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RegenXBio (RGNX)
NASDAQ:RGNX
Earnings Data
Report Date
Jul 30, 2025TBA Not Confirmed
Period Ending
2025 (Q2)Consensus EPS Forecast
-0.94Last Year’s EPS
-1.05Same Quarter Last Year
Strong Buy
Based on 11 Analysts Ratings
Earnings Call Summary
Earnings Call Date:May 12, 2025
|% Change Since: 16.31%
|Next Earnings Date:Jul 30, 2025
Earnings Call Sentiment|Positive
The earnings call revealed a strong start to the fiscal year for REGENXBIO, with significant clinical and financial progress. The company's strategic partnerships and manufacturing capabilities position them well for future commercial success, though regulatory uncertainties and competitive pressures remain challenges.Company Guidance
In the first quarter of 2025 earnings call, REGENXBIO provided guidance on several key metrics, highlighting robust progress across their gene therapy pipeline. The company anticipates FDA acceptance of the BLA for RGX-121, a potential first gene therapy for MPS II, with an expected approval in the second half of 2025. RGX-202, their candidate for Duchenne muscular dystrophy, has surpassed 50% enrollment in its pivotal study, with a BLA submission planned for mid-2026. The company is preparing for commercial supply production in Q3 2025, capable of producing 2,500 doses annually. Financially, REGENXBIO ended Q1 2025 with $272 million in cash, projecting this to fund operations into the second half of 2026, excluding potential non-dilutive financing. Additionally, the company is progressing on its retinal programs in collaboration with AbbVie, with pivotal trials for ABBV-RGX-314 targeting wet AMD and diabetic retinopathy.Strong Clinical Progress
REGENXBIO reported significant advancements in their late-stage clinical programs, including RGX-121 for MPS II and RGX-202 for Duchenne muscular dystrophy, with over 50% enrollment reached in pivotal studies.
Strategic Partnerships
The company established a key strategic partnership with Nippon Shinyaku to commercialize neurodegenerative franchises, including RGX-121 and RGX-111, enhancing their commercial prospects.
Solid Financial Position
The company ended the quarter with $272 million in cash, cash equivalents, and marketable securities, up from $245 million at the end of 2024, thanks to a $110 million upfront payment from Nippon Shinyaku.
Upcoming Data and Approvals
REGENXBIO anticipates FDA approval for RGX-121 in the second half of 2025 and plans to submit a BLA for RGX-202 in mid-2026.
Manufacturing Capabilities
Their Manufacturing Innovation Center in Maryland is set to produce RGX-202 commercial supply beginning in the third quarter of 2025, with the capacity to produce up to 2,500 doses annually.
Positive Phase I/II Data
The Phase I/II data for RGX-202 showed consistent microdystrophin expression and functional improvements in patients, with a favorable safety profile.
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 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% |
Aug 01, 2024 | $13.31 | $13.04 | -2.03% |
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 Jul 30, 2025, TBA Not Confirmed.
What is RegenXBio (RGNX) earnings time?
RegenXBio (RGNX) earnings time is at Jul 30, 2025, TBA Not 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 (Q2) is -0.94.