FibroBiologics Inc. (NASDAQ:FBLG) on Monday released the first batch of its CYWC628 drug product to support its Phase 1/2 clinical trial in patients with diabetic foot ulcers (DFUs).
FibroBiologics Advances CYWC628 Toward Clinical Testing In DFUs
The CYWC628 drug product was manufactured in accordance with the U.S. Food and Drug Administration's current Good Manufacturing Practices (cGMP) and has passed all required safety and quality testing, enabling its release for clinical use.
The milestone follows the company's recent completion of manufacturing the first cGMP batch of CYWC628.
FibroBiologics is a clinical-stage biotechnology company focused on developing and commercializing fibroblast cell-based therapies for chronic diseases.
CYWC628 is an investigational fibroblast-based therapy designed to address DFUs.
Company Prepares For Patient Enrollment
The Phase 1/2 clinical trial is evaluating the safety, tolerability, and preliminary efficacy of CYWC628 in patients with DFUs.
Interim results from the study are expected in the third quarter of 2026, with complete and primary safety and efficacy results reported by the end of 2026.
"With the first batch of the CYWC628 drug product released, we are now positioned to begin enrolling patients in our Phase 1/2 DFU trial," said Pete O'Heeron, Founder and CEO of FibroBiologics.
In April, FibroBiologics raised $3 million via 2.27 million shares and warrants to purchase up to 2.272 million shares at a combined price of $1.32. The Warrants have an exercise price of $1.32 per share.
Patent Filing Expands Platform Protection
In December 2025, FibroBiologics submitted a new patent application with the U.S. Patent and Trademark Office (USPTO).
The patent application covers a proprietary fibroblast-derived therapy platform for use in orthopedic and musculoskeletal conditions, including degenerative disc repair, cartilage repair, and joint restoration.
The application, if granted, strengthens the protection for the company's fibroblast technology that leverages fibroblast cells, spheroids, and/or fibroblast-differentiated chondrocyte spheroids to support structural and functional repair in orthopedic tissues.
FBLG Price Action: FibroBiologics shares were down 4.79% at $1.39 during premarket trading on Monday, according to Benzinga Pro. Over the past month, FBLG has gained about 2.2% versus a 9.9% rise in the S&P 500 and is down roughly 71% year-to-date compared to the index's 5.1% gain.
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