FibroBiologics Releases Third Batch of CYWC628 Drug Product for Phase 1/2 Diabetic Foot Ulcer Clinical Trial

FibroBiologics (Nasdaq: FBLG) announced the release of the third batch of its investigational drug product CYWC628 and its shipment to Australia to support an ongoing Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs).

Rhea-AI Summary

FibroBiologics (Nasdaq: FBLG) announced the release of the third batch of its investigational drug product CYWC628 and its shipment to Australia to support an ongoing Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs). The batch was manufactured under current Good Manufacturing Practices (cGMP) and passed all required safety and quality tests, enabling its use in the trial.

According to FibroBiologics, the additional drug supply will help clinical sites continue the study, which evaluates safety, tolerability and efficacy of CYWC628 as a topical allogeneic fibroblast cell-based therapy for refractory DFUs. The randomized, multicenter trial compares standard of care plus low- or high-dose CYWC628 to standard of care alone over up to 12 weeks of treatment. The company reported encouraging progress to date and anticipates reporting statistically significant interim primary outcome data in the second half of 2026.

Positive

• Third CYWC628 batch released and shipped to Australia for Phase 1/2 DFU trial support
• cGMP manufacturing and quality testing completed, enabling CYWC628 clinical use
• Randomized multicenter Phase 1/2 trial comparing low/high-dose CYWC628 plus standard care vs standard care only
• Interim data readout on primary outcomes anticipated in second half of 2026

Negative

• None.

Argus Aug 27 session 8 alerts

+5.67% close to close 0.9x rel. volume Open Argus

Details

Market move: FBLG +5.67% in the Aug 27 session. Phase 1/2 trial supply

+3.2% Peak in 39 min

$10.09M Mkt Cap at Peak Alert

On Aug 27, the day this news came out, FBLG closed 5.67% above the previous close. Argus tracked a peak move of +3.2% during that session. Our momentum scanner recorded 8 alerts for this stock that day.

Data tracked by StockTitan Argus for the Aug 27 session.

Key Figures

Drug Product Batch: Third batch Trial Phase: Phase 1/2 Treatment Duration: Up to 12 weeks +2 more

Drug Product Batch

Third batch

CYWC628 Phase 1/2 diabetic foot ulcer trial

Trial Phase

Phase 1/2

CYWC628 diabetic foot ulcer clinical trial

Treatment Duration

Up to 12 weeks

CYWC628 clinical trial

Interim Data Timing

Second half of 2026

Anticipated interim primary-outcome data

Patent Portfolio

270+ patents

Issued and pending patents

Previous Clinical trial Reports

5 past events · Latest: Jul 07

Same Type 5 events

1. Jul 07

   Third-batch manufacturing

   24h Move

   -3.3%

   Third CYWC628 batch completed manufacturing ahead of safety and quality testing.

2. Jun 16

   Patient dosing advance

   24h Move

   -9.3%

   Patient dosing advanced while a third GMP run supported ongoing trial supply.

3. Jun 03

   First patients dosed

   24h Move

   +1.9%

   First patients dosed in randomized Phase 1/2 diabetic foot ulcer study.

4. May 04

   Drug product release

   24h Move

   -5.5%

   First cGMP batch released after safety and quality testing for clinical use.

5. Mar 31

   Product manufacturing completed

   24h Move

   +0.8%

   First CYWC628 batch manufactured under CGMP standards for planned first-in-human trials.

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

Key Terms

cgmp, allogeneic, fibroblast cell-based therapy, refractory

4 terms

cgmp regulatory

"The batch was manufactured in accordance with current Good Manufacturing Practices (cGMP)"

cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

allogeneic medical

"an investigational topically administered allogeneic fibroblast cell-based therapy"

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 cell-based therapy medical

"an investigational topically administered allogeneic fibroblast cell-based therapy"

A fibroblast cell-based therapy is a medical treatment that uses living fibroblast cells—connective-tissue cells that make collagen and other structural proteins—to repair, regenerate or replace damaged skin, soft tissue, or organ-support structures. These cells can come from the patient or a donor and are grown and delivered in a controlled way (for example injected or placed into a scaffold). Investors care because such therapies aim at long-lasting biological fixes rather than drugs, so success depends on clinical trial results, manufacturing scale and regulatory approval, similar to how a custom-built repair crew differs from a mass-produced tool.

refractory medical

"treating refractory diabetic foot ulcers with up to 12 weeks of treatment"

Used in medical and clinical contexts, "refractory" describes a disease or condition that does not respond to standard treatments or relapses quickly after initially improving. For investors, that label signals both higher unmet medical need—potentially larger market opportunity for a successful new therapy—and greater clinical and regulatory risk, since treating refractory patients is often harder and requires stronger evidence of benefit.

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, Aug. 27, 2026 /PRNewswire/ -- FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics" or the "Company"), 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 release of the third batch of its CYWC628 drug product and its shipment to Australia in support of the ongoing Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs). The batch was manufactured in accordance with current Good Manufacturing Practices (cGMP) and has successfully passed all required safety and quality testing, enabling its release for clinical use.

"Having this batch released and on its way to Australia means our clinical trial sites will have what they need to continue this important study," said Pete O'Heeron, Founder and CEO of FibroBiologics. "The progress we have observed to date in this study is encouraging, and we anticipate reporting statistically significant interim data of primary outcomes in the second 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.  

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 conducting a prospective, multicenter, randomized 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.

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 sufficiency of drug product to report six-week interim safety and primary efficacy data, plans for, and the anticipated timing of the initiation and completion of, FibroBiologics' clinical trials, plans for, and the timing of, release of clinical trial results, and expectations relating to such clinical trial results. 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) 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; (f) FibroBiologics' ability to conduct clinical trials; and (g) the Company's ability to maintain compliance with applicable Nasdaq rules. 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

View original content to download multimedia:https://www.prnewswire.com/news-releases/fibrobiologics-releases-third-batch-of-cywc628-drug-product-for-phase-12-diabetic-foot-ulcer-clinical-trial-302861783.html

SOURCE FibroBiologics, Inc.

FAQ

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

What did FibroBiologics (Nasdaq: FBLG) announce about CYWC628 on August 27, 2026?

FibroBiologics announced release of the third batch of its CYWC628 drug product and shipment to Australia. According to FibroBiologics, the batch met cGMP standards, passed all safety and quality tests, and will support the ongoing Phase 1/2 diabetic foot ulcer trial.

What is CYWC628 in the FibroBiologics (FBLG) diabetic foot ulcer trial?

CYWC628 is an investigational, topically administered allogeneic fibroblast cell-based therapy for wound healing. According to FibroBiologics, preclinical data suggest CYWC628 may significantly accelerate wound healing compared to current treatments, supporting its evaluation in refractory diabetic foot ulcers.

What is the design of the Phase 1/2 CYWC628 trial for diabetic foot ulcers (FBLG)?

The CYWC628 study is a prospective, multicenter, randomized Phase 1/2 clinical trial in refractory diabetic foot ulcers. According to FibroBiologics, patients receive up to 12 weeks of standard care plus low- or high-dose CYWC628, or standard care alone, to assess safety, tolerability, and efficacy.

When does FibroBiologics (FBLG) expect interim data from the CYWC628 Phase 1/2 trial?

FibroBiologics anticipates reporting interim data on primary outcomes in the second half of 2026. According to FibroBiologics, progress observed so far in the study is encouraging, and the newly released batch helps ensure continued trial conduct.

How does the new CYWC628 batch support FibroBiologics’ diabetic foot ulcer trial (FBLG)?

The new CYWC628 batch provides additional clinical drug supply for Australian trial sites. According to FibroBiologics, successful cGMP manufacturing and testing enable its release for clinical use, ensuring sites have what they need to continue the ongoing Phase 1/2 study.

What conditions is FibroBiologics (FBLG) targeting beyond diabetic foot ulcers?

FibroBiologics is developing fibroblast-based therapies for multiple chronic diseases beyond diabetic foot ulcers. According to FibroBiologics, its patent portfolio spans wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer across various clinical pathways.