FibroBiologics Announces Successful Manufacturing of CYWC628 Drug Product to Support Upcoming Diabetic Foot Ulcer Clinical Trial

FibroBiologics (Nasdaq: FBLG) announced completion of manufacturing the first batch of its proprietary CYWC628 drug product to support planned first‑in‑human trials.

Rhea-AI Summary

FibroBiologics (Nasdaq: FBLG) announced completion of manufacturing the first batch of its proprietary CYWC628 drug product to support planned first‑in‑human trials.

The product was manufactured under FDA CGMP standards and will be released after required safety and quality testing. The company plans a Phase 1/2 diabetic foot ulcer trial in the first half of 2026.

Positive

• First batch manufactured under FDA CGMP
• Phase 1/2 trial planned in H1 2026
• 270+ patents issued and pending supporting platform
• First large-scale CGMP spheroid therapeutic manufacturing

Negative

• Product release pending successful safety and quality testing
• No clinical data yet from CYWC628 in humans
• Trial start not yet confirmed beyond planned timing

Argus Apr 1 session

+0.76% close to close Open Argus

Details

News Market Reaction – FBLG

On Apr 1, the first trading day after this news, FBLG closed 0.76% above the previous close.

Data tracked by StockTitan Argus for the Apr 1 session.

Key Figures

Patent portfolio: 270+ patents issued and pending Planned trial phase: Phase 1/2 Target indication: Diabetic foot ulcers +5 more

Patent portfolio

270+ patents issued and pending

FibroBiologics intellectual property estate

Planned trial phase

Phase 1/2

Upcoming CYWC628 trial in diabetic foot ulcer patients, first half of 2026

Target indication

Diabetic foot ulcers

CYWC628 fibroblast-based therapy target condition

Price change

-42.01%

Move over the last 24 hours prior to this news

52-week range

$2.26 – $30.60

52-week low and high before this announcement

Planned enrollment

120 patients

CYWC628 DFU Phase 1/2 trial in Australia (historical clinical-trial context)

Trial sites

10 Australian sites

CYWC628 DFU Phase 1/2 multicenter design

Treatment duration

Six weeks interim cohort

Interim analysis timing for CYWC628 DFU trial

Previous Clinical trial Reports

3 past events · Latest: Mar 05

Same Type 3 events

1. Mar 05

   Trial site onboarding

   24h Move

   +11.6%

   Completed onboarding of sites for CYWC628 Phase 1/2 DFU trial.

2. Dec 31

   IND filing

   24h Move

   -7.0%

   Filed Phase 1/2 IND for CYPS317 psoriasis fibroblast spheroid therapy.

3. Nov 20

   Regulatory trial approval

   24h Move

   -5.8%

   Received HREC approval in Australia for CYWC628 Phase 1/2 DFU trial.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

good manufacturing practices (cgmp), first-in-human clinical trials, fibroblast-based spheroid therapeutic, cgmp manufacturing, +1 more

5 terms

good manufacturing practices (cgmp) regulatory

"Manufactured in accordance with Food and Drug Administration’s (FDA’s) Good Manufacturing Practices (CGMP)"

Current Good Manufacturing Practices (cGMP) are regulatory standards that require drug, biologic and medical product makers to design, monitor and control manufacturing processes so products are safe, pure and consistently made. For investors, cGMP compliance is like a factory’s quality seal—meeting these rules reduces the risk of product recalls, regulatory fines or production shutdowns that can sharply affect a company’s revenue and reputation.

first-in-human clinical trials medical

"will support upcoming first-in-human clinical trials"

The first-in-human clinical trial is the initial study where an experimental drug or medical device is given to people to check basic safety, how the body processes it, and appropriate dosing; these trials are small and closely monitored. For investors, they are an early high-stakes milestone: clear safety and dosing results can remove major uncertainty and increase a program’s value, while problems can sharply reduce prospects—like a first road test that reveals whether a new product can move forward.

fibroblast-based spheroid therapeutic medical

"CYWC628 is not only the first fibroblast-based spheroid therapeutic candidate"

A fibroblast-based spheroid therapeutic is a medical treatment made from small, three-dimensional clusters of fibroblast cells—the connective-tissue cells that help repair and support the body—grown to act as a living implant or injectable product. Investors should care because these products aim to promote tissue healing or regeneration, but they require complex manufacturing, strict regulatory review, and careful safety and consistency controls, all of which affect development cost, timeline, and commercial scalability.

cgmp manufacturing regulatory

"represents the first large-scale CGMP manufacturing of a spheroid product for therapeutic use"

cGMP manufacturing stands for "current Good Manufacturing Practice" and describes regulated factory processes and quality checks that ensure drugs, biologics, or medical products are made safely, consistently, and to required purity standards. For investors, cGMP compliance matters because it reduces the risk of product recalls, regulatory shutdowns, or approval delays—similar to a restaurant passing health inspections so customers keep coming back and the business can keep operating.

phase 1/2 clinical trial medical

"move forward with our planned Phase 1/2 clinical trial utilizing CYWC628 in DFU patients"

A phase 1/2 clinical trial is an early human study that combines first-in-people safety and dosing checks (phase 1) with an initial look at whether the treatment appears to work (phase 2). Think of it as a short test drive where researchers both confirm the product won’t cause serious harm and gather early signs it could be effective; for investors, successful results reduce risk and can unlock value-creating milestones like larger trials or regulatory discussions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

HOUSTON, March 31, 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 the successful completion of manufacturing of the first batch of FibroBiologics’ proprietary CYWC628 drug product that will support upcoming first-in-human clinical trials. Manufactured in accordance with Food and Drug Administration’s (FDA’s) Good Manufacturing Practices (CGMP), the drug product will be released after it successfully passes all required safety and quality testing.

The CYWC628 fibroblast-based therapy targets diabetic foot ulcers, a condition that affects millions of patients worldwide and currently lacks effective long-term treatment solutions. 

“CYWC628 is not only the first fibroblast-based spheroid therapeutic candidate, its manufacture also represents the first large-scale CGMP manufacturing of a spheroid product for therapeutic use,” said Pete O’Heeron, Founder & Chief Executive Officer of FibroBiologics. “These achievements by our scientific team allow us to move forward with our planned Phase 1/2 clinical trial utilizing CYWC628 in DFU patients in the first half of 2026.”

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 expected research targets and indications of interest, and plans for, and the timing of, clinical trials. 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. When used in this communication, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. 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) FibroBiologics’ ability to manufacture sufficient drug product to conduct the CYWC628 clinical trial; (b) the manufactured drug product passing all required safety and quality testing; (c) risks related to FibroBiologics’ liquidity and its ability to maintain capital resources sufficient to conduct its business; (d) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; and (e) the ability of FibroBiologics to successfully prosecute its patent applications. 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 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. 

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did FibroBiologics (FBLG) announce on March 31, 2026 about CYWC628?

They completed manufacturing the first batch of CYWC628 to support human studies. According to the company, the batch was produced under FDA CGMP and will be released only after required safety and quality testing before clinical use.

When will FibroBiologics start the Phase 1/2 CYWC628 diabetic foot ulcer trial (FBLG)?

The company plans to initiate the Phase 1/2 trial in the first half of 2026. According to the company, manufacturing completion enables the planned trial timeline pending product release after safety and quality testing.

What condition does CYWC628 (FBLG) target and why is it notable?

CYWC628 targets diabetic foot ulcers, a chronic wound with limited long‑term treatments. According to the company, CYWC628 is a fibroblast‑based spheroid therapeutic developed to address this unmet medical need.

Was CYWC628 manufactured to CGMP standards as claimed by FibroBiologics (FBLG)?

Yes, the company reports CYWC628 was manufactured in accordance with FDA CGMP. According to the company, the batch represents the first large‑scale CGMP manufacturing of a spheroid product for therapeutic use.

What are the next steps for CYWC628 before patients can be dosed in the FBLG clinical trial?

The drug product must pass all required safety and quality testing before release. According to the company, successful completion of those tests is required to support initiation of the planned Phase 1/2 trial.