Metagenomi Therapeutics, Inc. MGX
Metagenomi Therapeutics, Inc. (Nasdaq: MGX) is a hematology drug developer. Its lead program, MGX-001, is in Pre-clinical for Hemophilia A (site-specific Factor VIII gene integration, AAV + LNP). Its next catalyst on record is MGX-001: Metagenomi plans to submit IND for MGX-001 in hemophilia A in Q4 2026. (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: MGX-001 — Metagenomi plans to submit IND for MGX-001 in hemophilia A in Q4 2026. (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| MGX-001 | Hemophilia A (NHP studies complete; pre-IND meeting held Q4 2025; IND planned Q4 2026) | gene therapy | Pre-clinical |
| MGX-001 large gene integration system | Antithrombin III deficiency and other secreted protein deficiencies (NHP proof of concept) | gene therapy | Pre-clinical |
| Ionis collaboration Wave 1: APOC3 | Hypertriglyceridemia (gene knockout; lead optimization) | gene therapy | Pre-clinical |
| Ionis collaboration Wave 1: TTR | Transthyretin amyloidosis (lead optimization) | gene therapy | Pre-clinical |
| Ionis collaboration Wave 1: AGT | Refractory hypertension (lead optimization) | gene therapy | Pre-clinical |
Recent results and decisions
- Sep 22, 2026submitted Metagenomi plans to submit IND for MGX-001 in hemophilia A in Q4 2026.
Q4 2026 IND Submission Submit IND for first-in-human Phase 1/2 study
Filing - Sep 22, 2026started First patient dosing in MGX-001 Phase 1/2 study expected in 2027.
2027 First Patient Dosed Global single-arm study; observe initial safety and efficacy within weeks of dosing
Filing - n/a Metagenomi completed Pre-IND Interaction with FDA in December 2025 with collaborative, favorable outcome.
Pre-IND Interaction Complete Dec 2025 FDA meeting — collaborative, favorable outcome
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.