Monopar: nasa tamang takbo ang pagsusumite ng NDA ng ALXN1840 sa kalagitnaan ng 2026

The company reiterated its plan to submit the NDA for ALXN1840 (tiomolibdate choline) to the FDA in mid-2026. New Phase 3 FoCus trial neurologic and liver-disease data were presented at AAN 2026 and will be shown at EAN and EASL 2026, but no regulatory filing has yet occurred.

Mahahalagang fact

Na-file: May 14, 2026, 06:00 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: MNPRMonopar
Asset: tiomolibdate choline
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 ex_962976.htm EXHIBIT 99.1 ex_962976.htm Exhibit 99.1 Monopar Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Updates Wilmette, IL, May 14, 2026 – 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 first quarter 2026 financial results and provided business updates. Recent Program Developments ALXN1840 for Wilson Disease – NDA Submission on Track for Mid-2026 In April 2026, Monopar presented new analyses from the randomized controlled Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline, TMC) at the American Academy of Neurology (AAN) Annual Meeting 2026. The late-breaker oral and poster pres

SEC 8-K