REGENXBIO, Inc. Aktie News

Regenxbio said on Monday the U.S. Food and Drug Administration has declined to approve its drug for a rare disease.

FDA issues Complete Response Letter for RGX-121 (clemidsogene lanparvovec) for treatment of Mucopolysaccharidosis II (MPS II) REGENXBIO plans to work with FDA on a path forward with the goal of resubmitting the BLA ROCKVILLE, Md., Feb. 9, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL...

ATLANTA, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether REGENXBIO Inc. (“REGENXBIO” or the “Company”) (NASDAQ: RGNX) complied with federal securities laws. On January 28, 2026, REGENXBIO announced it “received communication from the U.S. Food and Drug Administration (“FDA”) that the Company's Investigational New Drug applications for both its Phase I/II trial ev...

The FDA, on Wednesday, unexpectedly placed two of Regenxbio's experimental gene therapies on hold after a patient developed a tumor.

Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its experimental gene therapy programs for rare childhood diseases after a brain tumor was found in one treated patient.

ROCKVILLE, Md., Jan. 28, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) placed a clinical hold on its investigational gene therapy, RGX-111, for the treatment of MPS I, also known as Hurler syndrome, following preliminary analysis of a single case of neoplasm (intraventricular CNS tumor) in a participant treated in its Phase I...

Regenxbio Inc. faces pivotal catalysts in 2026, notably RGX-121's FDA decision and RGX-202 Duchenne data, potentially transforming it into a commercial-stage gene therapy company. RGX-121 offers a unique CNS-targeted approach for Hunter syndrome, with strong biomarker and neurodevelopmental data supporting its accelerated approval case ahead of the February 8 PDUFA date. RGNX's valuation appear...

REGENXBIO Inc. (RGNX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript