RegenXBio Inc. (RGNX)
NASDAQ:RGNX
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Earnings Data
Report Date
Aug 05, 2026Before Open (Confirmed)
Period Ending
2026 (Q2)Consensus EPS Forecast
0.25Last Year’s EPS
-1.38Same Quarter Last Year
Strong Buy
Based on 9 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call presented a notably positive clinical and programmatic update: RGX-202 met its pivotal primary endpoint with high biomarker expression, demonstrated an unusually strong correlation between microdystrophin and functional benefit (>0.9), and showed encouraging interim safety and functional signals with plans for potential accelerated approval in 2027. Key operational and regulatory risks were acknowledged — chiefly the limited number of mature 12‑month functional datapoints so far, reliance on external controls (and FDA concern about bias), and the possibility that the agency could request randomized trials which would materially delay approval. Remaining uncertainties on long‑term durability and the logistical burden of the prophylaxis regimen were also discussed. Overall the clinical readout and pipeline progress meaningfully outweigh near‑term risks, but regulatory process and more mature datasets remain critical next milestones.Company Guidance
Pivotal Phase III Primary Endpoint Met
AFFINITY DUCHENNE pivotal Phase III met its primary endpoint with high statistical significance: 93% (28 of 30 biopsied patients) exceeded the predefined microdystrophin >10% threshold. Interim safety available for 31 dosed pivotal patients.
Robust Microdystrophin Expression
Very high biomarker expression: 71.1% average microdystrophin across all patients, 80% of patients >40% expression, and 41.6% average expression in patients aged ≥8. Company noted among the highest vector copy numbers and product purity (cited >80% full capsids).
Strong Biomarker–Clinical Correlation
A highly statistically significant correlation between microdystrophin expression and functional improvement was reported: correlation coefficients >0.9 for both NSAA change from baseline and NSAA vs cTAP predicted value, supporting microdystrophin as a surrogate endpoint likely to predict clinical benefit.
Interim 12‑Month Functional Improvements vs External Controls
Interim 12‑month functional data (9 ambulatory patients aged ≥4) showed improvement across NSAA and timed function tests versus external controls (propensity-score weighted analyses). Caregiver-reported PODCI measures also improved. Clinical investigators corroborated meaningful functional gains and real-world patient videos were shared (1–2 year improvements).
Generally Favorable Safety Profile with Proactive Immunosuppression
RGX-202 was described as well tolerated: of 31 dosed patients there were 2 treatment-related SAEs (both resolved without sequelae: one subacute myocarditis and one asymptomatic liver injury). No drug-related thrombocytopenia, myositis or neurotoxicity were reported. Mean GGT and total bilirubin remained stable and well below upper limits of normal across 12 months.
Pipeline Progress, Enrollment and Near‑Term Commercial Planning
More than 50 patients dosed across pivotal and confirmatory studies with line of sight to dose ~60 patients by midyear. Company is planning for potential accelerated approval and commercial filing targeting 2027. Additional program highlights: retinal Phase IIb first‑patient dosing expected Q2 (triggers $100M AbbVie milestone), partial clinical hold on RGX-121 lifted, appeal of RGX-121 CRL filed, and company targeting three approvals over the next couple of years including two potential blockbusters.
RGNX Earnings History
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 |
|---|---|---|---|
May 14, 2026 | $10.04 | $6.25 | -37.80% |
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% |
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 Inc. (RGNX) report earnings?
RegenXBio Inc. (RGNX) is schdueled to report earning on Aug 05, 2026, Before Open (Confirmed).
What is RegenXBio Inc. (RGNX) earnings time?
RegenXBio Inc. (RGNX) earnings time is at Aug 05, 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 (Q2) is 0.25.