Monopar bắt đầu nộp hồ sơ NDA theo hình thức rolling cho ALXN1840 điều trị bệnh Wilson

Monopar has begun a rolling NDA submission to the FDA for ALXN1840 (tiomolibdate choline) in Wilson disease. The submission is now active, moving the asset from pre-submission to the formal review pathway. No PDUFA date or acceptance decision has been announced yet.

Thông tin chính

Nộp lúc: 12:00 22 thg 7, 2026
Sự kiện: Đã nộp đơn
Chiều hướng: Tích cực
Công ty: MNPRMonopar
Tài sản: tiomolibdate choline
Nguồn: SEC 8-K
Độ tin cậy: Có nguồn

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mnpr20260721_8k.htm false 0001645469 0001645469 2026-07-22 2026-07-22 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 22, 2026 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Delaware 001-39070 32-0463781 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 1000 Skokie Blvd., Suite 350 , Wilmette , IL 60091 (Address of principal executive offices) (Zip Code) ( 847 ) 388-0349 Registrant’s telephone number, including area code N/A (Former name or former address, if changed since last report) Securities regi

SEC 8-K