Monopar Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in developing proprietary therapeutics for cancer patients. It also focuses on building a drug development pipeline through the licensing, and acquisition of therapeutics in late preclinical and clinical development stages. The company was founded by Chandler Drew Robinson, Christopher M. Starr and Andrew P. Mazar in December 2014 and is headquartered in Wilmette, IL.
Clinical Trials
6
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
2
33.3%
Temporarily Not Available
2
33.3%
Terminated
2
33.3%
No approval data available
- Wolfe Research upgraded Abbott Laboratories to Outperform from Peer Perform, setting a $130 target price on the healthcare and diagnostics company. - AbbVie was also upgraded to Outperform from Peer Perform at Wolfe Research, with a $300 target price objective. - The upgrades came as markets rallied broadly after consumer price index data landed in line with expectations at 3.4% year-over-year. - Stryker was cut to Peer Perform from Outperform at Wolfe Research, while Monopar Therapeutics was downgraded to Neutral from Overweight at Cantor Fitzgerald.
- Monopar Therapeutics appointed Susan Rodriguez as Chief Commercial and Strategy Officer to lead commercial strategy as the company prepares for a planned New Drug Application submission for ALXN1840 in the first half of 2026. - ALXN1840 represents the first major advancement in Wilson disease treatment in decades, with a novel mechanism of action as an albumin tripartite complex activator that differentiates it from current first-line therapies. - The company reported positive long-term efficacy and safety data from 255 patients with a median treatment duration of 2.63 years, demonstrating statistically significant improvement in copper balance. - Monopar strengthened its balance sheet with approximately $91.9 million raised through an underwritten public offering and expects current funds to support operations through at least December 31, 2027.
- Monopar Therapeutics presented new long-term data on ALXN1840 (tiomolybdate choline) at the 150th American Neurological Association Annual Meeting, demonstrating sustained neurological improvement in Wilson disease patients over 6 years. - The pooled analysis from three clinical trials (n=255) showed statistically significant neurologic improvement on the Unified Wilson Disease Rating Scale, with patients crossing over from standard of care showing additional neurological benefits. - ALXN1840 demonstrated a favorable safety profile with less than 1% of patients experiencing drug-related neurological serious adverse events across more than 645 patient-years of treatment. - The findings complement recent hepatic efficacy data presented at EASL, underscoring ALXN1840's potential for treating both neurological and hepatic manifestations of Wilson disease.
- Monopar Therapeutics and EDNOC have received FDA authorization for an expanded access program providing MNPR-101-Zr imaging agent and MNPR-101-Lu therapeutic agent to patients with advanced solid tumors. - The program targets aggressive cancers including triple-negative breast, pancreatic, and colorectal cancers through selective targeting of the urokinase plasminogen activator receptor (uPAR). - EDNOC in Houston, Texas serves as the treatment center and is among the first private outpatient facilities designated as a Radiopharmaceutical Therapy Center of Excellence by SNMMI. - The expanded access program follows the initiation of Phase 1 clinical trials in Australia and represents continued progress in Monopar's radiopharmaceutical pipeline development.
• Monopar Therapeutics presented late-breaker data at EASL 2025 showing sustained clinical improvements in Wilson disease patients treated with ALXN1840 (tiomolybdate choline) over a median treatment duration of 2.63 years. • The pooled analysis from multiple clinical trials (n=255) demonstrated improvements in patient-reported symptoms, copper mobilization, and clinical assessments, with fewer than 5% of patients experiencing drug-related serious adverse events. • Patients reported higher convenience and effectiveness with ALXN1840 compared to standard of care, suggesting the drug candidate could provide meaningful benefits for the management of this rare genetic condition.
- Monopar Therapeutics in-licensed ALXN-1840 from Alexion for Wilson disease, planning regulatory discussions with the FDA focusing on patients with severe symptoms. - Phase 1 clinical trials for MNPR-101-Lu in advanced solid cancers and MNPR-101-Zr for tumor imaging are actively enrolling patients and showing promising early data. - A registered public offering generated $17.7 million, extending operational runway into the first half of 2026 to support clinical programs and R&D. - Monopar filed a provisional patent for new radiopharmaceutical compounds and linkers, aiming to expand its pipeline with high-value cancer targets.
- Monopar Therapeutics has acquired ALXN-1840, a late-stage drug candidate for Wilson disease, from Alexion, AstraZeneca Rare Disease, taking over global development and commercialization. - ALXN-1840, also known as bis-choline tetrathiomolybdate, is an investigational oral medicine designed to selectively bind and remove copper from the body and has shown promise in clinical trials. - The Phase 3 FoCus trial demonstrated that ALXN-1840 achieved three-times greater copper mobilization compared to standard-of-care, with rapid response observed at four weeks and sustained through 48 weeks. - Monopar's acquisition is driven by the continued unmet medical need in Wilson disease and testimonials from clinical trial patients who reported benefit from ALXN-1840.
