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Insight Molecular Diagnostics Inc.

IMDXFDA catalysts, PDUFA dates & pipeline intelligence
$3.31
▲ +0.03 · +0.79%

Financials

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52W LOW $2.4252W HIGH $8.51
Volume
5.00 K
Value Traded
396.55 K
Short % Float
9.71%
-4.65%Week
-20%1 Month
-35.43%3 Month
+3.47%6 Month
-93.47%5 Year
-94.7%All Time

Cash Data

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  • Monthly Burn
  • Burn Trend
  • Dilution Risk
  • SEC Filing

Key Stats

Market Cap
107.04 M
EPS (TTM)
-1.51
P/E Ratio
-
Ent. Value
89.58 M
Total Shares
32.72 M
Float Shares
10.22 M
Insiders
68.77%
Institutions
17.69%

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.

IMDX Catalyst Timeline

Dated clinical, regulatory and corporate events for Insight Molecular Diagnostics Inc.

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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 IMDX 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

Insight Molecular Diagnostics Inc. 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 IMDX program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
atezolizumab triple negative breast cancer (TNBC)Phase 32021-09-20DetermaIO outperformed 80 other immune related signatures; IO score demonstrated the ability to identify those TNBC patients who benefitted the most from the addition of atezolizumab; IO score was significantly more associated with pCR in atezolizumab arm than any other immune-related signaturesRead MoreOncocyte Announces Oral Presentation of New Data on Its DetermaIO Immunotherapy Response Test at the European Society for Medical Oncology Annual Meeting Randomized clinical trial data from NeoTRIPaPDL1 study establishesRead 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
SILVERMAN LOUDirectorDisposition -7,700 55,807 held$5.69 07/01/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in IMDX for Q2 2026.
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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.

IMDX Institutional Ownership Trends

Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

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
2026-11-20
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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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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 IMDX ranks across every disease it competes in

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See how IMDX ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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IMDX News

IMDX
Sep 2, 2026
IMDXConferences/Events

iMDx to Participate in Lake Street 10th Annual Best Ideas Growth “BIG10” Conference

Insight Molecular Diagnostics Inc. (IMDX) will participate in the Lake Street Capital Markets 10th Annual Best Ideas Growth Conference on September 10, 2026. CEO Josh Riggs and CFO Andrea James will represent the company in one-on-one meetings with investors at the Metropolitan Club in New York City. This event aims to enhance investor engagement and showcase the company's innovative diagnostics technology.

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IMDX
Aug 4, 2026
IMDXConferences/Events

iMDx to Release Second Quarter Results on August 10, 2026 and Attend Needham Virtual MedTech & Diagnostics 1x1 Conference

Insight Molecular Diagnostics Inc. (iMDx) will announce its second quarter 2026 financial results on August 10, 2026, followed by a live webinar for discussion. Additionally, CEO Josh Riggs and CFO Andrea James will attend the 11th Annual Needham Virtual MedTech & Diagnostics 1x1 Conference on August 11, 2026, conducting one-on-one meetings with investors.

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IMDX
Jul 23, 2026
IMDXFDA Updates

iMDx GraftAssure Assay Guides Use of Potentially Kidney-Graft-Saving Drug in New Lancet Group Publication

iMDx has announced a new study published in The Lancet Regional Health that highlights the effectiveness of donor-derived cell-free DNA (dd-cfDNA) monitoring in guiding treatment for kidney transplant patients. The study supports the use of iMDx's GraftAssure technology, which has received Medicare reimbursement coverage. This development indicates a significant market opportunity for iMDx as it seeks to expand the clinical applications of its testing technology.

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IMDX
Jul 16, 2026
IMDXFDA Updates

Favorable Medicare Coverage Decision Supports Commercial Adoption of iMDx GraftAssure Assay Portfolio

Insight Molecular Diagnostics Inc. (IMDX) announced a favorable Medicare policy that expands coverage for donor-derived cell-free DNA (dd-cfDNA) testing in transplant care. This policy supports the commercial adoption of iMDx's GraftAssure assay portfolio by providing reimbursement clarity and increasing testing frequency for kidney and heart transplant patients. The policy is expected to enhance patient access to critical monitoring tests.

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IMDX
Jun 29, 2026
IMDXGeneral

IMDx Chief Science Officer Ekkehard Schuetz Publishes 200th Research Paper

Insight Molecular Diagnostics Inc. announced that Chief Science Officer Prof. Dr. Ekkehard Schuetz has published his 200th research paper, solidifying his status as a leading figure in laboratory diagnostics. His contributions include advancements in molecular diagnostic testing for organ rejection and the development of the GraftAssure technology. This milestone highlights both his extensive experience and the ongoing innovation at iMDx.

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IMDX
Jun 22, 2026
IMDXGeneral

iMDx and the American Society of Transplant Surgeons Announce Recipients of the ASTS-iMDx Health Economics Research Grant

iMDx and the American Society of Transplant Surgeons have announced the recipients of the ASTS-iMDx Health Economics Research Grant. The grant has been awarded to Dr. Kenneth Andreoni and Dr. Kenneth Chavin for their contributions to understanding health economics in transplantation. This collaboration aims to enhance research in the field.

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IMDX
Jun 16, 2026
IMDXGeneral

Favorable Head-to-Head Data on iMDx’s GraftAssure with Competing NGS Assay Published in Clinical Chemistry

Insight Molecular Diagnostics Inc. announced the publication of a favorable study in Clinical Chemistry, comparing its GraftAssure test to a competing NGS assay. The study found a 99.2% agreement in assessing kidney transplant rejection risk, highlighting GraftAssure's enhanced sensitivity and potential for improved patient care. The findings support the integration of dd-cfDNA testing into clinical practice.

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IMDX
Jun 11, 2026
IMDXFDA Updates

IMDX GraftAssure Assay Sets New Standard in Screening Kidney Transplant Patients Per American Journal of Transplantation

Insight Molecular Diagnostics Inc. announced that its GraftAssure assay has been published in the American Journal of Transplantation, demonstrating superior diagnostic performance in kidney transplant rejection monitoring. The CM-Score significantly improves the positive predictive value to over 80% and retains a high negative predictive value. The company is pursuing FDA marketing authorization for its test kits to enhance local transplant center capabilities.

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IMDX
Jun 9, 2026
IMDXConferences/Events

iMDx to Highlight In-House Transplant Testing Opportunity and Host Key Opinion Leaders at American Transplant Congress

Insight Molecular Diagnostics Inc. (IMDX) will showcase its GraftAssure technology at the American Transplant Congress in Boston. The company aims to highlight the benefits of in-house organ rejection testing and announce grant winners for research on testing economics. iMDx is seeking FDA authorization for its GraftAssureDx kit, which promises faster, more affordable testing.

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IMDX
May 13, 2026
IMDXFDA Updates

IMDX Reports Q1 2026 Results and Update on Progress Toward GraftAssure Commercialization

Insight Molecular Diagnostics Inc. (IMDX) reported strong progress in Q1 2026 towards the commercialization of its GraftAssureDx kidney transplant monitoring assay. The company is engaging with major transplant centers and has received positive feedback from the FDA regarding its regulatory submission. Despite a net loss of $4.3 million, the company anticipates significant orders following FDA authorization later in 2026.

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IMDX
May 6, 2026
IMDXConferences/Events
▲ +9.8%on this news

iMDx to Release First Quarter 2026 Results on May 13, 2026

Insight Molecular Diagnostics Inc. (IMDX) will announce its first quarter 2026 financial results on May 13, 2026, after market close. A live Zoom webinar will follow at 2:00 PM PT to discuss these results and include a Q&A session. An archived replay will be available on the company's website.

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IMDX
May 1, 2026
IMDXGeneral

Insights Into the 2026 Fallopian Tube Cancer Therapeutics Market: Targeted Treatments and Early Diagnosis Fuel Market Expansion

The global fallopian tube cancer therapeutics market is set for substantial growth, expected to rise from USD 1.95 billion in 2025 to USD 5.54 billion by 2035, reflecting a compound annual growth rate of 11%. This expansion is attributable to increased focus on targeted treatments, rising awareness of gynecological cancers, and advancements in diagnostic methods. Key market players are enhancing their positions through strategic collaborations and expanding product portfolios, despite challenges such as high costs and disparities in healthcare infrastructure that may restrict therapy access. The market features significant advancements in early diagnosis and innovation in treatment options, such as PARP inhibitors.

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IMDX
Apr 14, 2026
IMDXConferences/Events
▲ +20.3%on this news

Real-World Evidence and Industry Momentum Builds for iMDx’s Flagship GraftAssure Assay

Insight Molecular Diagnostics Inc. (IMDX) announced positive real-world data for its GraftAssure assay, which will be showcased at several upcoming international conferences. The company is also hosting a fireside chat at the Needham Virtual Healthcare Conference. Despite a solid cash balance, iMDx remains pre-revenue and awaits FDA approval for its GraftAssureDx assay.

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IMDX
Mar 27, 2026
IMDXFDA Updates
▼ -13.4%on this news· ran to -38% by day 1

IMDX Submits GraftAssureDx for FDA Review and Reports Q4 2025 Results

Insight Molecular Diagnostics Inc. has submitted GraftAssureDx, the first kitted dd-cfDNA assay, for FDA review. The company reports increased interest from transplant centers, with 37 engaged in the U.S. alone. They anticipate a 150-day review process and are preparing for potential FDA queries. The assay aims to revolutionize organ rejection monitoring and management.

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IMDX
Mar 20, 2026
IMDXConferences/Events
▲ +8.7%on this news

iMDx to Release Fourth Quarter 2025 Results on March 26, 2026 and Attend Needham Virtual Healthcare Conference

Insight Molecular Diagnostics Inc. (iMDx) will announce its fourth quarter 2025 financial results on March 26, 2026, followed by a live webinar for discussion. Additionally, CEO Josh Riggs and CFO Andrea James will attend the 25th Annual Needham Virtual Healthcare Conference on April 15, 2026, engaging in one-on-one meetings with investors.

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IMDX
Mar 13, 2026
IMDXGeneral

Second Study Affirms Superiority of iMDx GraftAssure Assay’s Proprietary dd-cfDNA Combination Model Score

Insight Molecular Diagnostics Inc. has published a new peer-reviewed study affirming the superiority of its GraftAssure assay technology in kidney transplant monitoring. The study demonstrated that the proprietary Combination Model score outperformed traditional dd-cfDNA measures, indicating its potential for better predicting transplant rejection. This research supports iMDx's commercialization strategy and aims to enhance access to organ health testing for kidney transplant patients.

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IMDX
Mar 3, 2026
IMDXFDA Updates
▲ +10.3%on this news

Insight Molecular Diagnostics Completes Key Milestones Advancing GraftAssureDx Toward FDA Submission

Insight Molecular Diagnostics has completed significant milestones for its GraftAssureDx test kit, including a three-site reproducibility study and the collection of sufficient clinical samples for FDA submission. The company also received ISO 13485 certification, enabling regulatory submissions in the U.K. and E.U. The firm aims to enhance organ health testing for kidney transplant patients.

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IMDX
Feb 11, 2026
IMDXGeneral
▼ -22.7%on this news

iMDx Announces $26.0 Million Registered Direct Offering

Insight Molecular Diagnostics Inc. has announced a registered direct offering of 4,525,976 shares at $5.75 per share, expected to close on February 12, 2026. The offering aims to raise approximately $26 million for general corporate purposes, particularly to expand its GraftAssure product line into heart transplant rejection testing. Bio-Rad Laboratories, a significant shareholder, is participating in the offering.

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IMDX
Feb 11, 2026
IMDXGeneral
▼ -22.7%on this newsshared move

Insight ANNOUNCES $26.0 MILLION REGISTERED DIRECT OFFERING

Insight Molecular Diagnostics Inc. (Nasdaq: IMDX) announced a registered direct offering for the sale of 4,525,976 shares of its common stock at a price of $5.75 per share, expected to close on February 12, 2026. The offering aims to raise approximately $26 million to support general corporate purposes, including research and development in transplant diagnostics. The company intends to enhance its GraftAssure product line particularly focusing on heart transplant rejection testing. Street Capital Markets, LLC is acting as the sole placement agent for the offering.

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About Insight Molecular Diagnostics Inc.

Nashville, TN 58 employees imdxinc.com
Headquarters2 INTERNATIONAL PLAZA DR., SUITE 510, NASHVILLE, TN, 37217
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