Welcome to our dedicated page for Monopar Therapeutics news (Ticker: MNPR), a resource for investors and traders seeking the latest updates and insights on Monopar Therapeutics stock.
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) 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.
Monopar (Nasdaq: MNPR)/b) reported Q4 and full-year 2025 results and a business update. Key highlights include
Monopar (Nasdaq: MNPR) appointed Susan Rodriguez as Chief Commercial and Strategy Officer, effective immediately. In this newly created role she will lead commercial strategy and infrastructure as Monopar prepares a planned NDA submission for ALXN1840 in the first half of 2026.
Ms. Rodriguez brings over 30 years of biopharma commercial experience, including leadership roles at Avadel, Ardelyx, Tolmar, and Abbott, and experience launching rare-disease therapies and building commercial organizations.
Monopar Therapeutics (Nasdaq: MNPR) reported Q3 2025 results and program updates on Nov 13, 2025. The company ended the quarter with $143.7 million in cash, which it says funds operations through Dec 31, 2027. Monopar plans an NDA submission for ALXN1840 in early 2026 after new Phase 2 and long‑term hepatic and neurological data showing improved copper balance and sustained benefit. The FDA cleared an IND for MNPR-101-Lu (radiopharmaceutical) for a Phase 1 dosimetry and dose‑escalation trial. In September the company completed a public offering that raised net proceeds of ~$126.9M (gross) and used $35M to repurchase shares from a significant holder, leaving ~$91.9M net.
Monopar (Nasdaq: MNPR) presented new Phase 2 ALXN1840-WD-204 data at AASLD The Liver Meeting® 2025 on Nov 9, 2025 showing that ALXN1840 (tiomolybdate choline) produced a rapid, sustained improvement in daily copper balance in Wilson disease patients, driven primarily by increased fecal copper excretion.
The study cohort (n=8) showed a mean daily copper balance that was significantly lower vs pre-treatment baseline. Improvement occurred during the initial 15 mg once-daily dosing period (days 1–28) and across the full treatment window (days 1–39), which included 15 mg every other day or 30 mg once-daily dosing. Presentation materials and the abstract are available online.
Monopar Therapeutics (Nasdaq: MNPR) announced its abstract from the Phase 2 ALXN1840-WD-204 copper balance study was accepted for an oral presentation at AASLD – The Liver Meeting® 2025 in Washington, D.C.
The presentation, titled Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline, is scheduled for Sunday, November 9, 2025, 9:00–9:15 AM EST in the session “Distinct Pathways, Shared Progress: Metabolic/Genetic Disorders & Biliary Physiology.” Presenting author: Aftab Ala, MBBS, M.D., FRCP, Ph.D. The abstract is on the conference website and presentation materials will be posted at www.monopartx.com on November 9, 2025.
Monopar Therapeutics (Nasdaq: MNPR), a clinical-stage biopharmaceutical company, has announced the pricing of an underwritten registered offering totaling $135 million. The offering consists of 1,034,433 shares of common stock priced at $67.67 per share and pre-funded warrants for 960,542 shares at $67.669 per warrant.
The company expects to receive $100 million in gross proceeds after allocating $35 million for a stock repurchase from Tactic Pharma, LLC at $63.6098 per share. The funds will support general corporate purposes, including R&D, clinical trials, product manufacturing, and working capital. The offering is expected to close around September 25, 2025, led by Morgan Stanley, Leerink Partners, and Barclays as book-running managers.
Monopar Therapeutics (Nasdaq: MNPR) announced the publication of a peer-reviewed Letter to the Editor in the Journal of Hepatology regarding ALXN1840's effectiveness in treating Wilson disease. The letter addresses previous methodological limitations in copper balance analysis from the Phase 2 ALXN1840-WD-204 study.
The new analysis demonstrates that ALXN1840 significantly improved copper balance in patients, with key findings showing a mean daily difference of -0.367 mg (p=0.005) during the 15 mg/day treatment period. The overall treatment period showed a mean daily difference of -0.289 mg (p=0.023), with a cumulative mean change from baseline of -6.08 mg.