Monopar starts rolling FDA NDA submission for ALXN1840 in Wilson disease

• Monopar Therapeutics initiated a rolling NDA submission to the FDA for ALXN1840 in Wilson disease.
• The FDA authorized the rolling review; initial NDA sections have been submitted.
• ALXN1840 received FDA Rare Pediatric Disease designation in June 2026, supporting eligibility for a pediatric priority review voucher at approval.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Monopar Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607220800PRIMZONEFULLFEED9765768) on July 22, 2026, and is solely responsible for the information contained therein.