MNPR

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Monopar advances NDA rollout for Wilson disease candidate ALXN1840

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.

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Monopar Therapeutics Receives FDA Rare Pediatric Disease Designation for ALXN1840

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.

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Monopar's ALXN1840 shows statistically significant copper balance improvement in Phase 2 Wilson disease trial

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 pos

View filing at SEC.gov →
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