Guardant Health, Inc. GH
Guardant Health, Inc. (Nasdaq: GH) is an oncology diagnostics company. Its next catalyst on record is Shield MCD: Vanguard pilot study completion (2029).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Shield MCD — Vanguard pilot study completion (2029). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Shield blood test for colorectal cancer screening | Colorectal cancer screening | unclear | Approved |
| Guardant360 CDx | Advanced-stage cancer (NSCLC, colorectal, breast) | unclear | Approved |
| Guardant360 Liquid CDx | Advanced-stage cancer | unclear | Approved |
| Shield multi-cancer detection (MCD) test | Multi-cancer detection | unclear | Approved |
| Guardant Reveal | Residual and recurring disease in early-stage colorectal, breast and lung cancer | unclear | Approved |
| Guardant360 Liquid | Advanced-stage cancer | unclear | Approved |
| Guardant360 Tissue | Advanced-stage cancer | unclear | Approved |
| GuardantINFINITY | Cancer research and therapy development | unclear | Approved |
| GuardantOMNI | Advanced-stage cancer | unclear | Approved |
| Shield lung cancer screening test | Lung cancer screening in high-risk individuals ages 50-80 | unclear | Phase 3 |
Recent results and decisions
- Nov 5, 2026approval FDA approved Guardant360 CDx as a companion diagnostic for ETCAMAH (camizestrant), marking the first FDA approval of a liquid biopsy companion diagnostic for longitudinal testing in breast cancer.
Received U.S. Food and Drug Administration (FDA) approval and CE-marking in Europe for Guardant360 CDx as a companion diagnostic for AstraZeneca's ETCAMAH (camizestrant), the first FDA approval of a liquid biopsy companion diagnostic for longitudinal testing in breast cancer
Filing - Nov 5, 2026submitted Submitted a premarket approval (PMA) application to the FDA for Guardant360 Tissue.
Submitted a premarket approval (PMA) application to the FDA for Guardant360 Tissue
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
Other phase 3 oncology companies
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
- Summit Therapeutics Inc. SMMT
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.