The FDA has postponed its decision date for Regenxbio’s Hunter syndrome gene therapy to review additional longer-term ...

The US Food and Drug Administration (FDA) has extended Regenxbio’s review timeline of the Biologics License Application (BLA) ...

FDA extends the decision on Regenxbio's RGX-121 for Hunter syndrome to February 2026 following the submission of new ...

From my colleague Allison DeAngelis: A new oral weight loss drug developed by Viking Therapeutics hit the mark in a mid-stage ...

RegenXBio ( ($RGNX) ) has issued an announcement. On August 18, 2025, REGENXBIO announced that the FDA has extended the review timeline for its ...

Analysts have recently evaluated Regenxbio and provided 12-month price targets. The average target is $38.4, accompanied by a high estimate of $52.00 and a low estimate of $17.00. Highlighting a 8.13% ...

REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) extended its review timeline of the Biologics License Application (BLA) for clemidsogene lanparvovec (RGX ...

Delays from the Food and Drug Administration continue to pile up, with Maryland-based Regenxbio the latest to report the review of one of its assets ...

RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlying genetic cause of Hunter syndrome ...

US FDA extends review timeline of Regenxbio’s BLA for clemidsogene lanparvovec to treat Mucopolysaccharidosis II: Rockville, Maryland Wednesday, August 20, 2025, 18:00 Hrs [IST] ...

The FDA said data for PTC's drug did not prove "substantial evidence of efficacy." Elsewhere, the FDA delayed its decision on ...

Leerink analyst Mani Foroohar keeps an Outperform rating on Regenxbio (RGNX) after the company announced the FDA extended its review of ...