FibroBiologics Completes Site Onboarding for Phase 1/2 Clinical Trial for CYWC628 for the Treatment of Refractory Diabetic Foot Ulcers

Rhea-AI Summary

FibroBiologics (Nasdaq: FBLG) completed onboarding of clinical sites for its Phase 1/2 trial of CYWC628, an allogeneic fibroblast spheroid topical therapy for refractory diabetic foot ulcers.

The prospective, multicenter, open-label study will test low and high doses plus standard of care for up to 12 weeks, with an interim analysis after a predefined cohort completes six weeks. Southern Star Research will manage trial operations across APAC.

Positive

• Completed site onboarding for Phase 1/2 CYWC628 clinical trial
• Interim analysis planned after participants complete six weeks of treatment
• Southern Star Research contracted to manage trial operations with APAC coverage
• Study design includes up to 12 weeks of treatment across dose arms

Negative

• Open-label design may limit blinded efficacy interpretation
• Company may activate additional sites, indicating recruitment uncertainty
• No clinical efficacy or safety outcomes reported yet

News Market Reaction – FBLG

+11.58%

9 alerts

+11.58% News Effect

+16.5% Peak in 24 hr

+$3M Valuation Impact

$30M Market Cap

0.5x Rel. Volume

On the day this news was published, FBLG gained 11.58%, reflecting a significant positive market reaction. Argus tracked a peak move of +16.5% during that session. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $3M to the company's valuation, bringing the market cap to $30M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patent portfolio: 270+ patents Trial phase: Phase 1/2 Treatment duration: Up to 12 weeks +1 more

4 metrics

Patent portfolio 270+ patents Issued and pending across fibroblast technologies

Trial phase Phase 1/2 CYWC628 trial for refractory diabetic foot ulcers

Treatment duration Up to 12 weeks CYWC628 plus standard of care vs. standard of care alone

Interim analysis timing Six weeks After predefined participants complete six weeks of treatment

Market Reality Check

Price: $0.3401 Vol: Volume 910,956 is below t...

normal vol

$0.3401 Last Close

Volume Volume 910,956 is below the 20-day average of 1,269,282, indicating muted trading interest before this update. normal

Technical Shares at $0.3757 are trading below the 200-day MA of $0.49 and sit 75.44% under the 52-week high.

Peers on Argus

Momentum scanner shows only one peer, XCUR, moving with a 5.880000069737434% gai...

1 Up

Momentum scanner shows only one peer, XCUR, moving with a 5.880000069737434% gain and no news. Broader biotech peers show mixed single‑day moves, suggesting this development is more stock‑specific than sector‑driven.

Common Catalyst Another peer, ICU, also reported completion of an FDA enrollment requirement for a safety registry, reflecting multiple clinical-progress headlines in the biotech space.

Previous Clinical trial Reports

2 past events · Latest: Dec 31 (Positive)

Same Type Pattern 2 events

Date	Event	Sentiment	Move	Catalyst
Dec 31	IND filing	Positive	-7.0%	Filed Phase 1/2 IND with FDA to start CYPS317 psoriasis trials.
Nov 20	Trial approval	Positive	-5.8%	Received HREC approval in Australia for CYWC628 DFU Phase 1/2 trial.

Pattern Detected

Prior clinical-trial announcements for CYWC628 and CYPS317 were positive milestones but saw negative next-day price reactions, indicating a pattern of selling into clinical updates.

Recent Company History

Recent history shows FibroBiologics advancing multiple fibroblast-based programs. A Nov 20, 2025 update detailed HREC approval and an Australian Phase 1/2 DFU trial for CYWC628. On Dec 31, 2025, the company filed an FDA Phase 1/2 IND for psoriasis candidate CYPS317. Both clinical-trial news events led to negative 24-hour price reactions, so today’s site-onboarding milestone for CYWC628 continues an execution trend rather than a new strategic shift.

Historical Comparison

-6.4% avg move · Past clinical-trial headlines for FBLG (CYWC628, CYPS317) produced an average next-day move of -6.41...

clinical trial

-6.4%

Average Historical Move clinical trial

Past clinical-trial headlines for FBLG (CYWC628, CYPS317) produced an average next-day move of -6.41%, indicating prior selling pressure on similar updates.

For CYWC628, the company moved from HREC approval and trial setup in Australia to completing site onboarding for the Phase 1/2 DFU study. In parallel, CYPS317 advanced via an FDA Phase 1/2 IND filing for psoriasis, showing steady progression across the fibroblast spheroid pipeline.

Market Pulse Summary

The stock surged +11.6% in the session following this news. A strong positive reaction aligns with F...

Analysis

The stock surged +11.6% in the session following this news. A strong positive reaction aligns with FibroBiologics’ ongoing clinical execution, as CYWC628 advances from regulatory approval to fully onboarded Phase 1/2 sites for refractory diabetic foot ulcers. Historically, prior clinical-trial updates averaged a -6.41% move, so a sharp gain would contrast with past selling pressure. Investors could weigh this against Nasdaq compliance overhang and prior reverse-split approvals when considering sustainability.

Key Terms

phase 1/2, clinical trial, allogeneic, fibroblast spheroid-based therapy, +4 more

8 terms

phase 1/2 medical

"onboarding of the clinical sites has been completed for its Phase 1/2 clinical trial"

Phase 1/2 is a combined early-stage clinical trial that first tests a new drug or treatment for safety and the right dose, then quickly expands to check if it shows any signs of working in patients. For investors, results from a Phase 1/2 study offer an early read on both risk and potential reward—like a prototype test that both confirms a product won’t harm users and suggests whether it could sell—helping guide valuation and development decisions.

clinical trial medical

"Phase 1/2 clinical trial evaluating the safety and efficacy of CYWC628"

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

allogeneic medical

"investigational topically administered allogeneic fibroblast spheroid-based therapy, CYWC628"

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.

fibroblast spheroid-based therapy medical

"allogeneic fibroblast spheroid-based therapy, CYWC628, for the treatment of refractory DFUs"

A cell therapy that uses three-dimensional clusters of fibroblasts—cells that produce connective tissue—designed to repair or regenerate damaged tissue. Think of it like planting a small clump of young builders that work together more effectively than single cells spread around; that coordinated structure can survive better, signal to the body, and speed healing. Investors watch this approach for its potential clinical benefits, manufacturing complexity, regulatory hurdles, and market opportunity in wound care and regenerative medicine.

standard of care (soc) medical

"using either standard of care (SoC) plus a low or high dose of CYWC628, or SoC alone"

The standard of care (SOC) is the set of treatments or procedures currently accepted by medical professionals as the appropriate way to diagnose and manage a particular disease. For investors, SOC matters because new therapies are often measured against it in clinical trials and regulatory reviews — like a current market leader that any new product must outperform to gain adoption, reimbursement, and commercial success.

open label medical

"prospective, multicenter, open label study designed to evaluate the safety"

Open label is a clinical trial design in which both the participants and the researchers know which treatment or intervention is being given. For investors, this matters because knowledge of the treatment can influence reported effects and side effects—like how seeing a product label can change a shopper’s opinion—so open-label results are useful for safety and real-world experience but are generally viewed as less rigorous evidence of effectiveness than blinded studies.

cro technical

"Southern Star Research, a leading full-service Australian CRO with APAC coverage"

CRO stands for Contract Research Organization, a company that helps pharmaceutical and biotech firms manage and carry out clinical trials to test new medicines. For investors, CROs are important because they enable drug companies to develop new treatments more efficiently, potentially accelerating the path to market and affecting the company's growth prospects and success.

multicenter medical

"The clinical trial is a prospective, multicenter, open label study"

A multicenter study or trial is conducted at several independent locations or clinics rather than a single site, so researchers collect data from diverse groups and settings. For investors, multicenter designs matter because they increase the credibility and generalizability of results, reduce the risk that findings are due to one local population or practice, and often speed enrollment — all factors that can affect regulatory outcomes, market confidence and commercial prospects.

AI-generated analysis. Not financial advice.

HOUSTON, March 05, 2026 (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 that onboarding of the clinical sites has been completed for its Phase 1/2 clinical trial evaluating the safety and efficacy of CYWC628 for the treatment of refractory diabetic foot ulcers (DFUs).

The clinical trial is a prospective, multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of FibroBiologics’ investigational topically administered allogeneic fibroblast spheroid-based therapy, CYWC628, for the treatment of refractory DFUs. Participants will receive up to 12 weeks of treatment using either standard of care (SoC) plus a low or high dose of CYWC628, or SoC alone. FibroBiologics has completed site onboarding as outlined in the protocol for the clinical trial but will activate additional sites if needed to support recruitment objectives.

“This clinical trial will assess wound healing outcomes, durability of response, and safety parameters through regular clinical observation, testing, and imaging evaluations. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to assess primary safety and efficacy endpoints,” said Hamid Khoja, Ph.D., Chief Scientific Officer of FibroBiologics.

“Successfully engaging all clinical trial sites is a critical step as we advance towards trial initiation to demonstrate the potential of fibroblast spheroid-based therapies as a major breakthrough in DFU treatment,” said Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics. “With site onboarding complete, our human trial partners are in place and we are now focused on disciplined execution.  We look forward to generating data that can clearly inform how this therapy fits into the future of chronic wound care.”

Southern Star Research, a leading full-service Australian CRO with APAC coverage, is managing all aspects of the CYWC628 trial from start to finish. “The CYWC628 program is an excellent fit for Australia’s ecosystem and Southern Star Research’s expertise in complex early-phase trials. We look forward to generating high-quality data to support FibroBiologics’ innovative fibroblast spheroid therapy for patients with refractory diabetic foot ulcers,” said Lloyd Prescott, CEO of Southern Star Research.

For more information, please visit FibroBiologics' website, email FibroBiologics at info@fibrobiologics.com or follow FibroBiologics on LinkedIn, YouTube, Facebook or X.

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 plans for, and the anticipated timing of the initiation of and results from, FibroBiologics’ clinical trials, and the potential clinical benefits of fibroblasts and fibroblast-derived materials, including being a major breakthrough in DFU treatment. 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) the unpredictable relationship between R&D and preclinical results and clinical study results; (c) the ability of FibroBiologics to successfully prosecute its patent applications, (d) FibroBiologics’ ability to manufacture its product candidates; and (e) 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.

About CYWC628
CYWC628 is an investigational topically administered allogeneic fibroblast cell-based therapy for wound healing. Preclinical data suggest CYWC628 may significantly accelerate wound healing compared to currently available treatments.

FibroBiologics is planning a prospective, multicenter, open-label clinical trial evaluating the safety, tolerability, and efficacy of CYWC628 in treating refractory diabetic foot ulcers with up to 12 weeks of treatment using either standard of care plus a low or high-dose of CYWC628, or standard of care only.

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.

About Southern Star Research
Southern Star Research is a full-service clinical research organization headquartered in Australia, guiding small and mid-sized biotech, pharmaceutical, and medical device companies to confidently navigate complex early-phase clinical development globally. With a strong focus on quality, collaboration, and scientific excellence, Southern Star Research supports trials across a range of therapeutic areas and phases. For more information, email: media@southernstarresearch.com

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 March 5, 2026 about CYWC628?

They announced completion of clinical site onboarding for the Phase 1/2 CYWC628 trial. According to the company, sites are ready and the multicenter, open-label study will test low and high doses plus standard of care for up to 12 weeks.

When will the interim analysis for FibroBiologics' CYWC628 (FBLG) trial occur?

An interim analysis is planned after a predefined number of participants complete six weeks of treatment. According to the company, that analysis will assess primary safety and efficacy endpoints to inform next steps.

Who is managing the CYWC628 clinical trial for FibroBiologics (FBLG)?

Southern Star Research will manage all aspects of the CYWC628 trial from start to finish. According to the company, the CRO provides full-service support with APAC coverage for the program.

What is the design and treatment duration of the CYWC628 trial (FBLG)?

The trial is a prospective, multicenter, open-label Phase 1/2 study with up to 12 weeks of treatment. According to the company, participants will receive standard of care plus low or high dose, or standard of care alone.

Does FibroBiologics (FBLG) report any efficacy data for CYWC628 yet?

No efficacy or safety outcomes were reported at the announcement time. According to the company, data collection and an interim safety/efficacy readout will follow once the predefined cohort reaches six weeks.