Sinimulan na ng Monopar ang rolling NDA submission para sa ALXN1840 sa sakit na Wilson

Sinimulan na ng Monopar ang rolling NDA submission sa FDA para sa ALXN1840 (tiomolibdate choline) sa sakit na Wilson. Aktibo na ngayon ang submission, na naglilipat sa asset mula sa pre-submission patungo sa pormal na review pathway. Wala pang inihayag na PDUFA date o acceptance decision.

Mahahalagang fact

Na-file: Hul 22, 2026, 12:00 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: MNPRMonopar
Asset: tiomolibdate choline
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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