Forte Biosciences' FB102 Receives FDA Fast Track Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 11 2026
0mins
"FB102 received Fast Track Designation from the FDA in celiac disease, highlighting the unmet need and reinforcing FB102's potential to address the high unmet need in celiac disease. The clinical development for FB102 continues to progress well with important readouts coming shortly," said Forte Biosciences CEO Paul Wagner, PhD. "The topline results from our phase 2 celiac disease study are expected in 2026. Based on the strength of the positive results from the FB102 phase 1b CeD trial, which we reported in June 2025, we look forward to the phase 2 data further validating FB102 for the treatment of celiac disease. The FB102 phase 1b vitiligo clinical study is expected to have topline results shortly and the alopecia areata phase 1b data readout is expected in 2026. We remain very optimistic about FB102's potential to address the significant unmet medical needs across multiple indications representing what we believe to be multi-billion-dollar potential market opportunities."
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy FBRX?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on FBRX
Wall Street analysts forecast FBRX stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 20.770
Low
65.00
Averages
65.00
High
65.00
Current: 20.770
Low
65.00
Averages
65.00
High
65.00
About FBRX
Forte Biosciences, Inc. is a clinical-stage biopharmaceutical company that is advancing FB102, which is an anti-CD122 monoclonal antibody therapeutic candidate with potentially broad autoimmune and autoimmune-related indications. It is advancing clinical development of FB102 into patient-based trials for celiac disease and non-segmental vitiligo. The Company's FB102 program focuses on addressing key pathways implicated in these indications with a CD122 antagonist. CD122 is a subunit of IL-2/IL-15 receptors which are key regulators of NK cells and certain T cell subsets. FB102 has potentially other autoimmune and autoimmune-related applications including vitiligo, alopecia areata, and type 1 diabetes (T1D). Its subsidiaries include Forte Subsidiary, Inc. and Forte Biosciences Australia Proprietary Limited.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Forte Biosciences Receives Fast Track Designation for Celiac Disease
- FDA Fast Track Designation: Forte Biosciences' FB102 has received Fast Track Designation from the FDA for celiac disease, highlighting the unmet need and reinforcing FB102's potential, which is expected to position the company in a multi-billion-dollar market opportunity.
- Clinical Trial Progress: Topline results from the Phase 2 clinical trial of FB102 are anticipated in 2026, and based on the positive results from the Phase 1b trial reported in June 2025, Forte is optimistic about further validating FB102's efficacy in treating celiac disease.
- Financial Performance: Research and development expenses for Q1 2026 reached $20.5 million, a significant increase from $12.7 million in Q1 2025, primarily due to rising clinical trial costs, indicating the company's ongoing investment in advancing FB102's clinical development.
- Cash Position: As of March 31, 2026, Forte Biosciences reported $58.2 million in cash and equivalents, and successfully raised $172.5 million in April 2026, enhancing its financial flexibility for upcoming clinical trials.
See More
Forte Biosciences Prices Public Offering at $26.27 per Share
- Offering Size: Forte Biosciences has announced a public offering of 5.71 million shares at a price of $26.27 per share, with expected gross proceeds of approximately $150 million, which will provide crucial funding for the company's operations and research development.
- Underwriter Option: The underwriters have a 30-day option to purchase an additional 856,490 shares at the same price, which enhances market liquidity and investor confidence in the stock.
- Use of Proceeds: The company plans to utilize the net proceeds for working capital and general corporate purposes, including funding clinical development and other research activities, indicating a proactive approach to advancing its research pipeline for long-term growth.
- Financial Context: Forte Biosciences reported a GAAP EPS of -$4.71, and while currently in a loss position, this public offering will help improve its financial standing and support future business expansion.
See More
Forte Biosciences Prices Public Offering at $26.27 per Share
- Offering Size: Forte Biosciences announced a public offering of 5,709,936 shares at $26.27 per share, with gross proceeds expected to be approximately $150 million, indicating strong market demand for the company's equity.
- Underwriter Selection: Guggenheim Securities and Barclays are acting as joint book-running managers for the offering, reflecting the company's strategic considerations in selecting financial partners to enhance market confidence.
- Use of Proceeds: The net proceeds will be allocated for working capital and general corporate purposes, including funding clinical development of its product candidates and research activities, demonstrating the company's commitment to future product development.
- Compliance Statement: The offering is being conducted under SEC registration statement procedures, ensuring transparency and compliance of all related documents, which enhances investor trust in the company's governance.
See More
Forte Biosciences Launches Underwritten Public Offering
- Public Offering Initiation: Forte Biosciences (FBRX) has launched an underwritten public offering of common stock, which is expected to provide essential funding to support its clinical development and research activities.
- Additional Shares Option: The company may grant underwriters a 30-day option to purchase an additional 15% of shares, a strategy aimed at enhancing market liquidity and providing more opportunities for investors.
- Clear Use of Proceeds: The proceeds from the offering will primarily be used for working capital, clinical development, and research activities, demonstrating the company's commitment to future growth and investment in R&D.
- Financial Overview: Forte Biosciences reported a GAAP EPS of -$4.71, reflecting current financial challenges that may impact investor confidence in this offering.
See More
Forte Biosciences Reports FY 2025 Financial Results
- Financial Performance: Forte Biosciences reported a FY 2025 GAAP EPS of -$4.71, an improvement from -$12.17 in 2024, indicating efforts to control losses, yet financial health remains a concern moving forward.
- Cash Position: As of December 31, 2025, Forte had $77 million in cash and cash equivalents, which, while providing some liquidity, will be critical as the company advances FB102 through clinical trials and manages cash flow effectively.
- Equity Structure: Forte has 12.9 million shares of common stock and 4.9 million prefunded warrants outstanding as of December 31, 2025, which will influence future financing strategies and shareholder equity distribution.
- Expense Fluctuation Risk: The company noted that general and administrative expenses may fluctuate as it builds infrastructure and conducts multiple clinical trials, posing potential risks to profitability, especially if additional autoimmune indications are pursued.
See More
Forte Biosciences Grants Equity Inducement Awards
- Equity Incentive Program: Forte Biosciences has granted a total of 25,000 stock options to new non-executive employees as an inducement to attract talent and strengthen its team, which is expected to enhance the company's competitiveness in the biopharmaceutical sector.
- Grant Details: The options will vest over four years, with 25% vesting on the one-year anniversary of the employee's start date and the remaining 75% vesting in equal monthly increments over the following three years, ensuring long-term retention and stability of the workforce.
- Incentive Plan Background: This equity incentive is part of Forte's 2020 Inducement Equity Incentive Plan, aimed at driving the development of FB102 by attracting key talent, thereby expanding its market potential in the field of autoimmune diseases.
- Company Strategic Positioning: Forte Biosciences focuses on developing FB102, a proprietary anti-CD122 monoclonal antibody with broad autoimmune and related indications, and the implementation of this equity incentive will support the company's clinical development progress and market positioning.
See More
Forte Biosciences Receives Fast Track Designation for Celiac Disease
- FDA Fast Track Designation: Forte Biosciences' FB102 has received Fast Track Designation from the FDA for celiac disease, highlighting the unmet need and reinforcing FB102's potential, which is expected to position the company in a multi-billion-dollar market opportunity.
- Clinical Trial Progress: Topline results from the Phase 2 clinical trial of FB102 are anticipated in 2026, and based on the positive results from the Phase 1b trial reported in June 2025, Forte is optimistic about further validating FB102's efficacy in treating celiac disease.
- Financial Performance: Research and development expenses for Q1 2026 reached $20.5 million, a significant increase from $12.7 million in Q1 2025, primarily due to rising clinical trial costs, indicating the company's ongoing investment in advancing FB102's clinical development.
- Cash Position: As of March 31, 2026, Forte Biosciences reported $58.2 million in cash and equivalents, and successfully raised $172.5 million in April 2026, enhancing its financial flexibility for upcoming clinical trials.
See More
Forte Biosciences Prices Public Offering at $26.27 per Share
- Offering Size: Forte Biosciences has announced a public offering of 5.71 million shares at a price of $26.27 per share, with expected gross proceeds of approximately $150 million, which will provide crucial funding for the company's operations and research development.
- Underwriter Option: The underwriters have a 30-day option to purchase an additional 856,490 shares at the same price, which enhances market liquidity and investor confidence in the stock.
- Use of Proceeds: The company plans to utilize the net proceeds for working capital and general corporate purposes, including funding clinical development and other research activities, indicating a proactive approach to advancing its research pipeline for long-term growth.
- Financial Context: Forte Biosciences reported a GAAP EPS of -$4.71, and while currently in a loss position, this public offering will help improve its financial standing and support future business expansion.
See More
Forte Biosciences Prices Public Offering at $26.27 per Share
- Offering Size: Forte Biosciences announced a public offering of 5,709,936 shares at $26.27 per share, with gross proceeds expected to be approximately $150 million, indicating strong market demand for the company's equity.
- Underwriter Selection: Guggenheim Securities and Barclays are acting as joint book-running managers for the offering, reflecting the company's strategic considerations in selecting financial partners to enhance market confidence.
- Use of Proceeds: The net proceeds will be allocated for working capital and general corporate purposes, including funding clinical development of its product candidates and research activities, demonstrating the company's commitment to future product development.
- Compliance Statement: The offering is being conducted under SEC registration statement procedures, ensuring transparency and compliance of all related documents, which enhances investor trust in the company's governance.
See More
Forte Biosciences Launches Underwritten Public Offering
- Public Offering Initiation: Forte Biosciences (FBRX) has launched an underwritten public offering of common stock, which is expected to provide essential funding to support its clinical development and research activities.
- Additional Shares Option: The company may grant underwriters a 30-day option to purchase an additional 15% of shares, a strategy aimed at enhancing market liquidity and providing more opportunities for investors.
- Clear Use of Proceeds: The proceeds from the offering will primarily be used for working capital, clinical development, and research activities, demonstrating the company's commitment to future growth and investment in R&D.
- Financial Overview: Forte Biosciences reported a GAAP EPS of -$4.71, reflecting current financial challenges that may impact investor confidence in this offering.
See More
Forte Biosciences Reports FY 2025 Financial Results
- Financial Performance: Forte Biosciences reported a FY 2025 GAAP EPS of -$4.71, an improvement from -$12.17 in 2024, indicating efforts to control losses, yet financial health remains a concern moving forward.
- Cash Position: As of December 31, 2025, Forte had $77 million in cash and cash equivalents, which, while providing some liquidity, will be critical as the company advances FB102 through clinical trials and manages cash flow effectively.
- Equity Structure: Forte has 12.9 million shares of common stock and 4.9 million prefunded warrants outstanding as of December 31, 2025, which will influence future financing strategies and shareholder equity distribution.
- Expense Fluctuation Risk: The company noted that general and administrative expenses may fluctuate as it builds infrastructure and conducts multiple clinical trials, posing potential risks to profitability, especially if additional autoimmune indications are pursued.
See More
Forte Biosciences Grants Equity Inducement Awards
- Equity Incentive Program: Forte Biosciences has granted a total of 25,000 stock options to new non-executive employees as an inducement to attract talent and strengthen its team, which is expected to enhance the company's competitiveness in the biopharmaceutical sector.
- Grant Details: The options will vest over four years, with 25% vesting on the one-year anniversary of the employee's start date and the remaining 75% vesting in equal monthly increments over the following three years, ensuring long-term retention and stability of the workforce.
- Incentive Plan Background: This equity incentive is part of Forte's 2020 Inducement Equity Incentive Plan, aimed at driving the development of FB102 by attracting key talent, thereby expanding its market potential in the field of autoimmune diseases.
- Company Strategic Positioning: Forte Biosciences focuses on developing FB102, a proprietary anti-CD122 monoclonal antibody with broad autoimmune and related indications, and the implementation of this equity incentive will support the company's clinical development progress and market positioning.
See More
