MNPR Monopar

Monopar initiates rolling NDA for ALXN1840 in Wilson disease

Monopar began a rolling NDA submission to FDA for ALXN1840 on July 22, 2026. FDA granted Rare Pediatric Disease designation on June 30, 2026, potentially qualifying the company for a Priority Review Voucher upon approval. The company expects to complete the NDA submission within the next few months.

Monopar initiates rolling NDA submission for ALXN1840 in Wilson disease

Monopar has begun a rolling NDA submission to the FDA for ALXN1840 (tiomolibdate choline) in Wilson disease. The submission is now active, moving the asset from pre-submission to the formal review pathway. No PDUFA date or acceptance decision has been announced yet.

Monopar to present ALXN1840 FoCus trial analyses at EAN 2026

Monopar will present new Phase 3 FoCus trial analyses of ALXN1840 (tiomolibdate choline) at the 12th Congress of the European Academy of Neurology (EAN) June 27-30, 2026. The analyses show greater neurologic and global clinical benefit versus standard of care in Wilson disease patients. The poster presentation is furnished as Exhibit 99.2.

Monopar: ALXN1840 neurologic benefit data at EAN 2026

New Phase 3 FoCus subgroup analyses presented at EAN 2026 show ALXN1840 produced statistically significant neurologic improvement (UWDRS Part III, p=0.006) and greater global clinical benefit (CGI-I, p<0.001) versus standard of care in Wilson disease patients with neurologic symptoms. These data further support the planned NDA submission in mid-2026.

Monopar on track for ALXN1840 NDA submission mid-2026

The company reiterated its plan to submit the NDA for ALXN1840 (tiomolibdate choline) to the FDA in mid-2026. New Phase 3 FoCus trial neurologic and liver-disease data were presented at AAN 2026 and will be shown at EAN and EASL 2026, but no regulatory filing has yet occurred.

Monopar presents ALXN1840 neurologic data at AAN 2026

Monopar presented new Phase 3 FoCus trial analyses at the AAN Annual Meeting showing greater neurologic benefit for ALXN1840 versus standard of care in Wilson disease patients with neurologic symptoms at baseline. The data were presented on April 19, 2026 during the April 18-22 meeting window.

Monopar plans NDA submission for ALXN1840 in Wilson disease

The company announced it is preparing to submit an NDA to the FDA for ALXN1840 in Wilson disease in early 2026. Recent presentations at ANA and AASLD meetings highlighted long-term neurological, hepatic, and copper-balance data supporting the filing.