Forte Biosciences' Drug in the FDA Approval Process
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 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:
- September 15, 2025
- Indication:
- In celiac disease
Announcement
Forte Biosciences, Inc announced additional details from the oral presentation "FB102 prevents histological damage and mitigates gluten challenge-induced symptoms in a celiac disease phase 1b study - Jason Tye-Din, Walter and Eliza Hall Institute; Royal Melbourne Hospital" at the Tampere Celiac Disease Symposium 2025 (Tampere, Finland) on Friday September 12, 2025, further supporting the significant differentiation of FB102 in celiac disease.
AI Summary
Forte Biosciences shared new data from the oral presentation “FB102 prevents histological damage and mitigates gluten challenge-induced symptoms in a celiac disease phase 1b study” by Jason Tye-Din at the Tampere Celiac Disease Symposium on September 12, 2025. These findings further highlight FB102’s unique and targeted activity in celiac disease.
In the trial, FB102 reduced TCR γδ cell density by 1.5 from baseline versus a 3.9 increase with placebo (p=0.0007). Ki67-positive intraepithelial T cells rose by only 2.5 on FB102 compared to 8.6 with placebo (p=0.0006), indicating less inflammation. Natural killer cells dropped 95% after FB102 dosing, reflecting IL-15 pathway inhibition. There was no significant change in regulatory T cells at any timepoint.
These results underscore FB102’s differentiated profile in preserving intestinal health under gluten challenge. A phase 2 celiac trial is underway with topline data expected in 2026. Forte also anticipates data next year in vitiligo and alopecia areata studies.
Read Announcement- Drug:
- FB102
- Announced Date:
- September 15, 2025
- Indication:
- In celiac disease
Announcement
Forte Biosciences, Inc announced additional details from the oral presentation "FB102 prevents histological damage and mitigates gluten challenge-induced symptoms in a celiac disease phase 1b study - Jason Tye-Din, Walter and Eliza Hall Institute; Royal Melbourne Hospital" at the Tampere Celiac Disease Symposium 2025 (Tampere, Finland) on Friday September 12, 2025, further supporting the significant differentiation of FB102 in celiac disease.
AI Summary
Forte Biosciences presented new data on FB102 at the Tampere Celiac Disease Symposium 2025, showing significant protection against gluten-induced damage in a phase 1b trial. Patients receiving FB102 had a 1.5-unit drop in TCR γδ cell density versus a 3.9-unit increase with placebo (p=0.0007). These cells are known to drive inflammation and kill intestinal lining cells. FB102 also limited inflammation markers: Ki67-positive cells rose by 2.5 units compared to 8.6 units on placebo (p=0.0006).
In addition, natural killer (NK) cells dropped by 95% after FB102 dosing, indicating strong inhibition of the IL-15 pathway, which fuels celiac disease inflammation. Regulatory T cells remained similar between groups, suggesting that FB102 selectively targets harmful immune responses without affecting key immune regulators.
These results highlight FB102’s unique approach to preventing tissue damage and symptoms in celiac disease. A phase 2 trial is already underway with topline data expected in 2026.
Read Announcement- 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 September 15, 2025, involving FB102. The update was categorized as "Additional data," with the company reporting: "Forte Biosciences, Inc announced additional details from the oral presentation "FB102 prevents histological damage and mitigates gluten challenge-induced symptoms in a celiac disease phase 1b study - Jason Tye-Din, Walter and Eliza Hall Institute; Royal Melbourne Hospital" at the Tampere Celiac Disease Symposium 2025 (Tampere, Finland) on Friday September 12, 2025, further supporting the significant differentiation of FB102 in celiac disease."
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 10/3/2025 by MarketBeat.com Staff
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