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

Rhea-AI Summary

FibroBiologics (Nasdaq:FBLG) completed manufacturing the third batch of its CYWC628 drug product for an ongoing Phase 1/2 clinical trial in diabetic foot ulcer patients. The batch was produced under cGMP and is undergoing safety and quality testing before clinical release.

Upon release, FibroBiologics expects to have enough CYWC628 to complete the trial, with surplus doses for future R&D and reduced short-term cash outlays by avoiding additional vial manufacturing. The company anticipates reporting statistically significant interim data in Q3 2026.

Positive

• Third CYWC628 batch manufactured under cGMP for Phase 1/2 DFU trial
• Expected sufficient CYWC628 supply to complete diabetic foot ulcer clinical trial
• Surplus CYWC628 doses anticipated for future research and development
• Reduced short-term cash outlays by avoiding additional vial manufacturing
• Company targets statistically significant interim DFU trial data in Q3 2026

Negative

• None.

Market reaction after Phase 1/2 clinical trial manufacturing update: FBLG -3.26% in the Jul 7 session

-3.26%

1 alert

-3.26% Session close to close

$4.56M Market Cap

0.0x Rel. Volume

In the Jul 7 session, FBLG declined 3.26%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

Completing a third cGMP batch to fully supply the CYWC628 DFU trial, with interim data targeted for ...

Analysis

Completing a third cGMP batch to fully supply the CYWC628 DFU trial, with interim data targeted for Q3 2026, marks steady operational progress. Prior clinical updates have triggered both rallies and sell‑offs, so upcoming efficacy signals and funding choices remain key watchpoints.

Key Figures

Patent portfolio: 270+ patents Trial phase: Phase 1/2 Manufacturing batches: 3 batches +1 more

4 metrics

Patent portfolio 270+ patents Issued and pending IP cited for fibroblast‑based therapeutics

Trial phase Phase 1/2 CYWC628 clinical trial in diabetic foot ulcers

Manufacturing batches 3 batches Total CYWC628 batches expected to complete DFU trial supply

Interim data timing Q3 2026 Anticipated statistically significant interim DFU trial readout

Previous Clinical trial Reports

5 past events · Latest: Jun 16 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 16	trial dosing update	Positive	-9.3%	Reported first patient dosing and advancing CYWC628 manufacturing for DFU trial.
Jun 03	trial enrollment	Positive	+1.9%	Announced first patients enrolled and dosed in Phase 1/2 DFU trial.
May 04	drug batch release	Positive	-5.5%	Released first cGMP batch of CYWC628 for DFU trial clinical use.
Mar 31	manufacturing update	Positive	+0.8%	Completed first CYWC628 manufacturing batch to support planned DFU trial.
Mar 05	site onboarding	Positive	+11.6%	Completed site onboarding for Phase 1/2 CYWC628 trial in refractory DFU.

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

Pattern Detected

Clinical‑trial updates have drawn mixed reactions, with 3 of 5 similar CYWC628 milestones followed by positive one‑day moves and 2 by notable sell‑offs.

Key Terms

cgmp, phase 1/2, diabetic foot ulcers, interim data

4 terms

cgmp regulatory

"The batch was manufactured in accordance with cGMP standards"

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.

phase 1/2 clinical

"third batch of its CYWC628 drug product for the ongoing 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.

diabetic foot ulcers medical

"Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs)"

A diabetic foot ulcer is an open sore or wound on the foot that occurs when high blood sugar and nerve damage prevent normal healing, much like a small pothole that keeps widening because the road can’t be properly repaired. It matters to investors because these wounds drive demand for treatments, medical devices, wound-care drugs and hospital services, and they carry risks of infection and amputation that can shape healthcare costs, reimbursement decisions and clinical trial opportunities.

interim data clinical

"FibroBiologics anticipates reporting statistically significant interim data in Q3 2026"

Information collected and analyzed from an ongoing study, trial, or financial period before the project is finished. Interim data is like a mid-race snapshot that shows how things are progressing — it can reveal early signs of safety, effectiveness, or performance but is provisional and may change as more data come in, so it often influences investor expectations and market reactions.

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

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Company expects existing supply will suffice to complete clinical trial and lead to cost savings

HOUSTON, July 7, 2026 /PRNewswire/ -- 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 completion of manufacturing of the third batch of its CYWC628 drug product for the ongoing Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs).

The batch was manufactured in accordance with cGMP standards and is undergoing the required safety and quality testing ahead of release for clinical use. Upon release of the third batch, FibroBiologics expects to have sufficient drug product to complete the DFU clinical trial. The healing trend observed during the trial's early phase positions the Company to have surplus doses available for future research and development initiatives. This also translates into meaningful cost savings by eliminating the need for additional vial manufacturing. FibroBiologics anticipates reporting statistically significant interim data in Q3 2026.

"Producing sufficient drug product to complete our DFU clinical trial in only three batches is a significant achievement for the team," said Pete O'Heeron, Founder and CEO of FibroBiologics. "By not having to manufacture additional batches, we expect to reduce short-term cash outlays and experience significant cost savings."

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 complete the DFU clinical trial and support R&D activities, 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, a reduction in short-term cash outlays, and expected cost savings. 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

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SOURCE FibroBiologics, Inc.

FAQ

What did FibroBiologics (Nasdaq:FBLG) announce about CYWC628 on July 7, 2026?

FibroBiologics announced it completed manufacturing the third batch of CYWC628 for its Phase 1/2 diabetic foot ulcer trial. According to FibroBiologics, the batch was made under cGMP and is undergoing safety and quality testing before being released for clinical use.

How does completing the third CYWC628 batch impact the Phase 1/2 diabetic foot ulcer trial for FBLG?

Completing the third CYWC628 batch is expected to provide enough drug to finish the Phase 1/2 diabetic foot ulcer trial. According to FibroBiologics, early healing trends suggest surplus doses may remain, supporting future research and development initiatives without extra manufacturing.

When does FibroBiologics (FBLG) expect interim data from the CYWC628 diabetic foot ulcer trial?

FibroBiologics anticipates reporting statistically significant interim data from the CYWC628 Phase 1/2 diabetic foot ulcer trial in Q3 2026. According to FibroBiologics, this interim readout will follow completion of safety and quality testing on the newly manufactured third drug batch.

What cost savings does FibroBiologics (FBLG) expect from CYWC628 manufacturing for its DFU trial?

FibroBiologics expects meaningful cost savings by completing the DFU trial with only three CYWC628 batches. According to FibroBiologics, avoiding additional vial manufacturing should reduce short-term cash outlays while still providing sufficient and surplus drug product for trial and research needs.

How might surplus CYWC628 doses benefit future FibroBiologics (FBLG) research and development?

Surplus CYWC628 doses from the DFU trial are expected to support future research and development projects. According to FibroBiologics, early healing trends in the trial suggest not all manufactured doses will be needed, allowing remaining vials to be redirected to new R&D initiatives.

What condition is FibroBiologics (FBLG) targeting with CYWC628 in its Phase 1/2 trial?

CYWC628 is being evaluated in a Phase 1/2 clinical trial for patients with diabetic foot ulcers. According to FibroBiologics, the company focuses on developing therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, including this DFU program.