The earnings call presented a generally positive outlook with strong clinical progress and strategic partnerships. However, uncertainties around regulatory processes and competitive pressures create some challenges. The company is well-positioned financially and operationally to advance its pipeline.

Company Guidance

During the first quarter 2025 earnings call, REGENXBIO provided several key metrics and forward-looking guidance. The company reported cash, cash equivalents, and marketable securities totaling $272 million as of March 31, 2025, an increase from $245 million at the end of 2024, primarily due to a $110 million upfront payment from a collaboration with Nippon Shinyaku. REGENXBIO expects this cash position to fund operations into the second half of 2026. Research and development expenses were $53 million for the quarter, slightly decreased from the previous year's $54.8 million. The company anticipates FDA acceptance of their Biologics License Application (BLA) for RGX-121, a gene therapy for Hunter syndrome, in the second half of 2025, and aims to begin delivering the therapy to patients in the first half of 2026. Additionally, REGENXBIO is advancing RGX-202 for Duchenne muscular dystrophy, having surpassed 50% enrollment in its pivotal study, with a BLA submission expected in mid-2026. The manufacturing of RGX-202 is set to commence in the third quarter of 2025, with plans to produce up to 2,500 doses annually. The company also collaborates with AbbVie on ABBV-RGX-314 for retinal diseases, with pivotal trials ongoing and top-line data expected in 2026.

Strong Start to 2025

REGENXBIO reported a strong beginning to the year with significant clinical progress and the potential to transition to a commercial stage with multiple gene therapies.

RGX-121 BLA Submission

The BLA for RGX-121, a potential first gene therapy for MPS II, was submitted under the accelerated approval pathway and is on track for potential FDA approval in the second half of 2025.

Partnership with Nippon Shinyaku

A strategic partnership with Nippon Shinyaku was established to commercialize the neurodegenerative franchise, including RGX-121 and RGX-111.

Advancement of RGX-202 for Duchenne Muscular Dystrophy

RGX-202 pivotal study surpassed 50% enrollment, with strong interest from the patient community. The company plans to submit a BLA in mid-2026.

Manufacturing Innovation Center

The company will start producing RGX-202 commercial supply at its Manufacturing Innovation Center in the third quarter of 2025, capable of producing up to 2,500 doses annually.

Cash Position and Runway

The company ended the quarter with $272 million, an increase from $245 million at the end of 2024, and expects this to fund operations into the second half of 2026.

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

Daily Earnings Calendar >

RGNX Earnings History

Report Date	Fiscal Quarter	Forecast / EPS	Last Year's EPS	EPS YoY Change	Slides	Play Transcript
Nov 05, 2025	2025 (Q3)	-1.30 / -	-1.17	―	―	―
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)	―
Nov 08, 2023	2023 (Q3)	-1.46 / -1.41	-1.75	19.43% (+0.34)	―
Aug 02, 2023	2023 (Q2)	-1.19 / -1.66	-1.58	-5.06% (-0.08)	―

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
Aug 07, 2025	$8.23	$7.90	-4.01%
May 12, 2025	$7.97	$8.18	+2.63%
Mar 13, 2025	$6.55	$6.72	+2.60%
Nov 06, 2024	$9.43	$11.19	+18.66%

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 Nov 05, 2025, Before Open (Confirmed).

What is RegenXBio Inc. (RGNX) earnings time?

RegenXBio Inc. (RGNX) earnings time is at Nov 05, 2025, Before Open (Confirmed).

Where can I see when companies are reporting earnings?

You can see which companies are reporting today on our designated earnings calendar.

What companies are reporting earnings today?

You can see a list of the companies which are reporting today on TipRanks earnings calendar.

What is RGNX EPS forecast?

RGNX EPS forecast for the fiscal quarter 2025 (Q3) is -1.3.

Become an Expert with TipRanks Premium

What am I Missing?

Make informed decisions based on Top Analysts' activity

Know what industry insiders are buying

Get actionable alerts from top Wall Street Analysts

Find out before anyone else which stock is going to shoot up

Get powerful stock screeners & detailed portfolio analysis

Subscribe Now See Plans & Pricing