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

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

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

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 ...

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] ...

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

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

Regenxbio (RGNX) announced that the U.S. Food and Drug Administration extended its review timeline of the Biologics License Application for ...

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% ...

This phase 2b/3 trial follows new, positive 2-year data from the phase 2 ALTITUDE trial, in which sura-vec was well-tolerated ...

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

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 ...