FibroBiologics Files IND Application for CYPS317 Clinical Trials
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 31 2025
0mins
Should l Buy FBLG?
FibroBiologics announced the filing of a Phase 1/2 Investigational New Drug application with the U.S. Food and Drug Administration seeking regulatory clearance to initiate clinical trials of CYPS317, an investigational allogeneic fibroblast spheroid-based therapy for the treatment of moderate to severe psoriasis. This IND filing represents a major advancement for FibroBiologics' chronic inflammatory disease pipeline and follows a series of IND-enabling preclinical results demonstrating the potential of fibroblast spheroids to significantly reduce psoriasis disease severity and relapse in preclinical models. In animal studies, a single dose of CYPS317 matched or exceeded the therapeutic effects of multiple doses of anti-IL-23 monoclonal antibodies and yielded significant reductions in disease recurrence, underscoring both the durability and immunomodulatory capacity of this approach. FibroBiologics is pursuing a development program for CYPS317 with the goal of advancing first-in-human clinical trials following FDA review of the IND filing. The IND submission includes comprehensive preclinical pharmacology, safety, and manufacturing data supporting the therapeutic's mechanism of action, durability of effect, and safety profile.
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Analyst Views on FBLG
Wall Street analysts forecast FBLG stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for FBLG is 3.25 USD with a low forecast of 1.50 USD and a high forecast of 5.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.227
Low
1.50
Averages
3.25
High
5.00
Current: 0.227
Low
1.50
Averages
3.25
High
5.00
About FBLG
FibroBiologics, Inc. is a clinical-stage biotechnology company. The Company is focused on developing and commercializing fibroblast-based therapies for patients suffering from chronic diseases with significant unmet medical needs, including wound healing, multiple sclerosis, degenerative disc disease, psoriasis and certain cancers, and potential human longevity applications including thymic involution reversal. Its product candidates include CybroCell, CYMS101 and CYWC628. CybroCell is an allogeneic fibroblast cell-based therapy for degenerative disc disease. This technology is being designed as an alternative method for repairing the cartilage of the intervertebral disc (or any other articular cartilage). It is developing CYMS101 as an allogeneic fibroblast cell-based therapy to treat multiple sclerosis (MS) and has completed the Phase I study. It is developing CYWC628 as an allogeneic fibroblast cell-based therapy for wound healing. Its CYPS317 is used for the treatment of Psoriasis.
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.
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- Market Potential: The cachexia market related to cancer is projected to reach $3.2 billion by 2032, and this new patent provides FibroBiologics with a unique market opportunity that could significantly enhance its competitiveness in the biotechnology sector.
- Innovative Treatment Methods: The patent covers methods using immune-modulating fibroblasts cultured under specific conditions to suppress inflammation and address the root causes of cachexia, potentially offering new treatment options that improve patient quality of life.
- Strategic Importance: CEO Pete O'Heeron stated that the issuance of this patent not only expands global IP protection but also brings the company closer to delivering transformative therapies that could change the standard of care for millions of patients worldwide.
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- Investor Meetings: Throughout the event, FibroBiologics will offer one-on-one investor meetings aimed at attracting potential investors and demonstrating its innovative capabilities in cell therapy and tissue regeneration.
- Patent Portfolio: The company holds over 270 issued and pending patents across various clinical pathways, including wound healing, cancer, and human longevity, highlighting its strong R&D capabilities in the biotechnology sector.
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See More
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- Major Advancement: FibroBiologics has filed an IND application for CYPS317, a Phase 1/2 clinical trial targeting moderate to severe psoriasis, marking a significant breakthrough in its chronic inflammatory disease pipeline and enhancing its competitive edge in the biopharmaceutical sector.
- Efficacy Validation: Preclinical studies indicate that a single dose of CYPS317 matches the efficacy of multiple doses of anti-IL-23 monoclonal antibodies, significantly reducing disease recurrence, highlighting the therapy's potential to improve patient quality of life.
- Market Demand: Psoriasis affects over 8 million adults in the U.S., and despite advancements in biologic treatments, unmet needs persist; CYPS317 is poised to address this market gap, potentially increasing the company's market share in therapeutic solutions.
- Strategic Goals: FibroBiologics aims to achieve IND approval for all four of its product candidates by 2026, and the success of this application will lay the groundwork for future clinical development, further driving innovation in chronic disease treatment.
See More
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- Major Advancement: FibroBiologics has filed an IND application for CYPS317, a Phase 1/2 clinical trial, marking a significant step forward in its chronic inflammatory disease pipeline and expected to drive innovation in skin disease treatment.
- Efficacy Validation: Preclinical studies indicate that a single dose of CYPS317 matches the efficacy of multiple doses of anti-IL-23 monoclonal antibodies, significantly reducing disease recurrence, highlighting its potential in psoriasis treatment.
- Market Demand: Psoriasis affects over 8 million adults in the U.S., and despite advances in biologic treatments, unmet needs persist; CYPS317 aims to provide more durable efficacy and favorable safety profiles.
- Strategic Goals: FibroBiologics aims to achieve IND clearance for all four product candidates by 2026, with this filing representing a pivotal transition to clinical development, underscoring the company's commitment to innovation and clinical rigor.
See More
FibroBiologics Secures Canadian Patent for Cachexia Treatment
- Patent Issuance: FibroBiologics has secured Canadian Patent No. 3118732, focusing on the use of fibroblast cells to treat cachexia, further solidifying its intellectual property portfolio of over 270 patents and demonstrating the company's commitment to innovation in chronic disease therapies.
- Market Potential: The cachexia market related to cancer is projected to reach $3.2 billion by 2032, and this new patent provides FibroBiologics with a unique market opportunity that could significantly enhance its competitiveness in the biotechnology sector.
- Innovative Treatment Methods: The patent covers methods using immune-modulating fibroblasts cultured under specific conditions to suppress inflammation and address the root causes of cachexia, potentially offering new treatment options that improve patient quality of life.
- Strategic Importance: CEO Pete O'Heeron stated that the issuance of this patent not only expands global IP protection but also brings the company closer to delivering transformative therapies that could change the standard of care for millions of patients worldwide.
See More
Align Technology Reports Strong Q4 Earnings Beat
- Earnings Beat: Align Technology reported Q4 earnings of $3.29 per share, surpassing analyst expectations of $2.97, indicating a significant improvement in profitability and boosting market confidence in future growth.
- Sales Growth: The company achieved quarterly sales of $1.047 billion, exceeding the consensus estimate of $1.033 billion, demonstrating robust performance amid strong market demand.
- Stock Surge: Align's shares jumped 10.4% in pre-market trading to $178.13, reflecting a positive investor reaction to the financial results, which may attract more investor interest.
- Increased Market Confidence: This earnings beat not only enhances Align's market image but also potentially supports its future investment and expansion plans, further solidifying its leadership position in the industry.
See More
FibroBiologics CEO Pete O'Heeron to Present at DealFlow Discovery Conference on January 29, 2026
- Conference Presentation: FibroBiologics' Founder and CEO Pete O'Heeron will present at the DealFlow Discovery Conference on January 29, 2026, showcasing the company's latest advancements in chronic disease therapeutics.
- Investor Meetings: Throughout the event, FibroBiologics will offer one-on-one investor meetings aimed at attracting potential investors and demonstrating its innovative capabilities in cell therapy and tissue regeneration.
- Patent Portfolio: The company holds over 270 issued and pending patents across various clinical pathways, including wound healing, cancer, and human longevity, highlighting its strong R&D capabilities in the biotechnology sector.
- Industry Outlook: As a clinical-stage biotechnology firm, FibroBiologics is driving the next generation of medical advancements in cell therapy, aiming to provide potential cures for chronic diseases, which presents significant market potential and strategic importance.
See More
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- FibroBiologics Outperformance: FibroBiologics, Inc. (FBLG) surged 7.68% in after-hours trading to close at $0.41, indicating speculative interest or technical momentum despite no specific news.
- Nyxoah Earnings Boost Confidence: Nyxoah SA (NYXH) advanced 3.94% to $5.28 after reporting preliminary Q4 and full-year 2025 results, with guidance for Q1 2026 enhancing investor confidence in its growth trajectory.
- Fortress Biotech's Continued Volatility: Fortress Biotech, Inc. (FBIO) climbed 6.90% to $4.49 in after-hours trading, continuing a trend of volatility without any fresh news impacting the stock.
- Revvity Collaboration Drives Growth: Revvity, Inc. (RVTY) posted a 4.92% gain to close at $109.00, as investors digest the January announcement of a collaboration with Eli Lilly to expand access to predictive models via the Revvity Signals platform.
See More
FibroBiologics Files IND for CYPS317 Clinical Trials Targeting Psoriasis
- Major Advancement: FibroBiologics has filed an IND application for CYPS317, a Phase 1/2 clinical trial targeting moderate to severe psoriasis, marking a significant breakthrough in its chronic inflammatory disease pipeline and enhancing its competitive edge in the biopharmaceutical sector.
- Efficacy Validation: Preclinical studies indicate that a single dose of CYPS317 matches the efficacy of multiple doses of anti-IL-23 monoclonal antibodies, significantly reducing disease recurrence, highlighting the therapy's potential to improve patient quality of life.
- Market Demand: Psoriasis affects over 8 million adults in the U.S., and despite advancements in biologic treatments, unmet needs persist; CYPS317 is poised to address this market gap, potentially increasing the company's market share in therapeutic solutions.
- Strategic Goals: FibroBiologics aims to achieve IND approval for all four of its product candidates by 2026, and the success of this application will lay the groundwork for future clinical development, further driving innovation in chronic disease treatment.
See More
FibroBiologics Files IND for CYPS317 Clinical Trials Targeting Psoriasis
- Major Advancement: FibroBiologics has filed an IND application for CYPS317, a Phase 1/2 clinical trial, marking a significant step forward in its chronic inflammatory disease pipeline and expected to drive innovation in skin disease treatment.
- Efficacy Validation: Preclinical studies indicate that a single dose of CYPS317 matches the efficacy of multiple doses of anti-IL-23 monoclonal antibodies, significantly reducing disease recurrence, highlighting its potential in psoriasis treatment.
- Market Demand: Psoriasis affects over 8 million adults in the U.S., and despite advances in biologic treatments, unmet needs persist; CYPS317 aims to provide more durable efficacy and favorable safety profiles.
- Strategic Goals: FibroBiologics aims to achieve IND clearance for all four product candidates by 2026, with this filing representing a pivotal transition to clinical development, underscoring the company's commitment to innovation and clinical rigor.
See More
