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Monopar Therapeutics Inc.

MNPRFDA catalysts, PDUFA dates & pipeline intelligence
$70.54
▼ -0.11 · -0.16%

Financials

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Quarterly Cash
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52W LOW $50.0752W HIGH $124.82
Volume
79.01 K
Value Traded
32.88 M
Short % Float
27.57%
Days to Cover
6.0
-1.3%Week
-15.74%1 Month
-36.06%3 Month
+30.58%6 Month
+129.53%5 Year
+51.19%All Time

Cash Data

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  • Monthly Burn
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  • SEC Filing

Key Stats

Market Cap
473.48 M
EPS (TTM)
-2.66
P/E Ratio
-
Ent. Value
339.18 M
Total Shares
6.71 M
Float Shares
3.94 M
Insiders
41.33%
Institutions
77.32%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

MNPR Catalyst Timeline

Dated clinical, regulatory and corporate events for Monopar Therapeutics Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Monopar Therapeutics Inc.

294Total events
8Upcoming
48Tier-1 (high impact)
2019 to 2027Coverage

Upcoming catalysts 2

T1NDA Submission
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ALXN-1840
T1NDA Submission
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ALXN-1840

Event history 50

●Quarterly UpdateCorporate
Second quarter 2026 financial results reported
●Rolling Submission InitiatedALXN-1840Regulatory Filing
Rolling NDA submission initiated for ALXN1840
Wilson Diseasesource ↗
●Management ChangeCorporate
Appointment of Daniel Olmstead as SVP Market Access, Distribution and Patient Services
▲Rare Pediatric DiseaseALXN-1840Designation
FDA granted Rare Pediatric Disease designation to ALXN1840
Wilson Diseasesource ↗
▲Poster PresentationALXN-1840Presentation
Poster presentation at EAN 2026 of new analyses from Phase 3 FoCus trial
Wilson Diseasesource ↗
◆Poster PresentationALXN-1840Presentation
Poster presentation at EAN 2026 showing greater neurologic and global clinical benefit with ALXN1840 vs standard of care
Wilson diseasesource ↗
●Quarterly UpdateCorporate
Annual Meeting of Stockholders and election of Nicole Sweeny to Board
●Management ChangeCorporate
Nicole Sweeny elected to Board of Directors
▲Oral PresentationALXN-1840Presentation
Phase 2 ALXN1840 data presented at EASL 2026
Wilson diseasesource ↗
◆Timing GuidanceALXN-1840Presentation
NDA submission for ALXN1840 planned in mid-2026
Wilson diseasesource ↗
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How MNPR actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-06-30ALXN1840 NDA Submission NDA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

Pipeline Score
Pipeline Value
Valuation Signal
2
Drugs Scored
rNPV / MCap
Top Drug
Top 72%
Micro Cap
(rank 473 of 657)
Percentile Rank
Showing 2 of 2 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
MNPR-101-PCTA-177Lu Small moleculeNCT06617169Solid Tumor, AdultPhase 1 ACTIVE NOT_RECRUITING 12Feb 1, 2027
MNPR-101-DFO*-89Zr Small moleculeNCT06337084Solid Tumor, AdultPhase 1 ACTIVE NOT_RECRUITING 12Dec 1, 2026
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PTRS, rNPV, enrollment velocity, trial design quality and ML risk signals for every asset above.
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Clinical Trial Results

Readouts, endpoints and source filings for every MNPR program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
ALXN1840
Fast TrackOrphanRare Pediatric
Wilson diseasePhase 32026-06-26In the Phase 3 FoCus trial of ALXN1840 for Wilson disease, patients showed significant neurologic improvement (p=0.006) and greater global clinical improvement at Week 48 (p<0.001) compared to standard of care, with a total of 207 participants.Read MoreMonopar Presents New Analyses of Phase 3 FoCus Data at EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with ALXN1840 Versus Standard of Care in Wilson DiseaseRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
STARR CHRISTOPHER MDirectorOption 8,400 13,573 held$0.01 10/01/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
RA CAPITAL MANAGEMENT, L.P. 0.5 % (25 %) 61.78 M 667.21 K
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Shares held by hedge funds each quarter, and who bought or sold.

MNPR Institutional Ownership Trends

MNPR Short Interest

Shares sold short, counted twice a month.

27.57%
Short % of Float
of tradable shares sold short
1.1M
Shares Sold Short
+28.7% vs prior count
6.0 High
Days to Cover
trading days of normal volume to buy every short share back
180.4K
Avg Daily Volume
the average used for days to cover
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Two years of days to cover and shares sold short, with every count and its change.
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Options Data

Option Volume

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Option Volume
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

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Competitive positioning

How MNPR ranks across every disease it competes in

Competitive Position is a premium feature
See how MNPR ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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MNPR News

MNPR
Aug 19, 2026
MNPRGeneral

Monopar Appoints Jeffrey D. Kent, M.D., as Executive Vice President, Head of Medical Affairs; Announces Two ALXN1840 Presentations at AASLD – The Liver Meeting® 2026

Monopar Therapeutics has appointed Dr. Jeffrey D. Kent as Executive Vice President, Head of Medical Affairs, effective September 1, 2026. The company also announced that two abstracts on its drug candidate ALXN1840 for Wilson disease will be presented at the AASLD – The Liver Meeting 2026. The presentations aim to address unmet needs in Wilson disease treatment.

Read more →
MNPR
Aug 12, 2026
MNPRFDA Updates

Monopar Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Updates

Monopar Therapeutics reported its second quarter 2026 financial results, highlighting the initiation of a rolling NDA submission for ALXN1840, a treatment for Wilson disease. The FDA granted Rare Pediatric Disease designation for ALXN1840, which may lead to a Priority Review Voucher upon approval. Despite a net loss increase, the company showcased promising clinical trial results demonstrating significant neurologic improvements in patients.

Read more →
MNPR
Jul 22, 2026
MNPRFDA Updates

Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease

Monopar Therapeutics has begun the rolling submission of a New Drug Application (NDA) for ALXN1840, a novel treatment for Wilson disease. This marks a significant milestone as it may lead to the first new therapy for the condition in decades. The FDA has granted several designations to ALXN1840, enhancing its potential for approval. However, uncertainties regarding regulatory acceptance and market competition remain.

Read more →
MNPR
Jul 20, 2026
MNPRGeneral

Monopar Advances Launch Readiness with Addition of Veteran Commercial Executive Nicole Sweeny to Board of Directors and Expansion of Commercial Leadership Team

Monopar Therapeutics has bolstered its commercial leadership team in anticipation of launching its first product, ALXN1840, pending FDA approval. Nicole Sweeny has joined the Board of Directors, while Sharon Funk and Daniel Olmstead have been appointed to senior roles. The company aims to submit an NDA for ALXN1840 in mid-2026, targeting Wilson disease treatment.

Read more →
MNPR
Jun 30, 2026
MNPRFDA Updates

Monopar Therapeutics Receives FDA Rare Pediatric Disease Designation for ALXN1840 for the Treatment of Wilson Disease

Monopar Therapeutics announced that the FDA has granted Rare Pediatric Disease designation to its candidate ALXN1840 for Wilson disease. This designation could allow the company to obtain a pediatric Priority Review Voucher upon NDA approval, expediting the review process. ALXN1840 has demonstrated significant efficacy in clinical trials, showing improved copper balance in patients. The company emphasizes the urgent need for new treatment options for this serious condition.

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MNPR
Jun 26, 2026
MNPRPhases
▲ +7.8%on this newsshared move

Monopar Presents New Analyses of Phase 3 FoCus Data at EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with ALXN1840 Versus Standard of Care in Wilson Disease

Monopar Therapeutics presented new analyses from the Phase 3 FoCus trial of ALXN1840 at EAN 2026. The data demonstrated significant neurologic and global clinical improvements in Wilson disease patients compared to standard care. The findings support the company's upcoming New Drug Application submission to the FDA for ALXN1840, which has shown a favorable safety profile in previous studies.

Read more →
MNPR
Jun 1, 2026
MNPRPhases

Monopar Presents Phase 2 ALXN1840 Data Demonstrating Liver Disease Stabilization and Neurologic Improvement in Treatment-Experienced Wilson Disease Patients at EASL 2026

Monopar Therapeutics presented promising Phase 2 data for ALXN1840 at EASL 2026, showing stabilization of liver disease and improvements in neurologic symptoms in Wilson disease patients. The study involved 29 treatment-experienced patients and highlighted significant clinical outcomes, including quality of life enhancements. The results underscore ALXN1840's potential to address unmet medical needs in this patient population.

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MNPR
May 19, 2026
MNPRPhases

Monopar Announces Publication of Phase 2 Study Demonstrating ALXN1840 Significantly Improves Copper Balance in Patients with Wilson Disease

Monopar Therapeutics announced the publication of a Phase 2 study demonstrating that ALXN1840 significantly improves copper balance in patients with Wilson disease. The study showed a rapid and sustained improvement in daily copper balance, attributed to increased fecal copper excretion. ALXN1840 was well tolerated, indicating its potential as a new treatment option for this rare genetic condition.

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MNPR
May 14, 2026
MNPRGeneral

Monopar Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Updates

Monopar Therapeutics reported its first quarter 2026 financial results, highlighting a net loss of $3.9 million. The company is on track to submit a New Drug Application for ALXN1840 for Wilson disease by mid-2026, following positive results from the Phase 3 FoCus trial. Monopar's cash reserves are projected to sustain operations through 2027, despite rising R&D expenses.

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MNPR
Apr 19, 2026
MNPRPhases

Monopar Presents Phase 3 Data Showing Greater Neurologic Benefit with ALXN1840 vs SoC in Wilson Disease Patients with Neurologic Symptoms at AAN 2026

Monopar Therapeutics presented new Phase 3 data for ALXN1840, indicating significant neurologic benefits in Wilson disease patients with symptoms. The trial demonstrated higher rates of improvement and lower rates of worsening compared to standard care. The findings support the potential of ALXN1840 as a novel treatment option, with plans for a New Drug Application submission to the FDA in mid-2026.

Read more →
MNPR
Mar 30, 2026
MNPRGeneral

Monopar Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Business Update

Monopar Therapeutics announced its fourth quarter and full-year 2025 financial results, highlighting a productive year marked by advancements in the development of ALXN1840 for Wilson disease. The company plans to submit a New Drug Application for ALXN1840 in mid-2026. Despite a reduced net loss, the company faces ongoing regulatory uncertainties and increased expenses.

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MNPR
Mar 2, 2026
MNPRGeneral

Monopar Expands Leadership Team with Appointment of Seasoned Biopharma Executive Susan Rodriguez as Chief Commercial and Strategy Officer

Monopar Therapeutics has appointed Susan Rodriguez as Chief Commercial and Strategy Officer to lead its commercial strategy. This role comes as the company prepares to submit a New Drug Application for ALXN1840, a therapy for Wilson disease. Rodriguez brings over 30 years of experience in biopharmaceuticals, having previously held leadership positions at Avadel Pharmaceuticals and Ardelyx.

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MNPR
Nov 13, 2025
MNPRGeneral
▲ +5.4%on this news

Monopar Therapeutics Reports Third Quarter 2025 Financial Results and Recent Developments

Monopar Therapeutics reported its third quarter 2025 financial results, highlighting significant developments in its clinical programs. The company showcased promising data for ALXN1840 in treating Wilson disease and received FDA clearance for MNPR-101-Lu. Despite a net loss increase, Monopar raised $126.9 million through a public offering to support ongoing operations and future drug applications.

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MNPR
Nov 9, 2025
MNPRConferences/Events

Monopar Presents New Data and Analyses on Rapidly Improved Copper Balance in Wilson Disease Patients on Tiomolybdate Choline at AASLD - The Liver Meeting® 2025

Monopar Therapeutics presented promising data on ALXN1840, a treatment for Wilson disease, at the AASLD 2025 conference. The Phase 2 study showed a rapid and sustained improvement in copper balance among patients, primarily through increased fecal copper excretion. The findings suggest that ALXN1840 could be an effective therapy for managing Wilson disease.

Read more →
MNPR
Oct 15, 2025
MNPRConferences/Events
▼ -5.1%on this news· ran to -19% by day 3

Monopar Announces Abstract Accepted for Oral Presentation at AASLD - The Liver Meeting® 2025

Monopar Therapeutics announced that its abstract on the Phase 2 ALXN1840-WD-204 study has been accepted for oral presentation at the AASLD – The Liver Meeting® 2025. The event will take place in Washington, D.C., from November 7-11, 2025. The presentation materials will be available on the company's website shortly after the event.

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MNPR
Sep 24, 2025
MNPRGeneral
▲ +7.9%on this news

Monopar Therapeutics Inc. Announces Pricing of $135 Million Underwritten Offering of Common Stock and Pre-Funded Warrants

Monopar Therapeutics Inc. has announced the pricing of a $135 million underwritten offering of common stock and pre-funded warrants. The offering includes 1,034,433 shares priced at $67.67 each, with expected net proceeds of approximately $100 million. Monopar plans to utilize the funds for general corporate purposes, including R&D and a stock repurchase from Tactic Pharma.

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MNPR
Sep 24, 2025
MNPRFDA Updates
▲ +7.9%on this newsshared move

Monopar Announces Journal of Hepatology Publishes Physicians’ Letter to the Editor Demonstrating ALXN1840 Rapidly Improved Copper Balance in Wilson Disease Patients

Monopar Therapeutics announced the publication of a peer-reviewed Letter to the Editor in the Journal of Hepatology, highlighting that ALXN1840 significantly improves copper balance in Wilson disease patients. The analysis corrected previous methodological limitations from a Phase 2 study, demonstrating enhanced copper excretion. This publication reinforces the therapeutic potential of ALXN1840 for treating Wilson disease.

Read more →
MNPR
Sep 14, 2025
MNPRConferences/Events
▲ +10.7%on this news· ran to +35% by day 3

Monopar to Present New Long-Term Neurological Efficacy and Safety Data for ALXN1840 in Wilson Disease at the 150th American Neurological Association Annual Meeting

Monopar Therapeutics announced the presentation of new long-term data on ALXN1840 for Wilson disease at the 150th ANA Annual Meeting. The findings indicate significant neurological benefits and safety for patients, reinforcing the therapy's potential. The data, pooled from multiple clinical trials, highlights the treatment's efficacy over an average duration of 2.6 years.

Read more →
MNPR
Sep 3, 2025
MNPRConferences/Events
▲ +6.7%on this news· ran to +22% by day 3

Monopar Announces Abstract Accepted with Distinction for Oral and Poster Presentations at the Upcoming American Neurological Association 2025 Annual Meeting

Monopar Therapeutics announced that its abstract on ALXN1840 for Wilson disease has been accepted for both oral and poster presentations at the upcoming American Neurological Association Annual Meeting. The abstract, which discusses long-term neurological benefits, has received the prestigious designation of Abstract of Distinction. Presentations will be available online in mid-September 2025.

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About Monopar Therapeutics Inc.

Wilmette, IL 22 employees monopartx.com
Headquarters1000 SKOKIE BLVD SUITE 350, WILMETTE, IL, 60091
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