1차 출처 기록
중대신청 제출
Monopar, Wilson disease에 대한 ALXN1840의 rolling NDA 제출 개시
Monopar는 Wilson disease에 대한 ALXN1840 (tiomolibdate choline)의 FDA rolling NDA 제출을 시작했습니다. 제출이 현재 활성화되어 자산이 pre-submission에서 정식 심사 경로로 이동했습니다. 아직 PDUFA 날짜나 수리 결정은 발표되지 않았습니다.
핵심 사실
출처 발췌
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