FibroBiologics Files IND Application with the U.S. FDA to Advance Clinical Development of CYPS317 in Patients with Psoriasis

Rhea-AI Summary

FibroBiologics (Nasdaq: FBLG) filed a Phase 1/2 IND application with the U.S. FDA on Dec 31, 2025 to seek clearance to start first-in-human trials of CYPS317, an allogeneic fibroblast spheroid therapy for moderate to severe psoriasis.

The submission includes preclinical pharmacology, safety, and manufacturing data; animal studies showed a single dose of CYPS317 matched or exceeded multiple doses of anti-IL-23 antibodies and reduced disease recurrence. The company says it aims to advance clinical development and pursue IND clearance for all four product candidates in 2026.

Positive

• IND application filed with FDA on Dec 31, 2025
• Preclinical: single dose matched/exceeded anti-IL-23 effects in animals
• Preclinical: significant reductions in disease recurrence in models
• Submission includes pharmacology, safety, and manufacturing data

Negative

• No FDA clearance yet; IND under review before human trials
• Evidence limited to preclinical (animal) data, not human results
• Timeline target to clear all four candidates in 2026 is aspirational

Key Figures

Development phase Phase 1/2 CYPS317 IND application for moderate to severe psoriasis

Patent portfolio 270+ patents Issued and pending across fibroblast-based technologies

Disease prevalence Over eight million adults Psoriasis patients in the United States

Dosing comparison Single dose vs multiple doses CYPS317 matched/exceeded multiple anti-IL-23 antibody doses in animals

Therapy type Allogeneic fibroblast spheroids CYPS317 investigational treatment modality for psoriasis

Product pipeline goal Four product candidates Goal of IND clearance for all candidates in 2026

Market Reality Check

$0.2399 Last Close

Volume Volume 2,780,788 is 1.44x the 20-day average of 1,926,742, indicating elevated interest ahead of this filing. normal

Technical Shares at 0.2419 trade well below the 0.64 200-day MA and about 90% under the 2.42 52-week high, near the 0.2201 52-week low.

Peers on Argus 1 Up

FBLG was down about 3.24% pre-news while key peers showed mixed moves; ICU appeared on the momentum scanner up about 4.82% with no news, and several others were modestly negative or flat, pointing to largely stock-specific dynamics.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 16	Equity offering close	Negative	-8.4%	Closing of $1.7M registered direct offering with matching warrant coverage.
Dec 15	Equity offering	Negative	-33.1%	Announcement of $1.7M registered direct offering plus private placement warrants.
Dec 10	IP/patent news	Positive	+12.8%	New U.S. patent application for fibroblast-based chondrocyte spheroid platform.
Nov 26	Debt payoff	Positive	+1.5%	Payoff of Yorkville convertible notes and SEPA capacity for up to $10M equity.
Nov 25	Equity offering close	Negative	+3.1%	Closing of $1.5M registered direct offering with accompanying investor warrants.

Pattern Detected

Recent news often aligned with intuitive reactions: equity offerings generally pressured the stock, while IP and balance-sheet improvements tended to support modest gains, with one dilutive financing showing a contrary positive move.

Recent Company History

Over the past six weeks, FibroBiologics has combined financing activity with platform and balance-sheet developments. Multiple November and December 2025 registered direct offerings and related warrants raised several million dollars but generally weighed on the share price, including moves of -33.06% and -8.44%. In contrast, a new chondrocyte spheroid patent filing on Dec 10 and an announcement of debt payoff and SEPA capacity in late November saw modest to strong gains. Today’s IND filing for CYPS317 adds to this pattern of advancing fibroblast-based programs while managing dilution and listing risk.

Market Pulse Summary

The stock moved -7.0% in the session following this news. A negative reaction despite clinically focused news fits a pattern where financing, dilution and listing risks weigh heavily on sentiment. Earlier offerings around the $0.33 level prompted declines of up to -33.06%, and proxy materials highlight a planned reverse split to address Nasdaq deficiencies. Even with promising CYPS317 animal data and an expanding pipeline, investors may have prioritized balance-sheet risk and potential future equity issuance over long-dated psoriasis trial optionality.

Key Terms

investigational new drug (ind) regulatory

"announced the filing of a Phase 1/2 Investigational New Drug (IND) application"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

allogeneic medical

"an investigational allogeneic fibroblast spheroid-based therapy for the treatment"

Allogeneic describes a process or material involving different individuals of the same species, such as cells, tissues, or organs donated from one person to another. It is important to investors because products or treatments based on allogeneic sources can enable scalable, off-the-shelf solutions, potentially reducing costs and increasing accessibility in healthcare and biotech industries.

monoclonal antibodies medical

"matched or exceeded the therapeutic effects of multiple doses of anti-IL-23 monoclonal antibodies"

Monoclonal antibodies are lab-made proteins designed to bind a single, specific target on cells or viruses, like identical keys cut to fit one lock. They are used as medicines, tests, or targeted delivery tools and can precisely block or mark disease processes. Investors care because they can become high-value drugs with large sales, long patent protection, and binary risks tied to clinical trial results, regulatory approval, manufacturing scale and pricing.

extracellular matrix medical

"combining extracellular matrix signaling with localized and systemic immunomodulation"

A network of proteins and other molecules that sits outside cells and gives tissues their shape, strength and a medium for cells to send signals and move — like the scaffolding and wiring inside a building. Investors care because changes to this matrix play a major role in diseases, wound healing and tissue repair, making it a common target for drugs, medical devices and diagnostics that can drive regulatory decisions and commercial value.

immunomodulation medical

"combining extracellular matrix signaling with localized and systemic immunomodulation"

Immunomodulation is the intentional changing of the immune system’s activity—either ramping it up, calming it down, or redirecting it—to treat disease or prevent harmful reactions. Think of it like adjusting a thermostat for the body’s defenses: the goal is to achieve the right balance so patients heal without excessive inflammation or infection risk. For investors, immunomodulation matters because therapies in this area can address many diseases, carry regulatory and safety considerations, and often determine commercial potential and clinical risk.

autoimmune medical

"Psoriasis is an autoimmune skin disease that affects over eight million adults"

An autoimmune condition is when the body’s natural defense system mistakenly attacks healthy tissues, like a security guard that can’t tell residents from intruders. For investors, autoimmune diseases matter because they create long-term treatment needs, ongoing healthcare costs, and large markets for drugs, diagnostics, and devices; progress or setbacks in therapies, clinical trials, or approvals can strongly affect the value of companies working in this area.

AI-generated analysis. Not financial advice.

HOUSTON, Dec. 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced the filing of a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) 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 positive 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.

Psoriasis is an autoimmune skin disease that affects over eight million adults in the United States alone and can significantly impair quality of life and productivity. Despite advances in biologic treatments, unmet needs remain, particularly in achieving durable responses with favorable safety profiles.

“Filing this IND application with the FDA marks a pivotal transition from preclinical research to clinical development for CYPS317 and advances our goal of achieving IND clearance for all four of our product candidates in 2026,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “Psoriasis affects millions of patients who continue to face challenges with existing therapies. We believe allogeneic fibroblast spheroid-based therapeutics have the potential not only to improve disease outcomes, but also to redefine how chronic inflammatory disorders are treated. This filing underscores our commitment to innovation, clinical rigor, and delivering real impact for patients and clinicians.”

Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics, added: “Our preclinical data suggest that CYPS317 harnesses unique, multi-faceted biological activity, combining extracellular matrix signaling with localized and systemic immunomodulation, which may help restore normal tissue homeostasis in chronic inflammatory conditions such as psoriasis. We are excited to work closely with the FDA as we progress this promising program toward clinical evaluation.”

FibroBiologics continues to develop additional fibroblast-based therapies across a range of chronic disease indications, leveraging its differentiated platform of engineered organoids and native fibroblast spheroids and a broad intellectual property estate.

About FibroBiologics
Based in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 270+ US and internationally issued patents/patents pending across various clinical pathways, including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy and tissue regeneration. For more information, visit www.FibroBiologics.com. For more information, please visit FibroBiologics' website or email FibroBiologics at: info@fibrobiologics.com.

Cautionary Statement Regarding Forward-Looking Statements
This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the scope and strength of the Company’s intellectual property portfolio, the potential indications for FibroBiologics’ programs, the potential clinical benefits of fibroblasts and fibroblast-derived materials, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics’ current and future preclinical studies, clinical trials, and research and development programs, the robustness, progress, and momentum of FibroBiologics’ research and development program, and plans for, and the timing of, regulatory filings. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (b) expectations regarding the initiation, progress and expected results of FibroBiologics’ R&D efforts and preclinical studies; (c) the unpredictable relationship between R&D and preclinical results and clinical study results; (d) the ability of FibroBiologics to successfully prosecute its patent applications, (e) FibroBiologics’ ability to manufacture its product candidates; and (f) FibroBiologics’ ability to conduct clinical trials. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update, or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations.

General Inquiries:
info@fibrobiologics.com

Investor Relations:
Nic Johnson
Russo Partners
(212) 845-4242
fibrobiologicsIR@russopr.com

Media Contact:
Liz Phillips
Russo Partners
(347) 956-7697
Elizabeth.phillips@russopartnersllc.com

FAQ

What did FibroBiologics (FBLG) announce on December 31, 2025 about CYPS317?

FibroBiologics filed a Phase 1/2 IND with the FDA to seek clearance to start clinical trials of CYPS317 for moderate to severe psoriasis.

What preclinical results supported the CYPS317 IND filing by FBLG?

Animal studies showed a single dose of CYPS317 matched or exceeded multiple anti-IL-23 doses and reduced disease recurrence.

Does the CYPS317 IND filing mean FDA approved the therapy for patients?

No. The filing requests FDA review; clearance is required before first-in-human clinical trials can begin.

What regulatory goal did FibroBiologics state for 2026 related to FBLG programs?

The company aims to achieve IND clearance for all four of its product candidates in 2026.

What types of data were included in the CYPS317 IND submission by FBLG?

The submission includes preclinical pharmacology, safety, and manufacturing data supporting mechanism, durability, and safety.