---
title: "RegenXBio Advances RGX-202 With Positive Phase III Results"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/286412399.md"
description: "RegenXBio (RGNX) announced positive Phase III results for RGX-202, meeting primary endpoints in the AFFINITY DUCHENNE trial. Despite a significant revenue decline to $6.4 million and a net loss of $90.1 million, the company has lifted clinical holds and expects a $100 million milestone from AbbVie. The stock is rated as a Buy with a $25.00 price target, though concerns about financial performance and regulatory risks persist. RGNX focuses on gene therapies for rare diseases, with a market cap of $528.6 million."
datetime: "2026-05-14T11:58:21.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/286412399.md)
  - [en](https://longbridge.com/en/news/286412399.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/286412399.md)
---

# RegenXBio Advances RGX-202 With Positive Phase III Results

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RegenXBio ( (RGNX) ) has provided an announcement.

On May 14, 2026, REGENXBIO reported first-quarter 2026 results and unveiled positive topline data from its pivotal Phase III AFFINITY DUCHENNE trial of RGX-202, which met its primary endpoint with high statistical significance and showed a strong correlation between microdystrophin expression and functional improvement. The company also highlighted lifted clinical holds and progress across its retinal and neurodegenerative pipelines, while remaining loss-making with a sharp year-over-year revenue decline, a cash balance of $150.5 million expected to fund operations into early 2027, and plans to leverage internal manufacturing and partnership milestones to support future commercialization.

Revenues fell to $6.4 million for the quarter ended March 31, 2026, from $89.0 million a year earlier, primarily due to the absence of prior-year license revenue and lower Zolgensma royalties following U.S. patent expirations. REGENXBIO posted a net loss of $90.1 million versus prior-year net income, but expects a $100 million milestone from AbbVie upon first dosing in its Phase IIb/III diabetic retinopathy trial and is advancing surabgene lomparvovec toward pivotal readouts and global submissions, underscoring a transition toward late-stage, potentially commercial gene therapy assets despite near-term financial pressure.

The most recent analyst rating on (RGNX) stock is a Buy with a $25.00 price target. To see the full list of analyst forecasts on RegenXBio stock, see the RGNX Stock Forecast page.

**Spark’s Take on RGNX Stock**

According to Spark, TipRanks’ AI Analyst, RGNX is a Neutral.

The score is held down primarily by weak financial performance (large ongoing losses and continued cash burn) and bearish technical positioning (below key moving averages with negative MACD). Offsetting factors include constructive earnings-call catalysts and liquidity guidance into early 2027 (with a potential AbbVie milestone), but regulatory setbacks and program risk remain material.

To see Spark’s full report on RGNX stock, click here.

**More about RegenXBio**

REGENXBIO Inc. is a biotechnology company focused on adeno-associated virus (AAV) gene therapies, developing one-time treatments for rare and retinal diseases. Its late-stage pipeline includes RGX-202 for Duchenne muscular dystrophy, RGX-121 and RGX-111 for MPS II and MPS I with Nippon Shinyaku, and surabgene lomparvovec for wet AMD and diabetic retinopathy in collaboration with AbbVie.

**Average Trading Volume:** 828,415

**Technical Sentiment Signal:** Sell

**Current Market Cap:** $528.6M

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## Related News & Research

- [REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights | RGNX Stock News](https://longbridge.com/en/news/286405286.md)
- [REGENXBIO Announces Positive Topline Results from Pivotal Phase III AFFINITY DUCHENNE® Study of RGX-202 | RGNX Stock News](https://longbridge.com/en/news/286403513.md)
- [REGENXBIO Advances Duchenne Gene Therapy Toward Accelerated Approval](https://longbridge.com/en/news/286443456.md)
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