Insight Molecular Diagnostics Inc. IMDX
Insight Molecular Diagnostics Inc. (Nasdaq: IMDX) is a diagnostics company. Its next catalyst on record is GraftAssureDx: FDA decision on marketing authorization for kitted transplant assay (data package submitted 2026-03-25) (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: GraftAssureDx — FDA decision on marketing authorization for kitted transplant assay (data package submitted 2026-03-25) (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| GraftAssureDx (IVD kit) | Transplant rejection monitoring (kidney first) | unclear | NA_NON_THERAPEUTIC |
| GraftAssureCore (LDT, CLIA lab) | Transplant rejection surveillance | unclear | NA_NON_THERAPEUTIC |
| GraftAssureIQ (RUO kit) | Research use transplant dd-cfDNA | unclear | NA_NON_THERAPEUTIC |
| DetermaIO | Oncology therapy selection | unclear | NA_NON_THERAPEUTIC |
| DetermaCNI | Oncology therapy monitoring | unclear | NA_NON_THERAPEUTIC |
Recent results and decisions
- Sep 15, 2026n/a Insight Molecular Diagnostics amended its Chronix Biomedical earnout terms, capping CNI Monitor royalties at 10% of a sale to a third party.
Upon a CNI Monitor Sale, Chronix's equity holders will be paid a final payment of 10% of the gross proceeds received from such CNI Monitor Sale.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.