1차 출처 기록
중대신청 제출
Monopar, ALXN1840 NDA 2026년 중반 제출 예정
회사는 ALXN1840 (tiomolibdate choline)에 대한 NDA를 2026년 중반 FDA에 제출할 계획을 재확인했습니다. 새로운 Phase 3 FoCus 시험의 신경학적 및 간 질환 데이터가 AAN 2026에서 발표되었으며 EAN 및 EASL 2026에서 발표될 예정이지만, 아직 규제 제출은 이루어지지 않았습니다.
핵심 사실
출처 발췌
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