Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
MNPR Catalyst Timeline
Dated clinical, regulatory and corporate events for Monopar Therapeutics Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Monopar Therapeutics Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How MNPR actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-06-30 | ALXN1840 | NDA Submission | NDA |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| MNPR-101-PCTA-177Lu Small moleculeNCT06617169 | Solid Tumor, Adult | Phase 1 | ACTIVE NOT_RECRUITING | 12 | Feb 1, 2027 | ||||||
| MNPR-101-DFO*-89Zr Small moleculeNCT06337084 | Solid Tumor, Adult | Phase 1 | ACTIVE NOT_RECRUITING | 12 | Dec 1, 2026 |
Clinical Trial Results
Readouts, endpoints and source filings for every MNPR program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| ALXN1840 Fast TrackOrphanRare Pediatric | Wilson disease | Phase 3 | 2026-06-26 | In the Phase 3 FoCus trial of ALXN1840 for Wilson disease, patients showed significant neurologic improvement (p=0.006) and greater global clinical improvement at Week 48 (p<0.001) compared to standard of care, with a total of 207 participants.Read More | Monopar Presents New Analyses of Phase 3 FoCus Data at EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with ALXN1840 Versus Standard of Care in Wilson DiseaseRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| STARR CHRISTOPHER MDirector | Option | 8,400 13,573 held | $0.01 | 10/01/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in MNPR
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| RA CAPITAL MANAGEMENT, L.P. | 0.5 % (25 %) | 61.78 M | 667.21 K |
MNPR Institutional Ownership Trends
MNPR Short Interest
Shares sold short, counted twice a month.
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How MNPR ranks across every disease it competes in
MNPR News
Monopar Appoints Jeffrey D. Kent, M.D., as Executive Vice President, Head of Medical Affairs; Announces Two ALXN1840 Presentations at AASLD – The Liver Meeting® 2026
Monopar Therapeutics has appointed Dr. Jeffrey D. Kent as Executive Vice President, Head of Medical Affairs, effective September 1, 2026. The company also announced that two abstracts on its drug candidate ALXN1840 for Wilson disease will be presented at the AASLD – The Liver Meeting 2026. The presentations aim to address unmet needs in Wilson disease treatment.
Read more →Monopar Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Updates
Monopar Therapeutics reported its second quarter 2026 financial results, highlighting the initiation of a rolling NDA submission for ALXN1840, a treatment for Wilson disease. The FDA granted Rare Pediatric Disease designation for ALXN1840, which may lead to a Priority Review Voucher upon approval. Despite a net loss increase, the company showcased promising clinical trial results demonstrating significant neurologic improvements in patients.
Read more →Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease
Monopar Therapeutics has begun the rolling submission of a New Drug Application (NDA) for ALXN1840, a novel treatment for Wilson disease. This marks a significant milestone as it may lead to the first new therapy for the condition in decades. The FDA has granted several designations to ALXN1840, enhancing its potential for approval. However, uncertainties regarding regulatory acceptance and market competition remain.
Read more →Monopar Advances Launch Readiness with Addition of Veteran Commercial Executive Nicole Sweeny to Board of Directors and Expansion of Commercial Leadership Team
Monopar Therapeutics has bolstered its commercial leadership team in anticipation of launching its first product, ALXN1840, pending FDA approval. Nicole Sweeny has joined the Board of Directors, while Sharon Funk and Daniel Olmstead have been appointed to senior roles. The company aims to submit an NDA for ALXN1840 in mid-2026, targeting Wilson disease treatment.
Read more →Monopar Therapeutics Receives FDA Rare Pediatric Disease Designation for ALXN1840 for the Treatment of Wilson Disease
Monopar Therapeutics announced that the FDA has granted Rare Pediatric Disease designation to its candidate ALXN1840 for Wilson disease. This designation could allow the company to obtain a pediatric Priority Review Voucher upon NDA approval, expediting the review process. ALXN1840 has demonstrated significant efficacy in clinical trials, showing improved copper balance in patients. The company emphasizes the urgent need for new treatment options for this serious condition.
Read more →Monopar Presents New Analyses of Phase 3 FoCus Data at EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with ALXN1840 Versus Standard of Care in Wilson Disease
Monopar Therapeutics presented new analyses from the Phase 3 FoCus trial of ALXN1840 at EAN 2026. The data demonstrated significant neurologic and global clinical improvements in Wilson disease patients compared to standard care. The findings support the company's upcoming New Drug Application submission to the FDA for ALXN1840, which has shown a favorable safety profile in previous studies.
Read more →Monopar Presents Phase 2 ALXN1840 Data Demonstrating Liver Disease Stabilization and Neurologic Improvement in Treatment-Experienced Wilson Disease Patients at EASL 2026
Monopar Therapeutics presented promising Phase 2 data for ALXN1840 at EASL 2026, showing stabilization of liver disease and improvements in neurologic symptoms in Wilson disease patients. The study involved 29 treatment-experienced patients and highlighted significant clinical outcomes, including quality of life enhancements. The results underscore ALXN1840's potential to address unmet medical needs in this patient population.
Read more →Monopar Announces Publication of Phase 2 Study Demonstrating ALXN1840 Significantly Improves Copper Balance in Patients with Wilson Disease
Monopar Therapeutics announced the publication of a Phase 2 study demonstrating that ALXN1840 significantly improves copper balance in patients with Wilson disease. The study showed a rapid and sustained improvement in daily copper balance, attributed to increased fecal copper excretion. ALXN1840 was well tolerated, indicating its potential as a new treatment option for this rare genetic condition.
Read more →Monopar Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Updates
Monopar Therapeutics reported its first quarter 2026 financial results, highlighting a net loss of $3.9 million. The company is on track to submit a New Drug Application for ALXN1840 for Wilson disease by mid-2026, following positive results from the Phase 3 FoCus trial. Monopar's cash reserves are projected to sustain operations through 2027, despite rising R&D expenses.
Read more →Monopar Presents Phase 3 Data Showing Greater Neurologic Benefit with ALXN1840 vs SoC in Wilson Disease Patients with Neurologic Symptoms at AAN 2026
Monopar Therapeutics presented new Phase 3 data for ALXN1840, indicating significant neurologic benefits in Wilson disease patients with symptoms. The trial demonstrated higher rates of improvement and lower rates of worsening compared to standard care. The findings support the potential of ALXN1840 as a novel treatment option, with plans for a New Drug Application submission to the FDA in mid-2026.
Read more →Monopar Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Business Update
Monopar Therapeutics announced its fourth quarter and full-year 2025 financial results, highlighting a productive year marked by advancements in the development of ALXN1840 for Wilson disease. The company plans to submit a New Drug Application for ALXN1840 in mid-2026. Despite a reduced net loss, the company faces ongoing regulatory uncertainties and increased expenses.
Read more →Monopar Expands Leadership Team with Appointment of Seasoned Biopharma Executive Susan Rodriguez as Chief Commercial and Strategy Officer
Monopar Therapeutics has appointed Susan Rodriguez as Chief Commercial and Strategy Officer to lead its commercial strategy. This role comes as the company prepares to submit a New Drug Application for ALXN1840, a therapy for Wilson disease. Rodriguez brings over 30 years of experience in biopharmaceuticals, having previously held leadership positions at Avadel Pharmaceuticals and Ardelyx.
Read more →Monopar Therapeutics Reports Third Quarter 2025 Financial Results and Recent Developments
Monopar Therapeutics reported its third quarter 2025 financial results, highlighting significant developments in its clinical programs. The company showcased promising data for ALXN1840 in treating Wilson disease and received FDA clearance for MNPR-101-Lu. Despite a net loss increase, Monopar raised $126.9 million through a public offering to support ongoing operations and future drug applications.
Read more →Monopar Presents New Data and Analyses on Rapidly Improved Copper Balance in Wilson Disease Patients on Tiomolybdate Choline at AASLD - The Liver Meeting® 2025
Monopar Therapeutics presented promising data on ALXN1840, a treatment for Wilson disease, at the AASLD 2025 conference. The Phase 2 study showed a rapid and sustained improvement in copper balance among patients, primarily through increased fecal copper excretion. The findings suggest that ALXN1840 could be an effective therapy for managing Wilson disease.
Read more →Monopar Announces Abstract Accepted for Oral Presentation at AASLD - The Liver Meeting® 2025
Monopar Therapeutics announced that its abstract on the Phase 2 ALXN1840-WD-204 study has been accepted for oral presentation at the AASLD – The Liver Meeting® 2025. The event will take place in Washington, D.C., from November 7-11, 2025. The presentation materials will be available on the company's website shortly after the event.
Read more →Monopar Therapeutics Inc. Announces Pricing of $135 Million Underwritten Offering of Common Stock and Pre-Funded Warrants
Monopar Therapeutics Inc. has announced the pricing of a $135 million underwritten offering of common stock and pre-funded warrants. The offering includes 1,034,433 shares priced at $67.67 each, with expected net proceeds of approximately $100 million. Monopar plans to utilize the funds for general corporate purposes, including R&D and a stock repurchase from Tactic Pharma.
Read more →Monopar Announces Journal of Hepatology Publishes Physicians’ Letter to the Editor Demonstrating ALXN1840 Rapidly Improved Copper Balance in Wilson Disease Patients
Monopar Therapeutics announced the publication of a peer-reviewed Letter to the Editor in the Journal of Hepatology, highlighting that ALXN1840 significantly improves copper balance in Wilson disease patients. The analysis corrected previous methodological limitations from a Phase 2 study, demonstrating enhanced copper excretion. This publication reinforces the therapeutic potential of ALXN1840 for treating Wilson disease.
Read more →Monopar to Present New Long-Term Neurological Efficacy and Safety Data for ALXN1840 in Wilson Disease at the 150th American Neurological Association Annual Meeting
Monopar Therapeutics announced the presentation of new long-term data on ALXN1840 for Wilson disease at the 150th ANA Annual Meeting. The findings indicate significant neurological benefits and safety for patients, reinforcing the therapy's potential. The data, pooled from multiple clinical trials, highlights the treatment's efficacy over an average duration of 2.6 years.
Read more →Monopar Announces Abstract Accepted with Distinction for Oral and Poster Presentations at the Upcoming American Neurological Association 2025 Annual Meeting
Monopar Therapeutics announced that its abstract on ALXN1840 for Wilson disease has been accepted for both oral and poster presentations at the upcoming American Neurological Association Annual Meeting. The abstract, which discusses long-term neurological benefits, has received the prestigious designation of Abstract of Distinction. Presentations will be available online in mid-September 2025.
Read more →