Monopar Therapeutics Inc./$MNPR

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About Monopar Therapeutics Inc.

Monopar Therapeutics Inc is a clinical-stage biopharmaceutical company developing a treatment for Wilson disease and novel radiopharmaceuticals for oncology. Its Wilson disease product candidate is ALXN1840, a late-stage, investigational once-daily, oral medicine. The group radiopharmaceutical programs consist of Phase 1-stage MNPR-101-Zr for imaging cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac for the treatment of cancers that express urokinase plasminogen activator receptor (uPAR). It build drug development pipeline through both in-house efforts and licensing of late preclinical- and clinical-stage therapeutics. The Company operates as a single reportable segment, focusing on the development of clinical and preclinical product candidates.
Ticker
$MNPR
Sector
Health
Primary listing
NASDAQ
Employees
-

MNPR Metrics

BasicAdvanced
$727M
-
-$2.18
1.51
-

Bulls say / Bears say

The Phase 3 FoCus trial’s new analyses demonstrated that ALXN1840 produced statistically significant neurologic and global clinical improvements versus standard-of-care in Wilson disease patients, reinforcing its therapeutic potential ahead of the NDA submission. (Monopar Therapeutics)
ALXN1840 received Rare Pediatric Disease designation from the FDA on June 30, 2026, which offers eligibility for a valuable Priority Review Voucher upon approval, potentially accelerating review timelines or providing a monetizable asset. (Monopar Therapeutics)
Monopar initiated the rolling New Drug Application submission for ALXN1840 on July 22, 2026, submitting completed sections for FDA review, a critical step that could lead to the first novel Wilson disease therapy approved in decades. (Monopar Therapeutics)
The FDA’s approval remains uncertain even with the rolling NDA process; the agency may refuse to file or request additional clinical or manufacturing data, risking delays or increased development costs. (Monopar Therapeutics)
Monopar’s Q2 2026 net loss widened to $5.3 million from $2.5 million in Q2 2025, driven by a nearly threefold increase in R&D spending to $4.8 million, which heightens the risk of cash burn and potential shareholder dilution if further capital is required. (Monopar Therapeutics)
Its radiopharmaceutical portfolio remains in early development—MNPR-101-Zr is in Phase 1, MNPR-101-Lu in Phase 1a, and MNPR-101-Ac is preclinical—delaying any potential revenue contribution from oncology programs for several years and increasing technical and regulatory uncertainty. (Monopar Therapeutics)
Data summarised monthly by Lightyear AI. Last updated on 25 Aug 2026.

Funds containing MNPR

Funds
Fund name
Fund size
$MNPR weighting
SPDR Russell 2000 US Small Cap€R2US
€4.8B0.02%
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