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Monopar Therapeutics Inc. develops clinical and preclinical biopharmaceutical programs for Wilson disease and oncology radiopharmaceuticals. News about MNPR centers on ALXN1840, also described as tiomolibdate choline, a late-stage investigational oral therapy for Wilson disease, including analyses from the Phase 3 FoCus trial, copper-balance data, neurology and hepatology conference presentations, and related peer-reviewed publications.
Company updates also cover the MNPR-101 radiopharmaceutical programs for uPAR-expressing cancers, including MNPR-101-Zr imaging activity, MNPR-101-Lu therapeutic development and IND clearance, and preclinical MNPR-101-Ac work. Recurring corporate themes include financial results, public offerings, balance-sheet updates, and commercial or executive infrastructure as the company advances its pipeline.
Monopar (Nasdaq: MNPR) appointed Jeffrey D. Kent, M.D. as Executive Vice President, Head of Medical Affairs, effective September 1, 2026, to lead medical affairs as the company prepares for potential FDA review of its ALXN1840 New Drug Application for Wilson disease.
Monopar also reported that two abstracts on ALXN1840 (tiomolibdate choline, TMC), its late-stage albumin tripartite complex activator for Wilson disease, were accepted for presentation at AASLD – The Liver Meeting 2026 in Denver, November 5-9, 2026. One Phase 3 FoCus trial abstract on residual disease burden will be delivered as an oral presentation on November 8, and a second abstract on molybdenum balance and toxicity will be presented as a poster on November 5.
Monopar Therapeutics (Nasdaq: MNPR) reported second quarter 2026 results and major progress for ALXN1840 in Wilson disease. The FDA authorized a rolling NDA submission, initiated on July 22, 2026, which Monopar expects to complete within the next few months. On June 30, 2026, ALXN1840 received Rare Pediatric Disease designation, potentially enabling a pediatric Priority Review Voucher at approval. Monopar highlighted multiple 2026 presentations and a peer-reviewed publication showing ALXN1840 improved copper balance, neurologic symptoms, liver disease stability, and quality of life versus standard of care in clinical studies. In the pivotal Phase 3 trial, ALXN1840 met its primary endpoint with significantly greater copper mobilization over 48 weeks. As of June 30, 2026, Monopar held $134.3 million in cash, cash equivalents and investments, expects funding through at least December 31, 2027, and reported a Q2 2026 net loss of $5.3 million ($0.62 per share).
Monopar (Nasdaq: MNPR) has initiated a rolling New Drug Application (NDA) submission to the U.S. FDA for ALXN1840 (tiomolibdate choline, TMC), a first-in-class albumin tripartite complex activator for treating Wilson disease. The FDA has authorized rolling review, and Monopar has submitted the first completed NDA sections.
If the completed NDA is accepted for filing and later approved, ALXN1840 could become the first U.S. therapy with a novel mechanism of action for Wilson disease in decades. The candidate has Fast Track, Orphan Drug, and Rare Pediatric Disease designations, which may make Monopar eligible for a pediatric Priority Review Voucher upon approval.
Monopar (Nasdaq: MNPR) announced key commercial leadership additions to support the anticipated launch of its first potential commercial product, ALXN1840, for Wilson disease, pending U.S. FDA approval. Nicole Sweeny, former Chief Commercial Officer of KalVista Pharmaceuticals, was elected to the Board of Directors on June 22, 2026.
Monopar also appointed Sharon Funk as Senior Vice President, Sales and Marketing, and Daniel Olmstead as Senior Vice President, Market Access, Distribution and Patient Services. ALXN1840 is described as a first-in-class Albumin Tripartite Complex activator that has demonstrated clinical safety, efficacy and tolerability. The Company plans to submit a U.S. FDA New Drug Application for ALXN1840 in mid-2026 and states these appointments deepen its commercial expertise as it prepares for potential commercialization.
Monopar Therapeutics (Nasdaq: MNPR) announced that the FDA granted Rare Pediatric Disease (RPD) designation to ALXN1840 (tiomolibdate choline, TMC), its late-stage candidate for treating Wilson disease. The designation makes Monopar potentially eligible for a future pediatric Priority Review Voucher, which can shorten FDA review timelines or be sold to another sponsor.
Monopar (Nasdaq: MNPR) reported new Phase 3 FoCus analyses of ALXN1840 in neurologic Wilson disease, to be presented at EAN 2026. ALXN1840 showed significant neurologic improvement on UWDRS Part III (p=0.006) versus standard of care (SoC; p=0.435) and greater global clinical improvement on CGI-I at Week 48 (p<0.001).
More patients on ALXN1840 improved on UWDRS Part III, with similar or greater psychiatric and hepatic benefits versus SoC. Across Phase 2/3 (266 patients; median 2.58 years, max >8 years), drug-related SAEs occurred in 4.9%, neurologic SAEs in <1%, with no treatment-related deaths. These data support a planned mid‑2026 FDA NDA filing.
Monopar Therapeutics (Nasdaq: MNPR) presented Phase 2 ALXN1840-WD-205 data in treatment-experienced Wilson disease patients at EASL 2026. The 48-week, open-label trial in 29 patients showed high rates of liver histology stabilization or improvement, significant neurologic, global clinical, and quality-of-life gains, and a generally well-tolerated safety profile.
Monopar (Nasdaq: MNPR) announced publication of an open-label Phase 2 ALXN1840-WD-204 trial showing ALXN1840 (tiomolibdate choline) rapidly and significantly improves daily copper balance in Wilson disease patients.
In nine patients, key outcomes included a cumulative mean copper balance decrease of -6.08 mg over 21 days and about a 50% rise in the fecal copper output-to-intake ratio, with ALXN1840 generally well tolerated and no serious adverse events reported.
Monopar Therapeutics (Nasdaq: MNPR) reported Q1 2026 results and business updates. The company highlighted new Phase 3 FoCus trial analyses showing greater neurologic benefit of ALXN1840 versus standard of care in Wilson disease and confirmed plans to submit an NDA to the FDA in mid-2026.
Cash, cash equivalents and investments were $137.5 million as of March 31, 2026, expected to fund operations at least through December 31, 2027. Q1 2026 net loss was $3.9 million versus $2.6 million a year earlier, with higher R&D and G&A expenses partly offset by increased interest income.
Monopar (Nasdaq: MNPR) reported Phase 3 FoCus data showing ALXN1840 produced greater neurologic improvement and less worsening than standard of care in Wilson disease patients with neurologic symptoms through Week 48.
Key results: clinically meaningful worsening 25% SoC vs 9% ALXN1840 (p=0.038); improvement rates higher with ALXN1840 (45% vs 32%); durable benefit sustained ~3 years. Monopar plans an NDA submission to FDA in mid-2026.