Monopar Therapeutics Inc.

Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease

2026-07-22 08:00:00

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.

Monopar Advances Launch Readiness with Addition of Veteran Commercial Executive Nicole Sweeny to Board of Directors and Expansion of Commercial Leadership Team

2026-07-20 08:00:00

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.

Monopar Therapeutics: ALXN1840's Bull Case Has Improved

2026-07-03 10:10:15

Monopar Therapeutics has evolved from early radiopharma assets into a more concrete bet with ALXN1840 for rare diseases. ALXN1840 is their Wilson disease asset, which currently has a much clearer regulatory path, FDA designations, and even a possible Priority Review Voucher. MNPR's financing also seems safer this time around as they prepare ALXN1840's NDA and subsequent potential launch.

Monopar Therapeutics Receives FDA Rare Pediatric Disease Designation for ALXN1840 for the Treatment of Wilson Disease

2026-06-30 08:00:00

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.

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

2026-06-26 16:05:00

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.

Wall Street Analysts Believe Monopar Therapeutics (MNPR) Could Rally 88.92%: Here's is How to Trade

2026-06-15 10:55:30

The mean of analysts' price targets for Monopar Therapeutics (MNPR) points to an 88.9% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Monopar Presents Phase 2 ALXN1840 Data Demonstrating Liver Disease Stabilization and Neurologic Improvement in Treatment-Experienced Wilson Disease Patients at EASL 2026

2026-06-01 07:00:00

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.

Monopar Announces Publication of Phase 2 Study Demonstrating ALXN1840 Significantly Improves Copper Balance in Patients with Wilson Disease

2026-05-19 17:33:00

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.”