FibroBiologics Inc. (NASDAQ:FBLG) on Tuesday said it completed manufacturing of the first batch of FibroBiologics' proprietary CYWC628 drug product that will support upcoming first-in-human clinical trials.

Manufactured in accordance with the 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.

CYWC628 Targets Diabetic Foot Ulcers

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. 

A diabetic foot ulcer is an open sore, typically on the foot sole, affecting up to 15% of diabetics due to nerve damage (neuropathy) and poor circulation.

"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 & CEO of FibroBiologics.

Pipeline Progress And Reverse Stock Split

"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."

Last week, FibroBiologics approved a 1-for-20 reverse stock split, effective today.

In December 2025, FibroBiologics filed 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 moderate to severe psoriasis.

FBLG Stock Price Activity: FibroBiologics shares were down 36.4% at $1.445 at the time of publication on Tuesday, according to Benzinga Pro data.

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