After facing a delayed decision deadline and a clinical hold, Regenxbio’s Hunter syndrome gene therapy has been rejected by ...

Feb 9 (Reuters) - Regenxbio said on Monday the U.S. Food and Drug Administration had declined to approve its gene therapy for ...

The FDA recommended that REGENXBIO run a new study, treat more patients and include a placebo arm to support a resubmission for the gene therapy RGX-121.

The decision comes two weeks after the agency halted testing due to safety concerns and represents the latest regulatory setback for a gene therapy maker.

Shares of Regenxbio fell sharply premarket after the Food and Drug Administration rejected the biotech company's initial application for commercialization of a gene therapy for rare disease Hunter ...

Clear Street kept a 'Buy' rating, cut its price target to $45 from $50, and said its core thesis remains intact. ・The FDA ...

The Food and Drug Administration has declined to approve Regenxbio's gene therapy, RGX-121, for the treatment of Hunter syndrome, a rare and fatal neurodegenerative disease. The clinical-stage ...

The Food and Drug Administration has rejected a rare-disease gene therapy from Regenxbio, the company said Monday.

The discovery of a tumor in a patient who received REGENXBIO’s gene therapy for Hurler syndrome prompted the FDA to place a hold on that program along with the company’s Hunter syndrome program, which ...

Investing.com -- REGENXBIO (NASDAQ:RGNX) stock fell 27% after the company received a Complete Response Letter (CRL) from the ...

Fifteen-year-old Dominic Henriquez from Prosper, Texas, is bringing hope to boys like him who live with Hunter syndrome, a rare genetic disorder that primarily affects males. Dominic’s journey began ...

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for tividenofusp alfa for the treatment of Hunter syndrome, also known as ...