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Biotech catalyst, news and analysis PDUFA tracker
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Nov 12, 2026, 8:00 AM ET
Monopar Therapeutics reported a third quarter 2026 net loss of $6.2 million, or $0.72 per share, with cash of $129.4 million.
Nasdaq: $MNPRBiotech · Rare diseaseWilson disease NDAuPAR radiopharmaceuticalsSingle pivotal trial · no approval yet
MNPR Stock Hub: Monopar Therapeutics News, Wilson Disease NDA and uPAR Radiopharma
Monopar Therapeutics is taking ALXN1840, an oral copper-sequestering drug for Wilson disease, through a rolling New Drug Application that began on July 22, 2026 and that the company expects to complete within a few months. It held $134.3 million of cash, equivalents and investments at June 30, 2026, with a declared runway through at least December 31, 2027 and no debt, while two first-in-human radiopharmaceutical trials of MNPR-101 run in Australia. The pivotal Phase 3 trial met its primary endpoint on copper mobilisation with a least-squares mean difference of 2.18 µmol/L against standard of care (p<0.0001) and was run by the company that later abandoned the programme.
Full research report · PDF
Monopar Therapeutics ($MNPR) research report, as of November 9, 2026
26 pages: ALXN1840 and the Wilson disease evidence, the Phase 3 FoCus trial and the mechanistic dispute, the rolling NDA and the designations, the commercial question, the MNPR-101 radiopharmaceutical programme, six quarters of results, cash and runway, the September 2025 offering and dilution, ownership, management, catalysts and FAQ. Available in the Merlintrader Research Library. The report is a dated snapshot and is not updated after that date; this page follows the current situation.
Next catalyst
Completion of the rolling NDA for ALXN1840 — company guidance of “within the next few months”
Monopar began the rolling submission on July 22, 2026 after the FDA authorised it to file completed sections while the rest are finalised, and said on August 12, 2026 that it anticipated completing the submission within the next few months; as of November 9, 2026 completion had not been announced and no day had been given. The FDA then decides whether to accept the application for filing. Second-quarter release, August 12, 2026
Before that: third-quarter 2026 results, which the company had not dated as of November 9, 2026; it reported the second quarter on August 12, 2026. Estimated primary completion of the MNPR-101-Zr imaging trial in December 2026 on the registry entry.
MNPR stock at a glance
Close · Nov 6, 2026
$71.42
Regular-session Nasdaq close; the shares traded between $50.07 and $124.82 over the past twelve months.
Market value
~$479M
6,712,172 shares at $71.42; share count at July 31, 2026, a calculation.
Cash and investments · Jun 30, 2026
$134.3M
$52.758M of cash and $81.541M of investments; total liabilities $4.124M and no debt.
Net loss · Q2 2026
−$5.313M
$0.62 per share on 8,542,450 weighted-average shares; first half $9.206M.
R&D · Q2 2026
$4.767M
Up from $1.730M on ALXN1840 regulatory work, manufacturing and personnel; G&A $1.878M.
Declared runway
Dec 2027
Funds sufficient at least through December 31, 2027; company statement, no going-concern doubt.
Shares and pre-funded warrants
8.56M
6,712,172 shares and 1,843,303 warrants at $0.001 at June 30, 2026; 823,127 options and awards more.
Shelf capacity
~$165M
Unused of the $300M registered in August 2025, after $135.0M gross raised in September 2025.
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
The main risk: the asset was abandoned once, by the company that developed it. Alexion terminated the Wilson disease programme after Phase 2 mechanistic studies failed to show a net-negative copper balance or a reduction in hepatic copper, and the decision was not related to safety. Monopar’s application rests on one Phase 3 trial run by Alexion, on a pharmacodynamic primary endpoint, with neurologic and hepatic benefits as supportive analyses. There is no dated PDUFA goal date and no second pivotal trial.
▲ The constructive case
A completed 214-patient randomised Phase 3 with a least-squares mean difference of 2.18 µmol/L in copper mobilisation (p<0.0001), three FDA designations, a rolling NDA authorised rather than a request for another trial, and the possibility of a priority review voucher at approval. The balance sheet holds $134.3 million with no debt and a runway through December 31, 2027, against a $5.3 million quarterly loss. In the neurologic subgroup, clinically meaningful worsening at week 48 was 9% on ALXN1840 against 25% on standard of care (p=0.038).
▼ The cautious case
The drug is aimed at a market of roughly 5,000 diagnosed and treated American patients, served by generic chelators and zinc, with two gene therapies in clinical development. The company has never recorded revenue, its loss is widening as it builds a commercial organisation, and about $165 million of unused shelf capacity sits above 6.7 million shares. A refusal to file, or a complete response letter that returns to the mechanistic question, would cost a year and $20 million before anything is sold.
Latest MNPR news
Nov 12, 2026
Monopar Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Updates
Monopar Therapeutics reported a third quarter 2026 net loss of $6.2 million, or $0.72 per share, compared with $3.4 million, or $0.48 per share, for the third quarter of 2025. Cash, cash equivalents and investments were $129.4 million as of September 30, 2026, which the company expects to support operations through at least March 31, 2028. R&D expenses were $4,436,543 and G&A expenses were $3,031,302. The company is on track to complete the ALXN1840 NDA submission within the next several weeks.
Nov 9, 2026
Monopar presents residual disease burden data in treatment-experienced Wilson disease patients
Monopar presented baseline data from the Phase 3 FoCus trial at AASLD - The Liver Meeting 2026 in Denver, Colorado. Cirrhosis was present in 39% of treatment-experienced and 30% of treatment-naïve patients, and 47% of treatment-experienced patients were within the guideline-recommended copper target range at baseline. Long-term data showed neutral molybdenum balance and lack of molybdenum toxicity with ALXN1840, with serum uric acid within normal limits over six years of treatment.
MNPR stock catalysts: the dated calendar
- Next few months from August 12, 2026 — Completion of the rolling NDA submission for ALXN1840, not announced as of November 9, 2026. Company guidance
- After completion — FDA decision whether to accept the completed application for filing. Statutory sequence
- Undated — Third-quarter 2026 results; the second quarter was reported on August 12, 2026. Not yet dated
- 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
| Programme | What it is | Stage and evidence | What decides it |
|---|---|---|---|
| ALXN1840 Wilson disease | Oral, once-daily small molecule forming an albumin tripartite complex with copper; licensed from Alexion in October 2024 for $4.0M cash and 387,329 shares | Phase 3 FoCus, 214 patients randomised 2:1 against standard of care, primary endpoint dNCC AUEC over 48 weeks, least-squares mean difference 2.18 µmol/L (p<0.0001); rolling NDA began July 22, 2026 | FDA filing acceptance, then review; a label broad enough to support a launch; up to $94M of milestones and 10% to 20% royalties to Alexion |
| MNPR-101 uPAR radiopharmaceuticals | Humanised antibody against uPAR, 95% human, licensed for humanisation from XOMA; labelled with zirconium-89 for imaging, lutetium-177 for beta therapy and actinium-225 for alpha therapy | Phase 1 imaging NCT06337084, 12 patients, active not recruiting, estimated primary completion December 2026; Phase 1 dose escalation NCT06617169, 12 patients, active not recruiting, January 2027 | Dosimetry and tumour uptake in imaging; dose-limiting toxicity and any response signal in therapy; third-party manufacturing with no long-term contracts |
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 June 30, 2026 with $134.3 million of cash, cash equivalents and investments, down from $140.4 million at December 31, 2025. The net loss was $5.313 million in the second quarter and $9.206 million in the first half, and research and development rose to $4.767 million from $1.730 million a year earlier. Interest income of $1.299 million in the quarter offset part of that. The 10-Q states that funds are sufficient at least through December 31, 2027 and that there is no substantial doubt about the ability to continue as a going concern. Form 10-Q, June 30, 2026
The dilution already exists in the structure: 6,712,172 shares plus 1,843,303 pre-funded warrants at $0.001 and 823,127 options and awards, or 9,378,602 shares fully diluted. 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
3.9out of 5
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. 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 $98.7 million at June 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 6.7 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.
MNPR Stock FAQ: Monopar Therapeutics Questions Answered
When is the next MNPR catalyst?
The next step is completion of the rolling NDA for ALXN1840, which Monopar said on August 12, 2026 it anticipated completing “within the next few months”; as of November 9, 2026 completion had not been announced and no day had been given. After completion the FDA decides whether to accept the application for filing. Second-quarter release
Is Monopar’s ALXN1840 FDA approved?
No. As of November 9, 2026 ALXN1840 is investigational: the rolling NDA began on July 22, 2026 and had not been completed. It holds FDA Fast Track and Orphan Drug designations and, since June 2026, Rare Pediatric Disease designation, which gives the potential to receive a pediatric priority review voucher at approval. Rolling NDA release
Does Monopar Therapeutics have any revenue?
No. Monopar has recorded no product or licence revenue since inception and had an accumulated deficit of $98.7 million at June 30, 2026. Interest income of $2.631 million in the first half of 2026 offset part of $11.870 million of operating expenses. Form 10-Q
How much cash does Monopar have and how long will it last?
Monopar had $134.3 million of cash, cash equivalents and investments at June 30, 2026, which management estimates will fund its obligations at least through December 31, 2027; the company reported no substantial doubt about its ability to continue as a going concern. The net loss for the second quarter of 2026 was $5.313 million. Form 10-Q, Note 1
Will Monopar issue more shares?
It can. At June 30, 2026, Monopar had 6,712,172 common shares and 1,843,303 pre-funded warrants outstanding, plus stock-based awards for up to 823,127 shares. It has funded operations mainly through public offerings, at-the-market sales and pre-funded warrant placements, and its shelf registration statement filed in August 2025 allows offerings of up to $300 million of securities. Form 10-Q · Form S-3
When does Monopar report earnings?
The last report was the second quarter, released on August 12, 2026. As of November 9, 2026 the company had not dated the third-quarter report; it released the first quarter on May 14, 2026 and the full year on March 27, 2026. Second-quarter release
What does Monopar Therapeutics do?
Monopar is a clinical-stage biopharmaceutical company in Wilmette, Illinois, with 22 employees, that licenses late-stage assets. ALXN1840, licensed from Alexion in October 2024, is an oral copper-sequestering drug for Wilson disease under a rolling NDA; MNPR-101 is a uPAR antibody in two Phase 1 trials, one imaging with zirconium-89 and one therapeutic with lutetium-177. Form 10-K, 2025
What is Monopar’s rolling NDA for ALXN1840, and why does it matter?
A rolling submission lets a company file completed sections of a marketing application and have them reviewed while the remaining sections are finished; the FDA authorised Monopar to file ALXN1840 this way and Monopar submitted the first sections on July 22, 2026. It matters because the review clock starts only when the application is complete and accepted, so the completion date sets the date of a possible approval. Company release, July 22, 2026
Primary sources
- Form 10-Q, quarter ended June 30, 2026
- Second-quarter 2026 results, August 12, 2026
- Initiation of the rolling NDA for ALXN1840, July 22, 2026
- Rare paediatric disease designation, June 30, 2026
- Phase 3 FoCus neurologic analyses at EAN 2026, June 26, 2026
- Copper balance publication in Hepatology Communications, May 19, 2026
- First-quarter 2026 results, May 14, 2026
- Phase 3 FoCus neurologic data at AAN 2026, April 19, 2026
- Form 10-K, year ended December 31, 2025
- Definitive proxy statement, April 30, 2026
- Prospectus supplement, September 24, 2025
- Form S-3 shelf registration, August 29, 2025
- ClinicalTrials.gov, Phase 3 FoCus (NCT03403205)
- ClinicalTrials.gov, MNPR-101-Zr imaging (NCT06337084)
- ClinicalTrials.gov, MNPR-101-Lu dose escalation (NCT06617169)
Disclaimer. This content is published by Merlintrader for educational and informational purposes only. It is independent journalism and research. It does not constitute investment advice, an investment recommendation, an offer or a solicitation to buy or sell any security, and it is not a research report within the meaning of applicable United States securities regulation. Nothing here should be read as a recommendation to buy, sell or hold $MNPR or any other security.
Figures are taken from public filings with the U.S. Securities and Exchange Commission, company press releases, ClinicalTrials.gov and market data, and are stated with their reference dates. Data can change without notice. Readers should verify every figure against the primary source before acting on it.
Clinical-stage biotechnology companies carry high execution, regulatory and financing risk. Trials fail, endpoints miss, enrollment slips, regulators ask for more data or decline to file an application, and companies that spend ahead of revenue raise equity at whatever price the market will bear. This company held $134.3 million of cash, equivalents and investments at June 30, 2026 against a $5.313 million quarterly net loss, had 8,555,475 shares and pre-funded warrants plus 823,127 options and awards, and owes Alexion up to $94 million in milestones. Its lead asset was terminated once by the company that developed it. Every reader is responsible for their own decisions and should consult a licensed financial adviser where appropriate.
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