This company has been marked as potentially delisted and may not be actively trading. Forte Biosciences (FBRX) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsEarningsFDA EventsInsider TradesNews and TrendsOwnershipShort Interest Forte Biosciences' Drug in the FDA Approval ProcessThis 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. Top-line results - October 8,2026Top-Line Results Phase 2Drug: FB102Announced Date: October 8, 2026Indication: In celiac disease Announcementargenx SE announced positive topline results from the Phase 2 study evaluating FB102, a first-in-class CD122 inhibitor, in adults with celiac disease.Read AnnouncementResults - July 9,2026Results Phase 1bDrug: FB102Announced Date: July 9, 2026Indication: In celiac disease AnnouncementForte Biosciences, Inc announced positive results from the FB102 double-blind placebo-controlled phase 1b study in vitiligoAI SummaryForte Biosciences said its FB102 treatment showed positive results in a double-blind, placebo-controlled phase 1b study in vitiligo. The study enrolled 43 people, with 32 receiving FB102 and 11 receiving placebo. The main goal was to measure improvement in skin color loss using central review. FB102 showed a statistically significant benefit by day 64 and patients kept improving after the 12-week treatment period ended. By week 24, FB102-treated subjects had an additional 8-point improvement after treatment stopped, and those with more severe disease at baseline improved by 14 more points. In total, 84% of FB102-treated subjects improved, while none got worse. By comparison, 27% of placebo patients got worse. Side effects were mild to moderate, and the company said FB102 continued to show a strong safety profile. Forte said it will discuss the results on a conference call.Read AnnouncementAdditional data - September 15,2025Additional Data Drug: FB102Announced Date: September 15, 2025Indication: In celiac disease AnnouncementForte 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 SummaryForte 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 AnnouncementAdditional data - September 15,2025Additional Data Drug: FB102Announced Date: September 15, 2025Indication: In celiac disease AnnouncementForte 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 SummaryForte 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 AnnouncementPositive Data - June 23,2025Positive Data Phase 1bDrug: FB102Announced Date: June 23, 2025Indication: In celiac disease AnnouncementForte Biosciences, Inc. announced positive data from a Phase 1b trial in celiac disease for lead program FB102 (FB102-101).AI SummaryForte 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 Has Forte Biosciences received FDA approval? As of now, Forte Biosciences (FBRX) has not received any FDA approvals for its therapy in the last two years. What drugs has Forte Biosciences submitted to the FDA? In the past two years, Forte Biosciences (FBRX) has reported FDA regulatory activity for FB102. What is the most recent FDA event for Forte Biosciences? The most recent FDA-related event for Forte Biosciences occurred on October 8, 2026, involving FB102. The update was categorized as "Top-line results," with the company reporting: "argenx SE announced positive topline results from the Phase 2 study evaluating FB102, a first-in-class CD122 inhibitor, in adults with celiac disease." What conditions do Forte Biosciences' current drugs treat? Currently, Forte Biosciences has one therapy (FB102) targeting the following condition: In celiac disease. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Alumis FDA EventsArcutis Biotherapeutics FDA EventsBioMarin Pharmaceutical FDA EventsHCW Biologics FDA EventsMilestone Pharmaceuticals FDA EventsPureTech Health FDA EventsGlaukos FDA EventsJohnson & Johnson FDA EventsEli Lilly and Company FDA EventsTeva Pharmaceutical Industries FDA EventsAddex Therapeutics FDA EventsAclarion FDA EventsAgomAb Therapeutics FDA EventsCRISPR Therapeutics FDA EventsDare Bioscience FDA Events 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 Related Companies Rhythm Pharmaceuticals FDA Events Kiniksa Pharmaceuticals International FDA Events Ligand Pharmaceuticals FDA Events Iovance Biotherapeutics FDA Events Kodiak Sciences FDA Events PTC Therapeutics FDA Events Oruka Therapeutics FDA Events Travere Therapeutics FDA Events Cogent Biosciences FDA Events CRISPR Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:FBRX last updated on 10/8/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. From Our PartnersThe IRA Mistake That Could Cost Americans 55+ Thousands in 2026JPMorgan has raised its 2026 gold forecast to $6,300, with a credible path to $8,000, and now calls gold a cor...Golden Crest Metals | Sponsored100% overnight gains?Rumors are circulating that Elon Musk is preparing to acquire three publicly traded companies. Dr. Mark Sko...The Oxford Club | SponsoredThese gold assets are priced for $1,800 gold [it's over $4,000]Gold's major miners are generating record free cash flow, with margins as high as 75 percent even after gold's...Golden Portfolio | SponsoredYour withdrawal order could cost you in taxesIf you have $2M or more saved, the 4% rule points to roughly $92,000 a year - but it's a single-variable answe...SmartAsset | SponsoredElon Musk’s Hushed FCC Filing. Dec 8th.Elon Musk quietly filed a document with the federal government tied to artificial intelligence, one of the lar...Paradigm Press | SponsoredEarth's biggest energy source: near Grand CanyonThe largest energy source on Earth contains 50,000 times every oil and gas reserve on the planet combined - an...Behind the Markets | SponsoredThe trade I’ve been waiting for since 2011Ross Givens, Director of Research at Traders Agency, is calling for gold to reach $10,000 an ounce this superc...Traders Agency | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding Forte Biosciences, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Forte Biosciences With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Top-line results - October 8,2026Top-Line Results Phase 2Drug: FB102Announced Date: October 8, 2026Indication: In celiac disease Announcementargenx SE announced positive topline results from the Phase 2 study evaluating FB102, a first-in-class CD122 inhibitor, in adults with celiac disease.Read Announcement
Results - July 9,2026Results Phase 1bDrug: FB102Announced Date: July 9, 2026Indication: In celiac disease AnnouncementForte Biosciences, Inc announced positive results from the FB102 double-blind placebo-controlled phase 1b study in vitiligoAI SummaryForte Biosciences said its FB102 treatment showed positive results in a double-blind, placebo-controlled phase 1b study in vitiligo. The study enrolled 43 people, with 32 receiving FB102 and 11 receiving placebo. The main goal was to measure improvement in skin color loss using central review. FB102 showed a statistically significant benefit by day 64 and patients kept improving after the 12-week treatment period ended. By week 24, FB102-treated subjects had an additional 8-point improvement after treatment stopped, and those with more severe disease at baseline improved by 14 more points. In total, 84% of FB102-treated subjects improved, while none got worse. By comparison, 27% of placebo patients got worse. Side effects were mild to moderate, and the company said FB102 continued to show a strong safety profile. Forte said it will discuss the results on a conference call.Read Announcement
Additional data - September 15,2025Additional Data Drug: FB102Announced Date: September 15, 2025Indication: In celiac disease AnnouncementForte 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 SummaryForte 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
Additional data - September 15,2025Additional Data Drug: FB102Announced Date: September 15, 2025Indication: In celiac disease AnnouncementForte 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 SummaryForte 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
Positive Data - June 23,2025Positive Data Phase 1bDrug: FB102Announced Date: June 23, 2025Indication: In celiac disease AnnouncementForte Biosciences, Inc. announced positive data from a Phase 1b trial in celiac disease for lead program FB102 (FB102-101).AI SummaryForte 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
