MNPR news

Monopar Therapeutics initiated a rolling New Drug Application submission for ALXN1840 to treat Wilson disease. This regulatory advance represents a potential first novel mechanism of action in the US for decades.

Monopar Therapeutics received Rare Pediatric Disease designation for ALXN1840 treating Wilson disease. This grants potential eligibility for a Pediatric Priority Review Voucher upon NDA approval.

Monopar Therapeutics announced publication of Phase 2 study results demonstrating ALXN1840 (tiomolibdate choline) achieved statistically significant reductions in daily copper balance and increased fecal copper excretion in Wilson disease patients, with good tolerability. The positive clinical data …