's late-stage candidate for the treatment of Wilson disease.
The FDA grants RPD designation to therapies intended to treat serious or life-threatening diseases that primarily affect children from birth to 18 years of age.
The designation provides the Company with the potential at the time of NDA approval to receive a pediatric Priority Review Voucher (PRV), which can be used to obtain priority review of a subsequent marketing application or sold or transferred to another sponsor.
The priority review can reduce the FDA's target review time by several months.
For comments and feedback contact: editorial@rttnews.com
Business News
September 04, 2026 15:08 ET The job report and foreign trade data were the main economic news from the U.S. in the first week of September. Elsewhere in North America, the Canadian central bank announced its latest policy decision. Inflation data from Eurozone was the highlight in Europe. The latest interest rate decision by the Reserve Bank of New Zealand drew attention in Asia.