US FDA places clinical hold on Regenxbio's rare disease program

Jan 28 (Reuters) - Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its ...

FDA puts REGENXBIO gene therapy trials on hold after brain tumour

A five-year-old patient dosed with RGX-111 has developed a brain tumour four years after being dosed with the gene therapy.

FDA Clinical Hold Knocks REGENXBIO Stock

REGENXBIO shares sink after the FDA places a clinical hold on two gene therapy trials following a safety concern tied to ...

Regenxbio gene therapy trials suspended by FDA over safety worries

The development of a brain tumor in a study participant led regulators to suspend a Hurler syndrome therapy in early testing ...
Fierce Biotech

FDA puts clinical hold on Regenxbio gene therapies weeks before approval ruling

A central nervous system (CNS) tumor has prompted the FDA to place clinical holds on two Regenxbio gene therapies, including ...

REGENXBIO falls after FDA clinical hold on gene therapies

REGENXBIO (RGNX) stock plunges after FDA clinical hold on RGX-111/RGX-121 gene therapies over a tumor case. Read more here.

REGENXBIO: Key FDA Decision On Hunter Syndrome Just Weeks Away

Regenxbio Inc. faces pivotal catalysts in 2026, notably RGX-121's FDA decision and RGX-202 Duchenne data, potentially ...
American Association of Individual Investors

Why REGENXBIO Inc.’s (RGNX) Stock Is Down 18.49%

As of Wednesday, January 28, REGENXBIO Inc.’s RGNX share price has dipped by 18.49%, which has investors questioning if this is right time to buy.
BioSpace

REGENXBIO Delay Could Put Denali in Pole Position for Hunter Syndrome Approval

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 India

REGENXBIO stock tumbles after FDA places clinical holds on gene therapies

Investing.com -- REGENXBIO Inc. (NASDAQ:RGNX) stock fell 28% Wednesday after the FDA placed clinical holds on two of its ...
Investor's Business Daily on MSN

The 'confusing and unexpected' update that slammed Regenxbio stock

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

REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs

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 ...