FDA Events for Forte Biosciences (FBRX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Forte Biosciences (FBRX).
Over the past two years, Forte Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FB102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
FB102 - FDA Regulatory Timeline and Events
FB102 is a drug developed by Forte Biosciences for the following indication: In celiac disease.
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:
- FB102
- Announced Date:
- June 23, 2025
- Indication:
- In celiac disease
Announcement
Forte Biosciences, Inc. announced positive data from a Phase 1b trial in celiac disease for lead program FB102 (FB102-101).
AI Summary
Forte Biosciences, Inc. announced promising positive data from its Phase 1b trial in celiac disease for its lead program FB102 (FB102-101). In the study, 32 subjects were enrolled in a 3:1 randomization, receiving FB102 or placebo, followed by a 16-day gluten challenge. Key results showed that subjects on FB102 achieved better histological outcomes with a significant improvement in the composite VCIEL score compared to placebo. Additionally, the FB102 group showed a decrease in the density of CD3-positive T cells and a notable improvement in the villus:crypt ratio. Patients treated with FB102 also experienced a 42% reduction in gluten-induced gastrointestinal symptoms. These encouraging results support further research, as the company plans to advance into a Phase 2 celiac disease trial, with a topline readout expected in 2026.
Read Announcement
Forte Biosciences FDA Events - Frequently Asked Questions
As of now, Forte Biosciences (FBRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Forte Biosciences (FBRX) has reported FDA regulatory activity for FB102.
The most recent FDA-related event for Forte Biosciences occurred on June 23, 2025, involving FB102. The update was categorized as "Positive Data," with the company reporting: "Forte Biosciences, Inc. announced positive data from a Phase 1b trial in celiac disease for lead program FB102 (FB102-101)."
Currently, Forte Biosciences has one therapy (FB102) targeting the following condition: In celiac disease.
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:FBRX) was last updated on 7/12/2025 by MarketBeat.com Staff
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