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RegenXBio (RGNX)
NASDAQ:RGNX
Earnings Data
Report Date
Apr 30, 2025TBA Not Confirmed
Period Ending
2025 (Q1)Consensus EPS Forecast
0.46Last Year’s EPS
-1.38Same Quarter Last Year
Strong Buy
Based on 11 Analysts Ratings
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Earnings Call Summary
Earnings Call Date:Mar 13, 2025
|% Change Since: -10.08%
|Next Earnings Date:Apr 30, 2025
Earnings Call Sentiment|Positive
The earnings call presents a largely positive outlook with significant advancements in multiple programs, strong partnerships, and a solid financial position. The highlights of new BLA submissions, expected FDA approvals, and strategic partnerships significantly outweigh the lowlights, which include a decrease in cash and R&D expenses.Company Guidance
During the REGENXBIO earnings call for the fiscal year ending December 31, 2024, the company provided several key metrics and guidance for future developments. The company ended the fiscal year with $245 million in cash, cash equivalents, and marketable securities, a decrease from $314 million the previous year, but with expectations to fund operations into the latter half of 2026. Notably, REGENXBIO submitted a Biologics License Application (BLA) for RGX-121 under the accelerated approval pathway, with a potential FDA approval anticipated in the fourth quarter of 2025. The company is also progressing with their pivotal study for RGX-202, aiming for a mid-2026 BLA filing, and expects to complete enrollment by the end of the year. Furthermore, their partnership with AbbVie includes a $1.8 billion collaboration, with anticipated milestone payments to bolster non-dilutive financing options. The company highlighted their robust commercial readiness with the capacity to produce 2,500 doses of RGX-202 annually, and they are actively preparing for the commercial launch of multiple gene therapies.BLA Submission and Expected FDA Approval for RGX-121
REGENXBIO has submitted their first Biologics License Application (BLA) for RGX-121, a treatment for Hunter syndrome, with an expected FDA approval in Q4 2025.
Advancement in Diabetic Retinopathy Program
The diabetic retinopathy program is advancing to the pivotal stage with plans for BLA filings in 2026.
Strong Partnership with Nippon Shinyaku
Partnership with Nippon Shinyaku for MPS programs, providing strategic significance and potential milestones and revenue.
RGX-202 Duchenne Muscular Dystrophy Program Progress
Pivotal study for RGX-202 is rapidly advancing, with enrollment nearly halfway complete. Plans for a BLA submission by mid-2026.
ABBV-RGX-314 Retinal Franchise Progress
Partnership with AbbVie is advancing with late-stage studies and potential milestone payments as part of a $1.8 billion collaboration.
Strong Financial Position
Ended 2024 with $245 million in cash and securities, funding operations into the second half of 2026, with options for non-dilutive financing to extend runway.
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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
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RGNX Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
| 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% |
| May 08, 2024 | $16.67 | $15.68 | -5.94% |
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.
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FAQ
When does RegenXBio (RGNX) report earnings?
RegenXBio (RGNX) is schdueled to report earning on Apr 30, 2025, TBA Not Confirmed.
What is RegenXBio (RGNX) earnings time?
RegenXBio (RGNX) earnings time is at Apr 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 (Q1) is 0.46.
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