Monopar Therapeutics 8-K filings

Monopar Therapeutics announced second quarter 2026 financial results, highlighting the initiation of a rolling NDA submission for ALXN1840 for Wilson disease and providing business updates, alongside increased R&D expenses and a net loss.

Monopar Therapeutics has begun submitting its New Drug Application for ALXN1840 to the FDA for Wilson disease treatment, potentially offering a new therapeutic option.

Monopar Therapeutics announced its late-stage candidate, ALXN1840 (tiomolibdate choline), has received Rare Pediatric Disease designation from the FDA for the treatment of Wilson disease.

Monopar Therapeutics announced new Phase 3 FoCus trial data showing ALXN1840 provides superior neurologic and global clinical benefits for Wilson disease patients.

Monopar Therapeutics presented Phase 2 clinical trial results for ALXN1840 in Wilson disease patients at the 2026 EASL International Liver Congress.

Monopar Therapeutics announced positive results from a Phase 2 study published in Hepatology Communications, demonstrating that ALXN1840 significantly improves copper balance in Wilson disease patients.

Monopar Therapeutics announced first quarter 2026 financial results, highlighting progress on its ALXN1840 New Drug Application submission and providing business updates.

Monopar Therapeutics announced new Phase 3 data for ALXN1840 demonstrating greater neurologic benefit and less worsening compared to standard of care in Wilson disease patients with baseline neurologic symptoms.

Monopar Therapeutics announced its fourth quarter and full-year 2025 financial results, highlighting significant progress for its ALXN1840 Wilson disease program and a strengthened balance sheet.

Monopar Therapeutics Inc. announced the appointment of Susan Rodriguez as Chief Commercial and Strategy Officer to lead commercialization efforts for ALXN1840.

Monopar Therapeutics announced its third quarter 2025 financial results, highlighted by new clinical data for ALXN1840 and MNPR101, FDA IND clearance, and a significant capital raise.

Monopar Therapeutics announced positive Phase 2 data for ALXN1840 in Wilson disease, demonstrating rapid and sustained improvement in copper balance.

Monopar Therapeutics Inc. announced a $91.9 million net proceeds offering, a related share repurchase from a significant stockholder, and positive clinical data for its Wilson disease therapy ALXN1840.

Monopar Therapeutics announced new long-term neurological efficacy and safety data for its investigational therapy ALXN1840 in Wilson disease at the ANA Annual Meeting.

Monopar Therapeutics reports Q2 2025 financial results, advances ALXN1840 toward early 2026 NDA submission, and progresses radiopharmaceutical clinical trials.

Monopar Therapeutics Inc. announced that its shareholders re-elected all six directors, approved executive compensation, and voted for annual advisory votes on executive pay at its Annual Meeting held on June 17, 2025.

Monopar Therapeutics announced its Q1 2025 financial results, highlighting progress with ALXN1840 for Wilson disease and its radiopharmaceutical programs.

Monopar Therapeutics announces the presentation of long-term efficacy and safety data for ALXN1840 in Wilson disease at the EASL International Liver Congress 2025, showcasing encouraging results.

Monopar Therapeutics reports its Q4 and full-year 2024 financial results, highlighting progress with ALXN1840 and MNPR-101 programs, and a strengthened balance sheet.

Monopar Therapeutics announced the departure of its CFO, Karthik Radhakrishnan, and the appointment of Quan Vu as his successor, effective March 3, 2025.

Monopar Therapeutics announces the resignation of Michael J. Brown from the Board and the appointment of Lavina Talukdar, Senior Vice President at Moderna Inc., as a new director.

Monopar Therapeutics has secured approximately $37.6 million through a registered offering of common stock and a concurrent private placement of pre-funded warrants.

Monopar Therapeutics has announced the first patient has been dosed with their novel therapeutic radiopharmaceutical MNPR-101-Lu, targeting aggressive cancers.

Monopar Therapeutics reported its third quarter 2024 financial results, highlighted by the in-licensing of a late-stage Wilson disease drug and advancements in its radiopharmaceutical programs.

Monopar Therapeutics has announced the pricing of a public offering of common stock, expected to raise approximately $19.2 million before fees and expenses.

Monopar Therapeutics has obtained an exclusive worldwide license from Alexion Pharmaceuticals for ALXN-1840, a Wilson disease drug candidate that has completed a Phase 3 trial.

Monopar Therapeutics announced encouraging human clinical dosimetry data for its uPAR-targeted radiopharmaceuticals, MNPR-101-Zr and MNPR-101-Lu, at the European Association of Nuclear Medicine Annual Congress.

Monopar Therapeutics has filed a provisional patent for a new family of linkers designed to enhance the stability and versatility of its radiopharmaceutical treatments.

Monopar Therapeutics has commenced a Phase 1a clinical trial for its novel radiopharmaceutical MNPR-101-Lu, targeting advanced cancers.

Monopar Therapeutics reports positive early human clinical data demonstrating the tumor-targeting ability of its MNPR-101-Zr imaging agent.