Annexon, Inc. ANNX
Annexon, Inc. (Nasdaq: ANNX) is a CNS/neurology/psychiatry drug developer. Its lead program, tanruprubart (ANX005), is in Phase 3 for Guillain-Barre Syndrome (GBS). Its next catalyst on record is vonaprument: ARCHER II Phase 3 Month 15 primary endpoint readout (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: vonaprument — ARCHER II Phase 3 Month 15 primary endpoint readout (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| tanruprubart | Guillain-Barre Syndrome | antibody | Phase 3 |
| vonaprument | Geographic atrophy (dry AMD) | antibody | Phase 3 |
| ANX1502 | Cold agglutinin disease (autoimmune) | small molecule | Phase 1 |
Recent results and decisions
- Aug 12, 2026n/a Annexon added a Month 24 dual primary endpoint to ARCHER II (alongside Month 15) and launched an open-label extension study; success possible at either timepoint.
With a dual primary endpoint strategy, ARCHER II can achieve success in protecting against vision loss at either Month 15 or 24, which are independent efficacy timepoints.
Filing - Aug 6, 2026positive First 10 US/EU patients in open-label FORWARD study: all showed clinically meaningful muscle-strength improvement within four days of a single 30 mg/kg infusion; the one ventilated patient came off the ventilator within four days.
All patients treated in the study showed rapid, clinically meaningful improvement in muscle strength within four days.
Filing - Jan 12, 2026submitted Annexon filed the EU Marketing Authorisation Application (MAA) for tanruprubart in GBS with the EMA (ex-US regulatory submission).
MAA filed with European Medicines Agency with comprehensive data package demonstrating rapid impact on markers of neuroinflammation and disease activity, and patients recovering faster and more completely on both disability and functional outcome measures in placebo-controlled studies.
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 CNS/neurology/psychiatry 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.