Monopar Therapeutics
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Monopar Therapeutics (Nasdaq: MNPR) said the FDA authorized it to initiate a rolling NDA submission for ALXN1840 (tiomolibdate choline, TMC) for Wilson disease. The company submitted the first completed NDA sections. ALXN1840 has Fast Track and Orphan Drug designations and received Rare Pediatric Disease status in June 2026.
Biotech stocks hit 52-week highs on July 20, 2026, attributed to upcoming clinical catalysts. Xencor (XNCR) reached $20.26, up 7%, with Phase 2b XENITH-UC interim results expected by year-end 2026. Hemab (COAG) hit $52.15 after positive Phase 2 Sutacimig data. Monopar (MNPR) hit $115 on Phase 3 ALXN1840 Wilson disease results. SOPHiA (SOPH) rose above $6.50; Q1 revenue was $21.7M and 2026 guidance is $92M to $94M.
Biotech stocks hit 52-week highs on July 9, 2026. First Track Biotherapeutics (TRAX) rose 55.99% to $32.40 on Phase 1 trial starts and an FDA end-of-Phase 2 meeting. BridgeBio Pharma (BBIO) closed at $93.52, up 15.12%, citing Acoramidis and Phase 3 plans. Monopar (MNPR), 10x Genomics (TXG) and MapLight (MPLT) also reached highs amid clinical updates.
Recent MNPR coverage spans financial news, sector analysis and market movers.
Rolling NDA submission is a meaningful regulatory milestone that can improve approval odds and de-risk the path to a first-in-class Wilson disease therapy.
Breakout reflects progress toward first potential commercial product, with NDA timing and organizational changes as incremental catalysts.
NDA submission planning is a tangible catalyst that can sustain momentum, but the timeline still leaves execution risk.
A stated mid-2026 NDA timing is a tangible regulatory milestone that can re-rate probability-weighted timelines.
Routine shareholder-meeting outcomes; no new operational or financial guidance, but confirms governance and equity-plan approval.
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Monopar Therapeutics (Nasdaq: MNPR) said the FDA authorized it to initiate a rolling NDA submission for ALXN1840 (tiomolibdate choline, TMC) for Wilson disease. The company submitted the first completed NDA sections. ALXN1840 has Fast Track and Orphan Drug designations and received Rare Pediatric Disease status in June 2026.
2 min readBiotech stocks hit 52-week highs on July 20, 2026, attributed to upcoming clinical catalysts. Xencor (XNCR) reached $20.26, up 7%, with Phase 2b XENITH-UC interim results expected by year-end 2026. Hemab (COAG) hit $52.15 after positive Phase 2 Sutacimig data. Monopar (MNPR) hit $115 on Phase 3 ALXN1840 Wilson disease results. SOPHiA (SOPH) rose above $6.50; Q1 revenue was $21.7M and 2026 guidance is $92M to $94M.
4 min readBiotech stocks hit 52-week highs on July 9, 2026. First Track Biotherapeutics (TRAX) rose 55.99% to $32.40 on Phase 1 trial starts and an FDA end-of-Phase 2 meeting. BridgeBio Pharma (BBIO) closed at $93.52, up 15.12%, citing Acoramidis and Phase 3 plans. Monopar (MNPR), 10x Genomics (TXG) and MapLight (MPLT) also reached highs amid clinical updates.
6 min readBoundless Bio (BOLD) agreed to an all-stock merger with private Serapha Bio; it expects a pre-close cash dividend and plans to trade as Serapha on Nasdaq under “AATD” in Q4 2026. Monopar (MNPR) said its ALXN1840 Wilson disease NDA is on track for mid-2026. Galectin (GALT) reached FDA agreement on key Phase 3 MASH protocol elements; final protocol due Q3 2026.
7 min readMonopar Therapeutics (MNPR) filed an SEC Form 8-K — Submission of Matters to a Vote of Security Holders. mnpr20260622_8k.htm false 0001645469 0001645469 2026-06-22 2026-06-22 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 repo
2 min readMonopar Therapeutics presented Phase 2 ALXN1840 (tiomolibdate choline) data at EASL 2026 for treatment-experienced Wilson disease patients. In an open-label, multicenter 48-week trial (29 patients; 24 with paired biopsies), histology showed stabilization or improvement in multiple liver measures, with no statistically significant change in hepatic copper. The company also reported significant improvements in UWDRS Part III, CGI, and EQ-5D UK, with generally nonserious Grade 1–2 adverse events.
4 min readMonopar Therapeutics reported a net loss of $3.9 million in Q1 2026, an increase from $2.6 million a year prior, due to higher spending on its drug pipeline, with R&D expenses rising to $3.5 million. The company holds $137.5 million in cash, cash equivalents, and investments as of March 31, 2026, which is expected to fund operations through at least December 31, 2027. Monopar continues to focus on its clinical-stage programs, including ALXN1840 for Wilson disease and radiopharmaceutical programs for advanced cancers, and plans to submit an NDA for ALXN1840 in mid-2026.
3 min readWILMETTE, Ill., Nov. 09, 2025 ( GLOBE NEWSWIRE ) -- Monopar Therapeutics Inc. ( "Monopar" or the "Company" ) ( Nasdaq: MNPR ) , a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, is presenting new data and analyses today from the ...
3 min readWILMETTE, Ill., Nov. 09, 2025 ( GLOBE NEWSWIRE ) -- Monopar Therapeutics Inc. ( "Monopar" or the "Company" ) ( NASDAQ:MNPR ) , a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, is presenting new data and analyses today from the ...
2 min readThe average of price targets set by Wall Street analysts indicates a potential upside of 42.5% in Monopar Therapeutics (MNPR). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.
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