REGENXBIO Inc. 8-K

What Happened
REGENXBIO Inc. announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding its Biologics License Application (BLA) for RGX‑121, the company’s investigational gene therapy for Mucopolysaccharidosis type II (MPS II). The company received the CRL on February 7, 2026 and furnished a related press release on February 9, 2026 (Exhibit 99.1 to the Form 8‑K).

Key Details

• The FDA CRL for the RGX‑121 BLA was received by REGENXBIO on February 7, 2026.
• The company publicly announced the CRL via a press release dated February 9, 2026, filed as Exhibit 99.1 to the 8‑K.
• The 8‑K was signed and filed on February 9, 2026 by Patrick J. Christmas II, EVP, Chief Strategy & Legal Officer.
• The CRL indicates the FDA has identified issues that preclude approval of the BLA in its current form (as stated by the company).

Why It Matters
A CRL means the FDA has not approved RGX‑121 as submitted, which can delay potential approval, commercialization and any related revenue timelines for the therapy. For investors, this is a material regulatory setback that increases uncertainty around the program’s timing and potential value. Watch for follow‑up communications from REGENXBIO about the FDA’s stated deficiencies, planned next steps (e.g., data submissions or meetings with the FDA), and any revised regulatory or clinical timeline.