$RGNX·8-K

REGENXBIO Inc. · May 14, 7:15 AM ET

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REGENXBIO Inc. 8-K

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REGENXBIO Inc. Reports Q1 2026 Results; Announces RGX-202 Phase III Topline

What Happened
REGENXBIO Inc. announced its results of operations and financial condition for the quarter ended March 31, 2026, and disclosed topline and interim analysis from the pivotal Phase III AFFINITY DUCHENNE® trial of RGX-202. The company filed a Current Report on Form 8-K on May 14, 2026, furnishing a financial-results press release and an RGX-202 press release, and presented the trial topline/interim data in slides posted to its website.

Key Details

  • Filing date: May 14, 2026; reporting period: quarter ended March 31, 2026 (Item 2.02).
  • Clinical update: topline and interim analysis from the pivotal Phase III AFFINITY DUCHENNE trial of RGX-202 were presented (Item 7.01).
  • Press releases furnished as exhibits: Exhibit 99.1 (financial-results press release) and Exhibit 99.2 (RGX-202 press release) (Item 8.01 / 9.01).
  • Presentation materials are posted in the “Presentations and Publications” section at www.regenxbio.com.

Why It Matters
This filing combines the company’s quarterly financial disclosure with a material clinical update: topline/interim Phase III data for RGX-202, a program central to REGENXBIO’s pipeline for Duchenne muscular dystrophy. For investors, the earnings release provides the latest quarterly results and cash/operating information, while the Phase III topline update could affect the program’s development path, regulatory timeline, and investor sentiment. Investors should review the furnished press releases and the presentation on the company website for details and await any follow-up disclosures with full data.

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