Biotech Stock Intel
Catalyst CalendarPDUFA CalendarMover SignalsCompany Screener
Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
AboutMethodologyTermsPrivacy
Biotech Stock Intel
Catalyst CalendarPDUFA CalendarMover SignalsCompany Screener
Home/Stocks/RGNX/Catalyst
Phase 3Data readout

ABBV-RGX-314 (Subretinal Delivery)

Wet age-related macular degeneration (wet AMD)

RGNXRegenxbio
Expected catalystDecember 31, 2026Company guidance: Dec 31, 2026

Catalyst overview

Event details

Drug or asset
ABBV-RGX-314 (Subretinal Delivery)
Development stage
Phase 3
Event type
Data readout
Indication
Wet age-related macular degeneration (wet AMD)
Research signalsPotential moverHigh management interest

Research summary

What is being tracked?

This catalyst tracks a Phase 3 data readout for ABBV-RGX-314 (Subretinal Delivery) in Wet age-related macular degeneration (wet AMD). The expected timing is based on the latest available company guidance and may change.

Development notes

ATMOSPHERE®/ASCENT/FET studies. In collab w/ AbbVie. 10/6/25- Completion of enrollment w/ topline results in Q4 2026.11/06/25:- Enrollment of >1,200 participants in ATMOSPHERE and ASCENT pivotal wet AMD trials completed. Topline Phase 3 results remain expected in Q4 2026, and program is positioned as potential first approved gene therapy for wet AMD. 03/05/26:- Q4 2026 wet AMD pivotal topline reaffirmed; global regulatory submissions planned in 2027 with AbbVie. 05/14/26:- Q4 2026 ATMOSPHERE/ASCENT subretinal wet AMD topline and 2027 global regulatory submissions reiterated. 06/29/26:- Present 5-year Ph1/2a subretinal wet AMD data at ASRS July 2026. Q4 2026 topline reaffirmed. 07/18/26:- ASRS showed 5-year Ph1/2a wet AMD durability; Q4 2026 ATMOSPHERE/ASCENT topline expected. 08/06/26:- ATMOSPHERE/ASCENT topline remains Q4 2026; global submissions expected 2027.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

More from RGNX

Related pipeline programs

Phase 2/3

Surabgene lomparvovec (sura-vec, ABBV-RGX-314) (Suprachoroidal Delivery)

Diabetic retinopathy (DR)

View company pipeline

Company

Regenxbio

RGNX · NasdaqGS
Industry
Biotechnology
Pipeline assets
8
View RGNX research

BioPharma Pro

Track every date change

Watchlists, source history and catalyst alerts will be available with Pro.

Start free

Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
AboutMethodologyTermsPrivacy