FDA Events for Generation Bio (GBIO)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Generation Bio (GBIO).
Over the past two years, Generation Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ctLNP. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ctLNP - FDA Regulatory Timeline and Events
ctLNP is a drug developed by Generation Bio for the following indication: To silence disease-driving targets in T cells.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ctLNP
- Announced Date:
- January 6, 2025
- Indication:
- To silence disease-driving targets in T cells.
Announcement
Generation Bio Co. announced it is leveraging its validated T cell-directed lipid nanoparticle (ctLNP) to develop siRNA therapeutics to silence disease-driving targets in T cells.
AI Summary
Generation Bio Co. is advancing a novel therapeutic approach by using its validated T cell-directed lipid nanoparticle (ctLNP) technology to develop siRNA treatments. The company aims to silence specific, disease-driving targets within T cells responsible for inflammation and tissue damage in autoimmune conditions. By delivering siRNA precisely into T cells, ctLNP enables the modulation of these cells without disturbing other parts of the immune system. This targeted approach could overcome the challenges of past siRNA therapies, which struggled with selective cell delivery and effective cytoplasmic access. Early non-human primate studies have shown that the ctLNPs can successfully target key T cell populations, like CD4+ and CD8+ T cells, as well as natural killer cells involved in autoimmunity. Generation Bio plans to provide more details on its lead ctLNP-siRNA programs in the coming months as it moves closer to clinical trials.
Read Announcement
Generation Bio FDA Events - Frequently Asked Questions
As of now, Generation Bio (GBIO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Generation Bio (GBIO) has reported FDA regulatory activity for ctLNP.
The most recent FDA-related event for Generation Bio occurred on January 6, 2025, involving ctLNP. The update was categorized as "Provided Update," with the company reporting: "Generation Bio Co. announced it is leveraging its validated T cell-directed lipid nanoparticle (ctLNP) to develop siRNA therapeutics to silence disease-driving targets in T cells."
Currently, Generation Bio has one therapy (ctLNP) targeting the following condition: To silence disease-driving targets in T cells..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:GBIO) was last updated on 7/12/2025 by MarketBeat.com Staff
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