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Monopar nears completion of rolling NDA for ALXN1840 in Wilson disease as Q3 loss hits $6.2m

🇺🇸 Monopar Therapeutics (MNPR) · Thu 12 Nov 2026

Monopar Therapeutics says it expects to finish its rolling FDA submission for ALXN1840 within weeks, reporting $129.4 million in cash that it says funds operations through at least March 2028.

Monopar Therapeutics reported third-quarter 2026 results on 12 November, posting a net loss of $6.2 million. The US company said it held $129.4 million in cash, which it expects to fund operations through at least March 2028.

The main regulatory development is the company's rolling new drug application (NDA) to the US Food and Drug Administration for ALXN1840 (tiomolibdate choline) in Wilson disease. Monopar began the submission on 22 July 2026 and says it expects to complete it within weeks.

Monopar also presented Phase 3 FoCus baseline data and long-term molybdenum safety findings at the AASLD meeting in November 2026. The summary available does not give details of those datasets, and no further figures on the clinical results were provided.

As general context, a rolling submission lets a sponsor send completed sections of an application to the FDA in stages rather than all at once. The agency's review clock generally starts only once the final section is in.

What it means for your team

  • Regulatory teams tracking Wilson disease should watch for confirmation that the ALXN1840 NDA is complete, as this would trigger the FDA's filing review.
  • Safety and pharmacovigilance teams may want to review the long-term molybdenum safety findings presented at AASLD once full data are available.
  • Market-access teams should note the company's stated cash runway to at least March 2028, which covers the expected review period without a stated need for new funding.

Company's press release (SEC filing): Monopar Therapeutics ↗

Article written by VigiEye from the official source (Monopar Therapeutics). Claims are the company's own. AI-assisted; check the source before acting.

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