The FDA reviewed gene therapy applications and provided milestone payments for dosing involving Regenxbio and AbbVie.
Steady: 0 in the last 7 days
Updated sep 5
The latest in this situation
How it started
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
The FDA reviewed gene therapy applications and provided milestone payments for dosing involving Regenxbio and AbbVie.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- FDA placed a clinical hold on RGX-121 trials, leading to a sharp decline in REGENXBIO Inc.'s stock price.Sub-event
FDA provided milestone payments and reviewed gene therapy applications for Regenxbio and AbbVie.1 source
Keep exploring
The entities involved
Related events
- uniQure N.V. traded on the Nasdaq stock exchange and submitted a Biologics License Application (BLA) for accelerated approval of its gene therapy.
- Canandaigua National Trust Co of Florida bought a new stake in AbbVie shares and granted Breakthrough Therapy Designations for one of its drugs.
- A network focused on cell and gene therapies is expanding to include sites in Northern California, involving the CA Institute for Regenerative Medicine and the FDA.
- Research advances have led to the approval of new therapies by the FDA.
- Moderna and Merck are seeking FDA review for a novel cancer treatment, having co-led a Phase 3 mRNA vaccine trial.