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Get filing alertsREGENXBIO reports Phase III RGX-202 Duchenne trial data and Q1 2026 earnings
Filed May 14, 2026 · Period ending May 14, 2026 · ~1 min read
Key Changes
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Company presented topline and interim results from pivotal Phase III AFFINITY DUCHENNE trial evaluating RGX-202 gene therapy for Duchenne muscular dystrophy. Detailed data available in press release exhibit.
Item 8.01 verify on EDGAR → -
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REGENXBIO disclosed Q1 2026 financial results for quarter ended March 31, 2026. Specific financial figures, revenue, and guidance contained in attached press release.
Item 2.02 verify on EDGAR → -
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Two separate press releases attached as exhibits: one covering quarterly earnings (Exhibit 99.1) and one covering RGX-202 trial data (Exhibit 99.2). 8-K body contains no detailed metrics.
Item 9.01 verify on EDGAR →
Summary
REGENXBIO disclosed two significant events on May 14, 2026: pivotal Phase III clinical trial data for RGX-202, its gene therapy candidate for Duchenne muscular dystrophy, and first quarter 2026 financial results. The AFFINITY DUCHENNE trial represents a critical milestone for the company's lead program, as Phase III data typically determines whether a therapy can proceed to regulatory approval. The topline and interim analysis could materially impact the company's valuation depending on efficacy and safety outcomes.
The 8-K filing itself provides only summary disclosure, with all substantive information contained in two attached press release exhibits. Investors should review Exhibit 99.1 for quarterly revenue, cash position, operating expenses, and any updated guidance, and Exhibit 99.2 for detailed trial endpoints, patient outcomes, safety data, and the company's regulatory strategy. Watch for any FDA feedback or next steps announced in follow-on communications, as well as management commentary on the trial data's implications for the RGX-202 development timeline and potential commercial launch.
Section-by-Section Diff
Event · Item 2.02 — Results of Operations and Financial Condition
Item 2.02 — Results of Operations and Financial Condition filed; see Key Changes for terms.
Added in current filing · verify on EDGAR →
On May 14, 2026, REGENXBIO Inc. (the “Company”) issued a press release regarding its results of operations and financial condition for the quarter ended March 31, 2026.
The company announced its first quarter 2026 financial results through a press release. The 8-K itself does not contain the actual financial figures, which are in the attached press release exhibit. This is a standard quarterly earnings disclosure filing.
Event · Item 8.01 — Other Events
Item 8.01 — Other Events filed; see Key Changes for terms.
Added in current filing · verify on EDGAR →
On May 14, 2026, the Company issued a press release announcing topline and interim analysis of data from the AFFINITY DUCHENNE RGX-202 trial
REGENXBIO disclosed topline and interim analysis results from its AFFINITY DUCHENNE RGX-202 trial. This is a clinical trial update for RGX-202, which appears to be a gene therapy candidate for Duchenne muscular dystrophy. The actual data results are contained in the press release exhibit, not in the 8-K body itself.
Event · Item 9.01 — Financial Statements and Exhibits
REGENXBIO filed an 8-K attaching press releases on financial results and RGX-202, with no material disclosures in the body.
Added in current filing · verify on EDGAR →
Press release dated May 14, 2026 relating to REGENXBIO Inc.’s financial results.
The company attached a press release covering its financial results for an unspecified period. The 8-K body provides no detail on the results themselves; investors must review Exhibit 99.1 for earnings, revenue, guidance, or other financial metrics.
Added in current filing · verify on EDGAR →
RGX-202 Press Release dated May 14, 2026.
The company attached a separate press release regarding RGX-202, presumably a clinical program or product candidate. The 8-K body does not describe the content; investors must review Exhibit 99.2 for trial data, regulatory updates, or other program developments.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 4, 2026 · How we verify