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MDxHealth SA

MDXHFDA catalysts, PDUFA dates & pipeline intelligence
$0.6
▲ +0.03 · +5.81%

Financials

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52W LOW $0.4052W HIGH $5.33
Volume
77.42 K
Value Traded
82.53 K
Short % Float
2.34%
+9.39%Week
-15.98%1 Month
+24.06%3 Month
-70.76%6 Month
-93.42%5 Year
-93.42%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
57.65 M
EPS (TTM)
-0.66
P/E Ratio
-
Ent. Value
103.82 M
Total Shares
95.42 M
Float Shares
64.98 M
Insiders
31.90%
Institutions
38.14%

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.

MDXH Catalyst Timeline

Dated clinical, regulatory and corporate events for MDxHealth SA

Catalyst Timeline

Dated clinical, regulatory & corporate events for MDxHealth SA

2Total events
0Upcoming
0Tier-1 (high impact)
2026 to 2026Coverage

Event history 2

▲PublicationPresentation
Peer-reviewed publication of Oxford GPS-ProMPT study in European Urology Oncology
localized prostate cancersource ↗
▲Trial InitiationTrial
Initiation of GPS mdx testing in the UK ProtecT trial
localized prostate cancersource ↗
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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 MDXH actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
-Example Drug Phase 3 data readout Phase 3
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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

No drug pipeline

MDxHealth SA is a diagnostics company. The clinical trials it takes part in test other companies' drugs, so it has no drug pipeline of its own to score.

Clinical Trial Results

Readouts, endpoints and source filings for every MDXH program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
prostate cancer2019-05-031,955-patient clinical validation study; high sensitivity and negative predictive value for the detection of clinically significant prostate cancerRead MoreMDxHealth: Presentation of New Data for MDxHealth's Prostate Cancer Diagnostic Tests at AUA 2019 Annual MeetingRead 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
MVM Partners, LLCDirectorBuy 2,202,643 6,903,100 held$0.45 08/13/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
ORBIMED ADVISORS LLC 5.7 % 285.90 M 124.31 M
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

MDXH Institutional Ownership Trends

Options Data

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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

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Live calls and puts by strike: last price, volume and open interest for every expiry.
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Calls vs Puts by Expiry

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Competitive positioning

How MDXH ranks across every disease it competes in

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

MDXH
Aug 13, 2026
MDXHGeneral
▲ +74.9%on this news· ran to +85% by day 1

Mdxhealth Reports Second Quarter 2026 Financial Results

MDxHealth reported a 16% revenue growth in Q2 2026, reaching $27.2 million. Despite a net loss of $9.5 million, the company anticipates improved tissue growth rates and a return to positive adjusted EBITDA by year-end. The transition of Resolve customers and the integration of ExoDx are key factors in their strategy moving forward.

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MDXH
Jul 30, 2026
MDXHConferences/Events

Mdxhealth to Release Second Quarter 2026 Financial Results on August 13

Mdxhealth SA announced it will release its financial results for Q2 2026 on August 13, 2026. The results will be shared after market close, followed by a conference call at 4:30 PM ET. Investors can access the webcast 15 minutes prior to the call, with a replay available afterward.

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MDXH
Jul 24, 2026
MDXHFDA Updates

Mdxhealth Announces Receipt of Nasdaq Notification Regarding Minimum Market Value of Listed Securities Deficiency

Mdxhealth has received a notification from Nasdaq regarding its non-compliance with the minimum market value requirement of $35 million. The company has 180 days to rectify this deficiency, but its business operations remain unaffected. If compliance is not achieved by January 19, 2027, the company may face delisting or seek additional time to comply.

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MDXH
Jul 2, 2026
MDXHFDA Updates

Mdxhealth Announces Receipt of Nasdaq Notification Regarding Minimum Bid Price Deficiency

Mdxhealth SA received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement. The company has until December 28, 2026, to regain compliance by maintaining a closing bid price of at least $1.00 for 10 consecutive business days. The notification does not currently affect the company's listing, and Mdxhealth plans to monitor its share price closely.

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MDXH
Jun 29, 2026
MDXHPhases
▼ -6.3%on this newsshared move

Mdxhealth Announces Peer-Reviewed Publication of Oxford GPS-ProMPT Study in European Urology Oncology, Establishing Scientific Foundation for the Landmark GPS-ProtecT Randomized Controlled Trial

Mdxhealth announced the peer-reviewed publication of the Oxford GPS-ProMPT study in European Urology Oncology, marking a significant milestone in their collaboration with the University of Oxford. The study demonstrates that GPS mdx can effectively predict long-term outcomes for prostate cancer patients. This publication lays the groundwork for the ongoing GPS-ProtecT trial, which aims to validate GPS mdx as a genomic classifier in localized prostate cancer.

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MDXH
May 13, 2026
MDXHConferences/Events

Mdxhealth Reports Q1-2026 Results Conference call with Q&A today at 4:30 PM ET / 22:30

Mdxhealth SA reported its Q1 2026 financial results, revealing a 13% revenue increase to $27.4 million while also announcing the discontinuation of its Resolve UTI business due to reimbursement challenges. CEO Michael K. McGarrity emphasized a renewed focus on the company's core prostate cancer diagnostics and the integration of AI technologies to enhance operational efficiency. The exit from the Resolve business is expected to streamline operations but may incur restructuring costs.

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MDXH
May 13, 2026
MDXHGeneral

Mdxhealth Reports Q1-2026 Results

Mdxhealth reported its Q1-2026 financial results, highlighting a 13% revenue increase to $27.4 million. The company has decided to discontinue its Resolve UTI offering due to reimbursement challenges, allowing a renewed focus on its core prostate cancer diagnostics. Despite a slight decrease in net loss, operating expenses rose significantly due to the ExoDx acquisition. The company is optimistic about leveraging AI to enhance its diagnostics offerings.

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MDXH
Apr 30, 2026
MDXHGeneral

Unofficial English translation - For informational purposes only MDxHealth SA Limited Liability Company ( soci t anonyme) CAP Business Center Zone Industrielle des Hauts-Sarts Rue d'Abhooz 31 4040 Herstal, Belgium VAT BE

MDxHealth SA has announced plans for its ordinary and extraordinary general shareholders' meetings scheduled for May 28, 2026. The agenda includes discussions on the financial statements for the year ended December 31, 2025, the re-appointment of directors, and approval of new subscription rights. Significant resolutions include the issuance of new subscription rights and share options. The meetings will be held at the notary public's office in Ghent, Belgium, without an attendance quorum requirement for the ordinary session, while the extraordinary meeting will have specific quorum requirements.

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MDXH
Apr 30, 2026
MDXHConferences/Events

Mdxhealth to Release First Quarter 2026 Financial Results on May 13

Mdxhealth SA announced it will release its financial results for Q1 2026 on May 13, 2026. The results will be available after market close, followed by a conference call at 4:30 PM ET. The company specializes in precision diagnostics, particularly for prostate cancer and urologic diseases.

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MDXH
Mar 16, 2026
MDXHConferences/Events
▲ +5.3%on this news

Mdxhealth Highlights Data from Oxford’s ProMPT Study Demonstrating the Genomic Prostate Score GPS Test Predicts Adverse Outcomes Across Multiple Treatment Settings at EAU 2026

Mdxhealth has presented significant data at the EAU 2026 Congress regarding its Genomic Prostate Score (GPS mdx) test, highlighting its ability to predict adverse outcomes in prostate cancer patients across different treatment modalities. The GPS-ProMPT study showed that the test effectively identifies patients with indolent prostate cancer, allowing for potential treatment de-escalation. With a robust sample size and promising six-year freedom-from-failure outcomes, these findings position GPS mdx as a crucial tool in personalized prostate cancer management. The partnership with the University of Oxford is expected to further validate the clinical utility of GPS mdx in future studies.

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MDXH
Feb 27, 2026
MDXHGeneral

Mdxhealth Announces Fourth Quarter and Full-Year 2025 Financial Results

MDxHealth reported a 19% revenue growth for Q4 2025, reaching $29.5 million, and a 20% increase for the full year, totaling $107.9 million. The company anticipates continued growth into 2026, with guidance set between $137-140 million. However, net losses rose to $8.9 million in Q4, influenced by higher operating expenses and financial costs.

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MDXH
Feb 12, 2026
MDXHConferences/Events

Mdxhealth to Present Fourth Quarter and Full Year 2025 Financial Results and Corporate Update on February 26

Mdxhealth SA, a precision diagnostics company, has announced that it will release its financial results for the fourth quarter and full year of 2025 on February 26, 2026. A conference call is planned for the same day at 4:30pm ET, following the financial results announcement. Participants will have the opportunity to engage in a live Q&A session during the call, adding an interactive element to the update.

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MDXH
Feb 11, 2026
MDXHGeneral

EXOSOME DIAGNOSTICS, INC. Financial Statements

Exosome Diagnostics, Inc. released its financial statements for the year ending June 30, 2025, highlighting significant operational challenges. The company experienced a net loss of over $86 million, with operating expenses substantially outweighing sales revenue. This raises concerns regarding the company’s financial stability and its ability to continue operations, particularly given the overwhelming losses and liabilities reported in their statements.

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MDXH
Jan 12, 2026
MDXHGeneral
▲ +5.2%on this news

MDxHealth Reports Preliminary Fourth Quarter and Full Year 2025 Revenues, Issues 2026 Revenue Guidance, and Amends Earnout Terms with Exact Sciences IRVINE, CA

MDxHealth reported preliminary revenues of approximately $30.5 million for the fourth quarter and $109 million for the full year 2025, highlighting year-over-year growth of 23% and 21%, respectively. The company issued a 2026 revenue guidance of $137-140 million, projecting an increase of 26-28%. Additionally, MDxHealth amended its earnout terms with Exact Sciences, deferring payments over several years and issuing warrants. The CEO expressed confidence in achieving sustainable growth driven by their sales strategy and expanded offerings.

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MDXH
Jan 6, 2026
MDXHPhases

Mdxhealth and University of Oxford to validate GPS test in largest randomized trial of treatment effectiveness in patients with localized prostate cancer

Mdxhealth has initiated a significant collaboration with the University of Oxford to validate its Genomic Prostate Score (GPS) test in the ProtecT trial, the largest randomized study of treatment effectiveness in localized prostate cancer. This trial seeks to provide critical evidence supporting the clinical utility of GPS for predicting disease progression and treatment outcomes. The collaboration is expected to reshape clinical practice guidelines and enhance the personalization of care for prostate cancer patients worldwide.

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MDXH
Nov 12, 2025
MDXHGeneral

Mdxhealth Reports Results for the Third Quarter and Nine-Month Period Ended September 30, 2025

MDxHealth reported a strong financial performance for Q3 2025, with an 18% increase in revenue to $27.4 million and positive adjusted EBITDA of $1.0 million. The company highlighted the acquisition of Exosome Diagnostics, which is expected to enhance its product offerings. Despite a net loss of $8.0 million, MDxHealth remains optimistic about achieving its full-year revenue guidance of $108 million to $110 million.

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MDXH
Nov 3, 2025
MDXHGeneral

Mdxhealth to Release Third Quarter 2025 Financial Results on November 12

MDxHealth SA will announce its third quarter financial results for 2025 on November 12, after market close. A conference call with a live Q&A session will follow at 4:30 PM ET. The company emphasizes its role in precision diagnostics, providing vital molecular information for patient care.

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MDXH
Sep 15, 2025
MDXHGeneral

Mdxhealth Announces Closing of Exosome Diagnostics Acquisition from Bio-Techne

Mdxhealth has finalized its acquisition of Exosome Diagnostics from Bio-Techne, which includes the ExoDx Prostate test. The total deal is valued at $15 million, with a combination of cash and stock payments. This acquisition is expected to strengthen Mdxhealth's position in precision diagnostics, particularly in urologic cancers.

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MDXH
Aug 14, 2025
MDXHGeneral

INTERIM REPORT TABLE OF CONTENTS I. INTERIM MANAGEMENT REPORT 2 II. INTERIM CONDENSED UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS MDXHEALTH SA 5 1. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER C

MDxHealth has reported its interim financial results for the six months ending June 30, 2025, showcasing significant revenue growth of 21% year-on-year. Despite achieving an increase in gross profit and a notable reduction in operating loss, the company continues to face challenges such as a substantial accumulated deficit and ongoing net losses. Management's ability to maintain its operations hinges on accessing future financing and achieving positive cash flows. The report emphasizes the uncertainty surrounding the company's long-term viability amid these financial challenges.

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MDXH
Aug 5, 2025
MDXHGeneral
▲ +10.4%on this news

Mdxhealth Reports Preliminary Second Quarter 2025 Results, Reaches Positive Adjusted EBITDA, and Announces Acquisition of Exosome Diagnostics Business from Bio-Techne

MDxHealth reported a 20% increase in Q2 2025 revenues, reaching $26.6 million, and achieved positive adjusted EBITDA of $1.4 million. The company announced an agreement to acquire the ExoDx business from Bio-Techne for $15 million, which is expected to enhance its diagnostic capabilities and revenue growth. MDxHealth reaffirmed its 2025 revenue guidance of $108-110 million.

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About MDxHealth SA

364 employees mdxhealth.com
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