RegenXBio (RGNX) Earnings Dates, Call Summary & Reports

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Earnings Data

Report Date

May 06, 2026

Before Open (Confirmed)

Period Ending

2026 (Q1)

Consensus EPS Forecast

-1.28

Last Year’s EPS

0.12

Same Quarter Last Year

Analyst Consensus

Strong Buy

Based on 10 Analysts Ratings

Earnings Call Summary

Q4 2025

Earnings Call Date:Mar 05, 2026|

% Change Since:

Earnings Call Sentiment|Positive

The call highlighted multiple strong development and commercial catalysts: completed pivotal enrollment in Duchenne with differentiated efficacy and safety signals for RGX-202, substantial progress and promising outcomes in the Cirovec retinal programs (including large reductions in anti-VEGF injections and durable responses), an active AbbVie collaboration with a near-term $100M milestone, and solid revenue/financing transactions that support a runway into early 2027. Offsetting these positives are material regulatory setbacks in the MPS programs (CRL and clinical holds) driven by an AAV integration–associated tumor in one patient and biomarker/assay issues, plus higher R&D spend and reliance on milestone/monetization proceeds. Overall, the company appears to have multiple high-value, late-stage assets and funding pathways, but faces meaningful program-specific safety and regulatory risks that will need to be resolved.

Company Guidance

REGENXBIO said it finished 12/31/2025 with $241M in cash/cash equivalents/marketable securities (vs $245M a year earlier) after a $110M Nippon Shinyaku upfront and $145M net proceeds from a royalty monetization; 2025 R&D was $228M (vs $209M in 2024) and total 2025 revenue was $170M, and management expects this cash to fund operations into early 2027 (excluding a $100M AbbVie NAVIGATE milestone expected on first patient dose next quarter and any additional royalty proceeds, either of which could extend the runway). Key clinical/regulatory timelines: RGX‑202 pivotal enrollment completed Oct‑2025 (pivotal cohort ~30) with topline data expected early Q2‑2026 and the majority of pivotal patients to have 12‑month functional data in 2026; Phase‑1/2 RGX‑202 showed a 7.4‑point NSAA improvement vs CTAP at 18 months, >80% full capsids, no SAEs/AESIs reported, and dosing at 2e14 with the confirmatory study expanding safety exposures (~50 vs ~30). Retina and other program metrics: ATMOSPHERE/ASCENT enrollment complete with subretinal Cirovec wet AMD topline due Q4‑2026; NAVIGATE Phase‑2b/3 will enroll 136 NPDR patients in the Phase‑2b with a primary endpoint of ≥2‑step DRSS improvement at one year and first dosing next quarter (triggers $100M); ALTITUDE DL3 showed >70% reduction in vision‑threatening complications and a 93% reduction in annualized anti‑VEGF injections (60% injection‑free at 12 months). Finally, RGX‑121 received a CRL and RGX‑111/121 are on clinical hold; the company is pursuing a Type A meeting to resubmit.

RGX-202 Duchenne Pivotal Program Momentum

Completed dosing in the AFFINITY pivotal trial (enrollment completed Oct 2025); robust enrollment in confirmatory trial. Phase 1/2 18-month NSAA results showed a 7.4-point average improvement versus the CTAP natural-history model. Majority of pivotal patients exceeded expected functional outcomes at 12 months. Safety differentiation to date: no SAEs/AESIs reported in Phase 1/2 and no observed thrombocytopenia or liver injury; proactive immune suppression, novel construct and >80% full capsids at a 2e14 dose.

Regulatory Path and Near-Term Milestones for DMD

Topline pivotal study readout expected early in Q2 2026; FDA engagement planned midyear with a targeted pre-BLA meeting and intent to pursue accelerated approval. By 2026, majority of pivotal patients expected to have 12 months of functional data to support submission.

Cirovec (Wet AMD and Diabetic Retinopathy) Progress

ATMOSPHERE and ASCENT pivotal wet AMD trials enrollment complete; Phase 1/2 subretinal program shows durable outcomes through four years. Fellow-eye bilateral dosing study showed a 93% reduction in annualized anti-VEGF injection need at 12 months and 60% of recipients remained injection-free at that timeframe.

NAVIGATE Diabetic Retinopathy Program and AbbVie Collaboration

NAVIGATE Phase 2b/3 for diabetic retinopathy (suprachoroidal delivery) entering site activation with first patient dosing expected next quarter, which will trigger a $100 million milestone from AbbVie. ALTITUDE dose level 3 demonstrated no intraocular inflammation at two years with short-course topical steroids, 50% of subjects achieved ≥2-step DRSS improvement without additional treatment, and >70% reduction in vision-threatening complications versus historical control.

Commercial and Manufacturing Readiness

Company positioning to transition from late-stage development to a commercial entity with in-house manufacturing investments and co-development partnerships to support near-term potential product launches (Duchenne and retina indications).

Solid 2025 Revenue and Financing Transactions

Total annual revenue of $170 million in 2025, including a $110 million upfront from Nippon Shinyaku and increased royalty revenue included in the $145 million net proceeds from the royalty monetization with HealthCare Royalty Partners.

Cash Position and Runway with Upside Milestones

Cash, cash equivalents and marketable securities of $241 million as of 12/31/2025 (vs $245M as of 12/31/2024, a change of -1.6%). Management expects this balance to fund operations into early 2027; runway could be extended by a $100M AbbVie milestone on NAVIGATE dosing and potential additional monetization funds.

RegenXBio (RGNX) Earnings, Revenues Date & History

The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced

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RGNX Earnings History

Report Date	Fiscal Quarter	Forecast / EPS	Last Year's EPS	EPS YoY Change	Slides	Play Transcript
May 06, 2026	2026 (Q1)	-1.28 / -	0.12	―	―	―
Mar 05, 2026	2025 (Q4)	-0.96 / -1.30	-1.01	-28.71% (-0.29)	―
Nov 06, 2025	2025 (Q3)	-1.28 / -1.20	-1.17	-2.56% (-0.03)	―
Aug 07, 2025	2025 (Q2)	-0.94 / -1.38	-1.05	-31.43% (-0.33)	―
May 12, 2025	2025 (Q1)	0.46 / 0.12	-1.38	108.70% (+1.50)	―
Mar 13, 2025	2024 (Q4)	-1.14 / -1.01	-1.43	29.37% (+0.42)	―
Nov 06, 2024	2024 (Q3)	-1.12 / -1.17	-1.41	17.02% (+0.24)	―
Aug 01, 2024	2024 (Q2)	-1.29 / -1.05	-1.66	36.75% (+0.61)	―
May 08, 2024	2024 (Q1)	-1.26 / -1.38	-1.53	9.80% (+0.15)	―
Feb 27, 2024	2023 (Q4)	-1.27 / -1.43	-1.38	-3.62% (-0.05)	―

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

RGNX Earnings-Related Price Changes

Report Date	Price 1 Day Before	Price 1 Day After	Percentage Change
Mar 05, 2026	$9.14	$8.72	-4.60%
Nov 06, 2025	$11.61	$11.17	-3.79%
Aug 07, 2025	$8.23	$7.90	-4.01%
May 12, 2025	$7.97	$8.18	+2.63%

Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.

FAQ

When does RegenXBio (RGNX) report earnings?

RegenXBio (RGNX) is schdueled to report earning on May 06, 2026, Before Open (Confirmed).

What is RegenXBio (RGNX) earnings time?

RegenXBio (RGNX) earnings time is at May 06, 2026, Before Open (Confirmed).

Where can I see when companies are reporting earnings?

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What companies are reporting earnings today?

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What is RGNX EPS forecast?

RGNX EPS forecast for the fiscal quarter 2026 (Q1) is -1.28.