Skip to content
Visnia
CtrlK
EconomyAI buildoutMarket MapFundsWatchlist
Log in
Market cap
Revenue
Net income
Cash on hand
Gross margin
Net margin
EPS
P/E ratio
Search
Market mapFundsWatchlist
Visnia

MMonopar Therapeutics

EconomyAI buildoutMarket MapFundsWatchlist
Log in
M

Monopar Therapeutics

  • Overview
  • Financial statements
  • Metrics
  • Quarterly earnings
  • Similar companies
  • News
  • Insider Transactions

News

News

  • 2025 Proxy Statement
    Sep 26, 2026Monopar Therapeutics Inc. (MNPR) - Annual Meeting
  • 2024 Annual Report (10-K)
    Sep 26, 2026Monopar Therapeutics Inc. (MNPR) - Annual Meeting
  • 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
    Aug 19, 2026Monopar Therapeutics Inc. (MNPR) News

    WILMETTE, Ill., Aug. 19, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced the appointment of Jeffrey D. Kent, M.D., FACP, FACG, as Executive Vice President, Head of Medical Affairs, effective September 1, 2026. The Company also announced that two abstracts on ALXN1840 (tiomolibdate choline, TMC), its late-stage candidate for the treatment of Wilson disease, have been accepted for presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2026, taking place November 5-9, 2026, in Denver, Colorado. Appointment of Jeffrey D. Kent, M.D., as Executive Vice President, Head of Medical Affairs Upon joining Monopar, Dr. Kent will lead the Company’s medical affairs organization as Monopar prepares for potential U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA) for ALXN1840, its first-in-class albumin tripartite complex (ATC) activator drug candidate for the treatment of Wilson disease. “Dr. Kent’s training as a gastroenterologist and hepatologist, combined with his deep experience in rare disease, regulatory strategy, and product launches, makes him an exceptional fit for Monopar as we prepare to bring ALXN1840 to patients with Wilson disease,” said Chandler Robinson, M.D., Chief Executive Officer of Monopar. “The novel mechanism of action and compelling data package of ALXN1840 have the potential to meaningfully change how Wilson disease is treated,” said Dr. Kent. “I look forward to helping realize that potential for patients.” Dr. Kent brings more than 20 years of biopharmaceutical leadership experience across medical affairs, clinical development and regulatory strategy, with expertise spanning rare diseases, hepatology and gastroenterology, immunology and specialty therapeutics. Most recently, he served as Chief Medical Officer of Sling Therapeutics, where he led the Phase 2b clinical program evaluating linsitinib in thyroid eye disease. Previously, Dr. Kent spent more than a decade at Horizon Therapeutics, including serving as Executive Vice President, Medical Affairs, and as a member of the Executive Committee. During his tenure, he built and scaled Horizon’s global medical affairs organization and supported key programs, including the KRYSTEXXA franchise and the TEPEZZA Biologics License Application (BLA) and its successful FDA Advisory Committee meeting. Earlier in his career, Dr. Kent led global medical affairs for HUMIRA at Abbott Laboratories and served on the CELEBREX clinical development team at Searle/Pharmacia. AASLD – The Liver Meeting® 2026 Presentations The abstract, titled “Residual hepatic, neurologic, and psychiatric disease burden in treatment-experienced patients with Wilson disease: baseline findings from the FoCus Phase 3 trial,” was selected for an oral presentation, a distinction reserved for a small share of accepted abstracts. Frederick K. Askari, M.D., Ph.D., lead author of the abstract and Associate Professor of Internal Medicine and Director of the Wilson Disease Program at the University of Michigan Health System, will present the findings on Sunday, November 8, 2026, from 12:15 p.m. to 12:30 p.m. MT. The presentation will highlight the significant unmet need that persists despite years of treatment with currently available therapies, underscoring the importance of novel treatment options in Wilson disease. Additionally, a second abstract, titled “Neutral molybdenum balance and lack of molybdenum toxicity in subjects treated with tiomolibdate choline supports safety profile of TMC,” was selected for a poster presentation. Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Consultant Hepatologist at The Roger Williams Institute of Liver

  • Monopar Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Updates
    Aug 12, 2026Monopar Therapeutics Inc. (MNPR) News

    WILMETTE, Ill., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced second quarter 2026 financial results and provided business updates. Recent Program Developments ALXN1840 for Wilson Disease – Rolling NDA Submission Initiated On July 22, 2026, Monopar announced it had initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALXN1840. The FDA authorized Monopar to submit the NDA on a rolling basis, allowing completed sections of the application to be submitted and reviewed while the Company finalizes the remaining sections. The Company anticipates completing the NDA submission within the next few months. On June 30, 2026, the FDA granted Rare Pediatric Disease (RPD) designation to ALXN1840. The FDA grants RPD designation to therapies intended to treat serious or life-threatening diseases that primarily affect children from birth to 18 years of age. The designation provides the Company with the potential at the time of NDA approval to receive a pediatric Priority Review Voucher (PRV), which can be used to obtain priority review of a subsequent marketing application or sold or transferred to another sponsor. On June 28, 2026, Monopar presented new analyses from the Phase 3 FoCus randomized controlled clinical trial of ALXN1840 (tiomolibdate choline, TMC) at the 12th Congress of the European Academy of Neurology (EAN 2026). The poster presentation, titled “Greater clinical benefit with tiomolibdate choline versus standard-of-care in neurologic Wilson disease patients in the Phase 3 FoCus Trial,” showed significant neurologic improvement over time and greater global clinical improvement versus standard-of-care therapy in Wilson disease patients with neurologic symptoms at baseline. An oral late-breaker presentation on April 19, 2026, at the American Academy of Neurology (AAN) Annual Meeting also highlighted new analyses from the Phase 3 FoCus trial demonstrating greater neurologic benefit with ALXN1840 compared with standard of care (SoC) in Wilson patients with neurologic symptoms. On May 29, 2026, Monopar presented Phase 2 ALXN1840-WD-205 data at the European Association for the Study of the Liver (EASL) Congress 2026. The oral presentation, titled “ALXN1840 (tiomolibdate choline) stabilizes liver disease and improves neurological symptoms as well as quality-of-life in treatment-experienced Wilson disease patients,” demonstrated that, in a heavily pre-treated Wilson disease population, ALXN1840 can stabilize liver disease and provide clinically meaningful improvements in neurologic symptoms and quality of life. These findings complement the increased copper mobilization and clinical improvement shown in the completed Phase 3 pivotal trial (Study WTX101-301). On May 19, 2026, Hepatology Communications published the manuscript titled “Effect of tiomolibdate choline on copper balance in patients with Wilson disease: an open-label Phase 2 trial.” This peer-reviewed publication reported results from the Phase 2 ALXN1840-WD-204 study (NCT04573309) and demonstrated that ALXN1840 produced a rapid, statistically significant, and sustained improvement in daily copper balance in patients with Wilson disease, driven by increased fecal copper excretion. Susan Rodriguez, who joined as Chief Commercial and Strategy Officer in March 2026, is leading preparations for a potential commercial launch. Commercial readiness has been further strengthened by the appointment of Nicole Sweeny, former Chief Commercial Officer of KalVista Pharmaceuticals, to

  • Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease
    Jul 22, 2026Monopar Therapeutics Inc. (MNPR) News

    WILMETTE, Ill., July 22, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that it has initiated the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for ALXN1840 (tiomolibdate choline, TMC), its first-in-class albumin tripartite complex (“ATC”) activator for the treatment of Wilson disease. The FDA has authorized Monopar to submit the NDA on a rolling basis, allowing completed sections of the application to be submitted and reviewed while the Company finalizes the remaining sections. Monopar has submitted the first completed sections of the NDA. If the completed NDA is accepted for filing and subsequently approved, ALXN1840 would be the first therapy with a novel mechanism of action approved in the United States for Wilson disease in decades. “Wilson disease is a serious, lifelong condition, and patients and their families have waited a long time for a new treatment option,” said Chandler Robinson, M.D., Chief Executive Officer of Monopar. “Initiating the rolling NDA submission marks an important milestone in our efforts to bring this novel copper-sequestering therapy to patients.” In addition to Fast Track and Orphan Drug designations, ALXN1840 received Rare Pediatric Disease (“RPD”) designation by the FDA in June 2026. The RPD designation provides the Company with the potential, at the time of NDA approval, to receive a pediatric Priority Review Voucher (“PRV”). About Wilson Disease Wilson disease is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. It is caused by mutations in the ATP7B gene, which impairs the body’s ability to excrete copper. It is characterized by toxic accumulation of copper in the liver, brain, and other organs, leading to progressive and potentially fatal outcomes if untreated. About ALXN1840 ALXN1840 (tiomolibdate choline, TMC) is a novel first-in-class albumin tripartite complex (ATC) activator under investigation for the treatment of Wilson disease. ALXN1840 rapidly mobilizes and tightly sequesters excess copper in stable ATCs, suppressing copper’s redox reactivity, limiting oxidative damage, and blocking its transport across the blood–brain barrier. Clinical data have also demonstrated that ALXN1840 improves copper balance by increasing fecal copper excretion. In the pivotal Phase 3 trial, ALXN1840 met its primary endpoint, demonstrating rapid and sustained copper mobilization that was significantly greater than standard of care over 48 weeks in both previously treated and treatment-naïve patients. Across the ALXN1840 clinical development program, durable clinical improvement and favorable tolerability were observed across 645 patient-years of follow-up in 266 patients, with a well-characterized safety profile. About Monopar Therapeutics Inc. Monopar Therapeutics is a clinical-stage biopharmaceutical company developing ALXN1840, a late-stage program for Wilson disease, and a portfolio of radiopharmaceutical programs, including MNPR-101-Zr (Phase 1) for imaging advanced cancers along with MNPR-101-Lu (Phase 1a) and MNPR-101-Ac (late preclinical) for the treatment of advanced cancers. For more information, visit: www.monopartx.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forw

  • Monopar Advances Launch Readiness with Addition of Veteran Commercial Executive Nicole Sweeny to Board of Directors and Expansion of Commercial Leadership Team
    Jul 20, 2026Monopar Therapeutics Inc. (MNPR) News

    WILMETTE, Ill., July 20, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced the addition of seasoned commercial leaders to support the anticipated launch of the Company’s first commercial product, ALXN1840, pending U.S. Food and Drug Administration (FDA) approval. Nicole Sweeny, former Chief Commercial Officer of KalVista Pharmaceuticals, was elected to the Board of Directors at the Company’s Annual Meeting of Stockholders on June 22, 2026. In addition, Monopar has 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 a first-in-class Albumin Tripartite Complex (ATC) activator for the treatment of Wilson disease that has demonstrated clinical safety, efficacy and tolerability across a robust clinical development program. The Company plans to submit an FDA New Drug Application (NDA) for ALXN1840 in mid-2026. Nicole Sweeny’s 20-plus years of commercial leadership and rare disease launch experience will provide valuable strategic guidance as Monopar prepares for the potential commercialization of ALXN1840. “I’m pleased to join the Monopar Board of Directors as the Company prepares for its next, important phase of growth,” said Ms. Sweeny. “Throughout my career, I’ve seen firsthand the importance of pairing scientific innovation with thoughtful commercial strategy and disciplined execution. I look forward to contributing my experience alongside my fellow directors and the management team as the Company advances its mission, navigates the opportunities ahead and works to create lasting value for patients and shareholders.” Monopar also continued the build-out of its commercial organization with the appointments of Sharon Funk and Daniel Olmstead. Ms. Funk brings more than 20 years of biopharmaceutical commercial leadership experience, with a proven track record of successful scale up and product launches, most recently playing a key role in the commercialization of LUMRYZ at Avadel Pharmaceuticals, acquired by Alkermes Q1 2026. Mr. Olmstead brings more than 30 years of experience creating best-in-class market access, distribution and patient services strategies, most recently instrumental to the successful launches of novel therapies by Ardelyx and Akebia Therapeutics. “This is a pivotal time for Monopar as we advance ALXN1840 toward an NDA submission and prepare for a potential commercial launch,” said Susan Rodriguez, Chief Commercial and Strategy Officer of Monopar. “Sharon and Dan are highly experienced commercial leaders with a proven track record of successful launches of innovative therapies in the rare disease and specialty therapy space. I am also very pleased to welcome Nicole to the Monopar Board of Directors, who brings an invaluable commercial perspective to our Board and management team as we quickly advance our commercial readiness activities. These additions meaningfully deepen the commercial expertise at Monopar as we work to bring ALXN1840 to the Wilson disease community.” About Monopar Therapeutics Inc. Monopar is a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs. ALXN1840 is a first-in-class Albumin Tripartite Complex (ATC) activator for the treatment of Wilson disease in late-stage development. MNPR-101, a first-in-class targeted anti-uPAR (urokinase plasminogen activator receptor) antibody platform in Phase 1 development, is designed to enable targeted radiopharmaceutical imaging and

  • Monopar Therapeutics Receives FDA Rare Pediatric Disease Designation for ALXN1840 for the Treatment of Wilson Disease
    Jun 30, 2026Monopar Therapeutics Inc. (MNPR) News

    WILMETTE, Ill., June 30, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to ALXN1840 (tiomolibdate choline, TMC), the Company’s late-stage candidate for the treatment of Wilson disease. The FDA grants RPD designation to therapies intended to treat serious or life-threatening diseases that primarily affect children from birth to 18 years of age. The designation provides the Company with the potential at the time of NDA approval to receive a pediatric Priority Review Voucher (PRV), which can be used to obtain priority review of a subsequent marketing application or sold or transferred to another sponsor. Priority review can reduce the FDA’s target review time by several months. “Receiving Rare Pediatric Disease designation for ALXN1840 underscores the serious impact that Wilson disease has on patients and reinforces the urgency of bringing forward a new treatment option,” said Chandler Robinson, M.D., Chief Executive Officer of Monopar. About Wilson Disease Wilson disease is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. It is caused by mutations in the ATP7B gene, which impairs the body’s ability to excrete copper. It is characterized by toxic accumulation of copper in the liver, brain, and other organs, leading to progressive and potentially fatal outcomes if untreated. About ALXN1840 ALXN1840 (tiomolibdate choline, TMC) is a novel first-in-class albumin tripartite complex (ATC) activator under investigation for the treatment of Wilson disease. ALXN1840 rapidly mobilizes and tightly sequesters excess copper in ATCs, suppressing its redox reactivity, limiting oxidative damage, and blocking transport across the blood–brain barrier. Clinical data demonstrate that ALXN1840 improves copper balance by increasing fecal copper excretion. In the Phase 3 pivotal trial, ALXN1840 met the primary endpoint by demonstrating rapid and sustained copper mobilization significantly greater than standard of care over 48 weeks in both previously treated and untreated patients. Durable clinical improvement and a favorable safety and tolerability profile were observed across 645 patient-years of follow-up in 266 patients. ALXN1840 is an oral tablet with a once-a-day dosing regimen. About Monopar Therapeutics Inc. Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including MNPR-101-Zr (Phase 1) for imaging advanced cancers along with MNPR-101-Lu (Phase 1a) and MNPR-101-Ac (late preclinical) for the treatment of advanced cancers. For more information, visit: www.monopartx.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. An example of a forward-looking statement includes the statement concerning:

  • 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
    Jun 26, 2026Monopar Therapeutics Inc. (MNPR) News

    WILMETTE, Ill., June 26, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that new analyses from the Phase 3 FoCus randomized controlled clinical trial of ALXN1840 (tiomolibdate choline, TMC) will be presented at the 12th Congress of the European Academy of Neurology (EAN 2026), June 27–30, 2026, in Geneva, Switzerland. These analyses build upon the previously reported Phase 3 FoCus results demonstrating ALXN1840 met its primary endpoint of superior copper mobilization versus standard of care. In an encore poster presentation titled “Greater clinical benefit with tiomolibdate choline versus standard of care in neurologic Wilson disease patients in the Phase 3 FoCus Trial,” Aurélia Poujois, MD, PhD, Department of Neurology, Adolphe de Rothschild Foundation Hospital, Paris, France, will present results showing that ALXN1840 produced significant neurologic improvement over time and greater global clinical improvement compared to standard-of-care (SoC) therapy in Wilson disease (WD) patients with neurologic symptoms at baseline. ALXN1840 also demonstrated similar or better outcomes compared to SoC across a range of psychiatric and hepatic measures during the 48-week study. Key findings presented at EAN 2026:In the subset of patients with neurologic symptoms at baseline from the 2:1 randomized Phase 3 FoCus clinical trial (NCT03403205; n=207), ALXN1840 demonstrated improved outcomes compared to SoC across multiple clinical measures: Neurologic improvement on the rater-blinded, physician-assessed Unified Wilson Disease Rating Scale (UWDRS) Part III was significant and continued over time with ALXN1840 (p=0.006) but not with SoC (p=0.435). Global clinical improvement as assessed by the Clinical Global Impressions – Improvement (CGI-I) scale at Week 48 was significantly greater with ALXN1840 than with SoC (p<0.001). A greater proportion of patients treated with ALXN1840 achieved improvement on the rater-blinded UWDRS Part III at Week 48 compared with SoC, with consistent results observed across multiple improvement thresholds. ALXN1840 also produced similar or greater improvement than SoC at Week 48 across psychiatric and hepatic measures. Across Phase 2 and Phase 3 studies, ALXN1840 has demonstrated a well-characterized and favorable safety profile in 266 patients, with a median treatment duration of 2.58 years and maximum exposure of more than 8 years. Drug-related serious adverse events (SAEs) occurred in 4.9% of patients, including neurologic SAEs in less than 1% and no treatment-related deaths. “For Wilson disease patients with neurologic symptoms, meaningful improvement can be difficult to achieve with existing therapies, and some patients experience severe paradoxical worsening,” said Dr. Poujois. “These new analyses from the Phase 3 FoCus trial are encouraging because they show that ALXN1840 treatment was associated with continued neurologic improvement over time and greater global clinical benefit compared with standard of care.” The poster (link) is available on Monopar’s website. These findings further support Monopar’s planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for ALXN1840 in mid-2026. About Wilson DiseaseWilson disease (WD) is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. It is caused by mutations in the ATP7B gene, which impairs the body’s ability to excrete copper. It

  • Monopar Presents Phase 2 ALXN1840 Data Demonstrating Liver Disease Stabilization and Neurologic Improvement in Treatment-Experienced Wilson Disease Patients at EASL 2026
    Jun 1, 2026Monopar Therapeutics Inc. (MNPR) News

    WILMETTE, Ill., June 01, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced the presentation (link) of Phase 2 ALXN1840-WD-205 data at the European Association for the Study of the Liver (EASL) Congress 2026. In a presentation titled “ALXN1840 (tiomolibdate choline) Stabilizes Liver Disease and Improves Neurological Symptoms as well as Quality of Life in Treatment-Experienced Wilson Disease Patients,” lead author Valentina Medici, MD, Professor of Medicine at the University of California Davis, presented results from the open-label, multicenter Phase 2 trial evaluating the effects of ALXN1840 on liver pathology and clinical outcomes in heavily pre-treated patients with Wilson disease. Wilson disease is a rare and progressive genetic condition caused by mutations in the ATP7B gene, in which the body’s pathway for removing excess copper is compromised, leading to damage from toxic copper build-up in organs such as the liver and brain. Today’s standard of care therapies carry significant safety risks, including paradoxical neurologic worsening, and require cumbersome multi-dose daily regimens. The open-label, multicenter, pathologist-blinded Phase 2 trial evaluated ALXN1840 monotherapy over 48 weeks in 29 treatment-experienced (at least one year on standard of care) Wilson disease patients, with an optional 48-week extension period. The study population had extensive prior treatment, with a median duration of 13.8 years. Liver biopsy was performed at baseline and Week 48 to assess hepatic copper concentration, stage of fibrosis, and grade of steatosis. Neurologic, clinical, and quality-of-life outcomes were also assessed at baseline and Week 48, with patients continuing in the extension period assessed again at Week 96. Key findings presented at EASL 2026: Liver pathology stabilization and improvement: By Week 48, among the 24 patients with paired biopsies, the preponderance demonstrated stabilization or improvement across histologic measures assessed, including hepatocyte necrosis (96%), steatosis grade (88%), lobular inflammation (79%), portal inflammation (71%), NAFLD Activity Score total (71%), hepatocellular ballooning (75%), and fibrosis stage (67%). Hepatic copper concentration: No statistically significant change in hepatic copper concentration after 48 weeks, consistent with published Wilson disease studies of standard of care therapies showing hepatic copper remains stable or increases even after years on treatment. Neurologic improvement: Significant improvements in the Unified Wilson Disease Rating Scale (UWDRS) Part III score were observed at Week 48 (p < 0.05 vs. baseline). Global clinical status: Significant improvements in the Clinical Global Impressions (CGI) scale were observed at Week 48 (p < 0.05 vs. baseline). Quality of life: Significant improvements in patient-reported quality of life, as measured by the EuroQoL 5-Dimensions (EQ-5D) UK Health Index, were observed at Week 48 (p < 0.05 vs. baseline). Safety: ALXN1840 was generally well tolerated; most treatment-emergent adverse events were nonserious and Grade 1 or 2 in severity. A safety analysis of the extension period showed

  • Monopar Announces Publication of Phase 2 Study Demonstrating ALXN1840 Significantly Improves Copper Balance in Patients with Wilson Disease
    May 19, 2026Monopar Therapeutics Inc. (MNPR) News

    WILMETTE, Ill., May 19, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that Hepatology Communications has published a peer-reviewed manuscript entitled “Effect of Tiomolibdate Choline on Copper Balance in Patients with Wilson Disease: an Open-label Phase 2 Trial.” The publication, which can be found at (link), reports results from the Phase 2 ALXN1840-WD-204 study (NCT04573309) and demonstrates that ALXN1840 (tiomolibdate choline) produces a rapid, statistically significant, and sustained improvement in daily copper balance in patients with Wilson disease, driven by increased fecal copper excretion. Wilson disease is a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised, leading to damage from toxic copper build-up in organs such as the liver and brain. The open-label, single-arm Phase 2 trial evaluated daily dosing of ALXN1840 in nine patients with Wilson disease across two centers in the United Kingdom and New Zealand. Patients were admitted to a clinical research unit and initiated on a copper-controlled diet, with all copper intake and output collected during a pre-treatment baseline period and after initiation of daily ALXN1840 over multiple weeks. The publication builds on a recently published peer-reviewed Journal of Hepatology Letter to the Editor (link), which highlighted the importance of comparing outcomes to a pre-treatment baseline to accurately assess the effect of a potential Wilson disease treatment on copper balance. Key findings reported in the publication: Statistically significant reduction in daily copper balance from baseline, due to increased fecal copper excretion Cumulative mean decrease from baseline in copper balance of -6.08 mg over 21 days (95% CI: -10.18 mg to -1.98 mg) Mean daily copper balance change from baseline of -0.37 mg (p=0.005) during the 15 mg/day treatment period and -0.29 mg (p=0.023) through the overall study period Approximately 50% increase in the daily fecal copper output-to-intake ratio compared to baseline (p=0.041) Immediate increases in plasma total copper and directly measured non-ceruloplasmin-bound copper (dNCC), consistent with copper mobilization and formation of stable albumin tripartite complexes (ATCs) consisting of copper, ALXN1840, and albumin ALXN1840 was generally well tolerated; no serious adverse events were reported Notably, the observed improvements in copper balance and copper mobilization occurred in a Wilson disease patient population with a mean prior current standard of care treatment duration of 16 years, suggesting that despite years of treatment with currently available therapies, patients present with a considerable amount of residual copper in the body that ALXN1840 is able to mobilize and eliminate. This finding is consistent with data from the completed 48-week Phase 3 trial, in which ALXN1840

  • Overview
  • Financial statements
  • Metrics
  • Quarterly earnings
  • Burn Rate
  • Similar companies
  • News
  • Insider Transactions