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RegenXBio (RB0) Q3 2026 Earnings Report

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DE:RB0 Q3 2026 EPS Results

Actual EPS
-EUR 0.56
Consensus EPS
-EUR 1.15
Beat/Miss
Beat by +EUR 0.60
One Year Ago EPS
-EUR 1.07

DE:RB0 Q3 2026 Revenue Results

Actual Revenue
EUR 8.20M
Expected Revenue
EUR 9.75M
Beat/Miss
Missed by -EUR 1.55M
YoY Revenue Growth
-69.19%

Earnings Announcement Details

Quarter
Q3 2026
Date
11/05/2026
Time
Before Open
Conference Call
Thursday, November 5, 2026
DE:RB0 Upcoming Earnings

RegenXBio's next earnings date is estimated for March 2, 2027, based on past reporting schedules.

Q3 2026 Earnings Call Audio

DE:RB0 Q3 2026 Earnings Call
0:00 / 0:00

Q3 2026 Earnings Slide Deck

No slide deck is available for this earnings event.

Q3 2026 Earnings Call Summary

Q3 2026
Earnings Call Date:Nov 05, 2026|% Change Since:3.51%|
Earnings Call Sentiment|Positive

The call was strongly optimistic, with extensive progress across sura-vec and RGX-202, encouraging clinical and biomarker data, significant AbbVie milestone funding, a cash runway extending beyond late 2027 milestones, and preparations for potential commercialization. The principal negatives were the unresolved regulatory path for RGX-121, the expiration of U.S. ZOLGENSMA intellectual property, and the fact that major sura-vec and RGX-202 regulatory milestones remain pending.

Company Guidance

REGENXBIO expects top line results from both ATMOSPHERE and ASCENT this quarter, followed by global regulatory submissions in 2027; RGX-202 preparations are underway for a full BLA submission in the first quarter of 2027 under the accelerated approval pathway, supporting potential approval in the U.S. in the second half of 2027, while the AFFINITY RISE study is expected to initiate in the first half of 2027 and enroll approximately 100 patients with a 2:1 active to placebo randomization. The company expects its RGX-202 BLA to include safety data from more than 60 patients, expects pre-BLA meeting minutes about 30 days post the meeting, expects BLA acceptance about 2 months after submission, and expects a review process through the next 6 months. For wet AMD, the goal is at least a 50% reduction in treatment burden with a meaningful proportion of those patients not needing any injection, and cash runway is late into fourth quarter of 2027.

  • Multiple Potential Regulatory Milestones and Commercial PreparationREGENXBIO is approaching multiple potential regulatory approvals and preparing for commercialization. Sura-vec top-line data from the ATMOSPHERE and ASCENT pivotal studies are expected this quarter, global regulatory submissions are expected in 2027, and RGX-202 is advancing toward a potential BLA submission in the first quarter of 2027.
  • Broad Sura-vec Wet AMD OpportunityManagement highlighted the significant unmet need in wet AMD caused by the burden of frequent anti-VEGF injections. Sura-vec is being evaluated in newly diagnosed and treatment-experienced patients, including patients with high disease activity and bilateral disease, and is described as the only late-stage gene therapy program with reported clinical data supporting treatment in both eyes.
  • Sura-vec Commercial Infrastructure and Physician TrainingThe company stated that commercial infrastructure for subretinal delivery already exists through LUXTURNA and other approved therapies. More than 500 retina specialists have been trained, and many high-volume treatment centers are participating in the pivotal studies. AbbVie's global reach and eye-care capabilities are also supporting potential commercialization.
  • Large, Global Sura-vec Pivotal ProgramATMOSPHERE and ASCENT have enrolled more than 1,300 patients across 14 countries, making them the largest gene therapy trials ever conducted, according to management. Each study includes more than 600 patients, is powered at 90%, randomizes patients 1:1:1 to low-dose sura-vec, high-dose sura-vec or an on-label anti-VEGF control, and uses non-inferiority on change in BCVA at 54 weeks as the primary endpoint.
  • Long-Term Sura-vec Clinical DataIn the Phase I/II study at doses similar to those in the pivotal trials, sura-vec-treated patients demonstrated stable to improved visual acuity and meaningful reductions in anti-VEGF treatment burden through 5 years.
  • Sura-vec Bilateral Treatment DevelopmentThe company has addressed fellow-eye treatment in two studies: a bilateral treatment study and studies allowing patients to roll over for fellow-eye treatment. Management stated that roughly half of patients have or will develop fellow-eye disease, making the ability to treat both eyes a key component of the program's value proposition.
  • Diabetic Retinopathy Program ProgressREGENXBIO is enrolling the Phase IIb/III NAAVIGATE study in diabetic retinopathy. Dosing the first patient triggered a $100 million milestone payment from AbbVie. Management said anti-VEGF treatment is vastly underused in diabetic retinopathy because of treatment burden, particularly among predominantly middle-aged working adults.
  • Encouraging Three-Year ALTITUDE ResultsIn the Phase II ALTITUDE trial, 60% of patients improved by at least 2 steps on the diabetic retinopathy severity scale at 3 years without additional treatment. Additionally, 3 of 4 patients who improved by 1 step at 1 year without additional treatment subsequently improved by at least 2 steps by year 3.
  • RGX-202 BLA and Potential Approval TimelinePreparations are underway for a full BLA submission for RGX-202 under the accelerated approval pathway in the first quarter of 2027, supporting potential U.S. approval in the second half of 2027. The BLA is expected to include data from both pivotal and confirmatory studies, and management said the change from a rolling filing to a full filing is not expected to affect the eventual PDUFA timeline.
  • RGX-202 Clinical Efficacy and Biomarker CorrelationManagement reported robust microdystrophin expression, encouraging functional improvement and a favorable safety profile in the pivotal study. A statistically significant correlation was observed between microdystrophin expression and NSAA improvement at 1 year. The company stated that it is the only company to have correlated microdystrophin levels with functional benefit.
  • RGX-202 Safety and BLA Data PackageThe planned BLA is expected to include safety data from more than 60 patients across the pivotal and confirmatory studies. Management reported a significant reduction in liver toxicity in the pivotal dataset, no need to change the immunosuppression regimen across the pivotal and confirmatory studies, and consistent use of the same regimen throughout those studies.
  • RGX-202 Product and Manufacturing DifferentiationRGX-202 includes a C-terminal domain intended to make its construct closer to naturally occurring dystrophin. The company also highlighted a proactive immunosuppression regimen and a commercial-ready manufacturing process that delivers approximately 80% capsid purity. REGENXBIO said it has invested in CMC for more than 7 years and that most patients in the pivotal and confirmatory studies received product made with the intended commercial manufacturing process.
  • RGX-202 Global Development PlansThe confirmatory study has completed dosing, and the company remains on track to initiate the ex-U.S. AFFINITY RISE global, double-masked, placebo-controlled randomized study in the first half of 2027. The study is designed to enroll approximately 100 patients with a 2:1 active-to-placebo randomization.
  • Strong Liquidity and Extended Cash RunwayCash, cash equivalents and marketable securities totaled $251 million at September 30, 2026, compared with $241 million at December 31, 2025. The increase reflected the $100 million AbbVie milestone payment and $108 million of net proceeds from a July underwritten public offering of common stock and prefunded warrants. Cash runway is expected to extend late into the fourth quarter of 2027 and beyond multiple milestones.
  • Additional Settlement Proceeds and Royalty StreamsThe reported $251 million cash balance excludes a $39 million payment received in October 2026 under a settlement agreement with Sarepta Therapeutics. REGENXBIO continues to receive ZOLGENSMA royalties in select ex-U.S. territories and ITVISMA royalties in the U.S. and certain ex-U.S. territories.
  • Established Reimbursement Mechanics and Durability EvidenceManagement stated that reimbursement codes for subretinal administration are well established and that the primary additional reimbursement requirement is a J-code for the product itself. The company also highlighted five-year subretinal administration data in some wet AMD patients as important support for future payer discussions.
  • AbbVie Collaboration and ACHIEVE StudyAbbVie is leading payer discussions as commercialization approaches and has proactively undertaken the ACHIEVE Phase IIIb study. Management said the study and AbbVie's commitment to the global potential of one-time gene therapy should bolster the value proposition.
  • Wet AMD Treatment-Burden TargetFor the pivotal wet AMD studies, management stated that the goal is at least a 50% reduction in treatment burden, with a meaningful proportion of patients requiring no injections. The company emphasized that this target is being evaluated in a tough-to-treat population with high disease activity and treatment experience.
  • Wet AMD Study Design and Rescue CriteriaThe wet AMD pivotal studies include treatment-experienced patients and patients with high disease activity, estimated by management to represent roughly 40% of the population. Enrollment required a response to ranibizumab, while a one-week post-dose assessment was used to identify patients whose disease could recur quickly. Rescue criteria were prespecified and based on BCVA changes and/or OCT-measured fluid or disease activity.
  • Consistent RGX-202 Functional EffectsManagement reported that functional benefit was observed across the broad NSAA measure and multiple time-function tests, with particular focus on time to stand. Fourteen patients are expected to have time-function data available for the BLA, and the company plans to assess correlations between microdystrophin and time-function outcomes.
  • Financial and Regulatory Execution Remains on TrackManagement stated that all elements related to the RGX-202 BLA submission remain on track for the first quarter of 2027. Following the pre-BLA meeting, minutes are typically expected approximately 30 days later, while acceptance of the BLA for accelerated-approval review is expected approximately 2 months after submission.

DE:RB0 Earnings History

DE:RB0 earnings history
Report DateFiscal QuarterForecast / EPSLast Year's EPSEPS YoY ChangePress Release
Mar 02, 20272026 (Q4)-0.86--1.16――
Nov 05, 20262026 (Q3)-1.15-0.56-1.0748.33% (+0.52)
Aug 06, 20262026 (Q2)0.070.39-1.24131.16% (+1.62)
May 14, 20262026 (Q1)-1.20-1.540.11-1533.33% (-1.65)
Mar 05, 20262025 (Q4)-0.86-1.16-0.9-28.71% (-0.26)
Nov 06, 20252025 (Q3)-1.15-1.07-1.05-2.56% (-0.03)
Aug 07, 20252025 (Q2)-0.84-1.24-0.94-31.43% (-0.30)
May 12, 20252025 (Q1)0.410.11-1.24108.70% (+1.34)
Mar 13, 20252024 (Q4)-1.02-0.90-1.2829.37% (+0.38)
Nov 06, 20242024 (Q3)-1.00-1.05-1.2617.02% (+0.21)

The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.

Beat Missed