UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2026 |
REGENXBIO Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware | 001-37553 | 47-1851754 | ||
(State or Other Jurisdiction | (Commission File Number) | (IRS Employer | ||
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9804 Medical Center Drive |
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Rockville, Maryland |
| 20850 | ||
(Address of Principal Executive Offices) |
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Registrant’s Telephone Number, Including Area Code: (240) 552-8181 |
N/A |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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| Trading |
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Common Stock, par value $0.0001 per share |
| RGNX |
| The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
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 press release is furnished as Exhibit 99.1 to this Current Report on Form 8‑K and is incorporated by reference herein.
The information in Item 2.02 of this Current Report on Form 8‑K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 7.01. Regulation FD Disclosure.
On May 14, 2026, the Company presented topline and interim data analysis from the pivotal Phase III AFFINITY DUCHENNE® trial of RGX-202. A copy of the presentation materials is available on the “Presentations and Publications” section of the Company’s website at www.regenxbio.com.
The information in Item 7.01 of this Current Report on Form 8‑K and the presentation materials on the Company’s website shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On May 14, 2026, the Company issued a press release announcing topline and interim analysis of data from the AFFINITY DUCHENNE RGX-202 trial (the “RGX-202 Press Release”). A copy of the RGX-202 Press Release is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
| Description |
99.1 |
| Press release dated May 14, 2026 relating to REGENXBIO Inc.’s financial results. |
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99.2 |
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104 |
| The cover page from this Current Report on Form 8-K, formatted in Inline XBRL. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| REGENXBIO INC. |
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Date: | May 14, 2026 | By: | /s/ Patrick J. Christmas II |
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| Patrick J. Christmas II |