MNPR Stock Hub: Monopar Therapeutics News, Wilson Disease NDA and uPAR Radiopharma

MNPR stock at a glance

Where Monopar Therapeutics stands now

Monopar licenses late-stage assets and develops them with contractors from Wilmette, Illinois, with 22 employees. Its lead asset is ALXN1840 (tiomolibdate choline), an oral tablet that forms a stable albumin-copper complex, suppresses copper’s redox reactivity and increases faecal excretion; it holds orphan designation in the United States and the European Union, fast track status and, since June 30, 2026, rare paediatric disease designation. The Phase 3 FoCus trial randomised 214 patients against standard of care and met its primary endpoint on directly measured non-ceruloplasmin-bound copper. Form 10-K, 2025

On November 12, 2026 Monopar reported third-quarter results and said it is on track to complete the NDA submission within the next several weeks. At the AASLD Liver Meeting it presented, on November 8, baseline findings from the Phase 3 FoCus study: only 47% of treatment-experienced patients were within the guideline-recommended copper target range, and 73% of evaluable patients had at least two of cirrhosis, neurologic or psychiatric manifestations; a poster on November 5 reported neutral molybdenum balance and no molybdenum toxicity, with serum uric acid within normal limits over six years of treatment. These are company-presented analyses, not a new efficacy trial. Third-quarter release

Latest MNPR news

MNPR stock catalysts: the dated calendar

• November 5 and 8, 2026 — AASLD Liver Meeting: molybdenum-balance poster and FoCus baseline disease-burden findings. Completed
• November 12, 2026 — Third-quarter 2026 results and Form 10-Q; runway extended to at least March 31, 2028. Completed
• Within the next several weeks from November 12, 2026 — Completion of the rolling NDA submission for ALXN1840; guidance moved from “the next few months” (August 12) to “the next several weeks”. Company guidance
• After completion — FDA decision whether to accept the completed application for filing. Statutory sequence
• December 2026 — Estimated primary completion of the MNPR-101-Zr imaging and dosimetry trial. Registry estimate
• January 2027 — Estimated primary completion of the MNPR-101-Lu dose escalation. Registry estimate
• 2027, if accepted — NDA review: ten months standard, six months priority, from acceptance. Statutory clock
• At approval, if granted — Possible paediatric priority review voucher and the first Alexion milestone payment. Conditional
• Undated — European marketing authorisation application; orphan designation held, no filing announced. No announcement

Two programmes, two very different stages

Registry entries: NCT03403205 (last update June 17, 2024), NCT06337084 and NCT06617169 (last update September 3, 2026). Licence terms from the Form 10-Q at June 30, 2026.

Cash, burn and the shelf

The company ended September 30, 2026 with $129.4 million of cash, cash equivalents and investments, down from $140.4 million at December 31, 2025. The net loss was $6.196 million in the third quarter and $15.403 million in the first nine months; third-quarter research and development rose to $4.437 million from $2.590 million a year earlier and general and administrative expenses to $3.031 million from $1.503 million. Interest income of $1.271 million in the quarter offset part of that. Net cash used in operating activities was $12.896 million over nine months. The 10-Q states that available funds are sufficient at least through March 31, 2028, compared with December 31, 2027 in the previous quarterly report, and that there is no substantial doubt about the ability to continue as a going concern. Form 10-Q, September 30, 2026

The dilution already exists in the structure: at September 30, 2026, 6,762,620 shares plus 1,843,303 pre-funded warrants at $0.001 and stock-based awards for up to 849,606 shares, or 9,455,529 shares fully diluted, a calculation. The September 2025 offering sold 1,034,433 shares at $67.67 and 960,542 pre-funded warrants at $67.669, for $135.0 million gross and $126.9 million net before expenses, and the company used $35 million to repurchase 550,229 shares from its founding investor. About $165 million of the $300 million shelf registered on August 29, 2025 remains unused, a calculation.

Merlintrader Health Score · $MNPR

Assessed on November 9, 2026, after the second-quarter report of August 12, 2026 and the initiation of the rolling NDA on July 22, 2026. Reassessed on November 12, 2026 after the third-quarter report: the runway extension to March 31, 2028 and the shorter NDA completion guidance support the existing balance-sheet and catalyst scores, while no filing acceptance or PDUFA date exists yet; all pillar scores unchanged. Calculation: 0.30 × 4.5 + 0.30 × 4.0 + 0.20 × 3.0 + 0.10 × 3.5 + 0.10 × 4.0 = 1.35 + 1.20 + 0.60 + 0.35 + 0.40 = 3.90, rounded to 3.9. The score describes financial and operational robustness over twelve to eighteen months. It is not a rating, a target price or an indication to buy or sell.

Red flags

• The lead asset was terminated by Alexion after Phase 2 mechanistic studies failed to show a net-negative copper balance or a reduction in hepatic copper.
• One pivotal trial, rater-blinded, with a pharmacodynamic primary endpoint and no second Phase 3.
• No dated PDUFA goal date: everything depends on when the rolling submission is completed.
• A market of roughly 5,000 diagnosed and treated U.S. patients, served by generic chelators and zinc, with two gene therapies in development.
• No revenue since inception and an accumulated deficit of $104.9 million at September 30, 2026.
• Up to $94 million of milestones and royalties of 10% to 20% payable to Alexion, with a milestone tied to regulatory approval.
• About $165 million of unused shelf capacity above a 6.8 million share count, before 1.84 million pre-funded warrants.
• Radiopharmaceutical manufacturing outsourced, with no long-term contracts and a vendor acquired by a competitor.