Rosen Law Files Class Action Against Regenxbio Over Alleged Misleading RGX‑111 Clinical Data

Allegations center on RGX‑111 clinical data and safety

Rosen Law Firm announces a class action alleging that Regenxbio and certain defendants make materially false and misleading statements about RGX‑111, a one‑time gene therapy for severe Mucopolysaccharidosis Type I (Hurler syndrome). The complaint, covering purchases of Regenxbio securities from Feb. 9, 2022 through Jan. 27, 2026, contends the company touts positive biomarker and safety data from an ongoing Phase I/II study while concealing adverse facts about the therapy’s efficacy and safety. Rosen says those omissions and statements mislead investors about the true status of RGX‑111’s development program.

The suit focuses on disclosure practices at a time when gene therapy developers face heightened regulatory and public scrutiny over safety signals and long‑term efficacy. Plaintiffs assert that early-stage biomarker and safety claims, if overstated or unsupported, can distort perceptions of a program’s clinical trajectory and patient benefit, and that full transparency is critical for trial recruitment, regulator confidence and clinician trust. Regenxbio’s handling of Phase I/II communications therefore becomes central to both the legal case and broader industry discussions about how experimental gene therapies are presented to investors and the public.

The litigation is in its early stages and does not represent an admission of liability by Regenxbio. A lead plaintiff will direct litigation on behalf of the class, and potential remedies sought typically include compensation for purchasers who allege they were injured by the asserted misrepresentations. The proceedings may prompt closer examination of Regenxbio’s clinical disclosures and could influence how the company, and peer gene‑therapy firms, balance reporting interim results with caveats about study limitations and unresolved safety questions.

Investor deadline, claims process and firm record

Rosen notifies investors who purchased Regenxbio securities during the class period that anyone wishing to move to serve as lead plaintiff must do so by April 14, 2026. Investors may join the action via an online submission form, by calling the firm toll‑free at 866‑767‑3653 (Phillip Kim, Esq.) or by emailing [email protected]; the firm operates on a contingency fee basis and says there are no upfront costs for eligible clients.

Rosen highlights its track record in securities class actions, including securing large recoveries and top rankings from ISS Securities Class Action Services. The firm emphasizes its experience handling complex litigation for investors while noting that selection of qualified counsel is a key decision for plaintiffs.