Monopar memulai pengajuan NDA bertahap untuk ALXN1840 pada penyakit Wilson

Monopar memulai pengajuan NDA bertahap ke FDA untuk ALXN1840 pada 22 Juli 2026. FDA memberikan penetapan Rare Pediatric Disease pada 30 Juni 2026, yang berpotensi memberikan perusahaan Priority Review Voucher setelah persetujuan. Perusahaan memperkirakan akan menyelesaikan pengajuan NDA dalam beberapa bulan ke depan.

Fakta utama

Diajukan: 12 Agu 2026, 13.30
Peristiwa: Permohonan diajukan
Arah: Positif
Perusahaan: MNPRMonopar
Aset: tiomolibdate choline
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 ex_1003235.htm EXHIBIT 99.1 ex_1003235.htm Exhibit 99.1 Monopar Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Updates Wilmette, IL, August 12, 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 second quarter 2026 financial results and provided business updates. Recent Program Developments ALXN1840 for Wilson Disease – Rolling NDA Submission Initiated On July 22, 2026, Monopar announced it had initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALXN1840. The FDA authorized Monopar to submit the NDA on a rolling basis, a

SEC 8-K