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 - Dec 31, 2025positive Metagenomi completed Pre-IND Interaction in December 2025 for MGX-001 with favorable outcome from FDA meeting.
Pre-IND Interaction Complete Dec 2025 FDA meeting — collaborative, favorable outcome
Filing
1 more on record.
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 pre-clinical hematology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.