On January 28, 2026, Regenxbio disclosed via Form 8-K that the FDA placed clinical holds on its RGX-111 and RGX-121 programs following the identification of a tumor in a trial participant. The disclosure prompted a 30-35% decline in the company's share price.
SEC disclosure rules require public companies to provide investors with material information necessary to make informed investment decisions. Item 8.01 of Form 8-K permits companies to disclose material events not specifically covered by other items. Rule 10b-5 under the Securities Exchange Act of 1934 prohibits material misstatements and omissions in connection with securities transactions. The regulation encompasses not only affirmative false statements but also the omission of facts necessary to make other statements not misleading.
During the Q3 2025 earnings call on November 6, 2025, CEO Curran Simpson highlighted positive regulatory interactions, stating: "The FDA completed inspections of our clinical sites and in-house manufacturing facility with no observations, a rare and significant achievement." The emphasis on favorable inspection results without corresponding disclosure of safety concerns being evaluated by the agency created an asymmetric presentation of the company's regulatory standing.
Notably, the Q3 2025 earnings call transcript contains no discussion of the RGX-111 program for MPS I, despite this program being a material pipeline asset that would later be subject to the same FDA clinical hold. The absence of any update on this program during a quarterly investor communication raises questions about the completeness of the information provided to shareholders.
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